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Mercure Paris La Défense Grande Arche

2016 年 04 月 19 日 8:00 上午 - 2016 年 04 月 20 日 4:30 下午

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

The Regulatory Framework in Europe

Master the Regulatory Affairs essentials.

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

Session Chair(s)

Birka  Lehmann, MD

Birka Lehmann, MD

Patient Expert

University of Bonn, 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

University of Bonn, Germany

Patient Expert

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