Exchange agreements (SDEA)
Clear communication channels are of paramount importance in any pharmacovigilance system. The regulators want reassurance that safety information is exchanged effectively between different departments (e.g. Regulatory and Pharmacovigilance), between affiliate and headquarter companies and from one end of your organisation (for instance, your distributor in the Middle East) to the other (your Safety Board), and that the European Qualified Person for Pharmacovigilance will be updated with all safety issues and emerging safety concerns in real time. These are aspects that are frequently scrutinized (and found wanting) at regulatory inspection.
PrimeVigilance consultants can help establish clear communication channels within your organisation, formally documented in a Safety Data Communication Policy and supplemented by agreements on division of responsibilities between different company constituents1.
Our Consultants can write Safety Data Exchange Agreements, controlled documents shared by business partners that establish clear communication channels and methods. These can be complemented by the development of a Market Authorisation Map, which details the status of each product by country, and includes contacts within the associated manufacturers, marketing partners, distribution networks and vendors.
1. Cooper T. Licensing arrangements – global regulatory framework. Pharmacovigilance Rev (2007) 1, 13-15
Safety Data Exchanges Agreements: Compliant and Comprehensive
just one of the pharmacovigilance services from PrimeVigilance
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