Speakers

David Awotwe-Otoo, PhD

Senior Pharmaceutical Quality Assessor (SPQA), Division of Pharmaceutical Manufacturing Assessment II, OLDP, OPQ, CDER
FDA

David started working with the FDA as a graduate student intern in 2011. After graduating with a PhD in Pharmaceutical Sciences from Howard University, he worked as a ORISE (Oak Ridge Institute of Science Education) David fellow with the Division of Product Quality Research (DPQR) for six months before being hired permanently in 2012.
As a Senior Staff fellow with DPQR, he worked on complex regulatory research projects, including pre-formulation and formulation characterization of complex drug products and part of the group research who formed the basis for CDER Research on bioprocess improvements for biosimilar drug products.
David is currently a Senior Pharmaceutical Quality Assessor (SPQA) with the Office of Lifecycle Drug Products, involved with the review of post-approval CMC changes to generic drugs.

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