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WED Session 1: PROVISIONS UNDER THE NEW REGULATION – REQUIREMENTS FOR THE DATABASE AND TRANSPARENCY
Session Chair(s)
Fergus Sweeney, PHD
Head of Clinical Studies and Manufacturing Task Force
European Medicines Agency, Netherlands
Speaker(s)
The new EU Portal and Database – What to be expected by when?
Ana Rodriguez Sanchez Beato , PHD
European Medicines Agency, Netherlands
Head of Clinical and Non-Clinical Compliance, CTIS expert
Expectations by Member States for Competent Authorities and Ethics Committees
Stefan Strasser, MD
AGES, Austria
Head of Clinical Trials, Institute Surveillance
Learning From Experience – Industry’s hopes and concerns?
Angelika Joos, MPHARM
MSD, Belgium
Executive Director, Science & Regulatory Policy
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