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Plenary Session V: VICH Phase III 2011 – 2015 Future Opportunities

Plenary Session V: VICH Phase III 2011 – 2015 Future Opportunities. Brigitte Boenisch, IFAH Europe . VICH 4 Conference, 24-25 June 2010, Paris (France) International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products. The wider context.

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Plenary Session V: VICH Phase III 2011 – 2015 Future Opportunities

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  1. Plenary Session V: VICH Phase III 2011 – 2015Future Opportunities Brigitte Boenisch, IFAH Europe VICH 4 Conference, 24-25 June 2010, Paris (France) International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products

  2. The wider context • Global trade of animals, food, products • Emerging diseases spreading globally • Climate change • Role of animal health and veterinary medicines for food safety, food security and disease prevention/control • Speed and ease of access to information

  3. Focus on VICH • Low hanging fruits harvested during VICH Phase I (>30 guidelines) • Phase II • Shift of focus to maintaining what was achieved • Tackling newly identified areas for harmonisation

  4. VICH Strategy Phase III • Developing new technical guidelines • Maintaining and updating existing guidelines and monitoring their consistent implementation • VICH Global Outreach: provide a basis for wider international harmonisation of registration requirements

  5. VICH Current and future opportunities • Protection of public health, animal health and welfare, environment • Harmonised technical requirements • Reduced cost and time of new product development and use of test animals • Increased availability of safe and efficacious quality veterinary medicinal products

  6. Future opportunities: new technical guidelines • Bioequivalence • List of potential topics elaborated by the technical work stream at VICH4 (Safety, MetRes, Pharmacovigilance, Quality, Efficacy and Environmental Safety EWGs) • Emerging diseases, new technologies, food production, unmet needs

  7. Future opportunities: existing guidelines Consensusbuilding Dialogue,collaboration Quality, safety,efficacy Consistent interpretation Consistent implementation Certainty,predictability Reduction of animal testing Sciencebased Improvementsidentified Involve non-VICH countries?

  8. Future opportunities: VICH Global Outreach • Information and communication about the role of VICH relative to OIE, CODEX - managing expectations • Global regulatory governance of veterinary medicinal products to be progressed by OIE – reference to VICH guidelines as a final step • VICH to establish mechanisms to collect needs and expectations from non-VICH countries and to integrate those into the process (guidelines & governance)

  9. Future opportunities: Putting them into reality • Refine draft VICH Strategy for Phase III taking into account VICH4 input- long-term vs. mid-term vision - concrete action plan • Continuing to actively support OIE in its endeavours to improve the global governance of veterinary medicines – coordinate both strategies • Global needs of the future: continued dialogue with the global organisations

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