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New European Clinical Trial Regulation: A New Paradigm with Major Impact on Clinical Trial Stakeholders

Track:
How Can We Enable Clinical Research in Europe Further?

Day & Time:
April 18, 10:30AM - 12:00PM (Central Europe Standard Time)

Session Number:
S0901

Room Number:
Montreal

Type:
Session

Title:
New European Clinical Trial Regulation: A New Paradigm with Major Impact on Clinical Trial Stakeholders

Chair(s):
Elke Stahl, PhD
CTFG Co-Chair; Clinical Trial Unit
Federal Institute For Drugs and Medical Devices (BfArM), Germany

Description:
Are stakeholders ready for implementation of the EU Clinical Trial Regulation? Challenges, expectations and progress will be updated by Members States and sponsors.

Presentation(s) & Speaker(s):
The Implementation of the Clinical Trial Regulation at Member State Level: The State of Play in Belgium
Greet Musch, PhD
General Director
FAMHP, Belgium

Is Industry Prepared? Experiences from the German Pilot as an Example for Challenges for Industry
Thorsten Ruppert
Senior Manager Research/Development/Innovation
vfa - German Association of Research-Based Pharmaceutical Companies, Germany

Key Aspects to Consider to Ensure CTR Implementation Positively Impacts Non-For-Profit Clinical Research
Anastassia Negrouk
Head of International Policy Office, DPO
EORTC, Belgium