Bio

Daniela Drago, Ph.D., RAC is an Associate Professor and the Director of Regulatory Affairs Programs at George Washington University’s School of Medicine and Health Sciences.

Prior to joining academia, she has held senior positions in global regulatory and medical affairs at F. Hoffman-La Roche, Vifor Pharma, Reckitt Benckiser, and Bausch & Lomb. Dr. Drago has assisted in the development of hundreds of regulated products. She prepared and evaluated hundreds of global regulatory submissions and participated in numerous meetings with regulatory agencies.

She serves as an expert witness on FDA requirements, global regulatory strategies, and compliance matters.

Her current research interests focus on optimizing the development of FDA-regulated products and advancing regulatory science.

Currently, she is the Chair of the Regulatory Affairs Professional Society (RAPS) DC/Baltimore Chapter and the Expert Advisor on regulatory competencies for The Organization for Professionals in Regulatory Affairs (TOPRA). Dr. Drago also serves on the board of directors of the Association of Graduate Regulatory Educators (AGRE) and on the Regulatory Affairs Certification Board (RACB). She received her Ph.D. in chemistry from the Swiss Federal Institute of Technology (ETH Zurich).

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