Seminars
9th ISoP Seminar –
Intelligent Automation in Pharmacovigilance
4-5 Dec 2025 | Boston- Cambridge, MA 02142 | Hybrid event
9th ISoP Intelligent Automation in Pharmacovigilance Seminar
“From Innovation to Impact: Building Trustworthy AI in Pharmacovigilance“

Programme and Overview
Agenda
Why attend:
- Gain insights into practical applications of AI tools in everyday PV workflows.
- Discuss pathways to build trust in AI solutions, ensuring they are secure, ethical, and aligned with public health goals.
- Dive into governance and ethical considerations surrounding AI deployment, including regulatory expectations.
- Engage on how to navigate innovations like generative AI, ensuring they serve as enablers—not replacements—for expert decision-making.
Who should attend: Pharmacovigilance professionals, AI technologists, regulatory authorities, researchers, and healthcare leaders who are shaping the future of safety science.
| Day 1 – Thursday, Dec 4th 2025 | ||
| Session 1 | AI Governance and Risk Minimization | 9:00 am – 10:30 am |
| Session 2 | CIOMS Working Group XIV on Artificial Intelligence in Pharmacovigilance | 11:00 am – 12:30 pm |
| Session 3 | Oral Presentations | 1:30 pm – 3:00 pm |
| Session 4 | Panel Discussion | 3:30 pm – 4:30 pm |
| Day 2 – Friday, Dec 5th 2025 | ||
| Session 5 | Scaled Use Cases and Interpretability (Pharma Perspective) | 9:00 am – 10:30 am |
| Session 6 | Operational Approaches to Using and Enabling AI in PV | 11:00 am – 12:30 pm |
| Session 7 | Validating and Auditing AI tools in PV | 1:30 pm – 3:00 pm |
| Session 8 | Hackathon on AI Impact on Medication Errors | 3:15 am – 4:30 pm |
Speakers Abstracts Presentations (Session 3)
- #01 Automated Post-Marketing Exposure Calculation: A Web-Based Tool for Enhanced Pharmacovigilance Efficiency – Shikha Goel, Northeastern University, USA
- #02 Development of a new Drug-Event Modeling Tool Using Dynamic Probabilistic Distribution for Enhanced Safety Signal Detection – Bassem Toeama, MD Pharma Consulting Group, Canada
- #03 Lifecycle Validation and Audit Controls for AI/ML Systems in Pharmacovigilance – Gaurav Goel, Vitrana, USA
- #05 Integrating Natural Language Processing to Facilitate Pharmacovigilance Workflow: A Use-Case Applied for Structuring Data from Electronic Medical Records in Quebec – Jacinthe Leclerc, University of Laval, Canada
- #06 AI-Driven Multi-Source Analytics in Pharmacovigilance: From Reactive Detection to Predictive Safety Intelligence – Sumatha Kondabolu, Qualio, Canada
- #07 Toward machine-assisted pharmacovigilance: using contrastive learning to generate vector representations of adverse events from spontaneous reports – Mátyás Pétervári, Semmelweis University, Hungary
Meeting Venue
The International Society of Pharmacovigilance would like to extend its gratitude to Takeda for hosting the meeting at its premises.
Takeda
Meeting Room Floor 1 – 1.122/1.124, 125 Binney St, Cambridge, MA 02142