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PRIM&R PRESENTER

Ann Meeker-O’Connell

Director of FDA’s Office of Clinical Policy (OCLiP) in the Office of the Commissioner

Bio

Ann Meeker-O’Connell is the Director of FDA’s Office of Clinical Policy (OCLiP) in the Office of the Commissioner. In this role, she leads an organization that serves as the FDA focal point for good clinical practice issues in clinical trials of FDA-regulated products and is responsible for coordinating and leading the development of human subject protection and good clinical practice policy across the agency. Ms. Meeker-O’Connell has more than 20 years of experience in biomedical research and development in government, academic, and industry settings, including prior FDA service as the Acting Director of the Division of Good Clinical Practice Compliance within the Center for Drug Evaluation and Research. She received an M.S. in Pharmacology and was an NIH Integrated Toxicology Fellow at Duke University.

Presentations

IRBs and Expanded Access: Ethical Considerations and Implementing FDA Guidance Webinar

Publications


Committees