FDA Clinical Investigator Training Course (CITC) 2022, Day 1 – Part 3

Описание: 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

01:00 – Gene Therapy

22:46 – CarT Therapy

38:23 – International Clinical Trials

57:43 – Q&A Session 3

Speakers:

Lei Xu, MD., PhD
Branch Chief
General Medicine Brach 2 (GMB2)
Division of Clinical Evaluation & Pharmacology/Toxicology (DCEPT)
Office of Tissues and Advanced Therapies (OTAT) | CBER | FDA

Lianne Hu, MD., PhD., MPH, MS
Clinical Analyst
DCEPT | OTAT | CBER | FDA

Kassa Ayalew, MD., MPH
Branch Chief
Division of Clinical Compliance Evaluation (DCCE)
Office of Scientific Investigations (OSI)
CDER | FDA

Panelists:

Lei Xu, Lianne Xu, Kassa Ayalew
and
Leonard Sacks, MBBCh
Associate Director
Clinical Methodologies | Office of Medical Policy (OMP)
CDER | FDA

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

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