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Site Certification of Early Phase Research Units: An International Perspective

Track:
Nonclinical and Translational Development/Early Phase Clinical Development

Day & Time:
June 18, 10:30AM - 12:00PM (Pacific Standard Time)

Session Number:
333

Room Number:
7B

Level:
Intermediate

Type:
Session

Title:
Site Certification of Early Phase Research Units: An International Perspective

Chair(s):
Donna W. Dorozinsky, MSN, RN
President
DWD & Associates, Inc., United States

Description:
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(s):
Discuss the implications of early phase research site certification internationally; Discuss the experiences of Phase 1 site certification in the UK.

Presentation(s) & Speaker(s):
Certification: A US Early Phase Perspective
Royce A. Morrison, MD, MS
Principal Consultant
RMD Insight LLC, United States

Implementation of Site Certification
Elizabeth Allen, PhD
Vice President Phase 1
Guy's Hospital Drug Research Unit, Quintiles Limited, United Kingdom