Standards and AI for pharmacovigilance

Initiatives at Pistoia Alliance to improve pharmacovigilance

Pharmacovigilance teams across the industry face the same problems: fragmented systems, duplicated effort, and no shared playbook for adopting AI safely and compliantly. The Pistoia Alliance has two complementary, pre-competitive initiatives to tackle these challenges together:

• Pharmacovigilance Systems & Processes Standards (PS²): building common business-process, system and interoperability standards for pharmacovigilance.
• The Safety & PV AI Community of Experts: a forum for sharing best practices and building a harmonized understanding of regulatory expectations regarding AI.

Together, we aim to give the industry a shared foundation for PV: standardized, interoperable processes on one side, and a trusted, harmonized approach to AI on the other. The goal? To reduce cost and duplication while improving data quality, compliance and, ultimately, patient safety.
 
Watch the webinar to hear what we’ve achieved so far, where we’re headed, and how you can get involved.