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.

Christopher M. Mikson, Partner, DLA Piper LLP

This session was recorded as part of FDLI’s Introduction to Biological Products, Including Vaccines, Biosimilars, Cell and Gene Therapies, and Other Advanced Therapies Course in March 2022. 

 

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