Regulatory Education for Industry (REdI) Annual Conference 2024: Day 2 – Session 2 [Video]

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

00:50 – Electronic Submission Gateway (ESG) Modernization: ESG NextGen

31:34 – Q&A Session

41:25 – Artificial Intelligence (AI) | Machine Learning (ML): The New Frontier of Drug Development and Regulation

01:10:19 – Q&A Session

Speakers:

Jessica Bernhardt, MS
ESG Program Manager
Division of Application Services (DAS)
Enterprise Application Branch (EAB)
Office of Digital Transformation (ODT)
Office of Information Management and Technology (OIMT) | FDA

Bin Duan
ESG NextGen Lead Architect CTO
Precise Software Solutions Inc.

Qi Liu, PhD, MStat, FCP
Associate Director for Innovation & Partnership
Office of Clinical Pharmacology (OCP)
Office of Translational Sciences (OTS)
Center for drug Evaluation and Research (CDER) | FDA

Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/regulatory-education-industry-redi-annual-conference-2024-innovation-medical-product-development

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