is being presented by Salma Michor, CEO and Principal Consultant, with Michor Consulting EU and airs on Wednesday, September 1st, 2010. For more details or to register, please visit our site at www.fxconferences.com
Manufacturers placing medical devices on the European market must have a vigilance system in place to collect and evaluate reported incidents. To prevent the recurrence of such incidents it may be necessary to take corrective actions. At a higher level, the vigilance system forms an integral part of a post-market surveillance system (PMS).
In the EU the medical devices directive (MDD) establishes the principal mechanisms for providing feedback about medical devices. The revision of the MDD has had an impact on clinical evaluations/investigations and vigilance reporting. The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. New clauses added to Annex X of the MDD stipulate that all serious adverse events must be fully recorded and immediately reported to all Competent Authorities of the Member States in which the clinical investigation is being performed.
This audio conference takes a detailed look at EU provisions for post-marketing surveillance and vigilance for medical device trials under the revised Directive.
Thursday, July 29, 2010
Doing Business in Japan: Lessons from a Road Warrior
is being presented by Keith B. Russell, President, of Global Pharmaceutical Services Inc. and airs on Wednesday, September 8th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Do you know how to avoid being perceived as an 'ugly foreigner' when working in Japan? Does the idea of going to Japan on business create anxiety or sleepless nights? Do you worry about committing a faux pas – perhaps without even knowing – that could cast you and your company in an unflattering light? If so, this presentation is for you.
This audio conference discusses in detail everything you need to know related to the social, cultural and business issues you might encounter while working in Japan. Attendees benefit from the perspective of a road warrior who has traveled to Japan dozens of times over the past 23 years, and has spent up to 100 days a year in-country while working for a major international pharmaceutical company and as an independent entrepreneur.
Do you know how to avoid being perceived as an 'ugly foreigner' when working in Japan? Does the idea of going to Japan on business create anxiety or sleepless nights? Do you worry about committing a faux pas – perhaps without even knowing – that could cast you and your company in an unflattering light? If so, this presentation is for you.
This audio conference discusses in detail everything you need to know related to the social, cultural and business issues you might encounter while working in Japan. Attendees benefit from the perspective of a road warrior who has traveled to Japan dozens of times over the past 23 years, and has spent up to 100 days a year in-country while working for a major international pharmaceutical company and as an independent entrepreneur.
Thursday, July 22, 2010
Adapting Project Risk Mitigation and Prevention Tools in Real-Life Trials
is being presented by Susan Schenk, Clinical Development Services, Director, Operational Strategy & Planning, with Covance Inc. and airs on Tuesday, September 21st, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Managing and preventing risk is an integral part of clinical trial conduct in order to achieve high-quality data on time and on budget. However, industry data reveals that a large percentage of clinical trial budgets is allocated towards remediation, focused on fixing problems after they occur, rather than towards proactive activities to help predict and prevent costly errors. This audio conference showcases a complementary range of real-life examples of how to leverage sophisticated tools such as Failure Modes & Effects Analysis (FMEA) to proactively manage project-related risk.
However, in the project management arena, there is often a gap between the sophisticated tools and proactive approaches available to manage project-related risk, and the general level of understanding of how to deploy these tools.
Specifically addressing this issue, the audio conference aims to help close the gap by exploring a number of different ways to leverage theory into practice. Acknowledging the need for continuous mitigation of project-related risks, the speaker also demonstrates methods to overcome challenges that may occur mid-study, successfully absorbing and minimizing the impact to timelines and resources.
Managing and preventing risk is an integral part of clinical trial conduct in order to achieve high-quality data on time and on budget. However, industry data reveals that a large percentage of clinical trial budgets is allocated towards remediation, focused on fixing problems after they occur, rather than towards proactive activities to help predict and prevent costly errors. This audio conference showcases a complementary range of real-life examples of how to leverage sophisticated tools such as Failure Modes & Effects Analysis (FMEA) to proactively manage project-related risk.
However, in the project management arena, there is often a gap between the sophisticated tools and proactive approaches available to manage project-related risk, and the general level of understanding of how to deploy these tools.
