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Session 7, Track A: Optimizing Product Lifecycle in LATAM - Aligning Global Trends for Sustainable Access and Availability
Session Chair(s)
Maria Antonieta Roman
Head Regulatory Policy LaCan, Novartis, Mexico
Sara Glenn Tylosky, MBA
Chief Executive Officer, Farmacon Global, United States
This session explores efficient Life Cycle Management in Latin America through international convergence and global trends like PACMP and reliance. Gain insights into regional updates to ensure timely pharmaceutical availability.
Optimizing Pharmaceutical Lifecycle: Bridging Global Trends and Regional Convergence for Sustained Product Availability
Cammilla Horta Gomes, Roche
Daniela Marreco Cerqueira, ANVISA
Carlos Aicardo, European Medicines Agency
Learning Objective : At the conclusion of this session, participants should be able to - Assess how reliance, convergence, and post-approval international requirements (WHO, ICH Q12) impact risk and market access
- Apply portfolio prioritization and multi-country strategies to coordinate launches, manage changes, and ensure supply continuity
- Evaluate the implementation of global trends, such as PACMPs and reliance pathways, to streamline post-approval changes
Speaker(s)
Product Lifecycle in Latam: Aligning Global Trends for Sustainable Access and Availability
Cammilla Horta Gomes, MA
Latam Regulatory Policy Lead , Roche, Brazil
Speaker
Daniela Marreco Marreco Cerqueira, MS
Associate Director, Second Directorate, ANVISA, Brazil
Speaker
Carlos Aicardo, MSc
International Affairs Officer, International Affairs, European Medicines Agency, Netherlands
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