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Translating Academic Research Into Product Development: The What and Why of cGMP in Translational Science (Part 2 of 4)
Session Chair(s)
Paul Price, PHD, MS
Senior Regulatory Officer
National Institutes of Health (NIH), United States
As part of a series on GxP, this session will define cGMP and describe the importance of regulatory preparedness in developing a translational program, and how academic and medical institutions are preparing the next generation work force.
Learning Objective : Describe the basics of cGMP and the quality and regulatory requirements of drug manufacturing;. Explain how cGMP and GTP are implemented in cell and gene therapy;Discuss how academic institutions can implement programs to prepare students and support industry professionals in the area of GMP manufacturing.
Speaker(s)
The What and Why of cGMP
Paul Price, PHD, MS
National Institutes of Health (NIH), United States
Senior Regulatory Officer
cGMP Training in an Academic Environment: BTEC’s Program for Developing a Skilled Workforce for the Biopharmaceutical Industry
Gary Gilleskie, PHD
North Carolina State University, United States
Acting Director, Biomanufacturing Training and Education Center
Overview of the Relevant Regulations Covering Human Cells, Tissues, and Cellular and Tissue-Based Products
Olive Sturtevant, MS, MT
Dana-Farber Cancer Institute, United States
Senior Administrative Director, Cell Manipulation Core Facility