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Site Certification of Early Phase Research Units: An International Perspective
Session Chair(s)
Donna Dorozinsky, BSN, MSN
President & CEO, Just in Time GCP, United States
The Medicine and Healthcare Products Regulatory Agency (MHRA) has implemented a site certification process. An industry association has established guidelines for the operation of phase 1 units. This session will explore the impact of this on the industry.
Learning Objective : Discuss the implications of early phase research site certification internationally; Discuss the experiences of Phase 1 site certification in the UK.
Speaker(s)
Royce A. Morrison, MD, MS, FACP
Senior Consultant, Pacific Pharma Group, LLC, United States
Certification: A US Early Phase Perspective
Elizabeth Allen, PHD
Vice President Phase 1, Guy's Hospital Drug Research Unit, Quintiles Limited, United Kingdom
Implementation of Site Certification
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