Dr. Merton Smith, Dr. Bettye Walters, and Dr. Steve Vaughn to travel to attend and make presentations at the OIE Conference on Focal Points for Veterinary Products in Asia and to meet with representatives from the OIE Collaborating Centers in Japan and France to plan future participation in OIE Focal Points for Veterinary Products meetings, to plan for one-day VICH workshop to be presented to transitional countries/organizations immediately prior to the next VICH Steering Committee meeting to be held in Japan in November 2011, and to plan the course that CVM will present in May 2012 as an OIE Collaborating Center. Other attendees at this meeting will be representatives from the French and Japanese OIE Collaborating Centers with which CVM will have continuing future training and other cooperative activities.
In 2010 OIE launched a global program of capacity building for OIE Delegates and National Focal Points for Veterinary Products directed toward assuring good governance practices for the control of veterinary products in OIE member countries, including the acceptance of VICH standards for veterinary product safety, efficacy, and quality testing. CVM represented VICH at the first three meetings of the OIE Focal Points for Veterinary Products that were held during 2010 in Belgrade, Serbia; Cartagena de Indias, Colombia; and Johannesburg, South Africa. The fourth meeting will be held in Siem Reap, Cambodia on June 27-30, 2011 and CVM will be invited to be the representative of VICH. This June meeting will also serve as an opportunity to hold a planning meeting for the three OIE Collaborating Centers that have competence in strengthening veterinary medicine regulatory infrastructures: CVM, Japan’s National Veterinary Assay Laboratory, and France’s National Agency for Veterinary Medicines. The three Collaborating Centers will develop a day-long workshop for regulatory counterparts from 8-10 transitional countries that will be held in association with the November 2011 VICH Steering Committee meeting in Tokyo. CVM participation in these meetings will assure that the United States continues to influence the development of VICH standards and the acceptance of those standards by countries that have not participated in VICH to date. As an example, CVM has been the key to recently obtaining commitment by the Chinese Bureau of Veterinary Medicine and the China Institute of Veterinary Drug Control to participate in VICH in the future. Participation by CVM in these VICH and OIE activities directly furthers the goals of CVM, VICH, and OIE to help assure the worldwide availability of veterinary drugs that are safe, effective and of high quality by strengthen national veterinary product governance to better control animal disease and better guarantee the safety of food of animal origin. Effective governance includes adequate and effective animal medical product regulatory controls, including the standards for product development and testing that have been established by the VICH. CVM participation in the meetings of the OIE National Focal Points for Veterinary Products and in the VICH Global Outreach Initiative directly support the FDA grant to OIE (“Global Implementation of the Veterinary Medicinal Products (VICH) Guidelines”) and the strategic collaboration and operational ties between CVM and OIE.
Under its anticipated designation as an OIE Collaborating Center in May 2011, CVM plans to offer a week long training course in May 2012 at its facilities in Rockville. At this initial course offering, the countries that are invited to attend will be from Latin America. The aim of the course is to train foreign regulatory counterparts in the way the FDA regulates animal drugs (including its use of OIE, VICH, and other international standards) with the ultimate goal of greater assurances of safety of food from animal sources that is traded internationally. The course format will include both didactic as well as hands-on activities and will cover both pre and post approval standards and procedures. CVM will work with OIRISA and CAMEVET to canvas their members to identify individual country needs and to recommend most effect course formats. Presentations should reflect that there are different diseases and animal management systems in the Latin countries and should also reflect the heavy beef and aquaculture industries in that region. Topics that may have special significance to this specific audience, including generic and counterfeit drugs, will be covered. It is anticipated that two participants from each country will be invited to attend.