Please join David Burrow from FDA's Center for Drug Evaluation and Research as he discusses key opportunities for the clinical research industry to make their FDA inspection experience a positive one. Dr. Burrow will outline the impact inspections have on marketing applications and will identify key strategies to build quality into clinical research in order to prevent critical compliance issues. When problems do occur, inspected entities should be able to respond appropriately. In this session, you will be able to take away practical approaches to working with the FDA during an inspection, responding to 483s after an inspection, and responding to subsequent regulatory correspondence.This presentation is a webinar replay from the ACRP Conference LibrarySpeaker: David Burrow, PharmD, JD Director of the Office of Scientific Investigations (OSI) Center for Drug Evaluation and Research (CDER) FDA*Please email the contact person listed on this page to register for this eventClick here to purchase contact hours for this event.
With more than 20,000 members, the Association of Clinical Research Professionals (ACRP) is the only non-profit solely dedicated to representing, supporting, and advocating for clinical research professionals. ACRP supports individuals and life science organizations globally by providing community, education, and credentialing programs. Founded in 1976, ACRP is a registered 501(c)(3) charitable organization whose mission is to promote excellence in clinical research and whose vision is that clinical research is performed ethically, responsibly, and professionally everywhere in the world.
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