Led by the European Medicines Agency (EMA), the objective of this work package is to develop recommendations on the use of mobile devices and social media for the purpose of reporting ADRs, and the monitoring of safety medicines authorised in the EU.

Consultation with EMA’s Health Care Professionals Working Party (HCPWP), the Patients and Consumer Working Party (PCWP) and the EudraVigilance Expert Working Group (EV-EWG) aims to ensure stakeholder input throughout the project. Further, technical expertise will ensure compatibility of Individual Case Safety Report (ICSR) reporting standards, and associated product dictionaries.

Partners involved:

  • EMA
  • MHRA
  • HALMED
  • LAREB
  • Novartis Pharma
  • Janssen Pharmaceutica
  • Sanofi-Aventis Research & Development
  • UCB
  • Amgen