World Patient Safety Congress US
Rethinking benefit-risk: How AI is changing lifecycle decision making
Download the slides for our session
Rethinking benefit-risk: How AI is changing lifecycle decision making
Benefit–risk assessment (BRA) makes up the heart of a marketing application for a new therapy, providing regulators with one of the most important pieces of evidence to justify an approval. As clinical trials, marketing approvals, and post-market regulatory requirements have become more complex, however, the challenges of drafting a comprehensive and accurate lifecycle benefit-risk assessment have grown.
This session explores potential means of improving benefit-risk assessments by applying innovative statistical techniques, artificial intelligence, and deep pharmacovigilance and regulatory expertise in compiling benefit-risk assessments.
Benefit–risk assessment (BRA) makes up the heart of a marketing application for a new therapy, providing regulators with one of the most important pieces of evidence to justify an approval. As clinical trials, marketing approvals, and post-market regulatory requirements have become more complex, however, the challenges of drafting a comprehensive and accurate lifecycle benefit-risk assessment have grown.
This session explores potential means of improving benefit-risk assessments by applying innovative statistical techniques, artificial intelligence, and deep pharmacovigilance and regulatory expertise in compiling benefit-risk assessments.
Presenters
Sophie Besset-Dangla
VP, Head of Global Pharmacovigilance
Stephen Sun, MD, MPH
VP, Pharmacovigilance
Lin Li, PhD
Head of Statistics & Predictive AI