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XIII SEMINAR ON CONTROL AND HARMONIZATION OF VETERINARY DRUGS

Santo Domingo - República Dominicana
7 - 10 August 2007

 


Following the activities developed in CAMEVET since year 1992, and as a result of the 12th Seminar on harmonization of registration and control for veterinary medicines, which has been held in the city of Panama in 2006, next Seminar on Harmonization of Registration and control of Veterinary products will be held in the city of Santo Domingo, Dominican Republic from August 7th to 10th.

As a result of the proposals and conclusions from previous Seminars, many technical and operative items will be presented, and will focus on the actual situation related to the process of harmonization and application of the CAMEVET guidelines in the Member countries.
Technical guidelines on Audit Guides and protocols for evaluating the efficacy of products intended for internal parasites will also be discussed

Technical issues shall be discussed, as those related to the utilization of veterinary medicines in aquaculture, and the presentation of the proposals for working papers related to Good Manufacturing Practices for ectoparasiticides, as the criteria for stability tests in veterinary products.

A presentation related to the interaction between the Committee and the OIE and the relation of the CAMEVET activities and the Terrestrial and Aquatic Animal Health Codes related to Veterinary Medicines will also be included in the Seminar.

XIII SEMINAR ON HARMONIZATION OF REGISTRATION AND CONTROL FOR VETERINARY MEDICINES

Tuesday, August 7th

08:00 – 09:30 Registration
(Registration will be also available August 6th from 15:00 to 19:00)

10:00 – 11:00 Presentation of the working Agenda
Evaluation of the CAMEVET activities related to the Terrestrial and Aquatic Animal Health Code
Procedures for the participation of CAMEVET on the proposals for creation and modification of the OIE Standards
Dr. Luis Barcos – OIE - Regional Representative for Americas
Dr. Martín Minassian – CAMEVET Secretary

11:00 – 11:30 Discussion

11:30 – 12:30 Follow up of CAMEVET documents – Update and application of approved guidelines in the Member countries.
Dr. Martín Minassian – CAMEVET Secretary
Dr. Carlos Menéndez – Regional Coordinator of the Registration Officers for Veterinary Medicines and Animal Feedstuff – OIRSA

12:30 – 13:00 Discussion

13:00 - 14:00 Lunch

14:00 – 15:00 Good Veterinary Practices related to the use of Veterinary Medicines
Presentation of the working paper prepared by the ad-hoc group
Dr. Carlos Francia – CAPROVE (Argentina) Milson da Silva Pereira – SINDAN (Sindicato Nacional da Indústria de produtos para Saúde Animal)

15:00 – 16:00 (Continuation)- Discussion.

16:00– 17:30 Coffee

17:30 – 18:45 Opening session. Assumption of CAMEVET’s President and Vice-president
Opening speeches

Lic. José Manuel Mallén
President – Association of Manufacturers, Importers and Representatives of Veterinary Products

Dr. Angel Rafael Faxas Vargas
Livestock General Director - Dominican Republic

Dr. Luis Barcos
Regional Representative for Americas – World Organisation for Animal Health

Ing. Salvador Jimenez
State Agriculture Secretary - Dominican Republic

18:45 Cocktail

Wednesday, August 8th

08:30 - 09:30 Criteria for the establishment of shelf life in veterinary products
Presentation of the working paper (Step I)
Q.F. Griselda Malán – DILAVE – Uruguay
Working paper will be presented by Q.F. José Miguel Piera E. – IDIEF - Chile

09:30 - 10:00 Discussion

10:00 - 10:30 Coffee

10:30 - 11:15 Good manufacturing practices for ectoparasiticides
Presentation of the working paper (Step I)
Dr. Carlos Francia – CAPROVE (Argentina)

11:15 - 12:15 Efficacy tests for antiparasitic products for ruminants and swines
Presentation of the modification proposals for the working paper (Step III)
Dr. Martín Minassian – CAMEVET Secretary

11:30 a 13:00 Unlawful practices in veterinary products trade
Hernan Cifuentes Sguerra - APROVET - Colombia

13:00 - 14:00 Lunch

14:00 - 14:25 Regulatory aspects of biological products intended for aquaculture
Alice Bouffard - Veterinary Biologics Section - Canadian Food Inspection Agency

14: 25 - 14:40 Discussion

14:40 - 15:25 U.S. Animal Drug Regulations Including Aquaculture
Jannie M. Perron - Food and Drug Practice Group - Covington & Burling LLP

15:25 a 15:40 Discussion

15:40 - 16:15 Good Manufacturing Practices in Pharmacological and Biological products.
Revision of the proposals for modification of the audit guides for pharmacological and biological products.
Presentation of comments to the working paper (Step III)
Dr. Martín Minassian – CAMEVET Secretary

16:15 - 16:45 Coffee

16:45 - 17:45 Technical guidelines for Pharmacological and Biological Products: Results of the survey
Dr. Adela Encinosa Liñeiro– Subdirectora Instituto de Medicina Veterinaria - Cuba

17:45 - 18:15 Discussion

Thursday, August 9

08:30 - 09:30 Sampling in biological products
Dr. Ricardo Rego Pamplona –Head of Biological Products Division– MAPA - Brasil

09:30 - 10:30 Update on Bacterial Resistance
This presentation is directed to present the actual situation about the studies on antimicrobial resistance around the world and also the conclusions of international entities related to the fact that the ban on some drugs does not endorse any concrete benefit. Also focuses on presenting different alternatives for the administration of the OIE’s critically important antimicrobial list, and proposed alternatives by international organizations (IFAH) which are different from prohibitions.
The presentation is considered to be useful for Latin American regulatory authorities, regarding next Codex Alimentarius meetings, which will be held in Rome (September, 2007) and North Korea (October, 2007).
Tom Shryock - Microbiologist PhD, Elanco USA.

10:30 - 10:45 Coffee

10:45 a 11:30 Consequences of the banning of non hormonal growth promoters at the European Union
Dr. César Lópes - SINDAN

11:30 a 13:00 Recess – Executive Board Meeting

13:00 - 14:00 Lunch

14:00 – 16:00 Conclusions and Recommendations

16:00 - 16:30 Coffee

16:30 - 18:00 Conclusions and Recommendations
________________________________________
Activities related to the Seminar

Monday, August 6
18:00 Meeting for Representatives from Veterinary Products Industry
An open meeting for all of the representatives from Associations and companies will be developed, in order to exchange opinions and positions related to the activities carried out by CAMEVET.

JUEVES 9 DE AGOSTO
21:00 – Dominican party.

Friday, August 10
9:00 – 10:00 Experiences on the residues surveillance for veterinary products residues in animal products
Dra. Ofelia Flores – Centro Nacional de Servicios de Constatación en Salud Animal – México