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.
Tuesday, November 22, 2011
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.
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