Specifically addressing this issue, the audio conference aims to help close the gap by exploring a number of different ways to leverage theory into practice. Acknowledging the need for continuous mitigation of project-related risks, the speaker also demonstrates methods to overcome challenges that may occur mid-study, successfully absorbing and minimizing the impact to timelines and resources.
Wednesday, July 21, 2010
Creating Usable, Engaging Websites
is being presented by Daniel Szuc, Principal Usability Consultant, with Apogee Usability Asia Ltd and airs on Tuesday, August 31st, 2010. For more details or to register, please visit our site at www.fxconferences.com
Have you ever thought about which websites you love to visit and why? Why are some sites so hard to use?
Usability isn’t a "nice-to-have" in web design — it is essential. If people find it hard to do what they need to on the your website, then research shows they just won’t use it. According to Arthur Andersen, "More than 83% of Internet users are likely to leave a website if they feel they have to make too many clicks to find what they're looking for."
Designing and building a corporate website is an expensive and time-consuming undertaking, and too often, the end product falls short of what visitors want. This presentation looks at how to incorporate usability thinking into website design, discussing common approaches to get customers involved to find out what they need, and how to evaluate and test your site for usability.
Have you ever thought about which websites you love to visit and why? Why are some sites so hard to use?
Usability isn’t a "nice-to-have" in web design — it is essential. If people find it hard to do what they need to on the your website, then research shows they just won’t use it. According to Arthur Andersen, "More than 83% of Internet users are likely to leave a website if they feel they have to make too many clicks to find what they're looking for."
Designing and building a corporate website is an expensive and time-consuming undertaking, and too often, the end product falls short of what visitors want. This presentation looks at how to incorporate usability thinking into website design, discussing common approaches to get customers involved to find out what they need, and how to evaluate and test your site for usability.
Tuesday, July 20, 2010
Failure Modes & Effects Analysis (FMEA)
is being presented by Angelo Scangas, President of Quality Support Group, Inc. and airs on Tuesday, August 31st, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Failure Modes and Effects Analysis (FMEA) is a powerful technique designed to help the engineer improve the quality and reliability of design. When properly used, FMEA provides numerous benefits, including improved product/process reliability and quality, increased customer satisfaction, early identification and elimination of potential product/process failure modes, and prioritization of product/process deficiencies. It also facilitates capturing engineering/organization knowledge, emphasizes problem prevention, documents risk and actions taken to reduce risk, and provides focus for improved testing and development.
Applying this technique serves to identify critical parameters and support the continual improvement of products and services. Doing a comprehensive FMEA up-front, when product /process can be most easily and inexpensively implemented, will alleviate late-change crises. The process is disciplined, interactive and never- ending, and many industries require FMEAs as a preventive tool.
This audio conference introduces the topic of FMEA and provides a general guidance in the application of this powerful prevention technique.
Failure Modes and Effects Analysis (FMEA) is a powerful technique designed to help the engineer improve the quality and reliability of design. When properly used, FMEA provides numerous benefits, including improved product/process reliability and quality, increased customer satisfaction, early identification and elimination of potential product/process failure modes, and prioritization of product/process deficiencies. It also facilitates capturing engineering/organization knowledge, emphasizes problem prevention, documents risk and actions taken to reduce risk, and provides focus for improved testing and development.
Applying this technique serves to identify critical parameters and support the continual improvement of products and services. Doing a comprehensive FMEA up-front, when product /process can be most easily and inexpensively implemented, will alleviate late-change crises. The process is disciplined, interactive and never- ending, and many industries require FMEAs as a preventive tool.
This audio conference introduces the topic of FMEA and provides a general guidance in the application of this powerful prevention technique.
Friday, July 16, 2010
Human Factors Design, Testing & Risk Analysis
is being presented by William R. Mandel, Directory of Technology, with Oasis Medical Solutions and airs on Wednesday, August 25th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Human factors study has become a key element for FDA scrutiny. It is also a challenging field because subjective perspectives are evaluated and used to create a quantitative analysis, which must be concrete and testable. Careful consideration and execution must be utilized in navigating this less-than-comfortable process.
This presentation explores the multidimensional aspects of human factors design and testing from initial conception to manufacturing, and how to compile the essential core human factors elements to add to the design history file. Understanding terminology is a key aspect of this process. The speaker also discusses the importance of risk analysis and its process in relation to human factors testing. Finally, we explore the fundamentals of performing human factors testing in a real-world scenario and examine the methods of turning data into concrete, acceptable, easy-to-understand documentation.
