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FDA Advisory Committee Training

FDA Advisory Committee Training. An Industry Representative Perspective Alison Lawton Sr. VP Regulatory Affairs Genzyme Corporation. Background to Industry Representative. Introduced in FDA Modernization Act Non-voting member, non–SGE Financial interest disclosure Conflict of interest?

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FDA Advisory Committee Training

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  1. FDA Advisory Committee Training An Industry Representative Perspective Alison Lawton Sr. VP Regulatory Affairs Genzyme Corporation

  2. Background to Industry Representative • Introduced in FDA Modernization Act • Non-voting member, non–SGE • Financial interest disclosure • Conflict of interest? • Personal example

  3. Process for Nomination • Federal Register notice published • Industry organizations interested send a letter within 30 days • FDA requests organizations to consult in selecting candidate (if more than 1 identified) • Single nominee provided to FDA within 60 days

  4. How is the Industry Rep. Selected? • Industry Associations poll members for nominees • Nominees are reviewed by appropriate committee e.g. PhRMA RACC • Education, knowledge in subject, industry experience • Industry Associations agree on a single nominee • Nominee details sent to FDA

  5. What is the role of the Industry Rep.? • Represents global concerns for industry (not their own company) • Provide industry perspective to discussions e.g. cost or practical application of a proposal, regulatory standards • Speak with industry &/or sponsor before meeting to ensure appropriate representation

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