is being presented by Dr. Max Horneck, Head of eClinical Services, with Wega Informatik AG and airs on Thursday, January 19th, 2012. For more details, or to register please visit our site at www.fxconferences.com
There is no question that gathering real-life data on approved drug products is of vital importance. Data collected for marketed drugs is needed to generate thorough knowledge of the safety, efficacy and effectiveness. The challenge for clinical operations arises from significant cost pressure in post-authorization studies, while attempting to maintain an adequate level of quality and achieving study targets. Experience has shown that simply mapping procedures from early to late phase does not give the desired results. Budgets tend to be overstressed while targets and quality remain in danger.
In this audio conference, our speaker draws upon almost two decades of clinical experience and provides insight on how to to effectively maintain control of the study conduct and quality of data with reduced efforts by the use of risk mitigation, regional service providers and business intelligence. This presentation enables the attendees to safely plan and conduct late phase studies at significantly reduced costs while maintaining compliance with current regulations at the desired level of quality.
Thursday, December 15, 2011
Wednesday, December 7, 2011
eLabeling Medical Devices for the EU Market
is being presented by Salma Michor, CEO and Principal Consultant, with Michor Consulting EU and airs on Tuesday, January 10th, 2012. For more details, or to register please visit our site at www.fxconferences.com
Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. Originally e-labeling focused on IVDs, since these are usually used by healthcare professionals in a clinical environment, however, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce amendments pivotal for e-labeling for other devices.
In order to set up an e-labeling system, companies must develop and implement internal controls and procedures that promote adherence to regulatory requirements including applicable statutes, laws, regulations and directives. e-labelling provides several advantages in managing regulatory compliance but also poses some challenges. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling to gain competitive advantage.
Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. Originally e-labeling focused on IVDs, since these are usually used by healthcare professionals in a clinical environment, however, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce amendments pivotal for e-labeling for other devices.
In order to set up an e-labeling system, companies must develop and implement internal controls and procedures that promote adherence to regulatory requirements including applicable statutes, laws, regulations and directives. e-labelling provides several advantages in managing regulatory compliance but also poses some challenges. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling to gain competitive advantage.
Tuesday, December 6, 2011
Best Practices for Successfully Implementing a Global Content Management System
is being presented by Jason Arnsparger, Solutions Development Consultant, with ForeignExchange Translations, Inc. and airs on Thursday, January 12th, 2012. For more details or to register, please visit our site at www.fxconferences.com
Thinking about implementing a content management system? As the demand for technical, training, marketing documentation and product labeling increases, so too does the need to deliver this content more quickly and in more languages. To meet these requirements, many regulated companies are migrating towards structured authoring and content management systems that enable the re-use and re-purposing of existing content.
In this presentation, our speaker draws upon first-hand experience, first with a medical device company and more recently with a localization provider, and discusses tips, challenges, best practices and lessons learned with CMS implementations. Attendees receive valuable insight and hear first-hand how to reap the CMS benefits while minimizing implementation headaches.
Thinking about implementing a content management system? As the demand for technical, training, marketing documentation and product labeling increases, so too does the need to deliver this content more quickly and in more languages. To meet these requirements, many regulated companies are migrating towards structured authoring and content management systems that enable the re-use and re-purposing of existing content.
In this presentation, our speaker draws upon first-hand experience, first with a medical device company and more recently with a localization provider, and discusses tips, challenges, best practices and lessons learned with CMS implementations. Attendees receive valuable insight and hear first-hand how to reap the CMS benefits while minimizing implementation headaches.
Monday, December 5, 2011
Opportunities in the European Regulatory Framework for Orphan Medicinal Products
is being presented by Dr. Maureen Graham, Managing Director, of Diamond BioPharm Limited and airs on Wednesday, January 11th, 2012. For more details, or to register please visit our site at www.fxconferences.com
The orphan drug regulation in Europe came into force over 10 years ago, with the aim of stimulating research and development of medicinal products for rare diseases. Obtaining and maintaining orphan status opens up a number of opportunities to companies developing such products, but it is crucial to have a thorough understanding of the orphan rules in Europe in order to fully benefit from the incentives offered.
This audio conference presentation provides an overview of the legislative framework, and highlights the incentives available. Our speaker focuses on the most important aspects that need to be considered when compiling an application for orphan designation, and how this may impact the development program. Finally, the presentation summarizes both the potential pros and cons will be summarized.
The orphan drug regulation in Europe came into force over 10 years ago, with the aim of stimulating research and development of medicinal products for rare diseases. Obtaining and maintaining orphan status opens up a number of opportunities to companies developing such products, but it is crucial to have a thorough understanding of the orphan rules in Europe in order to fully benefit from the incentives offered.
This audio conference presentation provides an overview of the legislative framework, and highlights the incentives available. Our speaker focuses on the most important aspects that need to be considered when compiling an application for orphan designation, and how this may impact the development program. Finally, the presentation summarizes both the potential pros and cons will be summarized.
Thursday, December 1, 2011
Developing Effective Quality Agreements: Legal and Regulatory Issues
ia being presented by Alan Minsk, Partner, with Arnall Golden Gregory LLP and airs on Wednesday, December 14th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Supplier control has become a major focus area for FDA in recent years, and as such, an area which is seeing heightened enforcement efforts. This represents a significant challenge for medical device and pharmaceutical companies, who need to respond accordingly to ensure their supplier quality agreements will pass muster with FDA. The landscape is changing quickly, and those without the critical regulatory information will be ill-prepared for FDA scrutiny.
In this audio conference presentation, Alan G. Minsk, Partner and Chair of the Food and Drug Practice Team at Arnall Golden Gregory LLP, guides attendees through the critical points and the pitfalls to avoid when drafting quality agreements. The presentation addresses the vital legal and regulatory issues affecting pharmaceutical and medical device manufacturers, leaving attendees better prepared to meet customer and FDA expectations regarding supplier quality.
Supplier control has become a major focus area for FDA in recent years, and as such, an area which is seeing heightened enforcement efforts. This represents a significant challenge for medical device and pharmaceutical companies, who need to respond accordingly to ensure their supplier quality agreements will pass muster with FDA. The landscape is changing quickly, and those without the critical regulatory information will be ill-prepared for FDA scrutiny.
In this audio conference presentation, Alan G. Minsk, Partner and Chair of the Food and Drug Practice Team at Arnall Golden Gregory LLP, guides attendees through the critical points and the pitfalls to avoid when drafting quality agreements. The presentation addresses the vital legal and regulatory issues affecting pharmaceutical and medical device manufacturers, leaving attendees better prepared to meet customer and FDA expectations regarding supplier quality.
Tuesday, November 22, 2011
Risk and Reward – Using Social Media to Promote Medicinal Products in the EU
is being presented by Elisabethann Wright, Hogan Lovells International LLP and airs on Tuesday, December 6th, 2011. For more details, or to register please visit our site at www.fxconferences.com
The Internet provides an ever-growing source of information, both for healthcare professionals and consumers, concerning medicinal products. Although many countries around the world have developed regulations intended to govern the promotion of medicinal products, the very nature of the Internet makes it difficult to police. There are both opportunities and risks for the pharma company engaging in promotion using social media. This audio conference presentation examines the laws currently in place in the European Union governing promotion of medicinal products, and how these apply to promotion on the Internet and, in particular, via social media. Our speaker also examines the risks pharmaceutical companies face when establishing corporate websites and social media accounts.
The Internet provides an ever-growing source of information, both for healthcare professionals and consumers, concerning medicinal products. Although many countries around the world have developed regulations intended to govern the promotion of medicinal products, the very nature of the Internet makes it difficult to police. There are both opportunities and risks for the pharma company engaging in promotion using social media. This audio conference presentation examines the laws currently in place in the European Union governing promotion of medicinal products, and how these apply to promotion on the Internet and, in particular, via social media. Our speaker also examines the risks pharmaceutical companies face when establishing corporate websites and social media accounts.
Monday, November 21, 2011
Best Approaches for Your 510(k) Submission
is being presented by F. David Rothkopf, President, of MEDIcept and airs on Tuesday, November 22nd, 2011. For more details or to register, please visit our site at www.fxconferences.com
There has been a lot of news lately – both positive and negative – about the FDA’s 510(k) medical device clearance process. FDA, Congress, and many third parties are reviewing the process for efficiency and effectiveness. The FDA has hired many new reviewers, but training has been slow. They have released new guidance documents relating to 510(k) submission components, but they are radically different than the previous interpretation of the requirements.
The result of all this change has been that review times have increased by 65 percent since 2005, and the number of reject decisions – not substantially equivalent, NSE determinations – increased from a historic level of 3.5 percent to 8 percent of 510(k) submissions during the 2010 fiscal year.
This is the new normal. Even if you sent in a submission two years ago, it might not be acceptable now. So what exactly does FDA want to see in your 510(k) submission, and how do medical device manufacturers cope with this new reality?
There has been a lot of news lately – both positive and negative – about the FDA’s 510(k) medical device clearance process. FDA, Congress, and many third parties are reviewing the process for efficiency and effectiveness. The FDA has hired many new reviewers, but training has been slow. They have released new guidance documents relating to 510(k) submission components, but they are radically different than the previous interpretation of the requirements.
The result of all this change has been that review times have increased by 65 percent since 2005, and the number of reject decisions – not substantially equivalent, NSE determinations – increased from a historic level of 3.5 percent to 8 percent of 510(k) submissions during the 2010 fiscal year.
This is the new normal. Even if you sent in a submission two years ago, it might not be acceptable now. So what exactly does FDA want to see in your 510(k) submission, and how do medical device manufacturers cope with this new reality?
Friday, November 18, 2011
Clinical Evaluation of Medical Devices in the EU
is being presented by Anthony L. Fitzhugh, M.D., Project Manager/Lead Auditor, with TUV SUD America Inc and airs on Thursday, December 8th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Annex X of the Medical Device Directive (EC Directive 93/42/EEC) requires that a manufacturer who seeks to place a medical device on the market in the EU first conduct and document in the technical file/design dossier a clinical evaluation that fully evaluates the safety and efficacy of the device. An amendment (2007/47/EEC) to the Medical Device Directive—published in 2007— has made this requirement even more stringent than in the recent past. The clinical evaluation must now be documented in such a manner that this section of the file comprises a standalone document. Moreover, all manufacturers must actively maintain their compliance with the aforementioned clinical requirements as well as post-market clinical follow-up—unless it can be shown to be not necessary.
As a result of these changes, those working in regulatory affairs must ensure that they have the proper expertise and strategy in place to allow their company to comply with these requirements prior to and after placement of their medical device on the EU market. This audio conference presentation covers the EU regulatory framework for meeting the revised clinical requirements, as well as strategies for maintaining the clinical data section of the technical file or design dossier.
Annex X of the Medical Device Directive (EC Directive 93/42/EEC) requires that a manufacturer who seeks to place a medical device on the market in the EU first conduct and document in the technical file/design dossier a clinical evaluation that fully evaluates the safety and efficacy of the device. An amendment (2007/47/EEC) to the Medical Device Directive—published in 2007— has made this requirement even more stringent than in the recent past. The clinical evaluation must now be documented in such a manner that this section of the file comprises a standalone document. Moreover, all manufacturers must actively maintain their compliance with the aforementioned clinical requirements as well as post-market clinical follow-up—unless it can be shown to be not necessary.
As a result of these changes, those working in regulatory affairs must ensure that they have the proper expertise and strategy in place to allow their company to comply with these requirements prior to and after placement of their medical device on the EU market. This audio conference presentation covers the EU regulatory framework for meeting the revised clinical requirements, as well as strategies for maintaining the clinical data section of the technical file or design dossier.
Thursday, November 17, 2011
Optimizing Document Design for More Efficient Translation
is being presented by Amy Maxson, Technical Services Lead, with ForeignExchange Translations and airs on Thursday, December 1st, 2011. For more details, or to register please visit our site at www.fxconferences.com
Product documentation is often designed with little thought to its impact on the translation process. This represents a missed opportunity, since the layout and design of your documentation can have as great an impact on localization cost, turnaround time and quality as the content itself. However, it can be a real headache, trying to fit an ever-increasing number of languages – including double-byte languages – into your Instructions for Use, user manuals, and marketing materials. This audio conference presentation shares best practices and pitfalls to avoid when designing documents that will be translated into other languages. Attendees benefit from the first-hand insight of a veteran localizaton professional discussing how best to create graphics, set margins, select fonts and choose software to get the most out of their translation dollars.
Product documentation is often designed with little thought to its impact on the translation process. This represents a missed opportunity, since the layout and design of your documentation can have as great an impact on localization cost, turnaround time and quality as the content itself. However, it can be a real headache, trying to fit an ever-increasing number of languages – including double-byte languages – into your Instructions for Use, user manuals, and marketing materials. This audio conference presentation shares best practices and pitfalls to avoid when designing documents that will be translated into other languages. Attendees benefit from the first-hand insight of a veteran localizaton professional discussing how best to create graphics, set margins, select fonts and choose software to get the most out of their translation dollars.
Tuesday, November 15, 2011
Dealing With the New FDA: How the Focus is Changing
is being presented by Stephen D. Terman, Principal, Olsson Frank Weeda Terman Matz PC and airs on Thursday, Decemeber 1st, 2011. For more details, or to register please visit our site at www.fxconferences.com
Marketing a medical device in the United States requires complying with myriad Food and Drug Administration (FDA) regulations. Implementing an effective regulatory strategy can be complicated, time consuming and costly – manufacturers need to get it right the first time. For many years, dealing with FDA was fairly predictable. However, these days it is not 'business as usual' at FDA – change is in the air. FDA is under new, ever-changing management and has significantly increased the number of field inspectors. Enforcement actions are on the rise, both domestic and international. FDA has also pledged to “revamp” the 510(k) system. So many changes (and more sure to come) – how do manufacturers deal with the uncertainty?
This audio conference presentation discusses the ongoing changes within FDA, and what that means in terms of enforcement focus. Our speaker reviews the compliance mistakes made most often by device manufacturers, and provides pointers on how best to interact with FDA.
Marketing a medical device in the United States requires complying with myriad Food and Drug Administration (FDA) regulations. Implementing an effective regulatory strategy can be complicated, time consuming and costly – manufacturers need to get it right the first time. For many years, dealing with FDA was fairly predictable. However, these days it is not 'business as usual' at FDA – change is in the air. FDA is under new, ever-changing management and has significantly increased the number of field inspectors. Enforcement actions are on the rise, both domestic and international. FDA has also pledged to “revamp” the 510(k) system. So many changes (and more sure to come) – how do manufacturers deal with the uncertainty?
This audio conference presentation discusses the ongoing changes within FDA, and what that means in terms of enforcement focus. Our speaker reviews the compliance mistakes made most often by device manufacturers, and provides pointers on how best to interact with FDA.
