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Glossary
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.
A (3) | C (9) | D (2) | E (8) | F (4) | I (8) | M (3) | N (4) | O (1) | P (12) | Q (2) | R (1) | S (6) | T (1) | V (1)

Latest Glossary Articles


Voluntary Harmonization Procedure (VHP)

When a sponsor wishes to carry out a clinical trial in two or more EU member states, they can choose to go through the Voluntary Harmonization Procedure (VHP) as an alternative to the classical sep

Substantial amendment (SA)

A substantial amendment (SA) is a change to the conduct of the clinical trial that has a significant impact on the safety of the subjects or the scientific value of the study.

Non-substantial amendment

A non-substantial amendment is a change to the conduct of the clinical trial that does not have a significant impact on the safety of the subjects or the scientific value of the study.

European Union (EU) Legal Representative

Sponsors who are not based in the EU/EEA must appoint a legal representative based in the EU/EEA.

Applicant for Clinical Trial Applications (CTA)

An applicant is the sponsor’s representative for all communications with the competent authorities/ethics committees.

Post-Authorization Efficacy Study (PAES)

A Post-Authorization Efficacy Study (PAES) is a study performed after the marketing authorization and aiming principally to further evaluate the efficacy of the medicinal product.

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