Innovative Medicines Initiative WEB-RADR Workshop Report

This workshop was the first of two workshops organised in the context of the Innovative Medicines Initiative (IMI) WEB-RADR project, which focuses on the evaluation of the use of mobile technologies in pharmacovigilance to Recognise Adverse Drug Reactions (RADR). The use of new technology is a great opportunity to empower patients to report and to provide reporters such as healthcare professionals, patients, consumers and carers with accurate, timely and up-to-date information on how to use medicines safely and effectively.

The project will develop a mobile app prototype in support of adverse drug reaction reporting and the provision of drug safety information to app users from medicines regulatory authorities. The mobile app will be subject to a user-based evaluation by focus groups based on a variety of stakeholders of different ages and medical backgrounds.

A second aspect of the project is to assess the usefulness of social media analytics. This includes gathering and aggregating unstructured information from social media with the aim to analyse and to detect potential safety issues related to medicines, which may not be identified through traditional methods in pharmacovigilance.

Whilst new technologies may provide powerful tools in adverse reaction reporting and the monitoring of the safety of medicines, challenges with regard to ethical principles, data protection safeguards, the accountability for data processing, the monitoring of the use of data and the need for enhancing data security and anonymity are also to be analysed. The aim is to develop a policy framework based on recommendations for potential future implementation and use of the WEB-RADR project deliverables.

The workshop provided a unique opportunity to exchange views and to discuss expectations with members of the European Medicines Agency’s Healthcare Professionals Working Party and the Patients’ and Consumers’ Working Party, the Pharmacovigilance Risk Assessment Committee and pharmacovigilance experts, representatives from Young People (Paediatric Committee) experts in the area of medical ethics and data protection and IMI WEB-RADR Consortium members. The outcome of the workshop will inform the WEB-RADR Consortium and the project deliverables.

The full workshop report can be found here 1st WEB-RADR Workshop Report.