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CMC Strategy Forum Latin America 2019
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On behalf of the CASSS Board of Directors and the CMC Strategy Forum Global Steering Committee, I would like to extend to you a warm welcome to the 4th meeting of the CMC Strategy Forum Latin America 2019 that will be held in Brasilia, 12-13 March 2019. We are very pleased to have the strong support from ANVISA-National Health Surveillance Agency, as well as GrupoFarma Brasil, Interfarma-Association of Pharmaceutical Research and several other Latin America regulatory agencies (Chile, Mexico and Peru), as well as the continued support by CASSS and the United States Food and Drug Administration. The Forum will follow the established model of the CMC Forum series with focus on topics and regulatory updates relevant for Latin America and will feature an opening regulatory session that will include presentations from ANVISA, COFEPRIS, DIGEMID, as well as the US FDA. The technical sessions will be: Regulations for Post Approval Change of Biotherapeutics - Global Developments and Opportunities for the Region; ICH CTD Structure: Module 3 Considerations for Biologic Products; and Stability for Biotechnological Products. 

With this exciting program, I would like to extend to you an invitation to attend and participate actively in making this Forum a great success.

Wassim Nashabeh
On behalf of the CMC Strategy Forum Global Steering Committee


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Or contact CASSS at 510-428-0740 or alingel@casss.org



         


 

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