Unit 5: The European Medicines Agency (EMA)

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This unit 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 EMAs opinion on questions concerning medical products for human use.

The unit is divided into 4 courses beginning with an Introduction, followed by an overview of the main committees dedicated to public health and how patients can become and are involved in the Agency. The Unit ends with a short quiz.

You can start by watching this overview of the Agency.