Thursday, November 10, 2011
Re-engineering Procedures to Reduce Human Error
is being presented by Dr. Ginette Collazo, President, of Ginette M. Collazo, Inc. and airs on Wednesday, November 30th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Human error causes more that 80% of operational failures, and reducing human error is obviously a priority for all life sciences companies. Often, these errors are blamed on shortcomings in procedure. But, what is it about the procedures? What is exactly wrong with them? And do we really need all these procedures in the first place?
This audio conference presentation discusses how to identify procedures that need to be improved, and how be sure that re-engineering your procedures will, in the end, help achieve greater human reliability. Our speaker outlines a proven process for addressing procedural issues that might lead to human error, including areas such as diagnosis, document hierarchy, needs assessment, best practices, predictive methodology and typical mistakes when writing procedures.
Human error causes more that 80% of operational failures, and reducing human error is obviously a priority for all life sciences companies. Often, these errors are blamed on shortcomings in procedure. But, what is it about the procedures? What is exactly wrong with them? And do we really need all these procedures in the first place?
This audio conference presentation discusses how to identify procedures that need to be improved, and how be sure that re-engineering your procedures will, in the end, help achieve greater human reliability. Our speaker outlines a proven process for addressing procedural issues that might lead to human error, including areas such as diagnosis, document hierarchy, needs assessment, best practices, predictive methodology and typical mistakes when writing procedures.
Wednesday, November 9, 2011
Identifying & Defusing Troublesome Wage & Hour Issues
is being presented by Brian R. Garrison, Attorney, with Baker & Daniels LLP and airs on Tuesday, November 22nd, 2011. For more details or to register, please visit our site at www.fxconferences.com
The Fair Labor Standards Act has become the employment law of choice for many plaintiffs' lawyers, and wage and hour class actions have become the lawsuit du jour for them. Hundreds of these class actions have been filed over the last few years. Wage and hour issues can lead to huge liability and affect employers of all sizes in all industries. This presentation looks at the pay practices and policies that are fueling the flood of class actions. Our speaker discusses common employee classification mistakes and how to properly determine rate of pay. The presentation also reviews the steps you can take to avoid litigation stemming from wage & hour issues, and how to self-audit to ensure compliance and identify potential problems.
The Fair Labor Standards Act has become the employment law of choice for many plaintiffs' lawyers, and wage and hour class actions have become the lawsuit du jour for them. Hundreds of these class actions have been filed over the last few years. Wage and hour issues can lead to huge liability and affect employers of all sizes in all industries. This presentation looks at the pay practices and policies that are fueling the flood of class actions. Our speaker discusses common employee classification mistakes and how to properly determine rate of pay. The presentation also reviews the steps you can take to avoid litigation stemming from wage & hour issues, and how to self-audit to ensure compliance and identify potential problems.
Monday, November 7, 2011
Food Advertising & Labeling Substantiation: Responding to Heightened Enforcement Risks
is being presented by Bruce A. Silverglade, JD, Principal, with OFW Law PC and airs on Thursday, November 17th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Food and beverage companies making health benefit claims in their product advertising and labeling have been coming under increased scrutiny, and facing heightened regulatory and enforcement risks.
This audio conference presentation explores the implications of new FTC and FDA compliance standards, and discusses how to minimize exposure to these increased enforcement activities. Attendees also learn how federal actions can lead to class action lawsuits against food and beverage companies at the state level, and the steps that can be taken in advance to mitigate the risk.
Food and beverage companies making health benefit claims in their product advertising and labeling have been coming under increased scrutiny, and facing heightened regulatory and enforcement risks.
This audio conference presentation explores the implications of new FTC and FDA compliance standards, and discusses how to minimize exposure to these increased enforcement activities. Attendees also learn how federal actions can lead to class action lawsuits against food and beverage companies at the state level, and the steps that can be taken in advance to mitigate the risk.
Friday, November 4, 2011
Advanced Human Factors Engineering
is being presented by Maria Shepherd, Principal, with Data Decision Group and airs on Thursday, November 17th, 2011. For more details or to register, please visit our site at www.fxconferences.com
FDA's expectations are changing. Medical manufacturers are required by FDA and other global regulatory bodies to prove that human factors considerations have been met during product design and development. FDA takes these human factors requirements seriously, requiring that the manufacturer perform a systematic assessment of the intended user(s), how the device will be used, the environment in which it will be used, and existing use-related hazards.
This audio conference presentation reviews guidance documents issued by FDA regarding its human factors initiative. The speaker also presents several examples of a human factors engineering project, including templates that have been designed to assist in the process of usability testing in the medical industry.
FDA's expectations are changing. Medical manufacturers are required by FDA and other global regulatory bodies to prove that human factors considerations have been met during product design and development. FDA takes these human factors requirements seriously, requiring that the manufacturer perform a systematic assessment of the intended user(s), how the device will be used, the environment in which it will be used, and existing use-related hazards.
This audio conference presentation reviews guidance documents issued by FDA regarding its human factors initiative. The speaker also presents several examples of a human factors engineering project, including templates that have been designed to assist in the process of usability testing in the medical industry.
Thursday, November 3, 2011
Avoiding Liability from Employee Social Media Use
is being presented by Todd Wulffson, Employment Counsel, with Greenberg Traurig, LLP and airs on Wednesday, November 16th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Social Media has become a true cultural phenomenon. Companies of all sizes are taking advantage of social media to market their goods and services and expand their revenue base. However, social media also brings with it new, and in many cases, unknown liability issues. Companies are being held accountable for the activity of employees on social media – regardless of whether the company is specifically aware of that activity – and FTC guidelines can impose liability for activities by employee endorsers and affiliate marketers if the company does not exercise appropriate supervision. This audio conference presentation is specifically designed to provide HR and in-house counsel with the ability to recognize potential threats and take action proactively before liability arises.
Social Media has become a true cultural phenomenon. Companies of all sizes are taking advantage of social media to market their goods and services and expand their revenue base. However, social media also brings with it new, and in many cases, unknown liability issues. Companies are being held accountable for the activity of employees on social media – regardless of whether the company is specifically aware of that activity – and FTC guidelines can impose liability for activities by employee endorsers and affiliate marketers if the company does not exercise appropriate supervision. This audio conference presentation is specifically designed to provide HR and in-house counsel with the ability to recognize potential threats and take action proactively before liability arises.
Tuesday, November 1, 2011
Conducting Clinical Evaluations to Support Regulatory Approval and Marketing of Medical Devices
is being presented by Janette Benaddi, CEO, of Medvance and airs on Wednesday, November 16th, 2011. For more details, or to register please visit our site at www.fxconferences.com
With the recent amendments to the EU medical devices directive (MDD), there is much more emphasis being placed on the clinical evaluation process, and how this should be appropriately conducted. Indeed, in Europe it is now mandatory to conduct a clinical evaluation for some classes of medical device. In this presentation, our speaker reviews everything you need to know to be able to conduct a systematic literature review/clinical evaluation for your products, and prepare a report that will satisfy your Notified Body.
This audio conference is designed specifically for those involved in gathering clinical evidence and conducting clinical evaluations to support the regulatory approval and marketing of medical devices. It should be of particular interest to those involved in collating clinical evidence, including regulatory and clinical staff conducting literature reviews/clinical evaluations. It will also be of use to staff working in quality departments and research and development departments.
With the recent amendments to the EU medical devices directive (MDD), there is much more emphasis being placed on the clinical evaluation process, and how this should be appropriately conducted. Indeed, in Europe it is now mandatory to conduct a clinical evaluation for some classes of medical device. In this presentation, our speaker reviews everything you need to know to be able to conduct a systematic literature review/clinical evaluation for your products, and prepare a report that will satisfy your Notified Body.
This audio conference is designed specifically for those involved in gathering clinical evidence and conducting clinical evaluations to support the regulatory approval and marketing of medical devices. It should be of particular interest to those involved in collating clinical evidence, including regulatory and clinical staff conducting literature reviews/clinical evaluations. It will also be of use to staff working in quality departments and research and development departments.
Tuesday, October 25, 2011
Best Practices for Writing Safety Narratives
is being presented by Dr. Susan Sisk, Principal, with SFP Consulting, LLC and airs on Tuesday, November 15th, 2011. For more details or to register, please visit our site at www.fxconferences.com
As the scrutiny of safety data in marketing applications increases, so too does the importance and number of individual patient narratives. In addition to the customary description of cases for patients who died, those who had serious adverse events, and those who discontinued the trial as a result of an adverse event, narratives for other significant adverse events are also being requested, either at the pre-NDA meeting, or after the application is received (i.e., while the clock is ticking).
Thus, having templates that can accommodate these various events and an efficient process for preparation and review of patient narratives is more important than ever before. In this audio conference presentation, our speaker shares insight and best practices on developing templates and writing and reviewing patient safety narratives.
As the scrutiny of safety data in marketing applications increases, so too does the importance and number of individual patient narratives. In addition to the customary description of cases for patients who died, those who had serious adverse events, and those who discontinued the trial as a result of an adverse event, narratives for other significant adverse events are also being requested, either at the pre-NDA meeting, or after the application is received (i.e., while the clock is ticking).
Thus, having templates that can accommodate these various events and an efficient process for preparation and review of patient narratives is more important than ever before. In this audio conference presentation, our speaker shares insight and best practices on developing templates and writing and reviewing patient safety narratives.
Tuesday, October 18, 2011
Technical Documentation Requirements for Device Approval in the EU
is being presented by Tamas Borsai, Division Manager, MHS - Customer Service and Quality, with TUV SUD America Inc. and airs on Thursday, November 10th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Having a technical file for each medical product is one of the common and very basic requirements in all of the European medical device directives. Creating and maintaining these documents requires the proper expertise and strategy from those working in regulatory affairs for the device manufacturer.
The updated Medical Devices Directive – which became effective in 2009 - requests that Notified Bodies set up sampling programs of the technical files for all of their clients, and so the chance of a detailed review of a file by an auditor is higher than at any time previous.
This audio conference covers the regulatory framework with references to the European directives and guidance documents, possible strategies for setting up the technical file, and includes an illustrative case study.
Having a technical file for each medical product is one of the common and very basic requirements in all of the European medical device directives. Creating and maintaining these documents requires the proper expertise and strategy from those working in regulatory affairs for the device manufacturer.
The updated Medical Devices Directive – which became effective in 2009 - requests that Notified Bodies set up sampling programs of the technical files for all of their clients, and so the chance of a detailed review of a file by an auditor is higher than at any time previous.
This audio conference covers the regulatory framework with references to the European directives and guidance documents, possible strategies for setting up the technical file, and includes an illustrative case study.
Friday, October 14, 2011
EU Guidance on Stand-Alone Software Under the Medical Devices Directive
is being presented by Erik Vollebregt, Partner, with Axon and airs on Tuesday, November 8th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
EU medical devices regulation is very much in flux: the European Commission is working on the text of the recast of the medical devices directive (MDD), and work is underway on a new guidance on stand-alone software under the MDD. In the meantime, medical device companies are producing more software-enabled devices and software that might qualify as medical devices. Clinical institutions and others are developing an increasing number of medical apps and websites with diagnostic and therapeutic functionality. Given these developments, it is vital for companies and institutions to be aware of how these products are regulated, and to determine if and how their software products are regulated.
This audio conference presentation reviews the current EU rules for software related to or incorporated within medical devices, and also sheds light on where these regulations are likely headed in the future. Our speaker also discusses FDA guidance on mobile medical apps, and how it can help guide companies in their efforts in Europe.
EU medical devices regulation is very much in flux: the European Commission is working on the text of the recast of the medical devices directive (MDD), and work is underway on a new guidance on stand-alone software under the MDD. In the meantime, medical device companies are producing more software-enabled devices and software that might qualify as medical devices. Clinical institutions and others are developing an increasing number of medical apps and websites with diagnostic and therapeutic functionality. Given these developments, it is vital for companies and institutions to be aware of how these products are regulated, and to determine if and how their software products are regulated.
This audio conference presentation reviews the current EU rules for software related to or incorporated within medical devices, and also sheds light on where these regulations are likely headed in the future. Our speaker also discusses FDA guidance on mobile medical apps, and how it can help guide companies in their efforts in Europe.
Wednesday, October 12, 2011
Industry Update – European Human Tissues Regulation
is being presented by Richard van der Linden, Senior Consultant, with Signifix and airs on Tuesday, November 8th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Since the gradual implementation of the Human Tissues and Cells Directive 2004/23/EC (EUTCD) in the European Union, industry and hospitals now know the minimal safety and quality requirements for products made from human tissues and cells. The EUTCD’s transposition defines a framework defining Tissue Establishments (TE) – which can be profit or non-profit organizations – as centers via which the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells is regulated. Within the Tissue Establishment, the Responsible Person (RP) is responsible for safeguarding the safety and quality of the human tissues and cells.
In addition, a number of EU member states have put in place their own country-specific requirements on donor tissues and cells, which sometimes runs contrary to “free movement of tissues and cells” between member states, and puts constraints on acceptability of tissue and cell donors and the routes via which a tissue or cell product can cross borders.
This audio conference addresses the implications of transposition of the EUTCD in the different member states, reviews the definitions of TE and RP, and provides an update for attendees on the extra country-specific requirements added by individual member states.
Since the gradual implementation of the Human Tissues and Cells Directive 2004/23/EC (EUTCD) in the European Union, industry and hospitals now know the minimal safety and quality requirements for products made from human tissues and cells. The EUTCD’s transposition defines a framework defining Tissue Establishments (TE) – which can be profit or non-profit organizations – as centers via which the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells is regulated. Within the Tissue Establishment, the Responsible Person (RP) is responsible for safeguarding the safety and quality of the human tissues and cells.
In addition, a number of EU member states have put in place their own country-specific requirements on donor tissues and cells, which sometimes runs contrary to “free movement of tissues and cells” between member states, and puts constraints on acceptability of tissue and cell donors and the routes via which a tissue or cell product can cross borders.
This audio conference addresses the implications of transposition of the EUTCD in the different member states, reviews the definitions of TE and RP, and provides an update for attendees on the extra country-specific requirements added by individual member states.
Friday, October 7, 2011
FDA Imports: How to Deal with Holds, Detentions and Refusals
is being presented by Kyle Sampson, Partner, with Hunton & Williams LLP and airs on Thursday, November 3rd, 2011. For more details, or to register please visit our site at www.fxconferences.com
The FDA may detain and ultimately refuse the admission of food, drugs, devices and cosmetics offered for import if the products “appear” to violate regulatory requirements. FDA also may subject products, manufacturers, and countries to “detention without physical examination.” These FDA authorities are significant, as 40% of the drugs Americans take are manufactured outside the U.S., and 80% of active pharmaceutical ingredients come from non-U.S. sources. In 2011, more than 24 million shipments of FDA regulated products will be offered for import.
