November 8-10, 2021 | Virtual Conference

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Speakers

Andre Raw, PhD

Senior Science and Policy Advisor, Office of Lifecycle Drug Products, OPQ, CDER
FDA

Andre Raw received his B.S. degree from the Massachusetts Institute of Technology and his Ph.D. degree in chemistry from the University of California at Berkeley. He joined the FDA as a reviewer within the Office of Generic Drugs (OGD). During his tenure within FDA he has been promoted to Agency Expert and to Chemistry Division Director. Currently he is acting Senior Scientific and Policy Advisor in the Office of Life Cycle Drug Products (OLDP) in the Office of Pharmaceutical Quality (OPQ).

Dr. Raw was involved in the development of several important FDA initiatives, including the Guidance on Pharmaceutical Solid Polymorphism in Abbreviated New Drug Applications (ANDAs), Regulations on Listing of Polymorph Patents in the “Orange Book”, and Question Based Review, QbD Example for Generic Modified Release Products, and Guidance for Industry: Pharmaceutical Solid Co-Crystals. He was instrumental in FDA’s recent approval of generic versions of complex active ingredients including Lovenox (enoxaparin sodium) and Copaxone (glatiramer acetate).
More recently, Dr. Raw has been active in Risk Based Review and Quality Informatics Initiatives including Knowledge-Aided Assessment and Structured Application (KASA).

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