Nordic Pharmacovigilance Day - Programme

As Insud Pharma continues to expand across B2B and B2C operations, the scale and complexity of pharmacovigilance (PV) activities increase accordingly. To support timely delivery while maintaining quality and inspection readiness, we have initiated implementation of automation and AI-enabled tools across selected PV processes, using a pragmatic, controlled rollout focused on early learnings.

Our primary focus has been on AI-supported identification and triage of both global and local literature reports. Our objective was to improve screening efficiency and consistency across sources, while ensuring that medical assessment and final relevance decisions remain with PV professionals. In addition, we are exploring the use of AI agents for repetitive, periodic PV exercises requiring recurring coordination and documentation; this is currently in a structured try-and-error phase to understand value, limitations, and required human oversight.

Implementing AI-assisted solutions in a GxP-regulated environment requires a careful governance and validation approach, including clear ownership and oversight, risk-based assessment of intended use, defined user requirements, controlled configuration management, documented testing, and ongoing KPI monitoring. The presentation will share our current view and lessons learned to date.

• EMA inspections – when agencies work together
• When the legal pharmacovigilance landscape and GVP changes
• Words on inspection findings

Pharmacovigilance systems must remain effective during both anticipated and unanticipated disruptions. This presentation includes common continuity threats -including cyberattacks, health and safety emergencies, supplier failures, and workforce shortages – and discusses controls and strategies to prevent, reduce, and/or mitigate incidences, and maintain critical pharmacovigilance activities while protecting patient safety and regulatory compliance. Furthermore, experiences from a recent testing of a business continuity plan will be shared.

In the complex ecosystem of global pharmacovigilance, compliance is a team sport. True regulatory integrity requires absolute alignment between global strategy and local execution. This session brings together PV leaders from HQ and country offices to dissect the practical realities of shared responsibility. Panelists will share actionable insights on breaking down communication silos, managing conflicting local regulations, and fostering a culture of mutual accountability. Attendees will leave with proven strategies to transform their global-local relationship from a compliance challenge into a seamless, collaborative shield for patient safety.  

Relying on real-world data to support safety surveillance activities is not new to the field of pharmacovigilance. However, data originating from Traditional Randomized Clinical Trials have long been considered “the Gold Standard” by regulators, while less credibility has been attributed to safety study results based on real-world data.
With new opportunities for generating evidence from real-world data (RWD), to complement traditional clinical trials, regulators across regions are increasingly pointing towards the inclusion of generation of RWE to complement the totality of the medicinal product´s safety profile.
This talk will highlight methodological frameworks and study designs, such as structured data feasibility assessments and pragmatic clinical trial designs to strengthen the reliability and credibility of RWE to support safety surveillance and regulatory decision-making.
As the pharmacoepidemiological landscape continues to evolve, integrating high quality RWE into safety surveillance offers an unprecedented opportunity to improve patient protection, accelerate evidence generation, and ensure that decisions regarding patient safety more closely reflect real world practice.

This workshop will explore specific challenges in pharmacovigilance and provide a platform for discussion among professionals from different companies and backgrounds. The session aims to encourage the exchange of experiences, perspectives and emerging approaches related to current and future issues in the field.