Human factors study has become a key element for FDA scrutiny. It is also a challenging field because subjective perspectives are evaluated and used to create a quantitative analysis, which must be concrete and testable. Careful consideration and execution must be utilized in navigating this less-than-comfortable process.
This presentation explores the multidimensional aspects of human factors design and testing from initial conception to manufacturing, and how to compile the essential core human factors elements to add to the design history file. Understanding terminology is a key aspect of this process. The speaker also discusses the importance of risk analysis and its process in relation to human factors testing. Finally, we explore the fundamentals of performing human factors testing in a real-world scenario and examine the methods of turning data into concrete, acceptable, easy-to-understand documentation.
Thursday, July 15, 2010
Audio, Video & Subtitles: Localizing Multimedia Content
is being presented by Xavier Marchand, COO, of JBI Studios and airs on Wednesday, August 4th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Multimedia files using audio and video (A/V) have become an important part of training material and corporate communications for companies wanting to effectively address a global audience. However, this enriched content presents new challenges during the localization process: the multimedia component adds dramatically to the impact of communications, but can also prove costly if not handled properly.
This audio conference presents an overview of A/V localization, including a review of the various options for localizing A/V content, and the associated cost implications. Our speaker also discusses content development with an eye to streamlining translation, and provides strategies for organizing your assets to reduce translation and localization costs as well as turnaround time. Attendees also learn the common pitfalls to avoid during the multimedia localization process.
Multimedia files using audio and video (A/V) have become an important part of training material and corporate communications for companies wanting to effectively address a global audience. However, this enriched content presents new challenges during the localization process: the multimedia component adds dramatically to the impact of communications, but can also prove costly if not handled properly.
This audio conference presents an overview of A/V localization, including a review of the various options for localizing A/V content, and the associated cost implications. Our speaker also discusses content development with an eye to streamlining translation, and provides strategies for organizing your assets to reduce translation and localization costs as well as turnaround time. Attendees also learn the common pitfalls to avoid during the multimedia localization process.
Wednesday, July 14, 2010
QA Oversight of Contractors
is being presented by Marion Weinreb, President, of Marion Weinreb & Associates, Inc and airs on Tuesday, August 24th, 2010. For more details or to register for this event, please visit our website at www.fxconferences.com
Managing contractors is key to successful operations. As companies continue to outsource processes, the quality agreement becomes critical to supply chain operations. Quality agreements are required by the EU GMPs and are recommended per the International Conference on Harmonization's (ICH) Q10, known as Pharmaceutical Quality System.
This audio conference discusses what a quality agreement is and how to use it as a tool in managing your contractors. It also identifies the key elements of what to include in the quality agreement so that if something goes wrong, responsibilities have been clearly delineated and corrective action can proceed smoothly.
Managing contractors is key to successful operations. As companies continue to outsource processes, the quality agreement becomes critical to supply chain operations. Quality agreements are required by the EU GMPs and are recommended per the International Conference on Harmonization's (ICH) Q10, known as Pharmaceutical Quality System.
This audio conference discusses what a quality agreement is and how to use it as a tool in managing your contractors. It also identifies the key elements of what to include in the quality agreement so that if something goes wrong, responsibilities have been clearly delineated and corrective action can proceed smoothly.
Tuesday, July 13, 2010
Process and SOP Development for Medical Device Companies
is being presented by Phil Guarino, Managing Partner, with Quality Solutions Now (QSN)and airs on Wednesday, August 18th, 2010. For more details or to register, please visit our site at www.fxconferences.com
In order to thrive in today's economy, companies have had to "lean out" their organizations. With this push for a lean environment comes the responsibility to do things right the first time, and when issues arise and must be adressed, this must be done in a very efficient and compliant manner. This means re-engineering processes the right way.
This audio conference presentation focuses on how to create compliant yet efficient processes using 'lean compliance' techniques, which includes mapping process, determining inefficiencies and compliance gaps, with the end result being processes that are unambiguous and easy to follow. The speaker also discusses effective use of resources, employee involvement, abstract thinking, and effective change management, with the understanding that SOPs do not drive processes, processes drive SOPs.
