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THE IMPORTANCE FOR ALL TO ADOPT THE NEW PARADIGM IN CLINICAL RESEARCH: INTRODUCTORY SESSION

Track:
Innovation in Clinical Research

Day & Time:
March 26, 9:00AM - 10:30AM (Central European Standard Time)

Session Number:
0601

Room Number:
F1

Type:
Session

Title:
THE IMPORTANCE FOR ALL TO ADOPT THE NEW PARADIGM IN CLINICAL RESEARCH: INTRODUCTORY SESSION

Chair(s):
Clara Heering
Vice President Clinical Risk Management
ICON Clinical Research, Netherlands

Description:
Attendees will be brought to speed on the various pan-industry initiatives over RBM. The speakers will situate RBM in the context of optimising drug development, the regulatory framework for conducting research and its impact on study participants.

Presentation(s) & Speaker(s):
Industry Perspective
Jessica Holthuizen, MSc
Sr. Director, Clinical Operations Head
Janssen Pharmaceutica, Belgium

EMA Perspective
Ana Rodriguez, PhD
Head of Clinical and Non-Clinical Compliance
European Medicines Agency, European Union, United Kingdom