WP1 publication in Therapeutic Innovation & Regulatory Science

WEB-RADR Work Package 1 colleagues from Sanofi, Novartis, Lareb and the EMA have published their work on social media monitoring in Therapeutic Innovation & Regulatory Science (TIRS).

 

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. To read this article, please click click here: Social Media Monitoring and Adverse Drug Reaction Reporting in Pharmacovigilance: An Overview of the Regulatory Landscape.

 

This work will inform the development of a future policy framework on the further use of social media as a new pharmacovigilance data source in the European Economic Area. In addition, this paper elaborates on some current practical case management issues encountered by companies based on the existing regulatory guidance.