In recent years, lawmakers have pressed FDA to monitor imports more closely, driven by incidents of fatal drug contamination – like the 2008 incident involving the blood thinner Heparin. In response, FDA has launched new enforcement initiatives and increased the number of import holds, detentions and refusals. So how can importers adjust to this new reality? And what should they do if they run afoul of FDA? This audio conference presentation explains FDA’s powers in this area, recommends steps to avoid import problems, and describes how to fight holds, detentions and refusals.
The FDA may detain and ultimately refuse the admission of food, drugs, devices and cosmetics offered for import if the products “appear” to violate regulatory requirements. FDA also may subject products, manufacturers, and countries to “detention without physical examination.” These FDA authorities are significant, as 40% of the drugs Americans take are manufactured outside the U.S., and 80% of active pharmaceutical ingredients come from non-U.S. sources. In 2011, more than 24 million shipments of FDA regulated products will be offered for import.
In recent years, lawmakers have pressed FDA to monitor imports more closely, driven by incidents of fatal drug contamination – like the 2008 incident involving the blood thinner Heparin. In response, FDA has launched new enforcement initiatives and increased the number of import holds, detentions and refusals. So how can importers adjust to this new reality? And what should they do if they run afoul of FDA? This audio conference presentation explains FDA’s powers in this area, recommends steps to avoid import problems, and describes how to fight holds, detentions and refusals.
Tuesday, October 4, 2011
Best Practices for Conducting Ophthalmology Trials
is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Wednesday, November 2nd, 2011. For more details or to register, please visit our site at www.fxconferences.com
There are many challenges facing those who design, set up, and monitor ophthalmology trials. The first is deciding whether to study one eye or both eyes, and to understand the statistical implications of that choice. The next challenge is to understand the many assessments, measurements, and endpoints utilized in ophthalmology trials, and how to standardize their collection over many sites. Finally, monitors need to understand the data they are monitoring, in order to identify adverse trends and improbable values, thereby improving data quality.
In this audio conference, our speaker reviews the common and some not-so-common ophthalmic tests used as outcome measures in clinical trials, giving pointers for monitoring best practices in ophthalmology, and discussing site certification and standardization. The presentation also describes the statistical and study design issues, so that attendees understand how they will impact their decisions about study design and analysis.
There are many challenges facing those who design, set up, and monitor ophthalmology trials. The first is deciding whether to study one eye or both eyes, and to understand the statistical implications of that choice. The next challenge is to understand the many assessments, measurements, and endpoints utilized in ophthalmology trials, and how to standardize their collection over many sites. Finally, monitors need to understand the data they are monitoring, in order to identify adverse trends and improbable values, thereby improving data quality.
In this audio conference, our speaker reviews the common and some not-so-common ophthalmic tests used as outcome measures in clinical trials, giving pointers for monitoring best practices in ophthalmology, and discussing site certification and standardization. The presentation also describes the statistical and study design issues, so that attendees understand how they will impact their decisions about study design and analysis.
Monday, October 3, 2011
Complying with EMA's New Mandatory Requirements for Medicinal Product Information (EVMPD)
is being presented by Dr. Andrew Marr, Managing Director, of Marr Consultancy Limited and airs on Tuesday, Novemeber 1st, 2011. For more details, or to register please visit our site at www.fxconferences.com
The European Medicines Agency (EMA) recently announced that Marketing Authorisation Holders will have to provide medicinal product information for all authorised products in the European Union by July 2, 2012. This means an additional 400,000 records will need to be added to the Eudravigilance Medicinal Product Dictionary in less than 12 months, and information for 100,000 previously submitted products will need to be updated to meet new data and document requirements. This massive undertaking will impact every company with a medicinal product registered in the EU.
EMA has issued a detailed guidance and technical specification for providing this information – both data and product information (labeling) documents. These requirements pose a major challenge for industry to provide quality data on time. This audio conference presentation reviews the information EMA needs – and why – and discusses business process and technical options available to Marketing Authorization Holders, to support provision of data as required to EMA.
The European Medicines Agency (EMA) recently announced that Marketing Authorisation Holders will have to provide medicinal product information for all authorised products in the European Union by July 2, 2012. This means an additional 400,000 records will need to be added to the Eudravigilance Medicinal Product Dictionary in less than 12 months, and information for 100,000 previously submitted products will need to be updated to meet new data and document requirements. This massive undertaking will impact every company with a medicinal product registered in the EU.
EMA has issued a detailed guidance and technical specification for providing this information – both data and product information (labeling) documents. These requirements pose a major challenge for industry to provide quality data on time. This audio conference presentation reviews the information EMA needs – and why – and discusses business process and technical options available to Marketing Authorization Holders, to support provision of data as required to EMA.
Friday, September 30, 2011
Dealing with Language and Culture Issues in Emerging Markets for Clinical Research
is being presented by Faiz Kermani, President, of Global Health Education Foundation and airs on Thursday, October 27th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Emerging markets, such as India, China, Mexico and Brazil have experienced a surge in popularity as locations for outsourced clinical research. A wider availability of patients, low operational costs, and positive patient attitudes towards clinical trials have driven this trend. This has further significance given that these emerging regions are also becoming important markets for new products.
However, in expanding clinical research to these regions, sponsors must be careful not to overlook linguistic and cultural differences among the various patient populations. Language and culture are also important factors in dealing with local regulatory authorities and governmental agencies. It is also imperative that sponsors understand that by extending their reach to emerging regions, there are difficult questions to answer in how best to involve subjects in clinical trials and yet not be seen to be exploiting them. This presentation will summarize key linguistic and cultural themes impacting global clinical research, and suggest best practices for leveraging the opportunities of emerging markets while avoiding the pitfalls.
Emerging markets, such as India, China, Mexico and Brazil have experienced a surge in popularity as locations for outsourced clinical research. A wider availability of patients, low operational costs, and positive patient attitudes towards clinical trials have driven this trend. This has further significance given that these emerging regions are also becoming important markets for new products.
However, in expanding clinical research to these regions, sponsors must be careful not to overlook linguistic and cultural differences among the various patient populations. Language and culture are also important factors in dealing with local regulatory authorities and governmental agencies. It is also imperative that sponsors understand that by extending their reach to emerging regions, there are difficult questions to answer in how best to involve subjects in clinical trials and yet not be seen to be exploiting them. This presentation will summarize key linguistic and cultural themes impacting global clinical research, and suggest best practices for leveraging the opportunities of emerging markets while avoiding the pitfalls.
Tuesday, September 27, 2011
The FDA and Social Media
is being presented by Kelly Savage Day, Senior Associate, with Sedgwick LLP and airs on Wednesday, October 26th, 2011. For more details or to register, please visit our site at www.fxconferences.com
In this brave new world of Twitter, Facebook, LinkedIn and other social media websites, risk and opportunity may be combined. There is no question that social networking represents the emergence of a tremendous marketing and customer education opportunity, but there are also pitfalls for the FDA-regulated company. What happens if you go too far, say too much? Do you need to be concerned about the use of these networking sites by employees?
This audio conference presentation tackles some of the important issues that social media poses for life science companies – the benefits, risks, and mitigating that risk – and provides insight on how to use social media to positively impact your business, without running afoul of regulators.
In this brave new world of Twitter, Facebook, LinkedIn and other social media websites, risk and opportunity may be combined. There is no question that social networking represents the emergence of a tremendous marketing and customer education opportunity, but there are also pitfalls for the FDA-regulated company. What happens if you go too far, say too much? Do you need to be concerned about the use of these networking sites by employees?
This audio conference presentation tackles some of the important issues that social media poses for life science companies – the benefits, risks, and mitigating that risk – and provides insight on how to use social media to positively impact your business, without running afoul of regulators.
Monday, September 19, 2011
Sample Size for Design Verification and Validation
is being presented by Steven Walfish, Statistician, with GE Healthcare and airs on Thursday, October 20th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Design controls are an interrelated set of practices and procedures that are incorporated into the design and development process for medical devices to ensure that the completed design that is transferred to production is appropriate for its intended use. The goal of this presentation is to understand the requirements and statistical techniques involved in the design controls process.
This audio conference looks at the types of requirements that lend themselves to statistics in verification and validation. Our speaker also covers the relationship between risk and sample size. Participants gain a fundamental knowledge for determining sample size in statistical testing, while understanding how variance in the population can impact the sample size necessary to establish objective evidence.
Design controls are an interrelated set of practices and procedures that are incorporated into the design and development process for medical devices to ensure that the completed design that is transferred to production is appropriate for its intended use. The goal of this presentation is to understand the requirements and statistical techniques involved in the design controls process.
This audio conference looks at the types of requirements that lend themselves to statistics in verification and validation. Our speaker also covers the relationship between risk and sample size. Participants gain a fundamental knowledge for determining sample size in statistical testing, while understanding how variance in the population can impact the sample size necessary to establish objective evidence.
Friday, September 16, 2011
Energy Tax Incentives and Prospects for Reform
is being presented by Patrick Bousliman, Senior Policy Advisor, Holland & Knight, LLP and airs on Tuesday, October 18th, 2011. For more details, or to register please visit our site at www.fxconferences.com
What lies in store for the energy industry and its tax treatment? This audio conference presentation looks at energy tax incentives, particularly those for wind and solar power, in the context of growing budget deficits and Super Committee deliberations. Our speaker discusses the prospects for extending the production tax credit (PTC) for wind facilities, as well as the investment tax credit (ITC) for solar projects. The wind credit expires next year, and the industry will push hard for its extension. The solar credit doesn't expire until 2016, but many in the industry are concerned that the ITC will be targeted if incentives for other energy industries - such as oil and gas - are considered for repeal or modification. To that end, the speaker provides insight on deliberations of the Joint Select Committee, also known as the Super Committee, including what, if anything, that 12-person group might agree to. Finally, the presentation addresses options for reform of energy tax expenditures, including proposals to tie these expenditures to a performance standard.
What lies in store for the energy industry and its tax treatment? This audio conference presentation looks at energy tax incentives, particularly those for wind and solar power, in the context of growing budget deficits and Super Committee deliberations. Our speaker discusses the prospects for extending the production tax credit (PTC) for wind facilities, as well as the investment tax credit (ITC) for solar projects. The wind credit expires next year, and the industry will push hard for its extension. The solar credit doesn't expire until 2016, but many in the industry are concerned that the ITC will be targeted if incentives for other energy industries - such as oil and gas - are considered for repeal or modification. To that end, the speaker provides insight on deliberations of the Joint Select Committee, also known as the Super Committee, including what, if anything, that 12-person group might agree to. Finally, the presentation addresses options for reform of energy tax expenditures, including proposals to tie these expenditures to a performance standard.
Thursday, September 15, 2011
Developments, Trends and the Future of Neurological Devices
is being presented by Jessica Swartz, Consultant, with IMS Consulting Group and airs on Thursday, October 13th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
Neurostimulators are becoming increasingly prevalent in the treatment of a number of serious medical conditions, including Parkinson’s disease, epilepsy, depression and chronic pain. As market opportunities expand, companies are seeking ways to differentiate themselves and increase their clinical reach. This audio conference presentation provides an overview of both current and developmental neuorstimulation devices, and discusses the commercial and clinical significance of these therapies.
Our speaker examines how neurostimulation may affect the clinical management of nervous system disorders in the future, and provides strategic insight into the commercial relevance of these therapies. The presentation also discusses similarities and differences between the various devices, as well as potential opportunities within the neurological stimulator market.
Neurostimulators are becoming increasingly prevalent in the treatment of a number of serious medical conditions, including Parkinson’s disease, epilepsy, depression and chronic pain. As market opportunities expand, companies are seeking ways to differentiate themselves and increase their clinical reach. This audio conference presentation provides an overview of both current and developmental neuorstimulation devices, and discusses the commercial and clinical significance of these therapies.
Our speaker examines how neurostimulation may affect the clinical management of nervous system disorders in the future, and provides strategic insight into the commercial relevance of these therapies. The presentation also discusses similarities and differences between the various devices, as well as potential opportunities within the neurological stimulator market.
Wednesday, September 14, 2011
How to Minimize or Eliminate In-country Reviews Without Sacrificing Translation Quality
is being presented by Sonia Monahan, Executive Vice President of Quality Systems, with ForeignExchange Translations and airs on Wednesday, October, 12th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Every day another international labeling project is set up with its highest element of risk smack-dab at the end of the process. Quality validation is extremely important, especially in regulated industries, and validating translation quality is often accomplished by holding in-country reviews. This step typically consists of employees in local offices completing an assessment of the translation quality. The risks of this step are large, and include missed product launches due to delays in completing in-country reviews, and quality errors introduced by non-linguists during reviews.
In a recent survey on linguistic quality, respondents from the medical device industry, translation service providers, and professional language translators were asked, “What is your biggest translation challenge?”. The number-one answer was “in-country reviews”. The top answer to the question “How is quality measured?” was, ironically, “in-country review feedback”. But are in-country reviews an absolute necessity in order to achieve optimal translation quality? This audio conference examines ways to minimize or even remove the in-country review step from the translation cycle, while still adhering to regulatory and corporate requirements for translation validation.
Every day another international labeling project is set up with its highest element of risk smack-dab at the end of the process. Quality validation is extremely important, especially in regulated industries, and validating translation quality is often accomplished by holding in-country reviews. This step typically consists of employees in local offices completing an assessment of the translation quality. The risks of this step are large, and include missed product launches due to delays in completing in-country reviews, and quality errors introduced by non-linguists during reviews.
In a recent survey on linguistic quality, respondents from the medical device industry, translation service providers, and professional language translators were asked, “What is your biggest translation challenge?”. The number-one answer was “in-country reviews”. The top answer to the question “How is quality measured?” was, ironically, “in-country review feedback”. But are in-country reviews an absolute necessity in order to achieve optimal translation quality? This audio conference examines ways to minimize or even remove the in-country review step from the translation cycle, while still adhering to regulatory and corporate requirements for translation validation.
Tuesday, September 13, 2011
EU Regulatory Requirements for Medical Devices Utilizing Tissues of Animal Origin
is being presented by Steve Coppock, MHS Auditor, with TÜV SÜD America, Inc and airs on Tuesday, October 11th, 2011. For more details, or to register please visit our site at www.fxconferences.com
The medical device industry has a long and successful history in the use of tissues of animal origin in the design and manufacture of medical devices. However, with the first appearance in the mid 1990s of a variant form of Creutzfeldt-Jakob Disease (vCJD), a fatal brain disease of humans, as a result of the bovine spongiform encephalopathy (BSE or “mad-cow” disease) epidemic in the UK, regulatory requirements were enacted in the European Community aimed at minimizing the inherent risks associated with the safe use of such devices. This audio conference presentation discusses the risks inherent in devices using tissues of animal origin, and reviews the various European regulatory requirements and guidance documents applicable to such medical devices.
