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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)
Certification: A US Early Phase Perspective
Royce A. Morrison, MD, MS, FACP
Pacific Pharma Group, LLC, United States
Senior Consultant
Implementation of Site Certification
Elizabeth Allen, PhD
Guy's Hospital Drug Research Unit, Quintiles Limited, United Kingdom
Vice President Phase 1
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