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Preparation for FDA Advisory Panel and Other FDA Meetings

Preparation for FDA Advisory Panel and Other FDA Meetings. Margaret E. Hurley, M.D. President and CEO Hurley Consulting Associates Ltd. Chatham, NJ. Session Objectives. FDA and Sponsor and Perspective on How to Prepare for Meetings: Elements for Success Best Practices

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Preparation for FDA Advisory Panel and Other FDA Meetings

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  1. Preparation for FDA Advisory Panel and Other FDA Meetings Margaret E. Hurley, M.D. President and CEO Hurley Consulting Associates Ltd. Chatham, NJ

  2. Session Objectives FDA and Sponsor and Perspective on How to Prepare for Meetings: • Elements for Success • Best Practices • Pitfalls to Avoid

  3. What Session Will Cover • Regulations and Requirements • Basics of Advisory Committees and Other Meetings: • Purpose • Membership • Function • Step-by-Step “How To”

  4. Role of Regulatory Affairs • Leader • Planner • Strategist • Tracker • Facilitator • Team Member • Coach One of the Keys to Successful Meetings

  5. Key Success Factors • Early Planning • Establishing Strategy • Preparation • Tracking Despite This, Not All Meetings Result in the Sponsor’s Desired Outcome

  6. Program • Preparation Strategies for FDA Meetings • FDA Perspective –Kim Colangelo • Sponsor Perspective – Susan Mondabaugh, Ph.D. • Break • Preparing for Advisory Committee Meetings • FDA, CDER’s Advisors & Consultants Staff (ACS) Perspective – Igor Cerny, Pharm.D. • Sponsor Perspective – Robert Kirsch, Ph.D. • Questions

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