Establishing a Framework for the Use of Social Media in Pharmacovigilance in Europe.

The Innovative Medicines Initiative (IMI) WEB-RADR (Web-Recognising Adverse Drug Reactions) project looked at opportunities and challenges in using social media in pharmacovigilance as a rapidly evolving source of large, real-time data, which could provide new information on the actual use of medicines and potential safety issues. Two of the objectives were to develop principles for continuous monitoring of the safety of medicines without overburdening established pharmacovigilance systems and to propose a regulatory framework on the use of social media in pharmacovigilance. As a starting point, a review of existing legal requirements and regulatory guidance on social media use in pharmacovigilance was performed based on a survey conducted in 2014-2015.

Social Media Monitoring and Adverse Drug Reaction Reporting in Pharmacovigilance: An Overview of the Regulatory Landscape.

In the context of the European Union's Innovative Medicines Initiative (IMI) project titled Web-Recognizing Adverse Drug Reactions (WEB-RADR; http://web-radr.eu ), which focuses on the assessment of new data sources and the optimization of the collection of information on suspected adverse reactions in pharmacovigilance, a survey was performed in 182 countries/jurisdictions in 2014 to 2015. The goal was to gather information on existing practices, guidance, and legal requirements on social media monitoring to identify potential safety issues related to medicines.