Jose Alberto Ayala Ortiz

This presentation describes the responsibilities of the sponsor of clinical trials in the European Economic Area in line with the European legislation. The author is summarizing the legal background within the scope of clinical trials in the EU. Then the main elements under the sponsor responsibility are described, including the safety management plan, the investigator brochure, the study protocol, SUSAR reporting, annual safety reports or DSUR, and the provision of information of the… Mostrar más

This presentation describes the responsibilities of the sponsor of clinical trials in the European Economic Area in line with the European legislation. The author is summarizing the legal background within the scope of clinical trials in the EU. Then the main elements under the sponsor responsibility are described, including the safety management plan, the investigator brochure, the study protocol, SUSAR reporting, annual safety reports or DSUR, and the provision of information of the development medicinal product to the XEVMPD.

The author concludes that it is necessary to document and align sponsor processes with the European legislation in order to reach a study outcome in compliance with the regulations. Mostrar menos

Description of how an administrative cost saving decision has influence in patient safety, and how it does trigger a patient/pharmacist/doctor communication.

Review on the Royal Decree 577/2013 from 26 July 2013, which regulates the Pharmacovigilance of Medicinal Products for human use in Spain.

Description of the xEVMPD

Description of the new EudraCT portal

Obtaining farmacovigilance safety signals with the safety database Safety Easy.

Poster with results of the analysis for the spontaneous notifications of adverse reactions to medicines sent from patients to the Danish Medicines Agency in 2005

Testing experience between the Danish Medicines Agency and GSK Denmark