AFDO RAPS Healthcare Products Collaborative
BIO

Stephanie

Shapley

Associate Director for Policy, Office of Combination Products

FDA

Stephanie Shapley serves as Associate Director for Policy in FDA's Office of Combination Products, bringing over 20 years of FDA experience. Her roles have included Senior Regulatory Policy Advisor, Associate Director for Regulatory Affairs in Medical Policy, and Bioresearch Monitoring Specialist. She holds a biology degree from Binghamton University and an MBA from Sacred Heart University.

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The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.

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