WEB-RADR is developing a mobile app for patients and healthcare professionals to report suspected adverse drug reactions to national EU regulators, and investigating the potential for publicly available social media data for identifying drug safety issues. Reports received via the mobile app will be compared to those received via established reporting schemes for completeness, quality and value for detection of safety issues.
Launched in September 2014, our ground-breaking three-year project seeks to utilise the powers of social media and new technologies for pharmacovigilance purposes. It arose in response to the ninth call for Innovative Medicines Initiative (IMI) projects ‘WEBAE – Leveraging Emerging Technology for Pharmacovigilance’, and is based on the belief that modern pharmacovigilance practices should adapt to these new ways of communicating.
Led by a consortium of world-leading experts from industry, regulatory agencies, and academia, our project will deliver an EU-wide mobile phone app that enables users to report Adverse Drug Reactions (ADRs) directly to their National Competent Authority (NCA). There is potential to use the app as a platform for patients and clinicians to access accurate, timely, and up-to-date information on pharmacovigilance issues. We will also develop text mining techniques for publicly available data on social media sites, complementing existing methods of signal detection.
The expertise of the consortium will ensure that the tools developed are effective and support pharmacovigilance practices in the EU network. Such expertise will also prove invaluable in carefully forming the regulatory frameworks needed to launch such tools, such as how to approach and manage public data on social media sites.
Our project is managed by the same project management and communications team that are leading the European Commission (EC) Joint Action SCOPE (Strengthening Collaboration for Operating Pharmacovigilance in Europe). This will enable the alignment of the two projects, especially between ADR collection and signal management work streams, while common communication channels will enable the effective dissemination of outcomes to all stakeholders.
WEB-RADR has been structured to enable European Federation of Pharmaceutical Industries and Associations (EFPIA) partners to participate in all areas of the project, underlining the collaborative and inclusive approach that guides our work.
The WEB-RADR project is funded by the IMI, a large-scale public-private partnership between the EU and the pharmaceutical industry association EFPIA. IMI aims to boost biopharmaceutical innovation in Europe and to speed up the development of better and safer medicines for patients. Through its unique and innovative funding scheme, IMI supports research projects in the areas of safety and efficacy, knowledge management and education and training.
In addition to the large biopharmaceutical companies, the participating research consortia include small- and medium-sized enterprises, patient organisations, academia and other research organisations, hospitals and public authorities.
The EC’s Seventh Framework Programme contributes €1 billion to the IMI research programme. That amount is matched by in kind contributions worth at least another €1 billion from the pharmaceutical companies that are members of EFPIA.
Find out more: www.imi.europa.eu