Workshops/Meetings : Veterinary Medicinal Products

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OIE Regional Workshop on Risk Analysis for Import, Distribution and Handling of Animal Vaccines in collaboration with Malaysian Department of Veterinary Services
(Kuala Lumpur, Malaysia, 3-5 November 2009)

  1. A series of the OIE Regional Workshops on Harmonization of Registration of Veterinary Medicinal Products have been organized for last several years.  And this ASEAN+3 (PR China, RO Korea and Japan) Workshop was the follow-up of the previous Meeting on Vaccine Quality, Good Management Practices (GMP) and Good Laboratory Practice (GLP) held in Bandung, Indonesia, last January 2009. 
  2. The main objectives of the Workshop were to provide national competent authorities with the updated information on registration of animal vaccines and risk analysis of animal vaccines, especially for import, distribution and handling and to discuss the development of standards on risk analysis of animal vaccines in the Region.
  3. The Workshop was attended by 40 participants from Cambodia, R.O. Korea, Indonesia, Japan, Lao PDR, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam (for those countries, two officials responsible for each on Registration and for Laboratory Assay), ASEAN Secretariat and OIE (HQ and Asia-Pacific).
  4. The Workshop was opened with the welcome addresses delivered by Dr Teruhide Fujita, OIE Regional Representative for Asia and the Pacific and Dato Dr Mhd. Aziz bin Jamaluddin, Director General of Malaysian Veterinary Services.
  5. Every participating country reported its paper on Risk Analysis for Animal Vaccines, after the presentations by Dr Fujita on Background and Objectives of the Workshop, by Dr Michel Lomberd, OIE HQ on Risk Analysis for Import of Animal Vaccines; from Registration to Pharmacovigilance after Distribution to Farmers, by Dr Pudjiatmoko, Director of National Veterinary Assay Laboratory, Indonesia on Risk Analysis on Animal Vaccines in Indonesia, and by Dr Hidetaka Nagai, National Veterinary Assay Laboratory of Japan’s Ministry of Agriculture, Forestry and Fisheries on Risk Analysis on Animal Vaccines in Japan.
  6. The current Workshop noted a certain progress of harmonizing registration of animal vaccines in the Region, while Risk Analysis on animal vaccines needs to be further strengthened.
  7. The workshop recommended the following.
    (1)Development of Risk Analysis Models for animal vaccines (based on the OIE Standards) to support vaccine quality assurance in the Region,
    (2)Continuation of a regional technical workshop of Risk Analysis for animal vaccines to enhance understanding and identify gaps and develop the said models,
    (3)International/Regional Organizations’ support to Regional activities on Risk Analysis for animal vaccines.
    (4)As other matters, the follow-up actions related to this Workshop to be taken by ASEAN Member Countries were discussed and recommended.

Conclusions and Recommendations(PDF)