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.
Click here to view a recording of the webinar.
Agenda
- Welcome: who is the Pistoia Alliance? How has the pre-competitive collaboration model worked for PV over the last year?
- Meet the Steering Committee: introducing the speakers driving PV initiatives at the Pistoia Alliance.
- The state of play: key industry pain points in pharmacovigilance.
- From challenge to action: how PS² and the AI in PV Community of Experts complement each other in addressing those pain points.
- PS² work to date & outlook: what’s been achieved so far and where the multi-year program is heading.
- AI in PV Community of Experts: objectives and target deliverables.
- Why get involved: Hear what motivates Steering Committee members to drive this work.
- How to participate: the ways you can get involved in either initiative.
- Live Q&A
Speakers
- Jen Whitebrook — CSL · PS² Steering Committee
- James John — AbbVie · PS² Steering Committee
- Hosted by Marc Graber, Pistoia Alliance (initiative lead)