Biblioteca

Documentos conceptuales

  • VICH/IN/07003 - IFAH-Europe Concept Paper on Electronic Presentation of Regulatory Documents
  • VICH/13/063-dr2 - Draft 2 Concept Paper from the ESI EWG for the revision of VICH GL42
  • Minutes of the 29th VICH SC meeting held in Auckland (NZ) on November 11-14, 2013
  • Proposal for a Concept Paper of VICH Bioequivalence Guideline for the Registration of Animal Products
  • VICH/IN/07009 - Proposal for a Concept Paper of VICH Bioequivalence Guideline for the Registration of Animal Products
  • VICH/IN/08/020 - VICH Concept Paper that proposes to revise GL33, General Approach to Animal Testing, to include References to the 3Rs Principle
  • VICH/IN/08/022-rev - VICH Concept Paper requesting Revision of the GL 36
  • VICH/IN/09/003 - Concept Paper on the Establishment of an Expert Working Group to Elaborate the Requirements to Demonstrate Bioequivalence
  • VICH/IN/09/001 - VICH Revised Concept Paper on the proposed initiative to develop VICH guidance for studies that would establish an Acute Reference Dose for veterinary drug residues in food
  • VICH/IN/09/002-rev - Draft Concept Paper for the Harmonisation of the Target Animal Batch Safety Test for immunological veterinary medicinal products
  • VICH/IN/09/007 - Concept Paper that requests to revise VICH GL18 - Impurities: residual solvents in new veterinary medicinal products, active substances and excipients
  • VICH/10/050 - VICH Bioequivalence: Concept Paper on the establishment of an Expert Working Group to elaborate the requirements to demonstrate bioequivalence of veterinary pharmaceuticals by blood level studies
  • VICH/IN/10/012 - VICH Bioequivalence: The VICH blood level BE Guideline: Summary of TF Perspectives
  • VICH/10/057-fin-rev - VICH Concept Paper for the Establishment of an Electronic Standards Implementation of Adverse Event Reports Expert Working Group
  • VICH/IN/10/014 - draft 3 - Draft VICH Concept Paper from IFAH-Europe for the revision of VICH GL3 (R)
  • VICH/IN/13/015 - Concept Paper from FDA for the revision of VICH Anthelmintics GLs
  • VICH/16/070-Fin (update 22/07/16) - CP for 2 VICH GLs: (1) general principles for detection of extraneous viruses in veterinary vaccines and defining the testing of seeds and materials of animal origin (2) list of extraneous viruses that need to be covere
  • VICH/15/013 - Concept Paper for the Creation of an Ad Hoc Working Group on Training Implementation