Regulatory Education for Industry (REdI) Annual Conference 2024: Day 2 – Session 1

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

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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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

Upcoming Training - https://www.fda.gov/cdersbia
SBIA Listserv – https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352
SBIA 2024 Playlist – https://www.youtube.com/playlist?list=PLey4Qe-Uxcxaf1HvpvnKO8-n8u9QW412g
SBIA LinkedIn - https://www.linkedin.com/showcase/cder-small-business-and-industry-assistance
SBIA Training Resources - https://www.fda.gov/cdersbialearn
Twitter - https://twitter.com/FDA_Drug_Info
Email - [email protected]
Phone - (301) 796-6707 I (866) 405-5367