In order to thrive in today's economy, companies have had to "lean out" their organizations. With this push for a lean environment comes the responsibility to do things right the first time, and when issues arise and must be adressed, this must be done in a very efficient and compliant manner. This means re-engineering processes the right way.
This audio conference presentation focuses on how to create compliant yet efficient processes using 'lean compliance' techniques, which includes mapping process, determining inefficiencies and compliance gaps, with the end result being processes that are unambiguous and easy to follow. The speaker also discusses effective use of resources, employee involvement, abstract thinking, and effective change management, with the understanding that SOPs do not drive processes, processes drive SOPs.
Monday, July 12, 2010
Selecting a Phase I Clinical Trial Site
is being presented by Lorraine S. DeCesare, President, with LS Drug Development, Inc. and airs on Tuesday, August 17th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Phase I clinical trials are a critical step in the development program for an investigational product. First-in-man studies are the first step in the development program, but bioequivalency studies and food effect studies can also make or break the life cycle of an investigational product. Phase I studies are very different from Phase II-IV studies; all subjects in a Phase I study participate at the same time and at the time scheduled by the site, whereas in Phase III studies each subject participates on his own schedule. All activities in a Phase I study are conducted relative to the time of dosing and are usually minutes rather than days or even weeks apart as in Phase III studies.
This audio conference discusses the critical areas in selection of a clinical trial site for the conduct of Phase I studies, be they complex first-in-man studies or more routine bioequivalence studies.
Phase I clinical trials are a critical step in the development program for an investigational product. First-in-man studies are the first step in the development program, but bioequivalency studies and food effect studies can also make or break the life cycle of an investigational product. Phase I studies are very different from Phase II-IV studies; all subjects in a Phase I study participate at the same time and at the time scheduled by the site, whereas in Phase III studies each subject participates on his own schedule. All activities in a Phase I study are conducted relative to the time of dosing and are usually minutes rather than days or even weeks apart as in Phase III studies.
This audio conference discusses the critical areas in selection of a clinical trial site for the conduct of Phase I studies, be they complex first-in-man studies or more routine bioequivalence studies.
Friday, July 9, 2010
How to Measure Translation Quality
is being presented by Andres Heuberger, President, of ForeignExchange Translations, and airs on Thursday, August 12th, 2010. For more details or to register, please visit our site at www.fxconferences.com
The quality of translation lies in the eye of the beholder, making a "good" or "bad" judgement highly subjective. Miscommunication and stylistic preferences often mark these discussions and a surprising number of organizations and translation vendors have no quality system in place at all.
When there is no single, accepted definition of translation quality, how can organizations measure it? This audio conference will help you better understand the proven methodologies for measuring translation quality and sort through the myriad options available to find a solution that is right for you.
The quality of translation lies in the eye of the beholder, making a "good" or "bad" judgement highly subjective. Miscommunication and stylistic preferences often mark these discussions and a surprising number of organizations and translation vendors have no quality system in place at all.
When there is no single, accepted definition of translation quality, how can organizations measure it? This audio conference will help you better understand the proven methodologies for measuring translation quality and sort through the myriad options available to find a solution that is right for you.
Thursday, July 8, 2010
Stopping Workplace Absenteeism and FMLA Abuse
is being presented by Jodie-Beth Galos, Esq., SPHR, Employment Law Attorney and airs on Wednesday, August 11th, 2010. For more details or to register, please visit our site at www.fxconferences.com
The old saying goes that 90% of life is showing up. Unfortunately, some employees routinely don't. These no-show employees cause resentment for the rest of the crew, and besides creating morale issues, absenteeism racks up millions of dollars each year in lost productivity. What innovative, legally-sound techniques can you use to confront chronic absenteeism, eliminate abuse and save money? This audio conference addresses how to avoid legal landmines -- federal and state laws critical to absenteeism issues. The focus is on confronting problem employees and nipping excuses in the bud (including FMLA intermittent leave abuses). The presentation also looks at creating effective policies to reduce abuse in order to combat negative morale before it poisons your organization. This practical, fast-paced program provides the very latest information on creative techniques to reduce employee absenteeism, foster employee accountability and improve your organization’s bottom line.
