Nordic Pharmacovigilance Day - Programme

The use of digital social media and the need to reach customers and gain customer insights have greatly increased over the years. An activity-tailored and risk-proportionate strategy to screen data for safety information is essential for effective utilization of resources, while still fulfilling the applicable PV legal requirements. During the presentation I will describe how do we approach screening and handling of safety information from different types of digital listening and social media scraping activities conducted in Novo Nordisk.

Pharmacovigilance is essential for monitoring adverse drug reactions (ADRs) and ensuring the safety of medicinal products. Traditional methods of data analysis in pharmacovigilance can be limited in handling complex relationships between drugs and ADRs. Graph theory, a branch of mathematics concerned with the properties of graphs, offers a promising alternative approach.

This presentation aims to explore the general application of graph theory in pharmacovigilance, particularly in understanding complex drug-ADR relationships and enhancing the effectiveness of drug safety surveillance systems.

We utilized graph theory to construct and analyze networks of drug-ADR interactions. Data was gathered from pharmacovigilance databases, focusing on reported ADRs and their associated medicinal products. The networks were analyzed using various graph theory metrics such as connectivity, centrality, and community structure to identify significant patterns and relationships.

The application of graph theory facilitated the visualization and analysis of complex relationships in pharmacovigilance data. It revealed additional insights into the interconnected nature of drugs and reported ADRs, identifying key nodes (drugs and ADRs) that play critical roles in the network. This method also helped in detecting clusters of ADRs associated with specific drugs, which might not be evident through traditional pharmacovigilance methods.

Graph theory offers a valuable tool for the analysis of pharmacovigilance data, providing a deeper understanding of drug-ADR interactions. Its ability to represent and analyze complex relationships in a comprehensive manner can enhance the detection and evaluation of drug safety issues. The insights gained from this approach could lead to more effective strategies for managing drug-related risks and improving patient safety.

It is quite common for a Marketing Authorisation Holder (MAH) to subcontract certain activities within their pharmacovigilance system to a PV supplier. Nevertheless, each MAH retains ultimate responsibility for all parts in their pharmacovigilance system, including the completeness and accuracy of the pharmacovigilance system master file (PSMF). In other words, the MAH can delegate activities but never responsibility and must keep close oversight of the work performed by their subcontractors!
This presentation will discuss anonymised findings from PV inspections in relation to PV supplier oversight by MAH in areas such as:
– qualification, continuous assessment, and audit of PV suppliers
– explicit and detailed agreements
– written procedures relating to the implementation of contracts and PV agreements
– reconciliation of PV-data
– PV-training of suppliers
– et cetera

Abstract available soon

Join us for an engaging workshop focused on delving into the intricate governance of global Pharmacovigilance (PV) systems. In this session, we will unravel why discussions surrounding PV governance are often overlooked and explore the critical components that shape this vital aspect of drug safety management.

Key Topics Include:
1. QPPV Coverage: Unpacking the role of the Qualified Person for Pharmacovigilance (QPPV) and understanding the nuances of local QPPVs.
2. PV Organization Structure: Analyzing the dynamics of PV organizational structures, including considerations for affiliates, Local Safety Officers (LSOs), and outsourcing models.
3. Case Processing Setup: Exploring strategies for efficient case processing, effective follow-up procedures, and robust documentation practices.
4. Oversight Perspectives: Gaining insights into the level of oversight required from a QPPV perspective and best practices for maintaining regulatory compliance and patient safety.

This workshop offers a unique opportunity to exchange ideas, share experiences, and deepen your understanding of the governance landscape within global PV systems. Whether you’re a seasoned PV professional or new to the field, this session promises to enrich your knowledge and enhance your approach to PV governance. Join us and be part of this essential conversation shaping the future of drug safety

Post-marketing safety reporting requirements for combination products in the EU and US are governed by the primary mechanism of action and whether the device and drug components form a single integral product.

In the EU, post-market reporting requirements are determined by the overall regulatory classification, whereas a specific rule on post-market safety reporting requirements have been published by the FDA (21 CFR 4 Subpart B), to clarify reporting requirements for products that combine at least two of the three different components- drugs, biologics, and devices.

This presentation will provide an overview of the regulatory landscape for safety reporting on drug-device combination products as well as highlight the challenges faced during implementation of the regulations.

When attempting to integrate device requirements into a global pharmacovigilance system, the footprint it leaves on the QMS system is significant. Devices bring new vocabulary and requirements that are not part of the classic pharmacovigilance setup such as the concept of similar devices, device malfunctions and reportable events based on a risk assessment rather than actual patient harm.

The overall aim of risk management is to ensure that the benefits of a particular medicinal product exceed the risks by the greatest achievable margin. This aim is achieved by effective risk minimisation measures (RMMs).

For several decades it has been standard regulatory practice to require evidence of quality, efficacy and safety for medicines before they are made available to patients. Yet, it is only in recent times evidence of effectiveness of RMMs have been required, although effective risk minimisation may be a condition for a positive risk-benefit balance.

Despite existing guidelines and the importance of studies evaluating RMMs, the quality of evidence is often insufficient to determine their impact on patient safety. This has led to a growing consensus among stakeholders for the need for high-quality evidence to guide risk minimisation programs and transform pharmacovigilance into a more effective learning healthcare system. More studies with high-quality is needed to inform regulatory decision-making and enhance the scientific field of risk management.

In this presentation, I will address some of the shortcomings of current risk minimisation evaluation approaches and outline characteristics of effective risk minimisation strategies drawing on new findings from my PhD research and the updated Good Pharmacovigilance Practices (GVP) guideline on RMMs.