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Special Protocol Assessments: Decoding FDA’s SPA Program and Revised Guidance
When should you consider pursuing an SPA? If you do, how long will it take?
How has the revised guidance changed the process?
Join Alexander Varond — Associate at Hyman, Phelps & McNamara — for an overview of the SPA program and a discussion of the impact of the FDA’s new draft guidance on sponsors and regulatory affairs professionals, and key opportunities and challenges for sponsors.
After attending this 90-minute session you will:
Order today for a thorough understanding of the FDA’s SPA process and its benefits.
Alexander Varond, Associate, Hyman, Phelps & McNamara
Alexander Varond works on medical device and drug development, advertising and promotion and enforcement issues. He counsels clients on development matters such as clinical trial design, REMS, orphan drug designation, formal dispute resolution and patent and exclusivity issues. Mr. Varond also supports ongoing litigation efforts and performs due diligence for corporate transactions.
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