VICH Pharmacovigilance Guidelines Development and

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VICH Pharmacovigilance Guidelines Development and Harmonization VICH5 November 29, 2015 VICH Electronic Standards Implementation Margarita Brown, DVM MS, Chair FDA Center for Veterinary Medicine 1 GL24 Management of Adverse Event Reports

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01
VICH Pharmacovigilance Guidelines Development and Harmonization
VICH5 November 29, 2015
VICH Electronic Standards Implementation
Margarita Brown, DVM MS, Chair
FDA Center for Veterinary Medicine 1<br>
02
GL24 – Management of Adverse Event Reports
GL29 – Management of Periodic Summary Update Reports

Note: The EU legislation and FDA CVM regulations are currently under revision, including pharmacovigilance requirements referenced in the above two Management GLs

GL42 – Data elements for Submission of AEs
GL30 - Controlled Lists of Terms
GL35 – Electronic Standards for Transfer of Data VICH Pharmacovigilance GLs 2<br>
03
Management GLs
GL24 – signed October 2005, 2007
GL29 – signed June 2006

Technical GLs – FDA CVM focus for implementation
GL42 – signed October 2005, June 2010
GL30 – signed October 2007, June 2010
GL35 – signed February 2013
One technical document (Validation Procedures) for regional signature still pending Historical Progression 3<br>