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- Based in London, the EMA is the EU competent authority and publishes the guidelines on human and veterinary medicines.
Data collected in the frame of a clinical trial must be recorded in order to ensure that the protocol is complied with and as a basis for the analysis of the study results.
Investigators need to be provided with information about the investigational medicinal product (IMP) data, in order to facilitate their understanding of the rationale for, and their compliance with
Upon completion of a clinical trial, the sponsor is required to prepare a detailed report on the study.
Clinical trial sponsors are required to notify regulatory authorities and ethics committees when their clinical trials have ended.
A harmonized application form is used for clinical trial applications across the European Union.
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
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.
Sponsors who are not based in the EU/EEA must appoint a legal representative based in the EU/EEA.