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.
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