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Sharan Murugan
Aug 31, 20242 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...
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
Sharan Murugan
Mar 30, 20242 min read
USFDA Guidance: Regional Implementation Guide for E2B (R3) e-Transmission of ICSR and Providing Regulatory Submissions in Electronic Format: IND Safety Reports
Today (01 April 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics...
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