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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

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, DG Pre-Authorisation
Federal Agency for Medicines and Health Products (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 Regulatory and Intergroup Office
EORTC, Belgium