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CMC Strategy Forum Latin America Session I

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August 6, 2024


Contact: Randi Jacobs
Phone: 510-428-0740

The CMC Strategy Forum has established an excellent reputation for being the premier scientific meeting that brings together regulatory, industry, and academic professionals to discuss key emerging CMC issues that affect biotechnology in an open and transparent workshop format. The Latin America Forum explores a number of critical topics focused on improving the quality in development and manufacturing of biopharmaceutical products.

The 2024 Forum will be fully virtual and held in 2 separate sessions. Each sessions will be 3 hours and comprised of speaker presentations followed by an in-depth panel discussion. 

Session I - Tuesday, 6 August 2024
Session 1 will continue conversations for understanding barriers enabling risk-based classification of PACs, promoting convergence of regulatory variation reporting category assignment and defined HA review timelines and partner with HAs in the regions to identify pragmatic solutions like Reliance enabling regulatory efficiencies.

Session II - Tuesday, 13 August 2024
Session 2 aims to understand opportunities and challenges of implementing reliance in the region, how can industry partner with the HAs to move this along, are there other regulatory mechanisms that might be beneficial to consider?

For more information, visit CMC Strategy Forum Latin America