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.
Showing posts with label Alan Minsk. Show all posts
Showing posts with label Alan Minsk. Show all posts
Thursday, December 1, 2011
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.
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