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Session 7, Track B: Responsible AI for Safer Medicines - Advancing Pharmacovigilance Quality and Decision Making in Latin America
Session Chair(s)
Juan Asbun
Pharmacovigilance and Patient Safety Regional Lead, Takeda México, S.A. De C.V., Mexico
Diana Gonzalez, MD, MBA
Colombia PSL & PV Policy Lead Latam , Roche, Colombia
Artificial intelligence (AI) is rapidly transforming pharmacovigilance, redefining how drug risks are identified, analyzed, and communicated throughout their lifecycle. This symposium examines the emerging role of AI in risk management and safety communication, highlighting how these technologies can enhance—and not replace—scientific and regulatory judgment. The session will address the application of AI and machine learning models in key areas such as early detection of signals,risk prioritization, automation of pharmacovigilance processes, and evaluation of the effectiveness of risk minimization measures. Moreover, the discourse will address the bioethical and quality considerations inherent in the deployment of AI within pharmacovigilance.
Learning Objective : - Describe concrete applications of AI in pharmacovigilance risk management
- Identify the requirements for the responsible implementation of AI in pharmacovigilance and relate them to current regulatory expectations.
- Define a specific and feasible action to incorporate or evaluate the use of AI in a risk management or communication process across pharmacovigilance processes
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