VICH is to hold a fourth public conference in collaboration with the World Organisation for Animal Health (OIE), which will focus on discussion sessions related to the new VICH global outreach initiative.
VICH is to hold a fourth public conference in collaboration with OIE, which will focus on discussion sessions related to the new VICH global outreach initiative and will also comprise current activities of the Expert Working Groups.
VICH is a trilateral (EU-Japan-USA) programme aimed at harmonising technical requirements for veterinary product registration. Its full title is the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products. VICH was officially launched in April 1996.
The two day public conference, which will take place at the Paris headquarters of OIE on June 24-25, 2010, will follow a meeting of the OIE Collaborating Centres and Reference Laboratories, and is expected to have a strong participation of representatives from non-VICH countries.
The steering committee reviewed a proposal for a future strategy on global outreach towards non-VICH countries, in collaboration with OIE, aimed at providing a basis for wider international harmonisation of technical registration requirements. This strategy will be finalised after receiving input from non-VICH countries during the VICH conference.
The steering committee adopted the following draft Metabolism and Residue Kinetics Guidelines for release for public consultation at step 4: VICH GL 46 (Nature of Residues), VICH GL 47 (Comparative Metabolism Studies), VICH GL 48 (Marker Residue Depletion Studies) and VICH GL 49 (Analytical Methods used in Residue Depletion Studies). The consultation period in the VICH regions and Observer countries will be 6 months.
The steering committee agreed to initiate work on developing a guideline on requirements to establish bioequivalence of veterinary medicinal products and a guideline on statistical evaluation of stability data. The Steering Committee also agreed to review the current activities in the regions regarding rabies vaccines potency testing, in preparation of the possible future development of a guideline on this topic.
The steering committee reviewed the progress of the Expert Working Groups on pharmacovigilance, quality, biologicals quality monitoring, microbiological ADI and safety.
The 24th meeting of the steering committee is scheduled for 23 and 26 June 2010 in Paris, France.
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