Here you will find essential information concerning the BAH-WiDi PSUR project, including the aim of the project, detailed information about the offered service spectrum and the current list of PSUR Data Lock Points (DLPs). These are supplemented by the most important regulatory guidance documents.
The BAH-WiDi PSUR project offers a cost-effective means of outsourcing the preparation of a PSUR which complies with the requirements as laid down in the Guideline on Good Pharmacovigilance Practices (GVP). PSURs compiled within this project also contain the up-to-date benefit-risk assessment for your active substance or product based on the requested signal evaluation.
We can offer this service because PSURs are specific for an active pharmaceutical ingredient (API) and have to be submitted to Competent Authorities at defined time points. Therefore, API-specific information may be used commonly by marketing authorisation holders (MAHs). For products authorised in the EU, DLPs and reporting periods in the List of Union Reference Dates (EURD list) are binding.
Additionally, we offer PSUR preparation for all DLPs which are individually defined in your authorisation dossier.
Our service aims to supporting you to deal with the increasingly demanding pharmacovigilance requirements in an efficient, cost-effective manner.
If you have any queries or would like more detailed information, please do not hesitate to contact Dr. Ebeling & Assoc. GmbH.