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.
An applicant is the sponsor’s representative for all communications with the competent authorities/ethics committees.
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.
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.
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 separate Clinical Trial Application to each Competent Authority.
Patients, and/or in specific circumstances their legally designated representative(s), are requested to give written consent before participating in a clinical trial.
Patients invited to participate in a clinical trial (=subjects), and/or in specific circumstances their legally designated representative(s), shall be fully informed about the clinical trial in order to make an informed decision regarding their participation.
The quality of medicines and healthcare products in Europe is harmonized through different initiatives under the supervision of the European Council.
Marketing Authorization Holders are responsible for monitoring the safety of products placed on the market.
Administering an investigational drug to humans is subject to prior approval from regulatory authorities.