This unit will provide you with an overview of the following concepts as related to the activities of the European Medicnes Agency
- Evaluation of marketing authorisation, orphan designation, paediatric investigation plans, exceptional circumstances.
- Centralised procedure for marketing authorisation, scientific advice, arbitration and referral.
- Risk management plans.
- Committee for orphan medicinal products; Scientific Advice, Protocol assistance, Committee for Advanced Therapy.
- 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.