So, you want to meet with the FDA? Preparing for regulator meetings & how statisticians can influence these interactions
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What to expect from this video:
This webinar will be exploration into the process of interacting with FDA including how to prepare an effective meeting package with specific questions for regulatory consideration, last minute preparation leading up the meeting, and what to expect during the meeting. This presentation will include examples of interactions with specific review divisions focusing on the role of the FDA and industry statisticians in driving scientific discussions. The webinar will be led by Dr. Joshua Baker, PhD, VP of Biometrics who will present on his unique experiences interacting with regulators from the industry perspective and Dr. LaRee Tracy, PhD, Director of Biostatistics who will share her experiences as a former FDA/CDER statistical reviewer.