SCOPE project to improve EU pharmacovigilance capabilities

A three year EU-wide pharmacovigilance project is being coordinated by the MHRA to help member states meet the requirements of the new pharmacovigilance legislation. This ‘Joint Action’ is called Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE).

The main objective of SCOPE is to enable the National Competent Authorities in member states to move from the implementation of the new pharmacovigilance legislation to actually operating the requirements to the highest possible standards against agreed standards and best practice.

Funding of SCOPE by the European Agency for Health and Consumers (EAHC) was agreed in early November.  SCOPE was formally launched on 18 November 2013, where the MHRA arranged a workshop held at the EAHC in Luxembourg. It was attended by 40 delegates from 26 countries and institutions. The workshop provided an excellent opportunity to discuss topics such as adverse drug reaction reporting, signal detection and risk communications to inform and the participating member states.

Further updates on SCOPE will be provided as the Joint Action progresses. A SCOPE website will be launched in early 2014. More information on Joint Actions can be found on the European Commission website.