fda advisory committee training an industry representative perspective alison lawton sr. vp...
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FDA Advisory Committee Training
An Industry Representative Perspective
Alison Lawton
Sr. VP Regulatory Affairs
Genzyme Corporation
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Background to Industry Representative
Introduced in FDA Modernization ActNon-voting member, non–SGE
– Financial interest disclosure
Conflict of interest?– Personal example
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Process for Nomination
Federal Register notice publishedIndustry organizations interested send a
letter within 30 daysFDA requests organizations to consult in
selecting candidate (if more than 1 identified)
Single nominee provided to FDA within 60 days
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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
experienceIndustry Associations agree on a single
nominee Nominee details sent to FDA
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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