Pharmacovigilance Database

Our E2B-compliant pharmacovigilance database, the BPI Pheda, allows participating companies to enter, store and manage reports of adverse drug reactions (ICSR) into a company-specific online account. In addition, reports can be transmitted in an E2B-compliant format within the electronic European drug reaction reporting system (EudraVigilance).

Our service includes:

• E2B-compliant database for electronic transmission and administration of adverse reaction reports (ICSRs/SUSARs)
• transparent cost structure (costs based on the number of reportable reports per year)
• fully validated system (GAMP standard)
• software installation by user not required ("Software-as-a-Service")
• password protection of company data
• user-friendly user interface
• autonomous administration and electronic transmission by company
• transmission via gateway
• specific data queries and evaluations
• generation of tables for reports, e.g. PSURs, Annual Safety Reports
• integrated MedDRA Browser for coding of adverse reactions
• free support hotline
• support for EudraVigilance registration
• Option to participate in a MedDRA group license

• training courses available in English and German
• creation of literature reports in a E2B-compliant format
• creation and transmission of case reports by qualified personnel

For further information please visit www.psur.de or contact info@bpi-service.de.

You can find a collection of relevant regulative pharmacovigilance documents in our pharmacovigilance document library.