Agenda/Scientific Program

View the Scientific Program

The Forum 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 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.

Driving Regulatory Convergence Across Latin America

Throughout the past decade, the regulatory pharmaceutical landscape has been greatly defined and shaped by the focus given by various stakeholders to enhancing collaboration and convergence efforts. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) greatly expanded its membership since 2015, and now includes 23 Members and 38 Observers. The International Coalition of Medicines Regulatory Authorities (ICMRA), inaugurated in 2014, currently represents a key organization that supports sharing of information and best practices among regulators, addressing current and emerging human medicine regulatory and safety common challenges globally.

Despite the increasing efforts, the absence of globally convergent regulatory frameworks and practices is still a reality, and this leads to more than just disparities in review requirements across different jurisdictions. In one hand, for companies that operate in multiple markets, the lack of harmonization is translated into customized dossiers for specific countries and/or regions. Because of the workload involved in the preparation of tailor-made regulatory submissions, approval timelines are extended, delaying global accessibility to medicinal products. On the other hand, in a world where regulatory reliance practices are becoming more and more the norm, health authorities are challenged by the need to assess documentation describing requirements from reference authorities that differ from local regulations. Apart from the fact that these discrepancies in dossiers might raise concerns from regulators regarding practices from industry, they represent a complication in the verification of the “sameness of product”, which is critical for the use of reliance. 

For 2025, the CMC Strategy Forum Latam sessions will explore the current regulatory scenario, global initiatives that will shape the future of regulatory requirements and practices, and how regulators and industry in Latin America and the Caribbean can be better prepared.