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.