The Role of Industry and FDA Statisticians: Who are they, what do they do and the vital role they serve
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What to expect from this video:
The Underpinnings of Interacting with FDA during the Product Development Lifecycle Focused on the Role of the Statistician: A 3-part series led and moderated by a former FDA statistical reviewer and an industry/CRO expert. In this Webinar series, we will discuss the roles of statisticians in the pharmaceutical/biotechnology industry and within FDA with a focus on interactions between sponsors and FDA during the product development cycle. This series will be led by two experienced statisticians: one with comprehensive experience in industry and statistical consulting and the other with extensive experience as reviewer in the Center for drug Evaluation and Research (CDER) at FDA. The target audience for this webinar series includes industry and regulatory statisticians.
Part 1 will introduce the organization of the FDA focusing on the Office of New Drugs within CDER, roles and responsibilities of FDA and industry statisticians and various types of regulatory interactions between industry sponsors and FDA.