Clinical Trial Regulation Conference

This conference provides a forum for information exchange and discussion on conceptual and practical questions about critical issues affecting sponsors and Member States regarding the implemention the regulation.

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SESSION 1: CTREG IMPLEMENTATION STATUS IN MEMBER STATES

Session Chair(s)

Nick Sykes, MS

Policy Advisor, Regulatory Strategy

EFPIA, Belgium

Speaker(s)

Implementation Status in Denmark

Lene Grejs Petersen

Danish Medicines Agency, Denmark

Senior Adviser, Clinical Trials

Implementation Status in Italy

Sandra Petraglia, MD, PhD

AIFA - Agenzia Italiana Del Farmaco, Italy

Head of Pre Authorisation Department

Implementation Status in UK

Martin O'Kane

Novartis Pharmaceuticals, United Kingdom

Regional Head RA EU Policy & Liaison

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