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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
Eunjoo Pacifici, PHARMD, PHD
University of Southern California, United States
Director, International Center for Regulatory Science: Assistant Professor
Panelist
Paul Price, PHD, MS
National Institutes of Health (NIH), United States
Senior Regulatory Officer
Panelist
Andrew Norris, PHD
BCN Biosciences, United States
Director of Research
Panelist
Gary Gilleskie, PHD
North Carolina State University, United States
Acting Director, Biomanufacturing Training and Education Center
Panelist
Susan E Vogel, BSN, RN
National Institute of Allergy and Infectious Diseases, NIH, United States
Clinical Research Oversight Manager