Welcome to the CMC Strategy Forum Latin America

The annual CMC Strategy Forum Latin America will bring together industry, regulatory, and academic professionals to explore a number of critical topics focused on improving the quality in development and manufacturing of biopharmaceutical products. The topic for 2026 is "Advancing Regulatory Frameworks in Latin America: From ICH Alignment to Readiness for Emerging Technologies". The two-session series features speaker presentations followed by in-depth panel discussions that give you the opportunity to engage with fellow attendees in meaningful discussions on critical topics in Latin American biopharmaceuticals. We look forward to an informative Forum and hope to see you there. Be ready to collaborate and expand your knowledge.

The full scientific program will be available soon. View the full Forum abstract below.

Advancing Regulatory Frameworks in Latin America: From ICH Alignment to Readiness for Emerging Technologies 

The two-day framework will be built around two complementary themes, addressing the overarching topic of regulatory modernization in Latin America. Session I will concentrate on the journey to promote regulatory convergence to ICH guidelines, covering implementation strategies of key guidelines – such as those related to stability and the CTD; case studies; enablers, challenges, and lessons learned – both from the perspective of regulators and industry. 

Session II will shift to the discussion of emerging products and technologies offering an overview of global regulatory experiences, understanding regulatory readiness in Latin America, and discussing how strategies such as reliance can support patient access. 

These two sessions will integrate convergence, reliance and regulatory modernization as cross-cutting themes, tailoring discussions to realities of the region, and ensuring the program remains coherent, practical, and relevant for industry and Latam regulators of all maturity levels. 

"CMC Latin America is a great opportunity to continue learning and improving on international regulations, good practices and harmonization of ICH standards."
—Robin López Sánchez, CMC Strategy Forum Latin America 2025 Attendee
"An enriching opportunity to exchange insights and expand knowledge alongside representatives from regulatory agencies across Latin America, the EMA, and industry experts."
—Liliane Soriano Saadi, CMC Strategy Forum Latin America 2025 Attendee

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