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Mercure Paris La Défense Grande Arche

Apr 19, 2016 8:00 AM - Apr 20, 2016 4:30 PM

17/20 Esplanade Ch. de Gaulle - Rue des Trois Fontanot, 92000 Nanterre/Paris, France

The Regulatory Framework in Europe

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SESSION 1: EUROPEAN UNION – ROLE AND RESPONSIBILITIES OF EUROPEAN INSTITUTIONS. A COMPREHENSIVE OVERVIEW

Session Chair(s)

Birka Lehmann, MD

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)

Birka Lehmann, MD

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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Register Now (Credit Card)

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