FDA Clinical Investigator Training Course (CITC) 2024 – Day Two – Session Two

This annual training course provided participants with the essential knowledge and skills to conduct clinical trials effectively, ethically, and in accordance with regulatory standards. Session two of day two covered topics such as new trends in trial designs, Digital Health Technologies (DHT), decentralized trials, mRNA vaccines, and innovative therapeutics in gene therapy.

01:04 – Innovative Approaches to Clinical Trials
31:15 – Informed Consent: More than just a document
01:02:45 – Q&A Discussion Panel 1
01:21:45 – mRNA Vaccines
01:52:01 – Innovative Therapeutics: Gene Therapy
02:11:44 – Q&A Discussion Panel 2

Speakers | Panelists

Leonard Sacks, MBBCh
Associate Director for Clinical Methodologies
Office of Medical Policy (OMP)
CDER | FDA

Ann Meeker-O'Connell, MS
Director
Office of Clinical Policy (OCP)
Office of the Chief Medical Officer (OCMO)
Office of the Commissioner (OC) | FDA

(Moderator for Q&A session 2)
Mili Duggal
Health Science Policy Analyst
OMP | CDER | FDA

Karin Bok, MS, PhD
Deputy Director
Office of Vaccines Research & Review (OVRR)
Center for Biologics Evaluation and Research (CBER) | FDA

Nicole Verdun, MD
Super Office Director
Office of Therapeutic Products (OTP)
CBER | FDA

(Moderator for Q&A session 3)
Leonard Sacks, MBBCh
Associate Director for Clinical Methodologies
Office of Medical Policy (OMP)
CDER | FDA

Learn more at: https://www.fda.gov/drugs/news-events...

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