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Session 11: Sessions Track B: Pre-Approval Activities: How Much Information is Too Much?
Session Chair(s)
Kimberly Belsky, MS
Reg Policy & Intell and AdPromo, Regulatory Affairs
Independent, United States
Learning Objective : At the conclusion of this session, participants should be able to:- Discuss the basic regulatory requirements regarding pre-approval activities and past enforcement actions
- Leverage pre-launch strategic and tactical actions that reflect today’s regulatory environment including Payer discussions
- Integrate legal and compliance opportunities and risk mitigation into pre-approval actions
Speaker(s)
Speaker
Kevin Stark, MBA, RAC
Mallinckrodt, United States
Executive Director, Regulatory Affairs
Speaker
Joanne Curley, MBA
Jazz Pharmaceuticals, Inc., United States
Vice President, Head of Global Regulatory Affairs
Speaker
Kellie B. Combs, JD
Ropes & Gray LLP, United States
Partner