FDA Clinical Investigator Training Course (CITC) 2023, Day 1 – Part 1

This course was designed to promote professionalism in the clinical trial industry for individuals involved with submissions to FDA (Investigational New Drug (IND) application, New Drug Application (NDA), Biologics License Application (BLA)), and to familiarize stakeholders with the regulatory and scientific issues involved in the development and approval of medical drugs and biological products.

Timestamps

00:01 – Day One Welcome

00:36 – FDA Structure and Mandate

20:25 – Basics of Clinical Trial Design – Design, Population, Intervention, Outcomes

52:02 – Digital Health Technologies & Decentralized Clinical Trials

01:22:19 – Real-World Evidence (RWE)

01:39:00 – Q&A Discussion Panel

Speakers | Panelists:

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

Kimberly Smith, MD, MS
CAPT | USPHS
Real World Evidence Analytics
OMP | CDER | FDA

Fortunato Fred Senatore, MD, PhD, FACC
Lead Physician
Division of Cardiology and Nephrology (DCN)
Office of Cardiology, Hematology, Endocrinology and Nephrology (OCHEN)
Office of New Drugs (OND)
CDER | FDA

John Concato, MD
Associate Director of Real-World Evidence
OMP | CDER | FDA

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

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