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SESSION 1: EUROPEAN UNION – ROLE AND RESPONSIBILITIES OF EUROPEAN INSTITUTIONS. A COMPREHENSIVE OVERVIEW
Session Chair(s)
Birka Lehmann, MD
Senior Expert Drug Regulatory Affairs
Birka Lehmann, Germany
- Key organisations in the Marketing Authorisation Process
- European Commission
- European Medicines Agency (EMA): Scientific Committees
- National Competent Authorities (NCAs): Heads of Medicine Agencies (HMA)
- European Directorate for the Quality of Medicines (EDQM) and the European Pharmacopeia
- Cooperation between the organisations
- European Economic Area: Importance of single market
Speaker(s)
EUROPEAN UNION – ROLE AND RESPONSIBILITIES OF EUROPEAN INSTITUTIONS. A COMPREHENSIVE OVERVIEW
Birka Lehmann, MD
Birka Lehmann, Germany
Senior Expert Drug Regulatory Affairs
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