戻る Agenda
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)
A Sneak Preview of the CTCG Collaborate Project
Monique Al, PHD
Central Committee on Research Involving Human Subjects (CCMO), Netherlands
Special advisor CCMO
Changing the Rules of the Game to Be Future-Proof: Adopting a Risk-Based Approach for the Approval and Clinical Trials in EU
Lada Leyens, PHD, MSC
Takeda, Switzerland
Senior Director, EUCAN regulatory head GI
How Are the ACT EU Partners Contributing to the Future-Proof Implementation of the CTR?
Laura Pioppo, MSC
European Medicines Agency, Netherlands
ACT EU Programme Manager
Nikos Dedes
European AIDS Treatment Group (EATG), Greece
Representative