Home Pharma Pharmacovigilance Periodic Safety Update Report (PSUR) / Development Safety Update Report (DSUR)
Periodic Safety Update Report (PSUR) / Development Safety Update Report (DSUR)
The main objective of a PSUR is to present a comprehensive, concise, and critical analysis of the benefit-risk ratio of the medicinal product considering new or emerging information in the context of cumulative information on risks and benefits. The analysis of the benefit-risk ratio should incorporate an evaluation of the safety, efficacy and effectiveness information that becomes available during the reporting interval for the medicinal product in the context of what was known previously.
The Development Safety Update Report (DSUR) is annually reporting on medicinal products under development (including marketed drugs that are under further study) among the US and EU regions. During the clinical development of an investigational drug, periodic analysis of safety information is crucial for the ongoing assessment of any risks for trial subjects.
- LITERO prepares your PSUR in the framework of the post-authorisation evaluation at defined time points in the lifecycle of your medicinal product and in accordance with the EU-Directive 2001/83/EC and the GVP Module VII.
- We compilate your DSUR with safety information from all ongoing clinical trials and other studies that the sponsor is conducting or has completed during the review period in accordance with the ICH guideline E2F.
- Although the focus of the DSUR is on investigational drugs, there can be an overlap between the content of the DSUR and PSUR, and repetition may be predicted. The "modular approach" of the PSUR and DSUR aims to minimise duplication and to improve efficiency during the preparation and review of documents by enabling the common content of sections, where appropriate to be used interchangeably across different PSURs, DSURs and Risk-Management Plans.
- Further on, we support you with our many years of experience in the creation of relevant SOPs and process development so that you can successfully implement your pharmacovigilance strategies.