The Changing Face of Pharmacovigilance and the EU Risk Management Plan EMEA official Jan Petracek explains planned changes to pharmacovigilance activities in the EU and the implications for biosimilars. Faraz Kermani reports.

摘要

The entire way in which pharmacovigilance is currently carried out in the European Union is set to change, according to a top official at the European Medicines Agency. Addressing delegates to the European Generic medicines Association's 7th Annual Symposium on Biosimilar Medicines in London, UK, on 23-24 April, Jan Petracek, scientific administrator in the EMEA's Pharmacovigilance and Risk Management Sector, said that this was because the focus of pharmacovigilance was continually shifting from the obligatory activities of marketing authorisation applicants, to the science of the products themselves.