Unit 5: The European Medicines Agency (EMA)

This unit will provide you with an overview of the following concepts as related to the activities of the European Medicnes Agency

  1. Evaluation of marketing authorisation, orphan designation, paediatric investigation plans, exceptional circumstances,
  2. Centralised procedure for marketing authorisation, scientific advice, arbitration and referral.
  3. Risk management plans.
  4. Committee for orphan medicinal products; Scientific Advice, Protocol assistance, Committee for Advanced Therapy
  5. Preparing EMAs opinion on questions concerning medical products for human use.

The Unit is divided into 5 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. Course 5 offers a tour of the EMA website. The Unit ends with a short quiz.

You can start by watching this overview of the Agency.