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Swissmedic Guidance: Electronic Exchange of ICSR in E2B(R3) Format Through the B2B Gateway
As pharmacovigilance systems continue to move toward standardized electronic reporting, efficient and reliable exchange of Individual Case Safety Reports (ICSRs) is essential for the timely management of adverse drug reaction information. Swissmedic has established an electronic exchange process based on the ICH E2B(R3) standard for the transmission of ICSRs between Marketing Authorisation Holders (MAHs) and Swissmedic. The Guidance for Industry on the Electronic Exchange of
Sharan Murugan
Aug 94 min read
Swissmedic Guidance: The Electronic Exchange of ICSRs in E2B(R3) Format through PV Gateway
The Swissmedic released an updated guidance " Electronic Exchange of ICSRs in E2B(R2) Format through PV Gateway " that provides...
Sharan Murugan
Sep 1, 20242 min read
Swissmedic Guidance: The Electronic Exchange of ICSRs in E2B(R3) Format Through B2B Gateway
Today (26 August, 2024) the Swissmedic released " guidance for the industry on the electronic exchange of ICSRs in E2B(R3) format...
Sharan Murugan
Aug 26, 20242 min read