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This short course will explore machine learning (ML) within the Regulatory/ Pharmacovigilance (PV) landscape. The instructors will provide a high-level introduction to machine learning, including common tools and project tips. We will then evaluate example applications, such evaluation of Single Case Drug-Event-Pair (DEP) causality using the Modified Naranjo Causality Score for ICSRs (MONARCSi).
The course will also focus on important non-technical aspects of using ML in PV, including potential approaches to performance evaluation, monitoring over time, maintaining human oversight, reporting, and legal considerations. Since machine learning requires resources from across the organization, this course is designed for anyone interested in sponsoring or joining a machine learning project within their organization.