Nordic Pharmacovigilance Day - Programme

Signal detection and management strategies are critical components in ensuring patient safety and regulatory compliance within the pharmaceutical industry. These strategies involve a comprehensive approach to monitoring, evaluating, and managing potential safety signals that may arise from various data sources, including non-clinical studies, clinical trials, non-interventional studies, and spontaneous reports. The process begins with ongoing safety evaluation, where data is continuously monitored to identify any new or emerging safety signals. Once a potential signal is detected, it undergoes a rigorous analysis, prioritization and validation to determine its significance and potential impact on patient safety. Effective signal management also requires timely and clear communication of safety information to Health authorities and other relevant stakeholders. By employing these strategies, pharmaceutical companies can proactively ensure patient safety, manage safety risks, and maintain regulatory compliance. The continuous evaluation and effective communication of safety information are essential in building trust and safeguarding the well-being of patients

Observational healthcare data include evidence of the effect and side effect of all interventions. The question is how we may dig this out. We present the project PHAIR, a consortium of pharmacy-epidemiologists, authorities, and AI researchers that in collaboration with patients dig into this. We present methods from modern machine learning to find effects and side effects based on electronic healthcare records and the results of the first analyses.

With the enormous advances in AI what has been the impact so far on Pharmacovigilance? This presentation will assess the state of the art of AI in PV, reflect on future opportunities and suggest what the key obstacles are that are inhibiting the impact of AI in PV to date and reflect on how the influence of these obstacles might be mitigated

This session aims to equip PV professionals with practical strategies to effectively prepare for regulatory pharmacovigilance Inspections, focusing on common challenges, vulnerabilities and areas of non-compliance. Through real-case
examples and interactive exercises, the presentation will highlight the essential role of cross-functional collaboration among Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, and Scientific Departments. Emphasis will be placed on how misaligned communication and insufficient integration between departments can significantly impact GVP compliance and inspection outcomes.

What people will learn?

• Integration of processes and departments at both documentation level and in terms of QPPV authority and oversight
• Step-by-step overview of inspection preparation, starting from notification receipt
• Checklist-based documentation review (including participant-led completion of selected sections)
• Strategic selection of cross-functional personnel to be interviewed during the inspection (e.g. Regulatory Affairs, QA, Medical, Marketing)
• Management of the front room and back office during inspections, including supporting tools and systems

Quality in pharmacovigilance is essential for ensuring patient safety and the reliability of safety data throughout a product’s life cycle. In the area of pharmacovigilance, activities relating to detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems require a robust and well-structured Quality Management System (QMS) to function effectively.

During this session, we will explore the critical elements of quality in pharmacovigilance, including regulatory compliance, data integrity, the importance of audits and risk management, as well as inspections, training, and continuous improvement in sustaining efficient and compliant pharmacovigilance practices. Ultimately, ensuring a resilient pharmacovigilance quality system not only minimizes risks to patients but also enhances the scientific credibility of the pharmacovigilance processes and promotes regulatory compliance excellence

In today’s dynamic regulatory environment, pharmacovigilance (PV) outsourcing has become a strategic lever for pharmaceutical and biotech companies aiming to ensure compliance, scalability, and operational excellence. This presentation will explore the key learnings and insights derived from real-world PV outsourcing engagements across diverse organizational contexts.
We will delve into the importance of strategic partnerships, where success is driven not just by cost-efficiency, but by shared goals, trust, and aligned expectations. A core takeaway is that customization is crucial—there is no one-size-fits-all approach. Tailoring processes, tools, and team structures to each client’s needs enhances compliance and value delivery.
Attendees will gain practical recommendations for companies planning to outsource PV activities, including how to structure contracts, manage transitions, and build resilient collaboration models. We will also examine effective onboarding practices and assignment focus, which are pivotal for smooth knowledge transfer and minimizing operational disruptions.
Additionally, the presentation will highlight the role of governance and communication frameworks in ensuring transparency, performance tracking, and continuous improvement. Finally, we will explore the primary drivers behind PV outsourcing, from access to global expertise to operational flexibility and cost control.