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Translating Academic Research into Product Development: Integrating GXPs into the Process (Part 1 of 4)
Session Chair(s)
Nancy Pire Smerkanich, DRSC, MS
Assistant Professor Regulatory & Quality Sciences, University of Southern California School of Pharmacy, United States
This is the kickoff to a GxP series on the importance of implementing quality standards in early drug development conducted in academia and start-ups that govern how a compound is to be manufactured, tested in animals and studied in clinical trials.
Learning Objective : Define GxP, G(R)P, GMP, GTP, GLP, and GCP; Discuss the importance of GxPs in manufacturing and translational research; Identify the challenges of implementing GxPs in an academic research and development environment.
Speaker(s)
Panelist
Director, International Center for Regulatory Science: Assistant Professor, University of Southern California, United States
Panelist
Senior Regulatory Officer, National Institutes of Health (NIH), United States
Panelist
Director of Research, BCN Biosciences, United States
Panelist
Acting Director, Biomanufacturing Training and Education Center, North Carolina State University, United States
Panelist
Clinical Research Oversight Manager, National Institute of Allergy and Infectious Diseases, NIH, United States
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