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Translating Academic Research into Product Development: Integrating GCP Training into the Process (Part 4 of 4)
Session Chair(s)
Eunjoo Pacifici, PHARMD, PHD
Director, International Center for Regulatory Science: Assistant Professor, University of Southern California, United States
As part of a series on GxP, this session describes how approaches to better ensure quality in IITs can lead to more efficient product development. Monitoring/auditing, routine quality functions in industry-trials, are often lacking in IITs.
Learning Objective : Explain how quality initiatives in investigator-initiated trials (IITs) can lead to more efficient product development; Identify benefits of self-study modules to cross-train clinical trial professionals in essential concepts and practical approaches to monitoring/auditing; Describe the challenges to implementation of monitoring and auditing training programs.
Speaker(s)
Academic Perspective
Manager, Regulatory Affairs , Gilead, United States
Industry Perspective
Corporate Vice President, Parexel, United States
NIH Perspective
Clinical Research Oversight Manager, National Institute of Allergy and Infectious Diseases, NIH, United States
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