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New European Clinical Trial Regulation: A New Paradigm with Major Impact on Clinical Trial Stakeholders
Session Chair(s)
Elke Stahl, PhD
Senior Expert, Clinical Trials Department
Federal Institute For Drugs and Medical Devices (BfArM), Germany
Are stakeholders ready for implementation of the EU Clinical Trial Regulation? Challenges, expectations and progress will be updated by Members States and sponsors.
Speaker(s)
The Implementation of the Clinical Trial Regulation at Member State Level: The State of Play in Belgium
Greet Musch, PhD
FAMHP, Belgium
strategic adviser
Is Industry Prepared? Experiences from the German Pilot as an Example for Challenges for Industry
Thorsten Ruppert, PharmD
vfa - German Association of Research-Based Pharmaceutical Companies, Germany
Senior Manager Research/Development/Innovation
Key Aspects to Consider to Ensure CTR Implementation Positively Impacts Non-For-Profit Clinical Research
Anastassia Negrouk
EORTC, Belgium
Head of International Policy Office, DPO
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