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Welcome to the Pooling Project Pharmacovigilance

The increasingly extensive and complex requirements placed on the pharmacovigilance activities of marketing authorisation holders for medicinal products, including literature research and submission of Periodic Safety Update Reports, place a substantial strain on the human, technological, and financial resources of a pharmaceutical firm.

In response to these developments the BPI Service GmbH, in close cooperation with pharmaceutical firms, implemented the Pooling Project Pharmacovigilance, which went into production in August 2005. The project allows participating firms to fulfil the regulatory requirements for pharmacovigilance activities efficiently and at a lower cost. The basic concept behind the project is to provide access to information relevant to pharmacovigilance, which would be collected for a specific substance or active ingredient, independent of a specific firm or product. By providing access to this information via a joint database, the costs accrued by each firm are reduced in proportion to the number of participating firms.

Aside from competitive clear-cut pricing policies, the project also places an emphasis on the high quality of its service. The quality standards applied are to ensure the compliance of all participants with the regulatory requirements for pharmacovigilance inspections. As a result, multiple quality assurance measures have been implemented within the project, including detailed standard operating procedures (SOPs).

A comprehensive, customer-oriented service package is provided by the Pooling Project Pharmacovigilance. In particular, the feedback and input of the participating firms is applied to the Project to continuously improve and expand the services provided.

The Pooling Project Pharmacovigilance consists of three main modules:

  Literature Research and Assessment
  Periodic Periodic Safety Update Reports (PSURs)
  E2B-compliant Pharmacovigilance Database

The following pages provide more detailed information on the Pooling Project Pharmacovigilance, as well as general information concerning pharmacovigilance under the items “Legal Position” and “FAQ”.

In addition, BPI Service GmbH publishes a „Pharmacovigilance Newsletter“ every 4 months, providing current information on topics concerning pharmacovigilance. A wide spectrum of courses and seminars on pharmacovigilance-related topics are offered by Colloquium Pharmaceuticum (www.coll-pharm.de/Programmvorschau) to support your continuing education.