Many FDA approved products have uses beyond what they have been approved for. Manufacturers have to follow strict guidelines to inform physicians about these additional uses. Manufacturers also have to deal with consumers directly asking for more information about such uses.
Update yourself with all the FDA-acceptable practices to collect, distribute, and manage off-label information about FDA-approved products with our expert speaker Dr. Mukesh Kumar. You get practical advice based on multiple case studies regarding off-label promotion for products by the manufacturers.
Plus, you get a list of do’s and don’ts for discussing published material, clinical experience, investigational uses, and anecdotal information. Our expert will also discuss the Do's and don'ts of social media techniques in off-label promotion.
Here are a few highlights of the session:
Who should attend?
- Dr. David Lim
Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials, and multi-national project management for medicinal and diagnostic products. He has been involved in about 100...
More Events By The Speaker