ALADDIV The Latin American Alliance for the Development of the in Vitro Diagnostics

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1 ALADDIV The Latin American Alliance for the Development of the in Vitro Diagnostics 1

2 THE MODEL ALADDIV Aliança Latino Americana para o Desenvolvimento do Diagnóstico in Vitro Alianza Latino Americana para el Desarollo de Diagnóstico in Vitro

3 Group - Americas Rosanna Peeling, Carlos Gouvea, Adele Benzaken, Graciela Russomando Alain Mérieux, Patricia Velez Moller and Segundo Leon

4 ALADDIV Creation of new Alliance non profit organization Entity that would guarantee the convergence of interests of the several stakeholders in the segment of IVD, considering that they are: Conscious of the need of an effective, correct and early diagnostic test, with the adequate sensitivity and specificity for the proposed objectives; Conscious of the safety and efficacy aspects; Promoters of the access of patients to the new health technologies; Supporters of the general implementation of Quality Systems; Supporters of the harmonization or regulatory convergence that will allow a better predictability and cooperation among the countries in Latin America, mainly in Public Health Programs

5 ALADDIV Organization acting in the whole Latin American region, through a network of collaborating members, especially: Academy Industry (Associations) Healthcare Professionals (Associations) Public Laboratories (Government) Private Laboratories (Associations) It should reflect the complexity of the IVD productive chain, searching to share the best practices in the whole continent Defense of Universal Healthcare Systems Health Surveillance Action and Promotion of Health

6 INTERNATIONAL WORKSHOPS Accessible and Quality Assured in Vitro Diagnostic Tests for Public Health Programs Brasília, April 2012 (OPAS) Brasília, November 2012 (ANVISA) Curitiba, October / November 2013 (TECPAR)

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20 ALADDIV Main activities: Share knowledge and education in IVD Generate and share innovation within Americas, though new local productive arrangements; Search of international cooperation with other organizations, foundations, NGOs, and industries that may allow the necessary improvement of health conditions in the continent Develop leadership initiatives that may promote the benefits of the early diagnosis, generating clear gains in public health programs Promote the discussion for the regulatory issues and quality systems with the local government bodies, allowing the exchange of experience and discussion in favor of the convergence or harmonization of the sector legislation.

21 Web Site IVD Portal

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24 ISAGS Instituto Sul Americano de Governança em Saúde

25 Health Surveillance in South America" Available for download:

26 Health Surveillance in South America" The book recently launched by ISAGS, was organized thanks to a special collaborative effort of 12 countries, members of UNASUR. Dr José Gomes Temporão, ISAGS Coordinator and former MoH: Health must, among other objectives, contribute to the reduction of assimetry among the countries in the region and for such, are fundamental the policies and actions of the surveillance systems. From this perspective, ISAGS organized two workshops that made possible the debate of the national experiences and identification of the main issues of the countries of the region, enabling the introduction to the discussion of the challenges presented to the surveillance systems in a context of deep changes in the epidemiological standards.

27 ALADDIV Next steps: To structure ALADDIV Indicate regional leadership in each area of interest / project Establish permanent channels of communication for experience exchange and project development. First board elected: Chair = Brazil (Carlos Gouvea) Vice-Chair = Honduras (Freddy Tinajeros) Technical Director = Peru (Segundo Leon) Secretariat = Paraguay (Graciela Russomando)

28 ALADDIV Next steps: Keep on looking for the support/endorsement for future actions by WHO, PAHO, UNAIDS, ISAGS/Unasur, Mercosur, Bill & Melinda Gates Foundation, Fondation Mérieux, London School of Hygiene & Tropical Medicine, among others. Keep on identifying and involving the key stakeholders in the IVD areas in each country Act as a collaborating entity for IVD in South America Whenever possible, use existing structure for other networks, such as RedETSA (by PAHO)

29 Obrigado! Carlos Eduardo Gouvêa

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