The Periodic Safety Update Reports (PSUR) Database with a web-based query function, developed by researchers from the Pompeu Fabra University (UPF) and Hospital del Mar Medical Research Institute (IMIM), was launched in December 2020.
The Database contains PSURs provided by the eTRANSAFE pharma partners, which are pharmacovigilance documents that assess the risk-benefit balance of a medicinal product. The PSURs incorporate summarised quantitative information on the adverse health events observed during clinical trials and the pharmacovigilance of medicines, constituting key documents in regulatory procedures.
In order to facilitate the access to the database and the search for information, a user-friendly web-based graphical interface has been developed, providing diverse capabilities for exploring, filtering and ranking the information contained in the PSUR documents. The interface also includes a functionality for downloading Excel files with the information resulting from the queries. Additional functionalities will be incorporated into the PSUR database and into the web-based interface in the near future, such as the inclusion of more sophisticated querying capabilities and the connection to other standard vocabularies and databases in the framework of its integration into the eTRANSAFE Knowledge Hub