The medical device industry has a long and successful history in the use of tissues of animal origin in the design and manufacture of medical devices. However, with the first appearance in the mid 1990s of a variant form of Creutzfeldt-Jakob Disease (vCJD), a fatal brain disease of humans, as a result of the bovine spongiform encephalopathy (BSE or “mad-cow” disease) epidemic in the UK, regulatory requirements were enacted in the European Community aimed at minimizing the inherent risks associated with the safe use of such devices. This audio conference presentation discusses the risks inherent in devices using tissues of animal origin, and reviews the various European regulatory requirements and guidance documents applicable to such medical devices.
Monday, September 12, 2011
Complying with EU Requirements for Medical Device Software
is being presented by Poul Schmidt-Andersen, Managing Partner, with Danish Medical Devices Consulting and airs on Thursday, September 29th, 2011. For more details, or to register please visit our site at www.fxconferences.com
This audio conference presentation highlights the new European Union requirements for software systems arising from the latest amendments to the Medical Devices Directive (MDD). The presentation focuses on how software should be designed to ensure the repeatability, reliability and performance of systems according to the intended use. Our speaker also addresses how, in the event of a single fault condition in the system, appropriate means can be adopted and documented to show that risk has been eliminated or reduced as far as possible. The presentation also covers how to establish suitable documentation to demonstrate compliance and satisfy Notified Body reviewers.
This audio conference presentation highlights the new European Union requirements for software systems arising from the latest amendments to the Medical Devices Directive (MDD). The presentation focuses on how software should be designed to ensure the repeatability, reliability and performance of systems according to the intended use. Our speaker also addresses how, in the event of a single fault condition in the system, appropriate means can be adopted and documented to show that risk has been eliminated or reduced as far as possible. The presentation also covers how to establish suitable documentation to demonstrate compliance and satisfy Notified Body reviewers.
Wednesday, September 7, 2011
Driving Your Quality System With Effective Management Controls
is being presented by Vinny Sastri, President, of Winovia LLC and airs on Thursday, October 6th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
Over the last five years, management controls made up approximately 15% of all warning letters by subsystem annually. There is a scarcity of information and presentations on management controls even though it is the most important aspect of the quality system. This presentation will detail the importance of management controls in driving a quality organization.
It is up to management to ensure that an effective and sustainable quality system is implemented appropriate to the organization’s products and processes. Management should set the vision, strategy and goals, and this should be communicated to everyone within the organization. Leading by example and focusing on quality are keys to success. This audio conference presentation looks at how effective management controls lead to successful quality-centric and profitable organizations, as our speaker shares organizational best practices in this key area.
Over the last five years, management controls made up approximately 15% of all warning letters by subsystem annually. There is a scarcity of information and presentations on management controls even though it is the most important aspect of the quality system. This presentation will detail the importance of management controls in driving a quality organization.
It is up to management to ensure that an effective and sustainable quality system is implemented appropriate to the organization’s products and processes. Management should set the vision, strategy and goals, and this should be communicated to everyone within the organization. Leading by example and focusing on quality are keys to success. This audio conference presentation looks at how effective management controls lead to successful quality-centric and profitable organizations, as our speaker shares organizational best practices in this key area.
Tuesday, September 6, 2011
Using Short Style Guides to Harmonize Writers and Improve the Quality of Electronic Submissions
is being presented by Dr. Susan Sisk, Principal, with SFP Consulting and airs on Wednesday, October 5th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Many companies have style guides that span over 100 pages and cover everything from the fine points of template use to the details of punctuation preferences. While having these documents is a sign of a well-organized writing group, a smaller, project-specific style sheet of two to 10 pages can be used on large projects that call for cross-departmental work and/or the help of contractors. This miniature version of the style guide can bring disparate groups of writers up to speed quickly and ensure that the most important aspects of the company’s writing style are consistent throughout its documentation. Perhaps most importantly, the critical aspects of template use can be emphasized in this short format to ensure efficient publication of electronic submissions.
In this audio conference, our speaker provides tips and insight on developing and managing the use of short style guides, and how best to use them to improve the quality of your regulatory submissions.
Many companies have style guides that span over 100 pages and cover everything from the fine points of template use to the details of punctuation preferences. While having these documents is a sign of a well-organized writing group, a smaller, project-specific style sheet of two to 10 pages can be used on large projects that call for cross-departmental work and/or the help of contractors. This miniature version of the style guide can bring disparate groups of writers up to speed quickly and ensure that the most important aspects of the company’s writing style are consistent throughout its documentation. Perhaps most importantly, the critical aspects of template use can be emphasized in this short format to ensure efficient publication of electronic submissions.
In this audio conference, our speaker provides tips and insight on developing and managing the use of short style guides, and how best to use them to improve the quality of your regulatory submissions.
Tuesday, August 30, 2011
Clinical Evaluation of Medical Devices in the EU
is being presented by Anthony L. Fitzhugh, M.D., Project Manager/Lead Auditor, with TUV SUD America Inc. and airs on Thursday, September 29th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Annex X of the Medical Device Directive (EC Directive 93/42/EEC) requires that a manufacturer who seeks to place a medical device on the market in the EU first conduct and document in the technical file/design dossier a clinical evaluation that fully evaluates the safety and efficacy of the device. An amendment (2007/47/EEC) to the Medical Device Directive—published in 2007— has made this requirement even more stringent than in the recent past. The clinical evaluation must now be documented in such a manner that this section of the file comprises a standalone document. Moreover, all manufacturers must actively maintain their compliance with the aforementioned clinical requirements as well as post-market clinical follow-up—unless it can be shown to be not necessary.
As a result of these changes, those working in regulatory affairs must ensure that they have the proper expertise and strategy in place to allow their company to comply with these requirements prior to and after placement of their medical device on the EU market. This audio conference presentation covers the EU regulatory framework for meeting the revised clinical requirements, as well as strategies for maintaining the clinical data section of the technical file or design dossier.
Annex X of the Medical Device Directive (EC Directive 93/42/EEC) requires that a manufacturer who seeks to place a medical device on the market in the EU first conduct and document in the technical file/design dossier a clinical evaluation that fully evaluates the safety and efficacy of the device. An amendment (2007/47/EEC) to the Medical Device Directive—published in 2007— has made this requirement even more stringent than in the recent past. The clinical evaluation must now be documented in such a manner that this section of the file comprises a standalone document. Moreover, all manufacturers must actively maintain their compliance with the aforementioned clinical requirements as well as post-market clinical follow-up—unless it can be shown to be not necessary.
As a result of these changes, those working in regulatory affairs must ensure that they have the proper expertise and strategy in place to allow their company to comply with these requirements prior to and after placement of their medical device on the EU market. This audio conference presentation covers the EU regulatory framework for meeting the revised clinical requirements, as well as strategies for maintaining the clinical data section of the technical file or design dossier.
Monday, August 29, 2011
Avoiding FDA 483s, Warning Letters and Recalls with Harmonized Supplier Qualification
is being presented by John Avellanet, Managing Director & Principal, with Cerulean Associates LLC and airs on Tuesday, September 27th, 2011. For more details, or to register please visit our site at www.fxconferences.com
The FDA’s Office of Compliance is reorganizing to better address the challenges of globalization, regulatory harmonization and controlling a global supply chain. Part of FDA’s changes include increased citation of ICH guidance in Warning Letters and FDA Form 483s. And FDA inspectors are now being trained on ICH, GHTF and PIC/S guidelines when it comes to auditing firms for supplier control. Are you ready for the globalized FDA inspector?
This audio conference presentation provides attendees with a roadmap to successfully integrate regulatory harmonization and risk management into supplier selection, qualification, and management. The presentation highlights current FDA inspector thinking and questions to prepare for, along with a review of the hidden risks that companies inadvertently stumble into when transitioning to global supplier qualification and management. Our speaker also walks attendees, step-by-step, through the best practices necessary to implement a successful program that meets the challenges of 21st century global supply chain and current FDA inspector expectations.
The FDA’s Office of Compliance is reorganizing to better address the challenges of globalization, regulatory harmonization and controlling a global supply chain. Part of FDA’s changes include increased citation of ICH guidance in Warning Letters and FDA Form 483s. And FDA inspectors are now being trained on ICH, GHTF and PIC/S guidelines when it comes to auditing firms for supplier control. Are you ready for the globalized FDA inspector?
This audio conference presentation provides attendees with a roadmap to successfully integrate regulatory harmonization and risk management into supplier selection, qualification, and management. The presentation highlights current FDA inspector thinking and questions to prepare for, along with a review of the hidden risks that companies inadvertently stumble into when transitioning to global supplier qualification and management. Our speaker also walks attendees, step-by-step, through the best practices necessary to implement a successful program that meets the challenges of 21st century global supply chain and current FDA inspector expectations.
Friday, August 26, 2011
Customizing and "Right-sizing" Computer Validation
is being presented by Terri Mead, President, of Solutions2Projects, LLC and airs on Thursday, September 22nd, 2011. For more details, or to register please visit our site at www.fxconferences.com
Computer validation isn’t about checking the boxes. It’s about satisfying compliance requirements and meeting business objectives in a productive and useful fashion. Far too often validation resources do not take into consideration why deliverables are generated, and simply say they must be done. Computer validation should not be executed with a cookie-cutter approach, and the thought process and justification should be documented as part of the validation effort.
Computer validation makes sense from a business perspective in that it gives you documented evidence that your computer system is installed, operates and performs per your business requirements. It also gives your organization a control framework and baseline for change management. Approaching computer validation as a value-add to the business to decrease overall costs, rather than just an exercise to ‘check the box’ in a one-size-fits-all validation approach, can satisfy both compliance and corporate objectives.
This audio conference presentation looks at general computer validation approaches in a risk-based world, covering standard procedures that should be in place to support validated systems, and discussing standard computer validation deliverables. Our speaker also reviews when and why deliverables should be generated, where to document when deliverables aren’t generated, and provides real-life examples of computer validation deliverables.
Computer validation isn’t about checking the boxes. It’s about satisfying compliance requirements and meeting business objectives in a productive and useful fashion. Far too often validation resources do not take into consideration why deliverables are generated, and simply say they must be done. Computer validation should not be executed with a cookie-cutter approach, and the thought process and justification should be documented as part of the validation effort.
Computer validation makes sense from a business perspective in that it gives you documented evidence that your computer system is installed, operates and performs per your business requirements. It also gives your organization a control framework and baseline for change management. Approaching computer validation as a value-add to the business to decrease overall costs, rather than just an exercise to ‘check the box’ in a one-size-fits-all validation approach, can satisfy both compliance and corporate objectives.
This audio conference presentation looks at general computer validation approaches in a risk-based world, covering standard procedures that should be in place to support validated systems, and discussing standard computer validation deliverables. Our speaker also reviews when and why deliverables should be generated, where to document when deliverables aren’t generated, and provides real-life examples of computer validation deliverables.
Thursday, August 25, 2011
Budgeting for Translations
is being presented by Jason Heaton, with ForeignExchange Translations, Inc. and airs on Wednesday, September 21st, 2011. For more details, or to register please visit our site at www.fxconferences.com
Do you struggle with budgeting for translations? You’re not alone. Translation used to be an afterthought, a line item tacked onto the bottom of a budget. My, how things have changed... With the flattening world comes an increased need for localized, translated product documentation. In a tough global economy, companies’ upper management are sharpening pencils and paying more attention to translation costs. This means more pressure to find ways to accurately forecast, and budget for, translations.
The trouble is, translation work has many variables that conspire to make budgeting seem like something akin to fortune telling. Project schedules, different language needs and rates, document types and translation memory leveraging are only some of these variables. The key to increasing accuracy in translation budgeting lies in the ability to minimize or lock down the variability to a predictable level.
This audio conference provides an overview of the variables that impact translation budgeting. It offers an insider’s view of how projects are priced at a translation agency and how you can maximize efficiency and work with your providers to keep costs lower and more predictable. Finally, the discussion covers concrete tips on how to create ballpark budgets for your translation projects and extrapolate for quarterly and annual numbers.
Do you struggle with budgeting for translations? You’re not alone. Translation used to be an afterthought, a line item tacked onto the bottom of a budget. My, how things have changed... With the flattening world comes an increased need for localized, translated product documentation. In a tough global economy, companies’ upper management are sharpening pencils and paying more attention to translation costs. This means more pressure to find ways to accurately forecast, and budget for, translations.
The trouble is, translation work has many variables that conspire to make budgeting seem like something akin to fortune telling. Project schedules, different language needs and rates, document types and translation memory leveraging are only some of these variables. The key to increasing accuracy in translation budgeting lies in the ability to minimize or lock down the variability to a predictable level.
This audio conference provides an overview of the variables that impact translation budgeting. It offers an insider’s view of how projects are priced at a translation agency and how you can maximize efficiency and work with your providers to keep costs lower and more predictable. Finally, the discussion covers concrete tips on how to create ballpark budgets for your translation projects and extrapolate for quarterly and annual numbers.
Wednesday, August 24, 2011
CLIA Waiver Submissions – Common Mistakes, Recent Trends and FDA's Plans for the Future
is being presented by Dr. Gail E. Radcliffe, President, of Radcliffe Consulting and airs on Tuesday, September 20th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
Rapid test results in point-of-care settings enable clinicians to act immediately with appropriate treatment. However, personnel conducting these tests are not trained as laboratory technicians, so FDA requires demonstration – via submission of a CLIA Waiver – that these tests are simple and have a low risk of reporting erroneous results. In this audio conference presentation, our speaker provides insight on what should be included in a CLIA Waiver, and what sorts of tests qualify for this treatment. The presentation also reviews the most common mistakes made by diagnostics companies in their CLIA Waiver submissions, and takes a look at some recent trends and FDA's future goals in this area.
Rapid test results in point-of-care settings enable clinicians to act immediately with appropriate treatment. However, personnel conducting these tests are not trained as laboratory technicians, so FDA requires demonstration – via submission of a CLIA Waiver – that these tests are simple and have a low risk of reporting erroneous results. In this audio conference presentation, our speaker provides insight on what should be included in a CLIA Waiver, and what sorts of tests qualify for this treatment. The presentation also reviews the most common mistakes made by diagnostics companies in their CLIA Waiver submissions, and takes a look at some recent trends and FDA's future goals in this area.
Tuesday, August 23, 2011
Finding the Optimal Regulatory Pathway for Your Combination Product
is being presented by Suzanne O'Shea, Of Counsel, with Baker & Daniels, LLP and airs on Thursday, September 15th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Some view combination products as double the burden, but they also represent an opportunity for creativity and flexibility. And within the complexities of combination products, it is still possible to tailor a regulatory pathway that best meets your specific needs.
This audio conference presentation discusses marketing applications, how many are required and how many would best serve your needs. It also looks at whether the device component of a drug – device combination product can serve as a barrier to generic drug market entry. Our speaker also addresses the issue of cross labeling -- what is it? Is it still a possibility? The presentation explores the flurry of recent guidance documents on companion diagnostics, chemical action, and classifying products as drugs or devices. Do they help or hinder? The presentation provides attendees with a solid understanding of these topics, the possibilities arising from combination product innovations, and the current regulatory environment.
