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 three covered topics such as Good Clinical Practice (GCP) and evaluation of GCP compliance.
01:39 – FDA's Good Clinical Practice Compliance Review for NDAs and BLAs
28:46 – Clinical Investigator Inspection Readiness
52:55 – FDA’s Use of Alternative Approaches to Evaluate GCP Compliance
01:23:53 – Q&A Discussion Panel
01:46:09 – Closing Remarks
Speakers | Panelists
Cara Alfaro, PharmD
Senior Pharmacologist
Division of Clinical Compliance Evaluation (DCCE)
Office of Scientific Investigations (OSI)
Office of Compliance (OC)
CDER | FDA
Michelle Anantha, MSPAS, PA-C, RAC
Senior Pharmacologist
DCCE | OSI | OC | CDER | FDA
Emily Gebbia, JD
Associate Director for Regulatory Development
OSI | OC | CDER | FDA
(Moderator)
Kimberly Smith, MD, MS
Captain, United States Public Health Service
Senior Medical Advisor
Office of Medical Policy (OMP)
CDER | FDA
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