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Eurordis - Rare Disease Europe


Course 5: The European Medicines Agency (EMA)

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This course will provide you with an overview of the following concepts related to the activities of the European Medicines Agency:

  • Evaluation of marketing authorisation, orphan designation, paediatric investigation plans, exceptional circumstances.
  • Centralised procedure for marketing authorisation, scientific advice, protocol assistance, arbitration and referral.
  • Pharmacovigilance Risk Assessment Committee and Risk management plans.
  • Committee for orphan medicinal products, Committee for Advanced Therapies, the Paediatric Committee and Scientific Advice Working Party.
  • Preparing EMA’s opinion on questions concerning medical products for human use.

To complete this course, you need to read through all the lessons below. At the end of the course, once you have taken the final quiz, you will be able to download and print your certificate of completion.

You can start by watching this overview of the Agency: