Agência Nacionalde Vigilância Sanitária [email protected] CICAD/OEA
EXPERT GROUP CONCERNINGPHARMACEUTICAL PRODUCTS MEETING
Kleber Pessoa de MeloKleber Pessoa de Melo Chefe da Unidade de Produtos Controlados
Brasilia-DF(August 25-27, 2003 )
FINAL REPORTFINAL REPORT
BRAZILIAN PRESIDENCYBRAZILIAN PRESIDENCY
Agência Nacionalde Vigilância Sanitária [email protected] CICAD/OEA
Antigua and Barbuda HaitiArgentina HondurasBahamas JamaicaBarbados México
Belize NicaraguaBolivia PanamáBrasil Paraguay
Canada PerúChile República Dominicana
Colombia San Kittts and NevisCosta Rica Saint LuciaDominica Saint Vincent and the GrenadinesEcuador Suriname
El Salvador Trinidad and TobagoGrenada United States
Guatemala UruguayGuyana Venezuela
Member States Participated Member States Participated
Thirty-nine experts from the following member states participatedThirty-nine experts from the following member states participated
Agência Nacionalde Vigilância Sanitária [email protected] CICAD/OEA
Working Sessions Working Sessions
• Review and finalize the Guides for Control Systems, Review and finalize the Guides for Control Systems, Industry and Health ProfessionalsIndustry and Health Professionals . .
• Implementation of MEM Hemispheric recommendationsImplementation of MEM Hemispheric recommendations
• Reviewing the items remaining on the plan of actionReviewing the items remaining on the plan of action..
• Presentation by the delegation of Brazil concerning the Presentation by the delegation of Brazil concerning the national pharmaceutical control system that is currently national pharmaceutical control system that is currently being developed and implemented in Brazil.being developed and implemented in Brazil.
Agência Nacionalde Vigilância Sanitária [email protected] CICAD/OEA
GuidesGuides
• Elements for the Control of Pharmaceutical Products
•Mexico and USA•Reviewed•Finalized
•Guide for Health Professionals•Chile and Venezuela•Reviewed
•Revised Format
•Canada and Uruguay
•Guide for Industry•Colombia and Brazil •Revised Format•Deferred
Agência Nacionalde Vigilância Sanitária [email protected] CICAD/OEA
MEM RecommendationMEM Recommendation
8. Conduct a thorough review of domestic regulations for the control of Pharmaceuticals and strengthen coordination mechanisms among the relevant sectors.
• The Commission should encourage member states to:• review and update their national legislation and regulations
• The Executive Secretariat should:• establish a section in the CICAD web page concerning the control of
pharmaceutical products
• link to web pages maintained by member states • national pharmaceutical control legislation and regulations • substances that they control • the name and contact information of a person
• provide technical legal assistance
Agência Nacionalde Vigilância Sanitária [email protected] CICAD/OEA
MEM RecommendationMEM Recommendation
10. Implement a hemispheric communication and coordination system in order to improve and facilitate cooperation and coordination among member states on matters related to control of pharmaceutical products and controlled chemical substances at the national and international levels.
Executive Secretariat :•directory of operational points of contact
•directory of official Competent Authorities (INCB)
•CICAD / INCB•plan of action for National Drug Control Database (NDS) implementation
Expert group:• review existing best practices for communication and coordination for discussion during the next expert group meeting
• development of a reference paper
Agência Nacionalde Vigilância Sanitária [email protected] CICAD/OEA
RecommendationsRecommendations
• Member states
• Executive Secretariat
• Group of Experts
Agência Nacionalde Vigilância Sanitária [email protected] CICAD/OEA
Executive SecretariatExecutive Secretariat
• Web page• Technical Legal Assistance• CICAD / INCB implementation of NDS• Pilot training seminar
– Implementation of the elements guide– Caribbean
Agência Nacionalde Vigilância Sanitária [email protected] CICAD/OEA
Group of ExpertsGroup of Experts
1. Group of Experts to meet in 2004
Plan of action:
1. Finalize the Guide for Health Professionals
2. Develop a guide of best practices for communication and coordination
3. Develop a guide of best practices to overcome impediments to effective implementation of regulations and control systems (Chile)
4. Develop a guide of best practices for mechanisms to strengthen inspection, investigation and other control activities
Agência Nacionalde Vigilância Sanitária [email protected] CICAD/OEA
THANK YOUTHANK YOU
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