The Driver: The Steering Committee

The VICH Steering Committee is the driver of the harmonisation process.

The Driver : The Steering Committee
The 9-step procedure
The official Organisational charter

It is the only structure that is empowered to take decisions such as selecting topics, releasing draft guidelines for consultation, and adopting final guidelines for implementation in the three regions. The VICH Steering Committee meets twice a year, at the OIE headquarters in Paris during the initial two-year phase. The location of meetings now alternates between Japan, the EU and the US. All meetings are normally held in English, but participants can bring their own translators.

The 9-step procedure

  Step 1 The SC:
  • defines a priority item from a detailed concept paper sponsored by one of its members;
  • establishes an appropriate EWG, if needed and designates a chairperson. A topic leader in charge of drafting a Guideline is appointed and given a clear mandate to do the expected work;
  • ensures that each expert is properly briefed and has a clear mandate enabling him/her to meet the expected outcome in the timeframe defined by the SC, in accordance with established VICH guidance;
  • ensures that each topic leader has the required competence and interpersonal skills to lead an EWG and achieve its objectives.
  Step 2

The appropriate EWG elaborates a draft Guideline, and submits it to the Secretariat with the signatures of all experts.

  Step 3

The draft Guideline is submitted to the SC for approving its release for consultation.

  Step 4

Once adopted by the SC, the draft Guideline is circulated to all interested parties for consultation, applying an appropriate consultation period (normally 6 months). The regulatory coordinators should inform VICH secretariat when the consultation process in their region is delayed.

  Step 5 The comments received are directed to the EWG for consideration. At this step, the topic leader must be a representative of a regulatory authority. The EWG prepares a revised draft and submits it to the Secretariat with the signature of all experts. The signatures of industry experts are clearly separated from those of experts representing regulatory authorities.
  Step 6

The revised draft Guideline is submitted to the SC for approval.

  Step 7

Once approved by the SC, the final Guideline and a proposed date for its implementation are circulated to the regulatory authorities represented in the SC.

  Step 8

The SC members report to the SC on the implementation of the Guidelines in their respective regions.

  Step 9

Monitoring, maintenance and review of Guidelines:

  • The necessity to review adopted Guidelines should be determined, at least every 3 years, following the implementation in order to take account of new developments. The secretariat will notify the SC of the three years deadlines.
  • Any SC member may propose to review an adopted guideline at any time and inform the VICH secretariat in due time prior the next SC meeting. Such proposal should be accompanied by an abbreviated concept paper detailing the rationale and the background for review
  • If the SC acknowledges the need for a review of the adopted guideline, the SC will designate the appropriate EWG or a topic leader as the reviewer.
  • The SC decides on the appropriate step at which the revision procedure shall start.
  • The SC will propose a prioritisation rule for the first review of all Guidelines.

The official Organisational charter

  « VICH Strategy Phase III (2011-2015) (VICH/10/026-Final) »
  « VICH Work Programme 2006-2010 »