Signature Series Session
Please join David Burrow from the FDA's Center for Drug Evaluation and Research (CDER) as he discusses the transformation of clinical research and the advancement of drug development and clinical trial design. David will share perspectives on various clinical trial innovation activities including evolving study designs (e.g., master protocols), operational approaches (e.g., decentralized clinical trials (DCT)), and data sources (e.g., real-world data (RWD)). Hear directly from CDER’s Office of Compliance on balancing the critical interests involved in supporting innovation in clinical research along with the FDA’s role as a global regulatory and enforcement agency focused on protecting public health.
CEU: 1.00 ACRP
Speaker:
David Burrow, PharmD, JD, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
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