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
00:18 – Leveraging Small Business and Industry Assistance (SBIA) Resources
30:26 – Key Information in Informed Consent (Clinical Trials)
57:10 – Q&A Session
01:06:37 – FDA eCTD v4 Implementation Update and CDER NextGen Portal Update
01:43:03 – Q&A Session
Speakers:
Renu Lal, PharmD, BCACP, RAC-Drugs
Lieutenant Commander, US Public Health Service (USPHS)
Team Lead, Division of Drug Information (DDI)
Deputy Director
Small Business and Industry Assistance (SBIA)
Office of Communications (OCOMM)
Center for Drug Evaluation and Research (CDER) | FDA
Alyson Karesh, MD
Senior Clinical Advisor
Office of Medical Policy (OMP)
CDER | FDA
Suzanne R. Pattee, JD
Regulatory Counsel
Office of Clinical Policy (OCP)
Office of Clinical Policy and Programs (OCPP)
Office of the Commissioner (OC) | FDA
Jonathan Resnick
Project Management Officer
Division of Data Management Services and Solutions (DDMSS)
Office of Business Informatics (OBI)
Office of Strategic Programs (OSP)
CDER | FDA
Seyoum Senay
Supervisory Operations Research
DDMSS | OBI | OSP | CDER | FDA
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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
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