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Can We Talk? Alternative Strategies for Communicating with FDA
Session Chair(s)
Kim Quaintance-Lunn
Vice President, Head of Regulatory Science and Execution
Alexion, United States
Experienced regulatory professionals know that formal meetings are insufficient to address all the issues that arise during drug development. Our panel will discuss best practices and innovative ways to ensure optimal communications with FDA.
Learning Objective : Identify available avenues for communication with FDA; Evaluate opportunities to maximize effective interactions with FDA; Formulate strategic plans around communicating with FDA.
Speaker(s)
Consultant Perspective
Mark Ammann, PharmD
Quantum Regulatory Solutions, LLC, United States
President
Industry Perspective
Khyati Roberts, RPh
Retired, United States
Retired
FDA Perspective
Rachel E. Hartford
FDA , United States
Lead Consumer Safety Officer, Office of New Drugs, CDER
注册方法
Registration override should work.