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.
Tuesday, May 31, 2011
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.
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