Some view combination products as double the burden, but they also represent an opportunity for creativity and flexibility. And within the complexities of combination products, it is still possible to tailor a regulatory pathway that best meets your specific needs.
This audio conference presentation discusses marketing applications, how many are required and how many would best serve your needs. It also looks at whether the device component of a drug – device combination product can serve as a barrier to generic drug market entry. Our speaker also addresses the issue of cross labeling -- what is it? Is it still a possibility? The presentation explores the flurry of recent guidance documents on companion diagnostics, chemical action, and classifying products as drugs or devices. Do they help or hinder? The presentation provides attendees with a solid understanding of these topics, the possibilities arising from combination product innovations, and the current regulatory environment.
Monday, August 22, 2011
Cleaning Validation: Reducing Downtime with Compliance
is being presented by Todd Arney, Principle Consultant, with Technical & Quality Services, LLC and airs on Wednesday, September 14th, 2011. For more details or to register, please visit our site at www.fxconferences.com
This audio conference presentation provides attendees with the latest information on industry standards for cleaning and cleaning validation, as well as a discussion of the current regulatory requirements and FDA guidance on the subject. Our speaker shares his wealth of experience and insight on the impact of cleaning and cleaning validation on turnover time, and how it affects overall capacity in the operating environment. Attendees learn how to implement a robust cleaning and cleaning validation program "brick by brick" in their own facilities, including cleaning procedure design, limits and matrix approach, troubleshooting failure, and presenting validation documents to regulators.
This audio conference presentation provides attendees with the latest information on industry standards for cleaning and cleaning validation, as well as a discussion of the current regulatory requirements and FDA guidance on the subject. Our speaker shares his wealth of experience and insight on the impact of cleaning and cleaning validation on turnover time, and how it affects overall capacity in the operating environment. Attendees learn how to implement a robust cleaning and cleaning validation program "brick by brick" in their own facilities, including cleaning procedure design, limits and matrix approach, troubleshooting failure, and presenting validation documents to regulators.
Thursday, August 18, 2011
In-Vitro Diagnostics: Testing Times
is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Thursday, September 8th, 2011. For more details or to register, please visit our site at www.fxconferences.com
The regulations relating to the testing of new in-vitro diagnostic tests are not always clear. There are various regulations that require compliance: the In-Vitro Diagnostics Directive in the EU, ISO standards, and the US regulations. There is the added complexity of CLIA waivers in the US for those IVDs designed to be used outside the laboratory setting.
In this audio conference, the speaker will describe and review the regulations that govern the testing and approval of new in-vitro diagnostics in the EU and USA. Performance testing and CLIA waiver studies will be included. The aim is to clarify the requirements and assist in the design of any clinical testing that may be required.
The regulations relating to the testing of new in-vitro diagnostic tests are not always clear. There are various regulations that require compliance: the In-Vitro Diagnostics Directive in the EU, ISO standards, and the US regulations. There is the added complexity of CLIA waivers in the US for those IVDs designed to be used outside the laboratory setting.
In this audio conference, the speaker will describe and review the regulations that govern the testing and approval of new in-vitro diagnostics in the EU and USA. Performance testing and CLIA waiver studies will be included. The aim is to clarify the requirements and assist in the design of any clinical testing that may be required.
Wednesday, August 17, 2011
FDA and FTC Enforcement of Health and Structure/Function Claims
is being presented by Mark Mansour & Emily K. Strunk, Partner & Associate, with Akin Gump Strauss Hauer & Feld, LLP and airs on Wednesday, September 14th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Are berries "super food"? Does green tea protect against cancer? Can whole grains lower your cholesterol? And even if they do, can you say that on your food labels and advertising?
Health claims and structure/function claims for food and dietary supplement products are jointly regulated by the Food and Drug Administration (FDA) and Federal Trade Commission (FTC). As food labeling and marketing professionals get more creative in an effort to distinguish their products in a crowded marketplace and appeal to the increasingly health-conscious consumer, FDA and FTC have stepped up enforcement efforts to ensure that consumers are getting accurate information. Bad actors should beware, but even companies with the best intentions can land in hot water if claims are not properly vetted. Sometimes just a word can make the difference between a claim that violates the law and one that complies.
This audio conference provides attendees with an overview of FDA and FTC authority to regulate health and structure/function claims, a discussion of the current regulatory and enforcement climate including pending policy changes, and some tips on how food and supplement companies can avoid enforcement action.
Are berries "super food"? Does green tea protect against cancer? Can whole grains lower your cholesterol? And even if they do, can you say that on your food labels and advertising?
Health claims and structure/function claims for food and dietary supplement products are jointly regulated by the Food and Drug Administration (FDA) and Federal Trade Commission (FTC). As food labeling and marketing professionals get more creative in an effort to distinguish their products in a crowded marketplace and appeal to the increasingly health-conscious consumer, FDA and FTC have stepped up enforcement efforts to ensure that consumers are getting accurate information. Bad actors should beware, but even companies with the best intentions can land in hot water if claims are not properly vetted. Sometimes just a word can make the difference between a claim that violates the law and one that complies.
This audio conference provides attendees with an overview of FDA and FTC authority to regulate health and structure/function claims, a discussion of the current regulatory and enforcement climate including pending policy changes, and some tips on how food and supplement companies can avoid enforcement action.
Tuesday, August 16, 2011
Conducting Medical Device Studies Under the Revised ISO 14155
is being presented by Janette Benaddi, CEO, with Medvance and airs on Tuesday, September 13th, 2011. For more details or to register, please visit our site at www.fxconferences.com
The ISO 14155 standard was revised earlier this year and has been introduced in many countries as the standard to support the conduct of medical device clinical investigations. This audio conference presentation provides an in-depth review of the standard, and discusses how it should be implemented and utilized to conduct medical device studies.
In addition, our speaker goes beyond just looking at the standard, and provides attendees with guidance and insight on how to conduct a medical device clinical investigation – what documents to produce, what details to provide, and how to set up, manage, monitor and complete a medical device clinical investigation.
The ISO 14155 standard was revised earlier this year and has been introduced in many countries as the standard to support the conduct of medical device clinical investigations. This audio conference presentation provides an in-depth review of the standard, and discusses how it should be implemented and utilized to conduct medical device studies.
In addition, our speaker goes beyond just looking at the standard, and provides attendees with guidance and insight on how to conduct a medical device clinical investigation – what documents to produce, what details to provide, and how to set up, manage, monitor and complete a medical device clinical investigation.
Friday, August 12, 2011
Writing for a Global Audience
is being presented by Sonja Jacobsen, Manager of Project Services, with ForeignExchange Translations and airs on Thursday, September 8th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Ideally, developing content for a global audience takes into account translation considerations during the English authoring phase. However, translation and localization issues in the source material often only come to light during translation. This generally means a longer and most likely a costlier translation phase than most companies had anticipated, and can sometimes necessitate changes to the source content after it has already been released.
This audio conference presentation is designed to provide attendees with insight and guidance on how to author and structure English content which is targeting a global audience. Rather than simply providing an exhaustive list of do’s and don’ts in writing, the speaker seeks to explain and provide possible solutions to some of the translation challenges posed by US/English-centric content.
Ideally, developing content for a global audience takes into account translation considerations during the English authoring phase. However, translation and localization issues in the source material often only come to light during translation. This generally means a longer and most likely a costlier translation phase than most companies had anticipated, and can sometimes necessitate changes to the source content after it has already been released.
This audio conference presentation is designed to provide attendees with insight and guidance on how to author and structure English content which is targeting a global audience. Rather than simply providing an exhaustive list of do’s and don’ts in writing, the speaker seeks to explain and provide possible solutions to some of the translation challenges posed by US/English-centric content.
Wednesday, August 10, 2011
Government Enforcement on Medical Affairs and Commercial-Related Activities
is being presented by Jamie L. Kendall, Esq., Sr. Director, with Compliance Implementation Services, LLC and airs on Wednesday, September 7th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Corporate Integrity Agreements (CIAs) serve as intelligible “tea leaves” as the government’s focus on commercial-related activities continues to lead to medical affairs activity scrutiny. Who would have thought that CIAs executed over the past several years related to commercial activities should be construed as putting the pharmaceutical industry on notice that the government would be shifting its focus to include medical and scientific affairs activities? As the rise of recent off-label investigations and subsequent CIAs continue to become public, it is clear from CIA provisions that the government will be heavily scrutinizing medical affairs departmental activities.
Recent trends within the industry provide for a period of unprecedented change. The increase in high-profile government investigations leaves little room for mistakes within the medical and scientific affairs arena, as well as within the pharmaceutical industry in general. As CIA provisions serve as “tea leaves,” all companies within the industry are on notice that proper proactive compliance initiatives across all business units are essential.
This presentation provides attendees with an in-depth look at the government’s enforcement focus on medical affairs activities through settlements and CIA provisions, offers a commercial and medical affairs activity overlap discussion, best practices, and a discussion around off-label marketing and the evolving role of the medical science liaison.
Corporate Integrity Agreements (CIAs) serve as intelligible “tea leaves” as the government’s focus on commercial-related activities continues to lead to medical affairs activity scrutiny. Who would have thought that CIAs executed over the past several years related to commercial activities should be construed as putting the pharmaceutical industry on notice that the government would be shifting its focus to include medical and scientific affairs activities? As the rise of recent off-label investigations and subsequent CIAs continue to become public, it is clear from CIA provisions that the government will be heavily scrutinizing medical affairs departmental activities.
Recent trends within the industry provide for a period of unprecedented change. The increase in high-profile government investigations leaves little room for mistakes within the medical and scientific affairs arena, as well as within the pharmaceutical industry in general. As CIA provisions serve as “tea leaves,” all companies within the industry are on notice that proper proactive compliance initiatives across all business units are essential.
This presentation provides attendees with an in-depth look at the government’s enforcement focus on medical affairs activities through settlements and CIA provisions, offers a commercial and medical affairs activity overlap discussion, best practices, and a discussion around off-label marketing and the evolving role of the medical science liaison.
Tuesday, August 9, 2011
Best Practices for Managing In-Country Translation Reviews
is being presented by Andres Heuberger, President, of ForeignExchange Translations, Inc. and airs on Wednesday, August 31st, 2011. For more details on this event or to register, please visit our site at www.fxconferences.com
It's challenging enough for manufacturers to deal with evolving EU regulations, never mind that your head is spinning from coordinating the reviews of multiple translated components in numerous countries!
Internal politics, miscommunication across time zones, and vacation schedules can make translation reviews an expensive and time-consuming process. Rather than shifting responsibility overseas or skipping reviews altogether, attend this advanced audio conference.
With proper planning, open communication, and strong vendor relationships, it is possible to reduce turnaround time, keep translation costs manageable and even avoid a few headaches. This presentation shows you how.
It's challenging enough for manufacturers to deal with evolving EU regulations, never mind that your head is spinning from coordinating the reviews of multiple translated components in numerous countries!
Internal politics, miscommunication across time zones, and vacation schedules can make translation reviews an expensive and time-consuming process. Rather than shifting responsibility overseas or skipping reviews altogether, attend this advanced audio conference.
With proper planning, open communication, and strong vendor relationships, it is possible to reduce turnaround time, keep translation costs manageable and even avoid a few headaches. This presentation shows you how.
Monday, August 8, 2011
Jagged Little Pill: Are Innovators Liable for Generic Drug Manufacturers' Failure to Warn?
is being presented by Kelly Savage Day & Mike Healy, Senior Associate & Partner, with Sedgwick LLP an airs on Tuesday, August 30th, 2011. For more details or to register, please visit our site at www.fxconferences.com
The Supreme Court recently held that federal labeling laws preempt state failure-to-warn claims brought against manufacturers of generic drugs. While the 5-4 decision marks a significant win for generic companies, many innovators are concerned that the Court’s ruling may adversely affect their business by making it more likely that other courts will adopt the holding set forth in California’s Conte v. Wyeth decision. Under Conte, brand-name manufacturers may be liable for injuries suffered by those plaintiffs who take a generic version of their brand-name drug.
This audio conference examines the potential legal risks innovators face, and offers concrete suggestions for proactively mitigating these risks. The presentation focuses on the current status of the law concerning innovator-generic liability, featuring speakers with first-hand experience in this litigation and the industry-shaking issues it raises.
The Supreme Court recently held that federal labeling laws preempt state failure-to-warn claims brought against manufacturers of generic drugs. While the 5-4 decision marks a significant win for generic companies, many innovators are concerned that the Court’s ruling may adversely affect their business by making it more likely that other courts will adopt the holding set forth in California’s Conte v. Wyeth decision. Under Conte, brand-name manufacturers may be liable for injuries suffered by those plaintiffs who take a generic version of their brand-name drug.
This audio conference examines the potential legal risks innovators face, and offers concrete suggestions for proactively mitigating these risks. The presentation focuses on the current status of the law concerning innovator-generic liability, featuring speakers with first-hand experience in this litigation and the industry-shaking issues it raises.
Thursday, July 21, 2011
Optimizing Data Displays for Safety Messaging
is being presented by Dr. Susan Sisk, Principal, SFP Consulting, LLC and airs on Thursday, August 25th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Many times, tables and listings used for preparing clinical study reports, integrated summaries, and other clinical documents are designed without closely considering how these data displays will be used by the writer and review team to expedite document preparation and support messages about healthcare products. For example, does placebo come first on your tables and, if so, does that mean placebo is first in the text, or are you more interested in the test drug, mentioning placebo in context as a comparator? Or, have you ever written narratives from listings that required you to look up information in dozens of fields and then to do manual calculations to obtain “durations” required by the template, rather than the date-formatted data provided in the displays?
This audio conference presentation is designed to educate and to provoke dialog between statisticians and writers, as well as medical, regulatory, and project managers, with respect to appropriate display of clinical information to expedite document preparation and review.
Many times, tables and listings used for preparing clinical study reports, integrated summaries, and other clinical documents are designed without closely considering how these data displays will be used by the writer and review team to expedite document preparation and support messages about healthcare products. For example, does placebo come first on your tables and, if so, does that mean placebo is first in the text, or are you more interested in the test drug, mentioning placebo in context as a comparator? Or, have you ever written narratives from listings that required you to look up information in dozens of fields and then to do manual calculations to obtain “durations” required by the template, rather than the date-formatted data provided in the displays?
This audio conference presentation is designed to educate and to provoke dialog between statisticians and writers, as well as medical, regulatory, and project managers, with respect to appropriate display of clinical information to expedite document preparation and review.
Wednesday, July 20, 2011
Conducting Formative and Summative Usability Studies for Medical Devices
is being presented by Adam R. Shames, Director, Human Factors Research, with Design Science Consulting, Inc. and airs on Wednesday, August 24th, 2011. For more details, or to register please visit our site at www.fxconferences.com
The FDA expects it, your customers need it, and if you do it right, usability testing will all but guarantee that your product is a success. Done wrong, your product will never see its commercial launch.
