1. Project background

The IMI WEB-RADR project aims to explore the use of mobile technologies and social media to greatly enhance the way we protect patients who are using medicines.
WEB-RADR is a three-year research project and includes European medicines regulators, academics and the pharmaceutical industry. It is funded through the Innovative Medicines Initiative, a public private partnership between the European Commission and the European Federation of Pharmaceutical Industries and Associations.
The consortium intends to engage actively with patients, consumers, healthcare professionals and other interested parties throughout the project, which will focus on the following three key objectives:
- The development and user testing of mobile application programmes (apps) to report adverse drug reactions (ADRs)
- The use of new technology and analytical methods to enable early identification of potential safety issues with medicines from user comments (posts) in social media
- The utilisation of the mobile app for ADR reporting and social media by medicines regulators to communicate accurate, timely and up to date safety information on medicines to patients, consumers and healthcare professionals.
The project will also deliver recommendations to assist the development of a policy framework and an update of Good Pharmacovigilance Practices (GVP) with focus on the application of mobile technologies and social media in pharmacovigilance. Requirements of compliance with the current EU data protection legislation will be an integral part thus applying a forward looking approach the including an evaluation of new legal data protection framework as proposed in the draft General Data Protection Regulation (GDPR).