EU Network Pharmacovigilance Oversight Group (former ERMS FG)

Introduction/Overview

The European Risk Management Strategy Facilitation Group (ERMS FG) was established as a permanent Working Group in 2005.The ERMS FG aim was to develop a European Strategy for risk management, built on the National Competent Authorities (NCA’s) resources and expertise, and incorporating the EMA’s role in the coordination and the supervision of products authorised through the Community.

Mandate

To prioritise issues for HMA and EMA Management Board consideration, on criteria based on public health and risk to operation of the EU network pharmacovigilance system.

• Regularly scrutinising performance of the European Network Pharmacovigilance system in light of use of the enhanced legal tools

• Monitoring delivery and realisation of the benefits of the functional IT systems in particular to support signal detection from the EU population via EudraVigilance, and overseeing risk management relating to IT systems

• Monitoring business change management in the network, highlighting any risks to timely delivery, including resources

• Promoting collaboration to deliver the above objectives via engagement with the scientific committees (in particular PRAC, CHMP, CMDh and CAT) and the EU Telematics

• Timely review and approval of the new and revised Good Vigilance Practice modules and key business documents for information systems

• Ensuring regular review and audit of pharmacovigilance performance and impact metrics to improve the systems as appropriate

• Ensuring effective two-way information flow between operational pharmacovigilance and the EU telematics structures

•Seeking and promoting opportunities for pharmacovigilance to support the EU Network 2020 objectives in particular enabling innovation

Members and Representatives

  • To be representative of a broad range of Member States: Co-chairs of the PV Business Team, PRAC Chair and Vice-chair, CMDh Chair and Vice-chair, representatives of CHMP and CAT (one from each), Troika of Council Presidencies, European Medicines Agency. Observer: European Commission.
  • The Co-chair of the Group is Fergus Sweeney, EMA
  • Meeting cycle: Bi-monthly by teleconference or face to face meetings when needed.
  • The secretariat for the meeting is provided by NCA and EMA jointly.

Contact

Contact Point:

Amanda Bryan (secretariat), MHRA, UK
E-Mail: amanda.bryan@mhra.gov.uk

Activities and achievements

Overseeing performance of the European Pharmacovigilance system, particularly in light of the new legal provisions. Agrees draft technical contributions to implementation measures, Good Vigilance Practice Modules and reflection papers.