We had the privilege of sitting down with Sue Rees, an expert in the field of pharmacovigilance in Europe. With an impressive track record of over 30 years in the pharmaceutical industry, Sue has worked for renowned organizations such as GSK, AstraZeneca, and Amgen. Her expertise is underscored by her former role as the European Union Qualified Person for Pharmacovigilance (QPPV), making her a true authority in the field. Sue is currently leading two of our courses, “Pharmacovigilance Inspections & Audits Updates” and “Signal Management in Pharmacovigilance”. We’re excited to share her insights with you.
With over 30 years of experience in the pharmaceutical industry, could you share some pivotal moments or projects that significantly shaped your understanding of pharmacovigilance?
My first role in industry, where I was receiving phone calls from HCPs and patients reporting adverse event and being part of the spontaneous case processing gave me a real grounding in PV and the bedrock on which everything we do is founded – Individual Case Safety Reports. I think it is essential that every PV professional understands ICSRs and what they do and do not tell us about our products. I also had the opportunity in my career to work with some very experienced safety scientist and safety physicians from whom I learned a great deal about how to effectively manage a safety signal.
How do you see the role of technology, such as artificial intelligence and machine learning, in advancing pharmacovigilance practices and making them more efficient?
Technology can be very useful for enabling consistency in the way information is coded and processed and can release valuable resources for other activities such as signal evaluation. Using natural language processing for example can help to extract adverse event terms from large volumes of reports but human clinical and scientific judgement will always be needed to ensure we are making the best decisions for patient safety.
From your perspective, what is a current focus in pharmacovigilance inspections? Can you please share some common inspection findings and how do you see a changing pattern of inspection findings?
I think there is a different focus depending on the regulator and how mature the inspection process is in that region. In Europe the focus has shifted from assessing whether the processing of ICSRs is occurring on time to a more holistic view of how does the MAH assure that HCPs and patients are adequately informed about the safety profile of the product. This might include looking at implementation of risk minimisation measures, timely updates to labelling and interfaces with other functions to ensure all available data is taken in to account for signal detection. Some inspectorates are now targeting specific elements of the PV system at each inspection. There is also a move to conduct fewer on-site interviews and rely more on document review which may occur remotely.
In your experience, what are some of the common misconceptions or challenges that individuals new to pharmacovigilance often face, and how can they be effectively addressed?
Pharmacovigilance is often viewed as a function focussed only on compliance, with individuals working in PV seen as ‘police’. It is up to us, as PV professionals, to show our colleagues that PV is more than ICSRs and that by ensuring we effectively determine and communicate the safety profile of our products we can contribute not just to the safety of patients but to the commercial success of the products and organisation. To be successful I think you need to be pragmatic and focus on what is best for the patient.
Signal management is a critical process in pharmacovigilance. Could you provide an overview of what signal management entails and its significance in ensuring patient safety?
Signal management is the process of determining the safety profile of a product. It consists of reviewing all available data to look for signals – indications of possible adverse reactions or risks – and then analysing those data to determine if there is sufficient evidence that the product is likely to cause that event and finally determining if any further action is required to mitigate that risk. That might be just informing patients and prescribers in the product labelling but it might also be a change to the way the product is administered or even removing the product from the market if the risks continue to outweigh the benefits for patients.
From your perspective, how has signal management evolved over the years, and what trends do you see emerging in this field?
The biggest change to signal management I have seen is the introduction of automated data mining – using statistical methods to trawl databases and determine which events are being reported at a disproportionally greater rate. This has been great addition to the PV armamentarium, but is only suitable to be used in large, diverse databases. Outside of this I think the trend continues to be how to make the process of signal management more effective, particularly looking at how signal management then feeds in to the labelling process.
Pharmacovigilance regulations and requirements can vary globally. How do you ensure that signal management processes align with different regulatory expectations while maintaining a consistent approach?
As with any PV process the core process would most likely align with the most stringent requirements. If this is not possible, for example if a country has a need for rapid notification outside of the core process, then a local process may be necessary. In this instance the global team would need to have oversight and work to ensure that the local team had the information needed to fulfil the requirements.
Can you share any personal strategies or best practices you’ve developed over the years for staying updated with the latest signal management methodologies and guidelines?
I think it’s a combination of self-study – reviewing information on the regulatory agency websites for example and then learning from others – whether that be through my personal network or through attendance of conferences or meetings. The key is to be curious and to think about how you might practically apply what you are reading or hearing.
Looking ahead, what do you believe are the most pressing challenges that the field of pharmacovigilance and signal management will face, and how can professionals prepare to address these challenges effectively?
I think there will continue to be the drive to reduce resources and operate more efficiently and effectively which will inevitably lead to further use of technology. We need to be prepared to incorporate the technology into our processes in a risk-proportionate way – no be overly resistant to change. We also need to be conscious that technology will also impact the way we receive adverse event reports and that regulatory guidance may not keep up with the pace of change – sometimes we have to be comfortable operating in grey areas. Finally as medical science advances may be faced with implementing more complex risk management strategies and need to be watchful for novel adverse reactions.