Pharmacovigilance Risk Assessment Committee (PRAC): 2-5 September 2019, Amsterdam

Amsterdam
© PDC
date September 2, 2019 - September 5, 2019
city Amsterdam
organisation European Medicines Agency (EMA) i

The Pharmacovigilance Risk Assessment Committee (PRAC) is the committee that is responsible for assessing all aspects of the risk management of medicines for human use.


1.

European Medicines Agency (EMA)

The European Medicines Agency (EMA) is a decentralised body of the European Union with headquarters in Amsterdam. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.

The EMA is responsible for the scientific evaluation of applications for European marketing authorisation for medicinal products (centralised procedure). Under the centralised procedure, companies submit one single marketing authorisation application to the EMA.

2.

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