Nordic Pharmacovigilance Day

This one-day conference, designed to address the evolving landscape of drug safety, brings a variety of sessions covering key aspects of pharmacovigilance – from managing safety data in a digital world to navigating complex regulatory frameworks for drug-device combination products.

The day begins with registration and a welcome from the Scientific Board, setting an anticipatory tone for the series of expert-led discussions and interactive sessions to follow. Maria Laustsen Murholm, a compliance specialist in digital health from Novo Nordisk, initiates the conference with a presentation on managing safety data derived from digital media sources. In this talk, Murholm sheds light on how digital channels are transforming the ways in which data is gathered and analyzed, addressing both the opportunities and challenges of integrating digital health data into traditional pharmacovigilance practices.

Presentation at Nordic Pharmacovigilance Day

By applying graph theory to pharmacovigilance, Nowicki highlights how this mathematical framework can uncover intricate relationships within adverse event data, enabling safety teams to better predict and manage risks.

Following Murholm’s presentation, Peter Nowicki from RxLogix discusses the use of graph theory as a tool for enhancing drug safety analysis. By applying graph theory to pharmacovigilance, Nowicki highlights how this mathematical framework can uncover intricate relationships within adverse event data, enabling safety teams to better predict and manage risks. His insights reveal how data science can create more robust drug safety networks, ultimately strengthening patient safety across the industry.

Coffee break at Nordic Pharmacovigilance Day 2024

As attendees take a brief coffee break, they have the opportunity to network, exchange ideas, and discuss the morning’s sessions, setting the stage for the next presentations.

The conference resumes with a session led by Jeanette Johansson and Henrik Bengtsson, inspectors from the Swedish Medical Products Agency, who address the complex responsibilities involved in overseeing pharmacovigilance (PV) suppliers. Their talk emphasizes the importance of thorough and consistent oversight by marketing authorization holders (MAHs) and provides insight into best practices based on recent inspection outcomes. This session underscores the regulator’s perspective on the evolving expectations for safety compliance, especially in maintaining rigorous standards in collaboration with external PV suppliers.

Shortly after, Patricia Jiménez Vasquez from MSD AB offers an in-depth view into the process and expectations involved in pre-qualifying a PV supplier. Her presentation covers the essential steps for ensuring that PV suppliers meet the stringent requirements of pharmacovigilance protocols, focusing on the assessment and management of supplier compliance. This session is particularly beneficial for professionals involved in regulatory affairs and supplier management, as Vasquez shares practical guidance on creating and implementing efficient, compliant supplier relationships.

This interactive session encourages open dialogue and provides a platform for exploring best practices in global compliance, as participants consider ways to streamline processes and enhance collaboration.

Following a lunch break, the conference reconvenes with a collaborative workshop aimed at tackling the challenges of global PV system governance. In small group discussions, attendees work through case studies and share their experiences, discussing strategies for managing the governance of complex pharmacovigilance systems that span multiple regions and regulatory frameworks. This interactive session encourages open dialogue and provides a platform for exploring best practices in global compliance, as participants consider ways to streamline processes and enhance collaboration.

The afternoon sessions continue with a joint presentation by Ferring Pharmaceuticals’ senior pharmacovigilance physician, Juan Paolo Granada, and Maj-Britt Schmidt Andersen, who oversees compliance for medical devices within the company. They explore the specific challenges of post-market reporting for drug-device combination products, contrasting the regulatory requirements in the EU and the US. Their discussion focuses on the complexities that arise when device-specific requirements intersect with pharmacovigilance regulations, providing attendees with a nuanced understanding of compliance expectations and practical strategies for bridging regulatory differences across regions.

After another coffee break, the conference nears its close with a session led by Per Sindahl, a senior pharmacovigilance assessor at the Danish Medicines Agency, who discusses the authority’s perspective on assessing and enhancing the effectiveness of risk minimization measures (RMMs). Sindahl’s insights provide a valuable look into how regulatory bodies evaluate RMMs, with advice on optimizing these measures to improve patient safety and ensure adherence to regulatory standards.

By addressing both emerging technologies and pressing regulatory issues, the Nordic Pharmacovigilance Day 2024 is helping to shape the future of pharmacovigilance practices.

The day wraps up with closing remarks from the Scientific Board, summarizing the key takeaways and highlighting the conference’s contributions to advancing pharmacovigilance in the Nordic region. This event has served as a significant forum for sharing knowledge, fostering cross-border collaboration, and inspiring new approaches in drug safety. By addressing both emerging technologies and pressing regulatory issues, the Nordic Pharmacovigilance Day 2024 is helping to shape the future of pharmacovigilance practices, driving the industry towards safer, more effective systems for patient protection and regulatory compliance.