REdI 2024 | D1S05: CDER's Clinical Trial Innovation 🧪

This presentation introduced CDER's Center for Clinical Trial Innovation (C3TI) and outlined its approach to clinical trial innovation. The session described key activities and objectives of the center, highlighted the C3TI Demonstration Program, and reviewed program outcomes achieved to date. Various ways to connect and engage with C3TI were discussed to facilitate collaboration on clinical trial innovation initiatives.

Timestamps

00:43 – The Launching of C3TI

01:20 – Key Programs and Additional Focus Areas

02:53 – Understanding the Impact

10:12 – Objectives

11:52 – C3TI Demonstration Program

22:57 – Outcomes

25:36 – Questions

Speaker:

Kevin Bugin, PhD, MS, RAC
Deputy Director
Office of New Drugs (OND)
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

-----------------------

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 - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367