With plenty of acronyms, procedures or references, the regulatory and market access
environments are sometimes perceived as daunting. Deciphering the language is the
start to finding one’s path.
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Latest Glossary Articles

Post-Authorization Safety Study (PASS)

A Post-Authorization Safety Study (PASS) is a study performed after the marketing authorization and aiming principally to further evaluate the safety of the medicinal product or to measure the effe

EudraCT form

A harmonized application form is used for clinical trial applications across the European Union.

End of Trial (EoT) declaration

Clinical trial sponsors are required to notify regulatory authorities and ethics committees when their clinical trials have ended.

Clinical Study Report (CSR)

Upon completion of a clinical trial, the sponsor is required to prepare a detailed report on the study.

Core value dossier

Core value dossiers are used in the frame of reimbursement negotiations and to support HTA submissions, as well as national and local payers.


Cost-effectiveness is the ratio of the cost of a therapeutic or preventive intervention to a relevant measure of its effect.