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Strategies for Communicating with FDA
Session Chair(s)
Leah Christl, PHD
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
Amgen, United States
Do you ever wonder how your peers manage their interactions with FDA? Do you wonder why your peers get a response when you do not? What challenges, and what successes, have you had? Join us for an interactive session to discuss best practices and strategies for communicating with FDA. You will work in groups to evaluate a communication scenario, develop a set of options for your approach to communicating, and develop strategies, best practices, tips, etc. based on your experience and general knowledge. This is not an overview of meeting types or timelines; this is an opportunity to brainstorm ideas and share strategic best practices around communication.
Learning Objective : Explore various strategies for communication with FDA; Discover best practices for communication from your peers.
Speaker(s)
Session Co-Chair
Kim Quaintance-Lunn
Alexion, United States
Vice President, Head of Regulatory Science and Execution