Toward Translation: Adapting to FDA Regulation

Overview

Karp Research Building- 5th Floor Conference Room
1 Blackfan Circle
Boston, MA 02115
United States

Wednesday, 5 December 2018 - 1:00pm

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Details

Academic scientists engaging in basic research may find themselves solving problems with biomedical applications. There is a long journey between discovering a new molecule or biological mechanism and the development of a new treatment for patients. A critical part of that journey is the shift from discovery and proof of concept experiments to the pre-clinical experiments which lay the groundwork for First-in-Human studies.

This case-based workshop leverages actual warning letters from the FDA to investigators in academic settings. Our expert instructor will facilitate a discussion of situations surrounding an FDA audit and will answer questions as the group examines the critical role of Good Laboratory Practices (GLP) in biomedical research.

Workshop Goals:

  • Understand the principles and importance of Good Laboratory Practice
  • Know the impact of FDA regulation on biomedical research
  • Learn how to respond to an FDA audit and warning letter

Who should attend:

  • Basic research and discovery scientists
  • Researchers making the transition to pre-clinical and clinical research
  • Research administration professionals

About the Instructor

Robert Ezzell, Ph.D., MBA

Dr. Ezzell is the Associate Director of Global Regulatory Affairs at Sanofi. He brings more than 20 years of regulatory affairs experience to benefit workshop participants. He has worked with both drug and device regulatory submissions as well as leading post-market compliance efforts. His expertise covers FDA regulations, EU directives, and the International Standards governing Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and Good Clinical Practice (GCP).