Drawing on several real-life case studies, this audio conference presents attendees with a roadmap for conducting formative usability studies that lead to a successful summative study. Our speaker reviews the relevant standards such as IEC 62366, HE 75, and the FDA draft guidance entitled “Applying Human Factors and Usability Engineering to Optimize Medical Device Design” (June 22, 2011). The presentation provides insight on what device manufacturers need to do – and what not to do – to assure that their product passes its user-interface design validation, and demonstrate to the FDA that they have developed a safe and effective medical device.
The FDA expects it, your customers need it, and if you do it right, usability testing will all but guarantee that your product is a success. Done wrong, your product will never see its commercial launch.
Drawing on several real-life case studies, this audio conference presents attendees with a roadmap for conducting formative usability studies that lead to a successful summative study. Our speaker reviews the relevant standards such as IEC 62366, HE 75, and the FDA draft guidance entitled “Applying Human Factors and Usability Engineering to Optimize Medical Device Design” (June 22, 2011). The presentation provides insight on what device manufacturers need to do – and what not to do – to assure that their product passes its user-interface design validation, and demonstrate to the FDA that they have developed a safe and effective medical device.
Monday, July 18, 2011
Speaking opportunities at our audio conferences and webinars
Does your company cater to the medical device, IVD, pharma, or biotech industries? Are you interested in sharing your expertise with other industry professionals?The key element to the success of our ongoing FX Conferences audio conference series is the speaker relationships forged behind the scenes. We seek out and partner with thought leaders in the life sciences to bring our audience the latest information and guidance on industry hot topics - topics like regulatory submissions, clinical evaluations, human factors engineering and off-label promotion.
Many of our speaker partners have been working with us for years, having seen tangible value in showcasing their expertise to a targeted audience of life sciences executives. We share with our speakers all of the business development leads arising from each event, and offer the opportunity for revenue sharing as well. We strive to create win-win relationships with our speakers, and many of them have realized business opportunities as a result of their work with us.
Interested in finding out more? Get in touch with Rob Wagner at acsupport@fxtrans.com!
For a detailed proposal on your next clinical, regulatory, or marketing medical translation assignment, contact ForeignExchange Translations.
Thursday, July 14, 2011
Off-label Investigations: Recent Actions, Settlements and Enforcement Trends
is being presented by John E. Kelly & Cori Annapolen Goldberg, Partner & Senior Associate, with Fulbright & Jaworski L.L.P and airs on Wednesday, August 17th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Fighting health care fraud has been one of the current administration’s top law enforcement priorities. The past few years have seen bold and pointed steps by the Department of Justice (DOJ) and the U.S. Department of Health and Human Services (HHS) as well as federal lawmakers intent on proving the government’s commitment to the crackdown on health care fraud.
In the last two years, the DOJ has pursued and recovered a record amount of taxpayer dollars lost to health care fraud – more than in any other two-year period in the Department’s history. A major part of these recent recoveries comes from settlements involving off-label marketing and promotions by drug and device manufacturers. In 2009, DOJ announced the largest federal health care fraud takedown in U.S. history, which included the largest criminal fine ever imposed in the U.S. for any matter. The reason for the investigation and takedown? Off-label marketing.
With the government’s aggressive crackdown on health care fraud and abuse, it is imperative that companies arm themselves with the knowledge to identify risk areas and to protect themselves against government investigations that could cost billions in fines, penalties, and legal fees. This presentation looks at recent health care fraud and abuse as it relates to off-label marketing, and ways in which companies can protect themselves from undue scrutiny.
Fighting health care fraud has been one of the current administration’s top law enforcement priorities. The past few years have seen bold and pointed steps by the Department of Justice (DOJ) and the U.S. Department of Health and Human Services (HHS) as well as federal lawmakers intent on proving the government’s commitment to the crackdown on health care fraud.
In the last two years, the DOJ has pursued and recovered a record amount of taxpayer dollars lost to health care fraud – more than in any other two-year period in the Department’s history. A major part of these recent recoveries comes from settlements involving off-label marketing and promotions by drug and device manufacturers. In 2009, DOJ announced the largest federal health care fraud takedown in U.S. history, which included the largest criminal fine ever imposed in the U.S. for any matter. The reason for the investigation and takedown? Off-label marketing.
With the government’s aggressive crackdown on health care fraud and abuse, it is imperative that companies arm themselves with the knowledge to identify risk areas and to protect themselves against government investigations that could cost billions in fines, penalties, and legal fees. This presentation looks at recent health care fraud and abuse as it relates to off-label marketing, and ways in which companies can protect themselves from undue scrutiny.
Wednesday, July 13, 2011
Written Food Safety Plan Compliance Under the FSMA
is being presented by Shawn K. Stevens, National Food Safety Lawyer, with Gass Weber Mullins LLC and airs on Thursday, August 18th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Anyone involved in the food industry has heard about the new Food Safety Modernization Act (FSMA). Enacted in January 2011, the FSMA makes sweeping changes to the way food products are manufactured, distributed and regulated.
Although the FSMA imposes many new requirements on the food industry, the one that will likely have the greatest impact is the requirement that, prior to June 2012, food companies adopt and implement written food safety plans. In regulatory and legal terms, this means that regulated food companies will be required to develop and then closely follow a hazard analysis and critical control point (HACCP) methodology. Thus, whether you import, process or distribute food products, the new legislation can and will substantially impact the nature of your business.
This audio conference provides attendees with an overview of the new FDA requirements, along with how and when FDA will likely begin enforcing them, and how best to prepare your business for the coming changes.
Anyone involved in the food industry has heard about the new Food Safety Modernization Act (FSMA). Enacted in January 2011, the FSMA makes sweeping changes to the way food products are manufactured, distributed and regulated.
Although the FSMA imposes many new requirements on the food industry, the one that will likely have the greatest impact is the requirement that, prior to June 2012, food companies adopt and implement written food safety plans. In regulatory and legal terms, this means that regulated food companies will be required to develop and then closely follow a hazard analysis and critical control point (HACCP) methodology. Thus, whether you import, process or distribute food products, the new legislation can and will substantially impact the nature of your business.
This audio conference provides attendees with an overview of the new FDA requirements, along with how and when FDA will likely begin enforcing them, and how best to prepare your business for the coming changes.
Monday, July 11, 2011
Section 1603 – Qualifying for 2011 & Planning for the Future
is being presented by Gregory F. Jenner, Partner, with Stoel Rives LLP and airs on Thursday, August 11th, 2011. For more details, or to register please visit our site at www.fxconferences.com
The 1603 grant has been both a lifesaver and a game changer for the renewable energy sector. However, section 1603 is likely going the way of the dodo after 2011 unless construction has begun on a project before then. Therefore, it is imperative that developers and others understand how to meet the alternative tests for beginning construction. In addition, moving beyond 2011, the sunset of section 1603 will place increased emphasis on optimizing the use of tax equity and the various structures that are available.
This audio conference presentation focuses on qualifying for 1603 for the balance of 2011, and also reviews the available structures used to monetize tax incentives – including partnership flips, sale-leaseback transactions, leases with credit pass-through arrangements, and prepayment structures. Our speaker discusses the advantages and disadvantages of each, and provides attendees with insight and guidance to help them prepare for life after section 1603.
The 1603 grant has been both a lifesaver and a game changer for the renewable energy sector. However, section 1603 is likely going the way of the dodo after 2011 unless construction has begun on a project before then. Therefore, it is imperative that developers and others understand how to meet the alternative tests for beginning construction. In addition, moving beyond 2011, the sunset of section 1603 will place increased emphasis on optimizing the use of tax equity and the various structures that are available.
This audio conference presentation focuses on qualifying for 1603 for the balance of 2011, and also reviews the available structures used to monetize tax incentives – including partnership flips, sale-leaseback transactions, leases with credit pass-through arrangements, and prepayment structures. Our speaker discusses the advantages and disadvantages of each, and provides attendees with insight and guidance to help them prepare for life after section 1603.
Friday, July 8, 2011
Global Clinical Trials & ISO 14155: 2011 Compliance - Are Your Quality Systems Up to Date
is being presented by Dr. Joy Frestedt, President & CEO, of Frestedt Incorporated and airs on Wednesday, August 10th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Are your quality systems for clinical trials compliant with ISO 14155:2011 Clinical Investigations of Medical Devices for Human Subjects - Good Clinical Practices (2nd edition)?
ISO 14155 is an international standard designed to guide companies as they fulfill the many different regulatory requirements for international clinical trials. First issued in 2003, this 2011 update has attempted to unify many different standards for global clinical trials including requirements of the Global Harmonization Task Force, the International Conference on Harmonization Good Clinical Practice documents and some guidance information from the FDA. The goal of this work is to ensure clinical trial data generated anywhere in the world meets certain minimum standards. With over 65 pages of detailed requirements, ISO 14155:2011 now contains four administrative sections, three project management sections, two responsibilities sections and six annexes. Ensuring your systems are compliant with every component of this global standard is complicated work.
This presentation reviews the required elements to consider when conducting trials outside the United States, breaking the standard down into manageable parts and discussing how to integrate ISO 14155:2011 into your current clinical research quality system. The speaker provides a standard checklist to ensure your system/trials address all the required elements. This topic is especially timely, since the ISO 14155 standard was just released in January, 2011 and many companies are undergoing internal quality system updates to ensure their SOPs are compliant. This presentation is designed to make sure each member of the clinical, regulatory and quality teams fully understand what is included in ISO 14155 so they can be confident as they ensure all the parts of this essential standard are addressed in their day-to-day clinical trial activities. Participants will hear about the device-specific requirements of ISO 14155 including areas now harmonized with other standards, and get useful tips about how to navigate in-house quality system improvements designed to ensure compliance with the new ISO 14155: 2011 standard.
Are your quality systems for clinical trials compliant with ISO 14155:2011 Clinical Investigations of Medical Devices for Human Subjects - Good Clinical Practices (2nd edition)?
ISO 14155 is an international standard designed to guide companies as they fulfill the many different regulatory requirements for international clinical trials. First issued in 2003, this 2011 update has attempted to unify many different standards for global clinical trials including requirements of the Global Harmonization Task Force, the International Conference on Harmonization Good Clinical Practice documents and some guidance information from the FDA. The goal of this work is to ensure clinical trial data generated anywhere in the world meets certain minimum standards. With over 65 pages of detailed requirements, ISO 14155:2011 now contains four administrative sections, three project management sections, two responsibilities sections and six annexes. Ensuring your systems are compliant with every component of this global standard is complicated work.
This presentation reviews the required elements to consider when conducting trials outside the United States, breaking the standard down into manageable parts and discussing how to integrate ISO 14155:2011 into your current clinical research quality system. The speaker provides a standard checklist to ensure your system/trials address all the required elements. This topic is especially timely, since the ISO 14155 standard was just released in January, 2011 and many companies are undergoing internal quality system updates to ensure their SOPs are compliant. This presentation is designed to make sure each member of the clinical, regulatory and quality teams fully understand what is included in ISO 14155 so they can be confident as they ensure all the parts of this essential standard are addressed in their day-to-day clinical trial activities. Participants will hear about the device-specific requirements of ISO 14155 including areas now harmonized with other standards, and get useful tips about how to navigate in-house quality system improvements designed to ensure compliance with the new ISO 14155: 2011 standard.
Wednesday, July 6, 2011
Process Validation – Implementing the Finalized FDA Guidance
is being presented by Todd Arney, Principal Consultant, with Technical & Quality Services, LLC and airs on Thursday, August 4th, 2011. For more details, or to register please visit our site at www.fxconferences.com
This audio conference presentation discusses the relevant regulatory requirements and current standards for process validation, and provides attendees with insight and practical guidance on how to implement them. Our speaker draws on real-life examples and shares experience and insight on the real problems fellow industry professionals are wrestling with.
The presentation reviews the fundamental regulatory requirements for process validation, and builds upon them in successive layers with current industry standards. The takeaway for attendees is a comprehensive bottom-up plan of action that pharmaceutical professionals can follow to either establish their own validation programs or enhance the ones they already have in place.
This audio conference presentation discusses the relevant regulatory requirements and current standards for process validation, and provides attendees with insight and practical guidance on how to implement them. Our speaker draws on real-life examples and shares experience and insight on the real problems fellow industry professionals are wrestling with.
The presentation reviews the fundamental regulatory requirements for process validation, and builds upon them in successive layers with current industry standards. The takeaway for attendees is a comprehensive bottom-up plan of action that pharmaceutical professionals can follow to either establish their own validation programs or enhance the ones they already have in place.
Tuesday, July 5, 2011
Technical Documentation Requirements for Device Approval in the EU
is being presented by Tamas Borsai, Division Manager, MHS - Customer Service and Quality, with TUV SUD America Inc. and airs on Tuesday, August 9th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Having a technical file for each medical product is one of the common and very basic requirements in all of the European medical device directives. Creating and maintaining these documents requires the proper expertise and strategy from those working in regulatory affairs for the device manufacturer.
The updated Medical Devices Directive – which became effective in 2009 - requests that Notified Bodies set up sampling programs of the technical files for all of their clients, and so the chance of a detailed review of a file by an auditor is higher than at any time previous.
This audio conference covers the regulatory framework with references to the European directives and guidance documents, possible strategies for setting up the technical file, and includes an illustrative case study.
Having a technical file for each medical product is one of the common and very basic requirements in all of the European medical device directives. Creating and maintaining these documents requires the proper expertise and strategy from those working in regulatory affairs for the device manufacturer.
The updated Medical Devices Directive – which became effective in 2009 - requests that Notified Bodies set up sampling programs of the technical files for all of their clients, and so the chance of a detailed review of a file by an auditor is higher than at any time previous.
This audio conference covers the regulatory framework with references to the European directives and guidance documents, possible strategies for setting up the technical file, and includes an illustrative case study.
Wednesday, June 29, 2011
Usability and Clinical Testing for Home-use Medical Devices
is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Wednesday, August 3rd, 2011. For more details or to register, please visit our site at www.fxconferences.com
There are many devices and diagnostics that are or could be used by patients in their own homes: in-vitro diagnostics with complex software algorithms and connections to computer databases and websites; haemodialysis machines; ventilators; artificial hearts; intravenous infusion pumps; and various types of wound-care devices. Home-based use of complex devices to treat liver disease, depression, and heart disease are in development. In fact, any complex device that delivers therapy over a prolonged period of time needs to accommodate in-home use because payers will not pay for and patients will not comply with prolonged hospital or clinic-based treatment regimens.
In order to obtain labelling that allows use of a complex device or a diagnostic by the patients themselves, the medical device first needs to be designed in a way that minimizes potential use errors. This involves usability testing, which takes into account different characteristics of the patients who will use the device such as age, education, professional background, and different physical abilities (the so-called human factors). If clinical data are required for approval, these are usually obtained by testing the device in the intended setting such as patients using the devices at home. Setting up and managing clinical trials to accommodate these requirements can be challenging.
