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EU Clinical Trial Regulation and Its Implications
Session Chair(s)
Steffen Thirstrup, MD, PhD
Chief Medical Officer
European Medicines Agency, Netherlands
The new EU clinical trials regulation (CTR) will come into force in 2018 aiming for a more streamlined process with clearer roles and responsibilities. It will fundamentally change the way clinical trial applications are assessed and what information will be publically available. Is your organisation ready to meet these challenges?
Learning Objective : Establish the impact of the new EU Clinical Trial Regulation on early phase clinical trials and particularly phase I studies
Speaker(s)
Will Early-Phase Trials Suffer or Benefit?
Bruno Speder, MSc
SGS Life Science Services, Belgium
Head Clinical Regulatory Affairs
Ensuring a Swift and Timely Transition to Compliance with the CTR
Lene Grejs Petersen
Danish Medicines Agency, Denmark
Senior Adviser, Clinical Trials
Ethical Assessment of Clinical Trials Following EU CTR implementation – Are We Ready for Changes?
Anna Kubik, MS
KCR.S.A., Poland
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