FDA Clinical Investigator Training Course (CITC) 2022, Day 2 – Part 1

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

Timestamps

01:05 – Clinical Trial Quality

49:01 – Q&A Session - 4

1:07:49 – Real World Evidence

1:22:18 – Innovative Trial Designs (Decentralized Clinical Trials, Digital Health Technologies)

1:52:22 – Q&A Session - 5

Speakers:

Ann Meeker-O’Connell, MS
Director
Office of Clinical Policy (OCLiP)
Office of Clinical Policy and Programs (OCPP)
Office of the Commissioner (OC) | FDA

John Concato, MD
Associate Director of Real-World Evidence
Office of Medical Policy (OMP) | CDER | FDA

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

Panelists:

Q&A – 4
Leonard Sacks and Ann Meeker-O’Connell

Q&A – 5
Leonard Sacks and John Concato

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

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