The third major pillar of the Pooling Project Pharmacovigilance will comprise an
E2B- compliant joint database for electronic reporting of adverse reactions.
The database will provide participating firms with their own secure area within
the larger database and a gateway for electronic reporting. The database is due
to go into production beginning of 2007 and will allow participating firms to
access the database, enter data and send electronic reports via an online
platform.
The cost of using the E2B-database will be pooled among the participating firms
according to their reporting volume of electronic case reports. The costs of
another attractive feature, a group MedDRA license, will also be distributed
according to case volume and annual turnover. The peripheral services provided
along with the database (i.e. hotline, optional entry of case reports, etc.)
can be accessed by the firms as needed.
Firms who simultaneously use the Literature
Research Tool and the
PSUR-writing service will additionally profit from synergisms between
the services. For example, the CIOMS forms made available in the Literature
Research Tool will be available for export to the E2B- database for electronic
reporting as Individual Case Safety Reports (ICSR).
BPI-Pheda Demo
For an initial impression of the BPI-Pheda (E2B-compliant database for electronic reporting),
we have compiled demo films of the BPI-Pheda and its functions: