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Session 9 Plenary: How Advancements in AI are Revolutionizing the Pharmaceutical World
Session Chair(s)
Raphael Elmadjian Pareschi, PHARMD, MBA
Patient Safety Lead/ Head of Pharmacovigilance Brazil, Roche, Brazil
Flavia Firmino, PHARMD
Regulatory Policy Lead - Latin America, Eli Lilly and Company, Brazil
This session will present how advancements in AI are revolutionizing the regulatory submissions to streamline processes, reduce costs and time, and the crucial role of the electronic Common Technical Document (eCTD) in facilitating these advancements, ensuring that regulatory submissions are standardized and efficient. The session will also explore perspectives on AI applied for pharmacovigilance processes and the current landscape of AI regulations.
Learning Objective : At the conclusion of this session, participants should be able to:- Discuss recent advancements in AI for regulatory submissions
- Recognize the challenges and opportunities for eCTD implementation in Latin America and identify existing opportunities
- Explore the current landscape of AI regulations and identify the latest trends in AI for pharmacovigilance processes
Speaker(s)
Ana Mak
Associate Director - Lifecycle Department Regulatory & Access, Parexel, Argentina
eCTD in LATAM: Turning Regulatory Challenges into Innovation Opportunities
Nina S. Cauchon, PHD
Director Regulatory Affairs CMC, Amgen, United States
Pioneering the Future: CMC Post-approval Change (PAC) Dossier Automation and Delivery to Global Regulators Simultaneously
Felix Arellano, MD, PHD, FISPE
Global Head Safety Risk Management, F Hoffmann-La Roche, Switzerland
Innovation In Pharmacovigilance: Strategies for Personalized Safety
Jason Cober, MPA
Director Regulatory Review, AI, Digital Transformation , ProPharma, United States
Regulatory Perspectives on the Use of AI in the Development of Drug and Biologic Products
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