Optimize Presentation Preparation • Anticipate Panel Questions and Collaborate with Regulatory Agencies to Achieve Favorable Recommendation
- Washington, District of Columbia
Available for $495.00
It is now more important than ever to be well prepared for a FDA Advisory Committee review. CBI’s forum gives you the tools to meet this challenge.
The Food and Drug Administration Amendments Act (FDAAA) of 2007, created by PDUFA-IV, required the FDA to initiate independent reviews of most new products. Since then, Advisory Committees have broadened to cover post-marketing products, individual compounds and more. Due to the immense importance of an FDA Advisory Committee Meeting to a sponsor, it is crucial to properly prepare in order to present with poise, have a clear strategy to anticipate panel questions and present clinical and safety data effectively to achieve positive results. This event puts you ahead of the curve.
Hear from sponsor’s clinical and regulatory leaders, and foremost experts from past committees, consulting firms and government agencies about meeting the increasing demands of Advisory Committee review, including:
- FDA’s new guidance and process of preparing for an advisory committee meeting
- Rx to OTC switch process and planning for advisory committee boards
- Important steps to follow during preparation to ensure a successful review
- Demonstrating market need and value to a diverse panel of experts
- Preparation for the challenges of Q&A sessions