Contact Meeting on Wider International Harmonisation of VICH Guidelines, Tokyo, 15 November 2011

Agenda

Session 1: VICH and wider international harmonisation

1)

VICH: History, Functioning & Achievements

HM

2)

Background and objectives of the VICH considerations regarding wider international harmonisation

OIE

Session 2: VICH Guidelines

3)

What is VICH guideline-their role in the authorisation/registration of veterinary medicinal products

EU

4)

Preparation of a VICH Guidelines- the process from development to adoption

JMAFF

5)

Requirements & Consequences of the implementation of VICH Guidelines

FDA

6)

Overview of VICH Guidelines available and example of VICH Guidelines implemented in the regions (safety, quality,...)

EU

Session 3: Reflection on wider international harmonisation

7)

Facilitated discussion with non-VICH participants

Views on the best way forward to the global Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products will be discussed taking into account relevant factors such as:

  • Level of advancement regarding regulatory systems for veterinary medicinal products
  • Existing cooperation with organisations/bodies regulating veterinary medicinal products
  • Existing cooperation with other countries at regional level
  • Participation in OIE focal point training
  • Participation and/or Interest in twining
  • Needs for information dissemination

Session 4: Conclusion

8)

Summary and conclusions on possibilities for non-VICH countries to participate to the VICH programme and/or engagement in the VICH process and recommendations to the OIE and the VICH Steering Committee