This audio conference presentation discusses the process of designing and testing medical devices intended for use in the home, and provides case studies and insight on how best to obtain the requisite clinical data in a home setting.
There are many devices and diagnostics that are or could be used by patients in their own homes: in-vitro diagnostics with complex software algorithms and connections to computer databases and websites; haemodialysis machines; ventilators; artificial hearts; intravenous infusion pumps; and various types of wound-care devices. Home-based use of complex devices to treat liver disease, depression, and heart disease are in development. In fact, any complex device that delivers therapy over a prolonged period of time needs to accommodate in-home use because payers will not pay for and patients will not comply with prolonged hospital or clinic-based treatment regimens.
In order to obtain labelling that allows use of a complex device or a diagnostic by the patients themselves, the medical device first needs to be designed in a way that minimizes potential use errors. This involves usability testing, which takes into account different characteristics of the patients who will use the device such as age, education, professional background, and different physical abilities (the so-called human factors). If clinical data are required for approval, these are usually obtained by testing the device in the intended setting such as patients using the devices at home. Setting up and managing clinical trials to accommodate these requirements can be challenging.
This audio conference presentation discusses the process of designing and testing medical devices intended for use in the home, and provides case studies and insight on how best to obtain the requisite clinical data in a home setting.
Tuesday, June 28, 2011
Off-label Promotion – What FDA Looks For & What You Need to Know
is being presented by Alan Minsk, Partner, with Arnall Golden Gregory LLP and airs on Tuesday, July 26th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Off-label promotion is a perennial focus for FDA enforcement actions, and an area of chronic concern for pharmaceutical and medical device companies. The dividing line between legitimate scientific exchange of information and off-label promotion can, at times, be somewhat blurry. It is vitally important for everyone on your team to know what can and cannot be said in the name of product promotion, and for your company to have in place a strategy to stay compliant.
In this audio conference, our speaker reviews the regulations concerning product promotion in the life sciences, sharing experience and insight on some of the red-flag areas likely to attract unwanted attention from FDA. The presentation looks at the Good Reprint Practices guidance, and what it does and does not say about sharing off-label information. It also discusses the role of medical affairs and the medical science liaison, and reviews factors to consider when determining what is and is not acceptable promotional activity.
Off-label promotion is a perennial focus for FDA enforcement actions, and an area of chronic concern for pharmaceutical and medical device companies. The dividing line between legitimate scientific exchange of information and off-label promotion can, at times, be somewhat blurry. It is vitally important for everyone on your team to know what can and cannot be said in the name of product promotion, and for your company to have in place a strategy to stay compliant.
In this audio conference, our speaker reviews the regulations concerning product promotion in the life sciences, sharing experience and insight on some of the red-flag areas likely to attract unwanted attention from FDA. The presentation looks at the Good Reprint Practices guidance, and what it does and does not say about sharing off-label information. It also discusses the role of medical affairs and the medical science liaison, and reviews factors to consider when determining what is and is not acceptable promotional activity.
Friday, June 24, 2011
Using FDA’s Regulatory Harmonization to Better Manage a Global Supply Chain
is being presented by John Avellanet, President, of Cerulean Associates LLC and airs on Wednesday, July 27th, 2011. For more details or to register, please visit our site at www.fxconferences.com
The FDA’s Office of Compliance is reorganizing this year to better address the challenges of globalization, regulatory harmonization and controlling a global supply chain. Part of FDA’s changes include increased citation of ICH guidance in Warning Letters and FDA Form 483s. And FDA inspectors are now being trained on ICH, GHTF and PIC/S guidelines when it comes to auditing firms for supplier control. Are you ready for the globalized FDA inspector?
This audio conference presentation provides attendees with a roadmap to successfully integrate regulatory harmonization and risk management into supplier selection, qualification, and management. Presented by international supplier management and lean compliance expert John Avellanet, author of the acclaimed book, "Get to Market Now! Turn FDA Compliance into a Competitive Edge", the audio conference highlights current FDA inspector thinking and questions to prepare for, along with a review of the hidden risks that companies inadvertently stumble into when transitioning to global supplier qualification and management. Mr. Avellanet also walks attendees, step-by-step, through the best practices necessary to implement a successful program that meets the challenges of 21st century global supply chain and current FDA inspector expectations.
The FDA’s Office of Compliance is reorganizing this year to better address the challenges of globalization, regulatory harmonization and controlling a global supply chain. Part of FDA’s changes include increased citation of ICH guidance in Warning Letters and FDA Form 483s. And FDA inspectors are now being trained on ICH, GHTF and PIC/S guidelines when it comes to auditing firms for supplier control. Are you ready for the globalized FDA inspector?
This audio conference presentation provides attendees with a roadmap to successfully integrate regulatory harmonization and risk management into supplier selection, qualification, and management. Presented by international supplier management and lean compliance expert John Avellanet, author of the acclaimed book, "Get to Market Now! Turn FDA Compliance into a Competitive Edge", the audio conference highlights current FDA inspector thinking and questions to prepare for, along with a review of the hidden risks that companies inadvertently stumble into when transitioning to global supplier qualification and management. Mr. Avellanet also walks attendees, step-by-step, through the best practices necessary to implement a successful program that meets the challenges of 21st century global supply chain and current FDA inspector expectations.
Tuesday, June 21, 2011
Negotiating Clinical Study Agreements With Academic Medical Institutions
is being presented by Karen A. Mullin, JD, LLM and airs on Wednesday, July 20th, 2011. For more details, or to register please visit our site at www.fxconferences.com
The process of negotiating a clinical study agreement between a bio/pharmaceutical company and an academic medical institution can be difficult, in part due to the sometimes divergent goals of the two parties. This audio conference presentation reviews the expectations of both the bio/pharmaceutical company and the academic medical institution when negotiating clinical study agreements. Our speaker addresses in depth the key issues of confidentiality, publication, intellectual property rights and indemnification. The presentation also includes discussion of appropriate language to enable the parties to fulfill their different objectives and legal obligations. Finally, our speaker shares tips and insight on ways to speed up the negotiating process.
The process of negotiating a clinical study agreement between a bio/pharmaceutical company and an academic medical institution can be difficult, in part due to the sometimes divergent goals of the two parties. This audio conference presentation reviews the expectations of both the bio/pharmaceutical company and the academic medical institution when negotiating clinical study agreements. Our speaker addresses in depth the key issues of confidentiality, publication, intellectual property rights and indemnification. The presentation also includes discussion of appropriate language to enable the parties to fulfill their different objectives and legal obligations. Finally, our speaker shares tips and insight on ways to speed up the negotiating process.
Wednesday, June 15, 2011
GFSI Certification – Pitfalls and Best Practices
is being presented by Peter Stein, Corporate Director of Quality Assurance and Food Safety, with Piller's Corporation and airs on Thursday, July 14th, 2011. For more details, or to register please visit our site at www.fxconferences.com
The Global Food Safety Initiative (GFSI) standard was developed with the stated goal of encouraging continuous improvement in food safety management systems. However, for those companies seeking certification to the standard, the exact methodology isn't always clear. There are numerous aspects of the process and the audit that are not evident in the manual, and the specific requirements that must be met to achieve a passing grade can be somewhat dependent on the auditor.
This presentation provides an overview of the GFSI standard and, specifically, the SQF certification process. Our speaker, the corporate director of food safety and quality assurance with Piller's Corporation, discusses why Piller's chose SQF, and shares audit experiences at four further-processed RTE meat plants over the past two years. The presentation provides insight on what you need to know and where to start, as well as tips to help you pass the first time. The speaker also covers the interaction and cooperation needed from other departments, and the emphasis on in-plant auditing and questions asked to on-line workers in the plant. Finally, the presentation also reviews the scoring process and the audit summary itself.
The Global Food Safety Initiative (GFSI) standard was developed with the stated goal of encouraging continuous improvement in food safety management systems. However, for those companies seeking certification to the standard, the exact methodology isn't always clear. There are numerous aspects of the process and the audit that are not evident in the manual, and the specific requirements that must be met to achieve a passing grade can be somewhat dependent on the auditor.
This presentation provides an overview of the GFSI standard and, specifically, the SQF certification process. Our speaker, the corporate director of food safety and quality assurance with Piller's Corporation, discusses why Piller's chose SQF, and shares audit experiences at four further-processed RTE meat plants over the past two years. The presentation provides insight on what you need to know and where to start, as well as tips to help you pass the first time. The speaker also covers the interaction and cooperation needed from other departments, and the emphasis on in-plant auditing and questions asked to on-line workers in the plant. Finally, the presentation also reviews the scoring process and the audit summary itself.
Tuesday, June 14, 2011
3 Steps to Successful Translation Management
is being presented by Andres Heuberger, President, of ForeignExchange Translations, Inc. and airs on Thursday, July 7th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Translators have been around since the time of the Babylonians, yet the translation industry is still relatively new. Yellow Pages translation bureaus are a dime a dozen, but more and more companies are looking for a true partner that can help them effectively manage the translation process.
This audio conference gives you the skills to evaluate different vendors, service delivery methods and quality. It also enables you to put in place a process to document, measure, audit and improve your overall translation activities.
Translators have been around since the time of the Babylonians, yet the translation industry is still relatively new. Yellow Pages translation bureaus are a dime a dozen, but more and more companies are looking for a true partner that can help them effectively manage the translation process.
This audio conference gives you the skills to evaluate different vendors, service delivery methods and quality. It also enables you to put in place a process to document, measure, audit and improve your overall translation activities.
Wednesday, June 8, 2011
Managing Risk Under the Physician Payment Sunshine Law and Anti-kickback Statute
is being presented by Sheva Sanders, Partner with, Leonard, Street and Deinard and airs on Wednesday, June 29th, 2011. For more details, or to register please visit our site at www.fxconferences.com
As device-related therapies have become more complex, and technological capabilities have become more sophisticated, medical device companies have expanded their activities in support of those therapies. For example, many companies provide substantial and valuable support related to stocking their products, training and education on the use of their products, reimbursement-related support, and post-implant monitoring.
At the same time, laws such as the Physician Sunshine Payment Act and the Anti-kickback Statute – focusing on the perceived conflict of interest created through the transfer of value to provider-customers – have made it critical to be able to identify reportable or prohibited transfers of value.
This audio conference presentation explores the question of whether and when the product-related support activities are reportable under the Physician Sunshine Payment Act and similar state statutes, and whether and when such activities might constitute remuneration under the federal Anti-kickback Statute and similar state statutes.
As device-related therapies have become more complex, and technological capabilities have become more sophisticated, medical device companies have expanded their activities in support of those therapies. For example, many companies provide substantial and valuable support related to stocking their products, training and education on the use of their products, reimbursement-related support, and post-implant monitoring.
At the same time, laws such as the Physician Sunshine Payment Act and the Anti-kickback Statute – focusing on the perceived conflict of interest created through the transfer of value to provider-customers – have made it critical to be able to identify reportable or prohibited transfers of value.
This audio conference presentation explores the question of whether and when the product-related support activities are reportable under the Physician Sunshine Payment Act and similar state statutes, and whether and when such activities might constitute remuneration under the federal Anti-kickback Statute and similar state statutes.
Tuesday, June 7, 2011
Medical Market Research Best Practices: Not Just for the Marketing Department
is being presented by Maria Shepherd and airs on Thursday, June 30th, 2011. For more details on this event, or to register please visit our site at www.fxconferences.com
The medical device industry is complex and unique. Medical market research is utilized by a number of other departments in medical device companies, beyond the marketing department. FDA expects regulatory departments to provide market sizing data in submissions. The quality department needs usability research (a sister science to market research in form, but not function) for Human Factors Engineering usability testing mandates by FDA. R&D departments use Voice of the Customer, a tool that relies heavily on solid market research principles to obtain and analyze customer feedback on new product design.
This audio conference reviews basic principles and best practices for finding the market data and clinician (or patient/stakeholder) input that you need to meet the data collection objectives your function requires. The speaker will discuss these techniques and present several examples of market sizing data for regulatory submissions and human factors usability testing tools and best practices. Market research techniques for Voice of the Customer will also be covered in this audio conference, and will review identifying, profiling, screening and recruiting respondents for VOC research. An overview of best practices in interviewing and discussion guide development for the VOC qualitative in-depth component will be reviewed as well as developing, administering and analyzing online surveys for the quantitative component.
The medical device industry is complex and unique. Medical market research is utilized by a number of other departments in medical device companies, beyond the marketing department. FDA expects regulatory departments to provide market sizing data in submissions. The quality department needs usability research (a sister science to market research in form, but not function) for Human Factors Engineering usability testing mandates by FDA. R&D departments use Voice of the Customer, a tool that relies heavily on solid market research principles to obtain and analyze customer feedback on new product design.
This audio conference reviews basic principles and best practices for finding the market data and clinician (or patient/stakeholder) input that you need to meet the data collection objectives your function requires. The speaker will discuss these techniques and present several examples of market sizing data for regulatory submissions and human factors usability testing tools and best practices. Market research techniques for Voice of the Customer will also be covered in this audio conference, and will review identifying, profiling, screening and recruiting respondents for VOC research. An overview of best practices in interviewing and discussion guide development for the VOC qualitative in-depth component will be reviewed as well as developing, administering and analyzing online surveys for the quantitative component.
Thursday, June 2, 2011
Management Responsibilities Under FDA's Quality System Regulation
is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Thursday, July 28th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
The FDA’s Quality System Regulation (QSR), for medical devices marketed in the US, includes requirements for management responsibility. There are five major components: Quality Policy, Organization, Management Review, Quality Planning, and Quality System Procedures. This presentation explains the various components and offers recommendations for implementation.
It also examines the structure of regulation in 21 CFR §820.20 and its constituent parts. This section has many defined terms that bear on the understanding, and this presentation looks at these terms and explains what they mean.
Our speaker draws on many sources to provide attendees with understanding, including the regulation preamble – where FDA published its reasoning, intent and expectations – and also FDA’s Quality System Inspection Technique, which guides inspectors.
The presentation also examines some FDA warning letters to help participants understand the issues that FDA uncovers and considers important.
The FDA’s Quality System Regulation (QSR), for medical devices marketed in the US, includes requirements for management responsibility. There are five major components: Quality Policy, Organization, Management Review, Quality Planning, and Quality System Procedures. This presentation explains the various components and offers recommendations for implementation.
It also examines the structure of regulation in 21 CFR §820.20 and its constituent parts. This section has many defined terms that bear on the understanding, and this presentation looks at these terms and explains what they mean.
Our speaker draws on many sources to provide attendees with understanding, including the regulation preamble – where FDA published its reasoning, intent and expectations – and also FDA’s Quality System Inspection Technique, which guides inspectors.
The presentation also examines some FDA warning letters to help participants understand the issues that FDA uncovers and considers important.
