Pharmacovigilance and Risk Assessment Committee [PRAC]

Risk management is important in medicines development and pharmacovigilance in order to avoid crisis situations and harmful consequences. There are various kinds of risk; risk management strategies must assess and minimise these, and balance them with the benefits of the medicine being developed.

Pharmacovigilance is the practice of detecting, understanding, and preventing adverse events or any other medicine-related problem.

A medicine can be marketed in the European Union (EU) until the company has obtained a Marketing Authorisation (MA) for that medicine from the relevant regulatory authority. MAs are granted for medicines that are proved to be safe, effective and of high quality.

The European Patients’ Academy (EUPATI) guidance document on patient involvement in regulatory processes aims to support the integration of patient involvement across the entire process.