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GXP Requirements in Translational Research - Webinar Recording (Nov 2010)

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Description

GXP Requirements in Translational Research – From Bench to Bedside


Speaker: Adrian Gee, MIBiol, PhD, Director, Clinical Applications, Center for Cell and Gene Therapy, Baylor College of Medicine

Learning Objectives

  1. Gain an understanding of the regulatory continuum covering transition of a cellular therapy from research into clinical trial
  2. Understand the basic components of Good Laboratory, Manufacturing and Clinical Practices and where to find them
  3. Learn the role of the GMP staff in interfacing with the basic researchers and the clinician to accelerate the transition process
  4. Appreciate the non-manufacturing tasks that will fall to the GMP staff when transitioning a therapy from research into clinical practice
  5. Understand the role of the FDA in regulating this area and in enforcing the regulations

 

This product is a downloadable zipped folder containing an mp3 audio recording of the presentation and a PDF copy (or copies) of the Power Point slides.


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