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)

Lene Grejs Petersen

Senior EU CT policy adviser, Danish Medicines Agency, Denmark

Implementation Status in Denmark

Sandra Petraglia, MD, PHD

Head of Pre Authorisation Department, AIFA - Agenzia Italiana Del Farmaco, Italy

Implementation Status in Italy

Martin O'Kane

Regional Head RA EU Policy & Liaison, Novartis Pharmaceuticals, United Kingdom

Implementation Status in UK

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