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.

Matthew Hegreness, Partner, Covington & Burling 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 October 2023. 


Get Access

  • +$100 for nonmembers


Internet Explorer and Microsoft Edge are not supported by the checkout process.

Please use Chrome, Firefox, or Safari.  If you are unable to use these browsers, please contact us at 202-371-1420 or [email protected] and we will assist you.


Virtual Learning FAQ

On-demand webinar content is sent via email as soon as we are able to process and verify your order. This usually occurs within 1 business day.


On-demand content can be played back on most devices.


CLE credit is not currently available for pre-recorded sessions.

Related Content