ENCePP Guide on Methodological Standards in Pharmacoepidemiology

The ENCePP Guide on Methodological Standards in Pharmacoepidemiology (PE), now in its 11th revision as of July 2023, continues to serve as an essential reference for researchers, regulators, and marketing authorization holders. Key updates include recommendations on causal inference target trial emulation for increased study validity, the estimand framework for aligning with ICH Addendum E9 (R1), and the HARPER protocol template to enhance transparency and consistency in non-interventional studies.