German Pharmacovigilance Day - Programma

Aggregate reporting in pharmacovigilance is the periodic, systematic and cumulative evaluation of safety data from multiple sources including clinical trials and post-marketing experience, in order to assess the benefit-risk profile of an authorised medicine. The standard tool to be used is the Periodic Safety Update Report (PSUR), also called Periodic Benefit-Risk Evaluation Report (PBRER), being one of the core pillars of pharmacovigilance and lifecycle management. This session will look into the evolution of PSURs and their assessment in the context of the EU PSUR Single Assessment (PSUSA) from a regulatory perspective. It will provide insights into available guidance (e.g. from GVP) and will discuss those areas requiring particular attention. As the PSUSA aims at optimising the benefit-rik balance of authorised medicines we will also explore how to use this tool to evaluate the effectiveness of risk minimisation measures in place and how to adapt if necessary.

Regulatory obligations and expectations are growing, and the health environment is becoming increasingly complex. This has been going on for years leading to only more effort and perceived responsibilities. While innovation (Automation and AI) is embraced to manage the rising workload, there is an overall reluctance to stop or reduce any activities.
Why not take a step back and think about focusing on those tasks which are essential for our business and identifying other tasks that can be considered as “old-fashioned or obsolete” and provide only limited value for our business? In this roundtable we want to share your thoughts and ideas on obsolete activities and identify best practices and opportunities to do less of such tasks to keep focus on our key objective: Ensuring patient safety

The update to Implementing Regulation (EU) No 520/2012 refines core pharmacovigilance obligations that are routinely assessed during EU PV inspections. This session maps amended provisions to inspection expectations. It discusses common risk areas arising from the transition to the new framework and proposes documentation and governance measures to demonstrate compliance. 

This presentation introduces a lifecycle-based governance framework for AI systems in pharmacovigilance, grounded in the CIOMS Working Group XIV guidance. At its core is a “Governance Framework Grid” that maps CIOMS XIV’s guiding principles against lifecycle phases, from concept through routine use. Through practical examples, the presentation demonstrates how AI governance in pharmacovigilance is a continuous, controlled learning cycle in which principles like transparency, human oversight, and risk evolve together across the lifecycle.

Strict “No-AI” policies in Pharma-Projects are intended to protect Intellectual Property, yet they often trigger a dangerous “Prohibition Paradox.” By banning sanctioned tools, organizations inadvertently drive people toward “Shadow AI” – the unauthorized use of public LLMs to manage increasing workloads. This creates unvetted data exposure and allows “AI slop” (hallucinated or low-fidelity outputs) to enter GxP records without oversight.

This session analyzes the shift from reactive prohibition to a risk-based governance framework, illustrated by practical case studies. We examine different options for AI deployment—from private instances to specialized PV tools—and discuss strategies for working securely with third-party service providers and consultants. Rather than providing a rigid roadmap, the focus is on identifying the right questions to ask when balancing risk against value, ensuring GxP compliance and IP protection while enabling the operational innovation necessary for modern pharmaceutical companies.