戻る Agenda
AI in Medicines Lifecycle
Session Chair(s)
Thomas Brookland, MSc
Regulatory Science and Policy Lead
F. Hoffmann-La Roche Ltd, Switzerland
Luis Pinheiro, PharmD, MSc
Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce
European Medicines Agency, Netherlands
This session will focus on the emerging EU AI regulatory and policy landscape / ecosystem and how it relates to medicines development, with a specific focus on the EMA/HMA’s draft reflection paper on AI in medicines. With perspectives from regulators, legislators, patients and industry, we will discuss how these frameworks could impact the development of AI in medicines and explore practical recommendations to foster the development of reliable and responsible AI across medicines lifecycle development.
Learning Objective : After attending this event: You can distinguish different AI methods for anomaly detection in clinical trial data monitoring You can describe the steps necessary to develop AI tools to monitor clinical data You can explain the advantages and the pitfalls of AI in clinical trial monitoring
Speaker(s)
AI in Healthcare: EU Regulatory Context
Hannah-Marie Weller
European Commission, Luxembourg
Directorate-General Communications Networks, Content and Technology
Regulatory Perspectives on AI in the Medicinal Product Lifecycle
Gabriel Westman, DrMed, MSc
Swedish Medical Products Agency, Sweden
Head of Artificial Intelligence
Overview of Use of AI Across the Life-Cycle Drug Development
Nicole Mahoney, PhD
Novartis Pharmaceuticals Corporation, United States
Executive Director US Regulatory Policy & Intelligence
AI-Based Error Detection for Multimodal Study Data to Modernize Clinical Trial Data Management
Rogier Landman, PhD
Pfizer, United States
Associate Director Data Science
Patient Perspective on the Ethics of AI in Healthcare
Milana Trucl
European Patients' Forum, Belgium