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Module 1 - General Topics
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Guidelines
VICH GL30
VICH GLs 24, 29, 35, 42
Pharmacovigilance
Pharmacovigilance of veterinary medicinal products: management of adverse event reports (AERs)
VICH GL24 (Pharmacovigilance) - October 2007 - Implemented in December 2015
Pharmacovigilance of Veterinary Medicinal Products - Management of Periodic Summary Update Reports
VICH GL29 (Pharmacovigilance) June 2006 - Implemented in June 2007
Pharmacovigilance: VICH Step By Step Document (5 November 2014 - version 1.0.2)
VICH GL35
Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data
Revised VICH GL35 (R1) (Pharmacovigilance: ESTD) - March 2023 - For implementation at step 7 in the regions by March 2024
Pharmacovigilance of Veterinary Medicinal Products: Data Elements for Submission of Adverse Events Reports (AERs)
Revised VICH GL42 (R1) (Pharmacovigilance: Data Elements) - March 2023 - For implementation at step 7 in the regions by March 2024