European Medicines Agency listens to stakeholder expectations for pharmacovigilance reforms

The European Medicines Agency has hosted a second workshop on the changes to the safety-monitoring of medicines in Europe, where it heard the expectations from patients, consumer groups, healthcare professionals and the pharmaceutical industry.


The second stakeholder forum on the implementation of the new pharmacovigilance legislation, which took place on Friday 17 June, involved discussions between the Agency, key stakeholder groups and medicines regulatory authorities from the European Union (EU) Member States.

Topics included the establishment of the Pharmacovigilance and Risk Assessment Committee, the introduction of public hearings, direct reporting of side effects by patients and the development of EudraVigilance, the database of adverse events reported within the EU. Discussions also covered some of the challenges that lie ahead during the implementation phase.


The new pharmacovigilance legislation was adopted in the EU in December 2010 and aims to save lives by strengthening the European-wide system for monitoring the safety of medicines. The outcome of the day's discussions will be used to guide the implementation of the legislation, which is scheduled to come into force in July 2012.


The slides used to support the workshop's presentations are available on the stakeholder forum page, together with a summary report, the agenda and a list of the participants. Videos from the day will be published within the next few weeks.


The Agency is planning to hold further meetings on the implementation of the new legislation during 2011 and 2012. It will publish details of these meetings on this website.



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