Pooling Project Pharmacovigilance
The increasingly extensive and complex requirements placed on the pharmacovigilance activities of marketing authorisation holders for medicinal products are a substantial strain on the human, technological, and financial resources of a pharmaceutical firm.
Comprehensive Pharmacovigilance Solutions
- Product flyer
The service spectrum of the BPI Service GmbH includes
- continuous literature searches and evaluations
- compilation of Periodic Safety Update Reports (PSURs)
- maintenance of a joint E2B-compliant database (BPI-Pheda) for the administration, retention and electronic transmission of adverse reaction reports
- templates for Standard Operating Procedures (SOPs)
- conduct of „friendly audits“
- focussed training and continuing education courses as well as coaching of staff on pharmacovigilance-specific topics
Project Benefits
Our goal is to provide comprehensive pharmacovigilance services to pharmaceutical companies. At the same time, we seek to identify standard processes that can be harmonized across multiple clients, thereby eliminating redundant work. This generates significant cost savings in human resources.
Convincing Quality
Aside from our attractive pricing, which also includes full cost transparency, quality management is an important aspect of our services. Various quality assurance measures such as project-specific SOPs and validation of IT systems ensure full regulatory compliance.
You can find a collection of relevant regulative pharmacovigilance documents in our pharmacovigilance document library.