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Futureproofing of the EU Clinical Trials Regulation (CTR)
Session Chair(s)
Marianne Lunzer, DrMed
Assessor, Dept of Clinical Trials, Federal Office for Safety in Health Care, AGES, Austria
Martin O'Kane
Regional Head RA EU Policy & Liaison, Novartis Pharmaceuticals, United Kingdom
The session will provide multistakeholder views on ongoing activities happening in the landscape, including the first milestones in Collaborate, as well as highlights from ACT EU programme, including a wider European perspective on development of risk-based approaches.
Learning Objective
The objective of the session is to understand the progress and lessons learned during the first year of experience following full implementation of the EU CTR. It aims to give a voice to regulators, ethics committees, trial sponsors, and patients via presentations and active debate on the advantages of the system and ways to maximizing its potential for the benefit of patients and EU research.
Learning Objective : The objective of the session is to understand the progress and lessons learned during the first year of experience following full implementation of the EU CTR. It aims to give a voice to regulators, ethics committees, trial sponsors, and patients via presentations and active debate on the advantages of the system and ways to maximizing its potential for the benefit of patients and EU research.
Speaker(s)
Monique Al, PHD
Special advisor CCMO, Central Committee on Research Involving Human Subjects (CCMO), Netherlands
A Sneak Preview of the CTCG Collaborate Project
Lada Leyens, PHD, MSC
Senior Director, EUCAN regulatory head GI, Takeda, Switzerland
Changing the Rules of the Game to Be Future-Proof: Adopting a Risk-Based Approach for the Approval and Clinical Trials in EU
Laura Pioppo, MSC
ACT EU Programme Manager, European Medicines Agency, Netherlands
How Are the ACT EU Partners Contributing to the Future-Proof Implementation of the CTR?
Nikos Dedes
Representative, European AIDS Treatment Group (EATG), Greece
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