Wednesday, June 1, 2011
Complying with FCPA and Related Anti-Corruption Measures
is being presented by David F. Axelrod, Managing Member, with Axelrod Laliberte LLP and airs on Wednesday, June 22nd, 2011. For more details, or to register please visit our site at www.fxconferences.com
For the first 20 years of its existence, the Foreign Corrupt Practices Act (FCPA) was rarely used, and EU countries had nothing comparable. More recently, however, the FCPA has been aggressively enforced against individuals, as well as U.S. and foreign companies. Fines have been imposed at unprecedented levels and individuals (including a former U.S. Congressman) jailed. EU governments have also gotten serious about fighting corruption, starting with the 1998 OECD convention against bribery and culminating, so far, with the UK anti-bribery statute.
This audio conference presentation looks at the history, scope and elements of the FCPA, anti-corruption compliance programs, red flags, investigations, and U.S. government expectations for pre-transaction due diligence. It also covers defenses and policy considerations concerning a key exception to liability, facilitating payments. Our speaker also discusses the UK anti-bribery statute and its key differences from the FCPA. Finally, the presentation looks at the relevance of the statute to smaller companies that may have only a limited overseas presence.
For the first 20 years of its existence, the Foreign Corrupt Practices Act (FCPA) was rarely used, and EU countries had nothing comparable. More recently, however, the FCPA has been aggressively enforced against individuals, as well as U.S. and foreign companies. Fines have been imposed at unprecedented levels and individuals (including a former U.S. Congressman) jailed. EU governments have also gotten serious about fighting corruption, starting with the 1998 OECD convention against bribery and culminating, so far, with the UK anti-bribery statute.
This audio conference presentation looks at the history, scope and elements of the FCPA, anti-corruption compliance programs, red flags, investigations, and U.S. government expectations for pre-transaction due diligence. It also covers defenses and policy considerations concerning a key exception to liability, facilitating payments. Our speaker also discusses the UK anti-bribery statute and its key differences from the FCPA. Finally, the presentation looks at the relevance of the statute to smaller companies that may have only a limited overseas presence.
Tuesday, May 31, 2011
When a 510(k) or PMA Goes Off Track - FDA's Appeals Process
is being presented by Jeffrey K. Shapiro, JD, Director, with Hyman, Phelps & McNamara, PC and airs on Tuesday, June 21st, 2011. For more details, or to register please visit our site at www.fxconferences.com
It goes without saying that the ability to successfully obtain FDA approval is critical to the success of a medical device and, by extension, a medical device company. However, sometimes even the most dedicated of efforts fall flat when FDA says "No." What then? What can you do if FDA says it believes there is not an adequate predicate device for your product? Or if FDA is requiring an overly burdensome clinical study? Or imposing data requirements that were not applied to your competitor's similar 510(k) six months earlier?
This presentation covers the appeals processes that are available to medical device companies when FDA takes an adverse action during premarket review of a 510(k) or PMA. Our speaker draws upon years of experience to provide practical tips and advice on how to resolve a dispute with FDA so that your 510(k) or PMA can move forward to clearance or approval. The presentation looks at the best approach to take, and what to expect in terms of the length of the appeals process, and the likelihood of success.
It goes without saying that the ability to successfully obtain FDA approval is critical to the success of a medical device and, by extension, a medical device company. However, sometimes even the most dedicated of efforts fall flat when FDA says "No." What then? What can you do if FDA says it believes there is not an adequate predicate device for your product? Or if FDA is requiring an overly burdensome clinical study? Or imposing data requirements that were not applied to your competitor's similar 510(k) six months earlier?
This presentation covers the appeals processes that are available to medical device companies when FDA takes an adverse action during premarket review of a 510(k) or PMA. Our speaker draws upon years of experience to provide practical tips and advice on how to resolve a dispute with FDA so that your 510(k) or PMA can move forward to clearance or approval. The presentation looks at the best approach to take, and what to expect in terms of the length of the appeals process, and the likelihood of success.
Friday, May 27, 2011
Choosing and Managing Contract Medical Writers
is being presented by Dr. Susan Sisk, Principal, with SFP Consulting, LLC and airs on Thursday, July 14th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Contract writers, whether freelancers or CRO personnel, can be an important extension of medical writing resources during planned workload peaks or when unexpected writing projects arise.
This audio conference presentation is designed to provide sponsors with information on how to get the best product from a contract writer, and to show contractors how to ensure they produce materials that meet sponsors’ expectations.
Our speaker provides attendees with practical recommendations and case studies of successful collaborations, and emphasizes the process of report writing – including preparation of a shell report prior to availability of final data displays, and other activities that can maximize sponsor input and minimize the timeline after database lock.
Contract writers, whether freelancers or CRO personnel, can be an important extension of medical writing resources during planned workload peaks or when unexpected writing projects arise.
This audio conference presentation is designed to provide sponsors with information on how to get the best product from a contract writer, and to show contractors how to ensure they produce materials that meet sponsors’ expectations.
Our speaker provides attendees with practical recommendations and case studies of successful collaborations, and emphasizes the process of report writing – including preparation of a shell report prior to availability of final data displays, and other activities that can maximize sponsor input and minimize the timeline after database lock.
Thursday, May 26, 2011
Understanding the New USP Chapter 1224 for Analytical Method Validation
is being presented by Dr. Ludwig Huber, Director, of LabCompliance and airs on Wednesday, June 15th, 2011. For more details or to register, please visit our site at www.fxconferences.com
It is important to maintain the validated state when transferring validated methods between laboratories and sites, so that the receiving laboratory can produce the same reliable results. However, to date there has been no official guidance on what exactly is expected to maintain 'the validated state'. That is changing. The U.S. Pharmacopeia (USP) recently published a proposal for a general chapter <1224>, which will become official with USP 35. Also, the FDA has released an official guidance on how to conduct and document method transfer.
This audio conference presentation looks at FDA and international expectations for method transfer, and discusses how to properly conduct and document a transfer. It explores the various approaches and laboratory responsibilities, and looks at how to develop a transfer plan and pre-approval protocol. The speaker also provides attendees with an understanding of USP and FDA requirements, and provides recommendations and tools for effective implementation.
It is important to maintain the validated state when transferring validated methods between laboratories and sites, so that the receiving laboratory can produce the same reliable results. However, to date there has been no official guidance on what exactly is expected to maintain 'the validated state'. That is changing. The U.S. Pharmacopeia (USP) recently published a proposal for a general chapter <1224>, which will become official with USP 35. Also, the FDA has released an official guidance on how to conduct and document method transfer.
This audio conference presentation looks at FDA and international expectations for method transfer, and discusses how to properly conduct and document a transfer. It explores the various approaches and laboratory responsibilities, and looks at how to develop a transfer plan and pre-approval protocol. The speaker also provides attendees with an understanding of USP and FDA requirements, and provides recommendations and tools for effective implementation.
Wednesday, May 25, 2011
Reducing Your Risk Under the FCPA & Other Anti-Corruption Laws
is being presented by Jesse A. Witten, Partner, with Drinker Biddle & Reath LLP and airs on Tuesday, May 14th, 2011. For more details, or to register please visit our site at www.fxconferences.com
The U.S. Department of Justice (DOJ) and Securities and Exchange Commission (SEC) have made enforcement of the Foreign Corrupt Practices Act (FCPA) a top priority, especially as it relates to pharmaceutical and medical device manufacturers. No pharmaceutical and device manufacturer can expect to evade a government investigation indefinitely. Even smaller companies need to be able to demonstrate that they exercise due diligence, either in the event of an investigation or if they ever seek to partner or merge with a larger company.
This audio conference presentation provides guidance for companies with international operations on how best to develop and implement a set of internal controls to reduce enforcement risk under the FCPA and other international anti-corruption laws.
The U.S. Department of Justice (DOJ) and Securities and Exchange Commission (SEC) have made enforcement of the Foreign Corrupt Practices Act (FCPA) a top priority, especially as it relates to pharmaceutical and medical device manufacturers. No pharmaceutical and device manufacturer can expect to evade a government investigation indefinitely. Even smaller companies need to be able to demonstrate that they exercise due diligence, either in the event of an investigation or if they ever seek to partner or merge with a larger company.
This audio conference presentation provides guidance for companies with international operations on how best to develop and implement a set of internal controls to reduce enforcement risk under the FCPA and other international anti-corruption laws.
Tuesday, May 24, 2011
Re-examinations, Litigation, and Other Mechanisms for Addressing “Problem” Patents
is being presented by Kevin McCabe & Dr. Eldora Ellison, Directors, Biotechnology/Chemical and Litigation Groups Sterne, Kessler, Goldstein & Fox P.L.L.C. and airs on Tuesday, June 7th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Sooner or later, nearly all high technology companies encounter one or more patents that may present a roadblock to bringing a product to market or to conducting important research.
This audio conference presentation provides an overview of the legal tools available in the United States to help address such “problem” patents. In particular, our speakers provide a detailed discussion of patent re-examinations and the interplay between re-examinations and litigation. Additionally, the presentation looks at other mechanisms that may be used when one encounters a problematic patent, such as licensing, design-arounds, protests, interferences, and arbitration.
This presentation is informative both for companies that are concerned with patents held by others, as well as companies that may seek to enforce their own patents and thus subject such patents to validity challenges. The knowledge of these tools, and their various pros and cons, provided through this presentation give companies needed information to assist their strategic decision-making.
Sooner or later, nearly all high technology companies encounter one or more patents that may present a roadblock to bringing a product to market or to conducting important research.
This audio conference presentation provides an overview of the legal tools available in the United States to help address such “problem” patents. In particular, our speakers provide a detailed discussion of patent re-examinations and the interplay between re-examinations and litigation. Additionally, the presentation looks at other mechanisms that may be used when one encounters a problematic patent, such as licensing, design-arounds, protests, interferences, and arbitration.
This presentation is informative both for companies that are concerned with patents held by others, as well as companies that may seek to enforce their own patents and thus subject such patents to validity challenges. The knowledge of these tools, and their various pros and cons, provided through this presentation give companies needed information to assist their strategic decision-making.
Friday, May 13, 2011
Navigating China's Medical Device Regulations
is being presented by Chang-Hong Whitney, MBA, RAC, President, Whitney Consulting Ltd. and airs on Thursday, June 16th, 2011. For more details, or to register please visit our site at www.fxconferences.com
China's medical device regulations have evolved greatly over the past twenty years. However, navigating the Chinese regulatory system is still a daunting task for many western companies. This audio conference provides essential information on the Chinese regulatory requirements for medical devices. Our speaker provides attendees with first-hand insight and guidance, drawing upon the experience and knowledge gleaned from daily dealings with SFDA officials and through managing numerous registration projects in China. Attendees learn the essential requirements for getting their medical products approved for the Chinese market, the time and costs involved, issues to watch for and obstacles down the road.
China's medical device regulations have evolved greatly over the past twenty years. However, navigating the Chinese regulatory system is still a daunting task for many western companies. This audio conference provides essential information on the Chinese regulatory requirements for medical devices. Our speaker provides attendees with first-hand insight and guidance, drawing upon the experience and knowledge gleaned from daily dealings with SFDA officials and through managing numerous registration projects in China. Attendees learn the essential requirements for getting their medical products approved for the Chinese market, the time and costs involved, issues to watch for and obstacles down the road.
Thursday, May 12, 2011
Alliance Management - Bridging the Gap Between Drugs and Diagnostics
is being presented by David Kern, RAC MBA, Senior Director, Myraqa and airs on Tuesday, July 12th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Alliance management has long been a core competency in many drug companies, as a way of helping to ensure that compounds discovered by biotech partners make their way to the market. Yet the relationship between drug and diagnostics companies has been a challenge for both sides. Understanding how to manage these strategic relationships is critical to the successful development of a companion diagnostic test, and there can be consequences for a drug company not taking an active role in these alliances.
In this audio conference presentation, our speaker examines the issue, and discusses when and how to start looking for a diagnostics partner, how to structure the relationship, and how best to work together for mutual benefit.
Alliance management has long been a core competency in many drug companies, as a way of helping to ensure that compounds discovered by biotech partners make their way to the market. Yet the relationship between drug and diagnostics companies has been a challenge for both sides. Understanding how to manage these strategic relationships is critical to the successful development of a companion diagnostic test, and there can be consequences for a drug company not taking an active role in these alliances.
In this audio conference presentation, our speaker examines the issue, and discusses when and how to start looking for a diagnostics partner, how to structure the relationship, and how best to work together for mutual benefit.
Wednesday, May 11, 2011
Preparing for FDA GCP Inspections – Essentials for Sponsors and Clinical Sites
is being presented by Kimberly Kiner, President, of 2K Clinical Consulting and airs on Wednesday, June 8th, 2011. For more details, or to register please visit our site at www.fxconferences.com
GCP inspections, particularly those involving FDA investigators, are often seen as an intimidating and adversarial experience, as opposed to a useful process for improving quality and ensuring compliance. However, there are steps you can take to make the process less stressful, and to avoid the most common issues arising during these inspections.
In this audio conference, our speaker, a former FDA investigator, shares insight on how FDA prepares for an inspection, and reviews GCP regulations and FDA guidelines used for inspections. The presentation provides attendees from sponsor companies (pharmaceutical, biotech, device/diagnostics) and clinical sites with practical information on how to utilize quality improvement methods to effectively prepare for FDA GCP inspections.
GCP inspections, particularly those involving FDA investigators, are often seen as an intimidating and adversarial experience, as opposed to a useful process for improving quality and ensuring compliance. However, there are steps you can take to make the process less stressful, and to avoid the most common issues arising during these inspections.
In this audio conference, our speaker, a former FDA investigator, shares insight on how FDA prepares for an inspection, and reviews GCP regulations and FDA guidelines used for inspections. The presentation provides attendees from sponsor companies (pharmaceutical, biotech, device/diagnostics) and clinical sites with practical information on how to utilize quality improvement methods to effectively prepare for FDA GCP inspections.
Tuesday, May 10, 2011
FDA on the Edge: What's Next for 510(k)?
is being presented by Robert J. Klepinski, Regulatory Attorney, with Fredrikson & Byron and airs on Thursday, June 2nd, 2011. For more details, or to register please visit our site at www.fxconferences.com
Various tracks are coming together in 2011 which will affect the manner in which 510(k)s and other submissions will be reviewed by FDA. The Institute of Medicine report has been peer-reviewed and is expected to be released shortly. However, the FDA list of intended changes contains several items that are about to change, regardless of IOM recommendation.
For medical device manufacturers, it is a time of expectation and, perhaps, a little trepidation. This audio conference takes a look at what is likely to change, and discusses how best to prepare for this new reality.
Various tracks are coming together in 2011 which will affect the manner in which 510(k)s and other submissions will be reviewed by FDA. The Institute of Medicine report has been peer-reviewed and is expected to be released shortly. However, the FDA list of intended changes contains several items that are about to change, regardless of IOM recommendation.
For medical device manufacturers, it is a time of expectation and, perhaps, a little trepidation. This audio conference takes a look at what is likely to change, and discusses how best to prepare for this new reality.
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