Signature Series Session
Join Dr. David Burrow from FDA's Center for Drug Evaluation and Research as he explores operational strategies for implementing Quality by Design and the integration of Risk Based Quality Management Systems into routine trial design and conduct. Dr. Burrow will build on the key themes discussed in his 2024 Signature Series presentation titled, “Reimagining Clinical Research: The Transformation of Trial Design & Conduct” and bring his own unique perspectives to the next stage of reimagining clinical research and removing barriers to innovation. Take away practical approaches to mitigating obstacles, advancing the shared interests of human subject protection, generating high quality evidence of safety and effectiveness, and enabling action through strategies to manage fear - both as an organization and as an individual.
Objectives:
Discuss key themes of Quality by Design, Critical to Quality factors, and Risk Based Quality Management Systems.
Advance shared understanding of the CDER Center for Clinical Trial Innovation (C3TI) and other FDA drug development programs.
Provide strategies to advance innovation and enhance quality while also minimizing fear of regulatory oversight.
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