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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
Amelia Spinrad, MS
Gilead, United States
Manager, Regulatory Affairs
Industry Perspective
Stan Jhee, PharmD
Parexel, United States
Corporate Vice President
NIH Perspective
Susan E Vogel, BSN, RN
National Institute of Allergy and Infectious Diseases, NIH, United States
Clinical Research Oversight Manager
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