Content in this video provided updates and cutting-edge insight on novel artificial intelligence (AI), clinical trial designs and innovative strategies, safety data in clinical trials, combination products, electronic submissions and more. Subject matter experts provided insight on FDA’s perspectives, adoption of regulatory guidelines, opportunities for stakeholders to engage with CDER and best practices.
Timestamps
00:38 – Reimagining Clinical Research: The Transformation of Trial Design & Conduct
41:01 – Q&A Session
49:47 – Advanced Manufacturing Technologies (AMT) Designation Program
01:20:52 – Q&A Session
Speakers:
Dave Burrow, PharmD, JD
Director
Office of Scientific Investigations (OSI)
Center for Drug Evaluation and Research (CDER) | FDA
Ranjani Prabhakara, PhD
Policy Lead
Office of Policy for Pharmaceutical Quality (OPPQ)
Office of Pharmaceutical Quality (OPQ)
CDER | FDA
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