The old saying goes that 90% of life is showing up. Unfortunately, some employees routinely don't. These no-show employees cause resentment for the rest of the crew, and besides creating morale issues, absenteeism racks up millions of dollars each year in lost productivity. What innovative, legally-sound techniques can you use to confront chronic absenteeism, eliminate abuse and save money? This audio conference addresses how to avoid legal landmines -- federal and state laws critical to absenteeism issues. The focus is on confronting problem employees and nipping excuses in the bud (including FMLA intermittent leave abuses). The presentation also looks at creating effective policies to reduce abuse in order to combat negative morale before it poisons your organization. This practical, fast-paced program provides the very latest information on creative techniques to reduce employee absenteeism, foster employee accountability and improve your organization’s bottom line.
Tuesday, July 6, 2010
Strategic Immunogenicity Planning for Successful Biosimilar Development
is being presented by Ana T. Menendez, Senior Director, Biotechnology, with Catalent Pharma Solutions and airs on Tuesday, August 10th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
The FDA has recently provided a pathway to biosimilar development, which is expected to increase annual biosimilar revenues from $0.06 billion in 2008 to $1.95 billion by 2014 (Visiongain Report Biosimilars and Follow-on Biologics 2009-2024, 2009).
Biopharmaceuticals demonstrate therapeutic success because of their excellent targeting ability. This advantage is tempered with the danger of inducing an unwanted immune response in patients. Immunogenicity programs need to establish immunogenic similarity between innovator and biosimilar. Quick identification, characterization and interpretation of antibody response is crucial to interpret changes in the potency and safety of the drug.
The first part of this audio conference reviews intrinsic and external factors that can significantly impact immunogenicity risk management. The next two sections explain key documents (regulatory & industry), methods and timeline expectations to assure compliance. The last section discusses relevant case studies that highlight the impact of immunogenicity on the success of clinical trials.
The FDA has recently provided a pathway to biosimilar development, which is expected to increase annual biosimilar revenues from $0.06 billion in 2008 to $1.95 billion by 2014 (Visiongain Report Biosimilars and Follow-on Biologics 2009-2024, 2009).
Biopharmaceuticals demonstrate therapeutic success because of their excellent targeting ability. This advantage is tempered with the danger of inducing an unwanted immune response in patients. Immunogenicity programs need to establish immunogenic similarity between innovator and biosimilar. Quick identification, characterization and interpretation of antibody response is crucial to interpret changes in the potency and safety of the drug.
The first part of this audio conference reviews intrinsic and external factors that can significantly impact immunogenicity risk management. The next two sections explain key documents (regulatory & industry), methods and timeline expectations to assure compliance. The last section discusses relevant case studies that highlight the impact of immunogenicity on the success of clinical trials.
Monday, July 5, 2010
A Practical Approach to Medical Device Risk Management
is being presented by Harvey Rudolph, Ph.D., HRRM, LLC, Risk Management Consultant and airs on Tuesday, August 3rd, 2010. For more details or to register please visit our site at www.fxconferences.com
Risk management is required by almost all regulatory bodies and is necessary for implementing many standards that medical device manufacturers use in designing and developing their products. Over the past ten years, most manufacturers have tried to model their risk management system on the one described in ISO 14971, because that is the one accepted by most regulatory bodies and referenced in most standards. However, myriad problems have been encountered in trying to implement risk management within existing quality management systems. Why is this? If ISO 14971 is so great, why isn’t it easier to do? What are the factors inhibiting success in making risk management work? In this audio conference, leading risk management expert Dr. Harvey Rudolph discusses some of the major issues facing medical device companies, and practical solutions.
Risk management is required by almost all regulatory bodies and is necessary for implementing many standards that medical device manufacturers use in designing and developing their products. Over the past ten years, most manufacturers have tried to model their risk management system on the one described in ISO 14971, because that is the one accepted by most regulatory bodies and referenced in most standards. However, myriad problems have been encountered in trying to implement risk management within existing quality management systems. Why is this? If ISO 14971 is so great, why isn’t it easier to do? What are the factors inhibiting success in making risk management work? In this audio conference, leading risk management expert Dr. Harvey Rudolph discusses some of the major issues facing medical device companies, and practical solutions.
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