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.
Join this webinar to hear what we’ve achieved so far, where we’re headed, and how you can get involved.
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)
This webinar is open to everyone, from pharma and biotech safety teams, PV technology vendors and system integrators, regulators, to anyone interested in the future of pharmacovigilance.
Register