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Regulation of Biological Product/Drug Development: An Introduction

Summarize preclinical and clinical testing, sources of Good Clinical Practice (GCP) requirements and phases of the clinical trial process. Identify the obligations of sponsors and investigators. Learn about interacting with FDA during product development. Understand compliance and enforcement considerations for development programs.

Natasha V. Leskovsek, Of Counsel, Cooley LLP

This session was recorded as part of FDLI’s Introduction to Biologics: Vaccines, Biosimilars, Cell and Gene Therapies, and More Course in March 2024.

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