Documents

Meta-analysis of safety - thoughts from CIOMS X

EURO-SALT - a study of drug exposed acute liver injury in European transplant centres

Pragmatic Trials - The Salford Lung Study

EMA draft framework of collaboration with academia

Scientific guidance on post-authorisation efficacy studies

The General Data Protection Regulation and use of health data_ challenges for pharmaceutical regulation

ENCePP Seal studies and imposed PASS_ new compliance and disclosure measures

EMA patient registries initiative

Table of effects in benefit-risk assessments

Promoting ENCePP at national level - Introduction to the Italian model