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CMC Strategy Forum Latin America 2017
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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 fourth meeting of the CMC Strategy Forum Latin America 2017 that will be held 9-10 October 2017 in Mexico City, Mexico. We are very pleased to have the strong support from COFEPRIS-Federal Commission for the Protection against Sanitary Risk regulatory agency in Mexico, as well as AMIIF, CANIFARMA and several other Latin America regulatory agencies (Brasil, Argentina, Chile, Ecuador 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 COFEPRIS, ANVISA, AEMPS, DIGEMID, as well as the FDA and EMA. In addition, FIFARMA is planning a half-day session to discuss “Reliance and Recognition – Good Regulatory Practices to Solve Capacity Issues and Accelerate Access” and “PANDRH – Procedure for Prioritizing Areas of Work and FIFARMA’s Project Proposals”. The technical sessions will include discussion on: “ICH CTD Structure for Module 3 for Biotech” and “Stability for Biotech 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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