Compliance Trainings, Online
2016-04-06
Description : Many FDA approved products have uses beyond what they have been approved for. Manufacturers have to follow very strict guidelines to inform physicians about these additional uses. Manufacturers also have to deal with consumers directly asking for more information about such uses. This seminar will discuss FDA-acceptable practices to collect, distribute and manage off-label information about FDA-approved products. Practical advice based on multiple case studies regarding off-label promotion for products by manufacturers. Attendees will get a list of do’s and don’ts for discussing published material, clinical experience, investigational uses, and anecdotal information. Social media techniques will also be discussed. Areas Covered in the Session : FDA-permitted off-label promotion techniques FDA guidance about off-label information management What is an Off-Label Use? Pros and cons of common methods for off-label promotion Converting off-label to on-label information Do’s and don’ts of social media techniques in off-label promotion Legal Vs Regulatory Paradigms Commercial Promotion of Off-Label Use Common Myth: FDA Does not Allow Off-Label Use Regulation of Advertisement Request for Off-Label Information Do’s and Don’ts for Responding to Unsolicited Request Risks with Soliciting information Distributing Peer-Reviewed Published Literature Common Complaints from FDA What to Expect in the Near Future Speaker’s Recommendation and Suggestions on PASS-IT Solutions Conclusion Who Will Benefit: Manufacturers of FDA regulated products: Drug, Medical Device and Biotech Companies, Dietary supplement manufacturers Marketing and Advertising Professionals Financial analysts and investors, venture capitalists, insurance professionals Legal experts involved in advising manufacturers of marketed products Senior management for companies developing new products for US market Regulatory affairs professionals, research analysts
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