Safety Observer 191
The EMA has published a list of metadata describing Real-World Data (RWD) sources and studies.
Report 191 — Highlights
EMA & TTS
The EMA recently hosted a workshop to discuss the pathophysiology of thrombosis with thrombocytopenia syndrome (TTS), which has been associated with adenovirus-based COVID-19 vaccines.
EU “Big Data” project
The EMA has published a list of metadata describing real-world data sources and studies in a move intended to help researchers identify and use this information.
New ENCePP Guide
The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) has issued the tenth revision of its guide on methodological standards in Pharmacoepidemiology.
Australia & DAEN
The Australian Therapeutic Goods Administration (TGA) has announced the launch of a Beta version of the Database of Adverse Event Notifications (DAEN).
