Pharmacovigilance

Before the marketing authorisation is granted, information regarding the safety of a medicinal product is collected from a limited number of patients in clinical trials. Safety reports (DSUR) summarise this information on a yearly basis during the development phase. However, the knowledge of the safety of medicinal products is incomplete at this stage due to the limited number of included patients. For this reason, there is a legal requirement to continuously and systematically collect and evaluate the experiences gained during the administration as part of the EU risk management plan before and/or after the marketing authorisation and within the scope of regular safety reports (PSUR, PBRER) after receiving marketing authorisation.

s4s offers you precise support in all aspects of safety-related documentation in accordance with ICH and NtA volume 9 , starting with annual development safety update reports (DSUR), via the presentation of the safety profile and monitoring and risk reduction measures of your medicinal product in the EU risk management plan (EU-RMP), up to extensive literature searches and the preparation of periodic safety update reports (PSUR, PBRER) – also as part of the expert opinion of the benefit-risk profile of your medicinal product for extension of the marketing authorisation.

The services of s4s in the area of pharmacovigilance include:

• Literature searches in all relevant databases
• Consulting in our areas of expertise
• Preparation of pharmacovigilance system master files (PSMF), in compliance with GVP
• Periodic safety update reports (PSUR), periodic benefit risk evaluation reports (PBRER), in compliance with GVP and ICH E2C(R2), respectively
• Annual development safety update reports (DSUR), in compliance with GVP
• EU risk management plans (EU-RMP), in compliance with GVP