Introduction to the European Union regulatory system and European Medicines Agency for international regulators and non-governmental organisations

• Date:
  Lundi, 18 septembre 2017, Journée Entière
• Lieu:
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

This two-day awareness session is for international regulators and non-governmental organisations. It gives an insight into the European Union (EU) regulatory system for medicines and the role of the European Medicines Agency (EMA). Insight into the EU system is of prime importance in an increasingly globalised world where worldwide regulators rely on close cooperation. The EU system is one of the most advanced in the world, but it is also one of the most complex. It is based on a network of decentralised agencies in the EU Member States, supported and coordinated by EMA.

Documents

Programme - Introduction to the European Union regulatory system and European Medicines Agency for international regulators and non-governmental organisations

Module 01 - Presentation - Introduction to the EU Regulatory Network: Transparency, Trust and Reliance

Module 04 - Presentation - Specificities of products for veterinary use

Module 05 - Presentation - Dealing with unmet medical needs and support to innovation

Module 07 - Presentation - Good practice and inspections

Module 10 - Presentation - Stakeholders engagement

Module 11 - Presentation - EMA and international cooperation

Video recording