When a pharmaceutical firm participates in the Literature Research and
Assessment service of the Pooling Project Pharmacovigilance, it orders a
specific substance or substances for research. The BPI Service GmbH performs
the database screening and the cursory assessments of the case reports found.
The conduct of the database screening, literature assessment and posting is
regulated by standard operating procedures (SOPs). The search terms used for
the database searches are standardized and include the substance ordered by the
firm and all of its relevant synonyms. The found literature entries are
assessed, saved to the database and posted online.
All literature entries are clustered into three groups:
„Potential Cases“ * :||Cases that may fall
under the 15-day reporting deadline.
„PSUR relevant“ * :||Cases that may be
relevant for future PSUR-writing, though they do not fall under the 15-day
„Others“ * :||Cases that require neither immediate
reporting, nor are relevant to a PSUR. These are publications that may be of
general interest to the marketing authorization holder.
(* These assessment are based on German pharmaceutical law and pertain to the
reporting of cases to the German national authorities.)
The cursory clustering of literature cases is followed by a detailed evaluation
of the original literature and the generation of completed CIOMS forms
(Potential Cases only) and line listings, which can then be downloaded, saved,
and edited for a small fee by the participating firm (for example, when writing
All literature entries for a firm’s ordered substances can be viewed online at
any time. In addition, the website offers several filter and sorting functions,
making the online platform of the database very user-friendly. The tool
includes an automatic email function to notify participants immediately when
new entries for their substances are posted.