Periodic Safety Update Report
The EU Directive 2001/83/EC and the “Guideline on Good Pharmacovigilance Practices” (GVP) – Module VII “Periodic Safety Update Report” – provide guidance on the preparation, submission and assessment of PSURs, as well as recommendations for quality systems for PSURs and training of staff members on the PSUR process. These standards also apply to international PSUR/PBRER formats. According to the guidance, the main objective of PSURs/PBRERs is to present a critical and comprehensive analysis of the benefit-risk profile of a medicinal product taking into account new or emerging information in the cumulative benefit-risk analysis.
For PSUR/PBRER compilation we evaluate data on drug safety from your studies, from the spontaneous reporting system including information from regulatory authorities and literature as well as reports on efficacy and benefits of the concerned medicinal product:
The PSUR/PBRER is thus based on the evaluation of customer specific data as well as information from the literature. Synergies ensue with Signal Management and CoBRA® which is an essential element of the PSUR according to GVP. We offer PSUR compilation on an individual basis or as part of the joint preparation within the BAH-PSUR-Project. The BAH-PSUR-Project has been audited successfully.
Please do not hesitate to contact us for an individual offer.