Nordic Pharmacovigilance Day - Programme

The world of medicines and usage of medicines is ever changing and increased globalization is providing more opportunities for companies and authorities to communicate and organize their activities worldwide. Likewise the flow and amount of data including drug safety information has vastly increased. Recent years has also provided important technical developments and possibilities to support pharmacovigilance processes with automation and IT-solutions.

The presentation provides the perspective from a pharmacovigilance inspector, on how to balance the new settings and possibilities while ensuring compliance and adequate quality for reliable assessment of pharmacovigilance data and benefit-risk profiles of medicines. How do we as inspectors make best use of available data and global networks for our inspections? And what typical pitfalls and challenges do we see in companies when we conduct pharmacovigilance inspections?

Risk minimization measures (RMM) aim to prevent or reduce the occurrence or severity of an adverse drug reaction when a medicine is used in daily practice, and RMM play an important role in strengthening the positive benefit-risk balance of a medicine. During the post-marketing period it is important to monitor the outcome of these measures in order to ensure that RMM have fulfilled their objectives i.e. the risks are sufficiently minimized, well as to provide evidence if any changes to the RMM or their implementation may be necessary.

During this session methods used for assessing the effectiveness of RMM including their outcomes will be presented. Experiences from regulatory perspective as well as results from ongoing research on outcome of evaluation and the subsequent changes in RMM during post-marketing period will also be addressed. All topics will be supported with examples and case studies allowing an interactive discussion with the audience.

The Pharmacovigilance domain consists of specialized and complex set of activities and pharmaceutical companies, irrespective of their size struggle with the resource and competency constraints in this area both during product clinical development and life cycle management.

This session will focus on a small Danish pharma company’s approach to outsourcing of PV activities including benefits and challenges encountered. One should always remember that independent of outsourcing only a certain set of assignments or tasks – partially or completely – the responsibility always resides with the sponsor. How to maintain an effective oversight will be the key take-home learning from this session.

Back in May 2017, a new Medical Devices Regulation (MDR) (2017/745) in Europe was published in the official Journal of the European Union providing the industry with a three years’ transition period to meet the MDR requirements. However, due to Covid-19 pandemic, the European Parliament adopted European Commission’s proposal to extend the transition period with one year ending the new extended transition period on 26th of May 2021.

The new MDR covers updates to Vigilance and Post-Market Surveillance requirements while introducing a new role of Person Responsible for Regulatory Compliance (PRRC) that ensures manufacturer’s compliance with Vigilance and Post-Market Surveillance requirements. The MDR also addresses economic operators role to cover their supply chain responsibilities. Additionally, the MDR introduces a new requirement to obtain Notified Body opinion for medicinal products with integral device part for their marketing authorisation in Europe.

During the session, further details on MDR’s Vigilance and Post-Market Surveillance requirements will be provided and best practice examples will be shared.

Moderator: Doris Stenver – Independent Pharmacovigilance Adviser, Founder of Unique Advice

Interactive session to share learnings from the pharma industry related to ensuring patients safety and pharmacovigilance during pandemic situation. Initially, Bettina Østergaard Eriksen from Novo Nordisk will briefly share perspective on the experiences from the recent situation.

The session will then open up for the participants to share experiences across the pharma industry and create a mutual learning environment based on dialogue amongst the participants/audience.

Denmark has a long tradition for using registries to collect data either for individual treatment purposes or as valuable tools for epidemiological research. In addition, these registries provide a unique base for novel use of real world evidence in signal detection, validation and assessment. In the past years the major part of validated signals raised to the Pharmacovigilance Risk Assessment Committee (PRAC) at the European Medicines Agency’s (EMA) from DKMA originated from other sources than traditional databases with spontaneously reported adverse drug reactions, which is in contrast to most other member states and EMA.

In this presentation examples of analyses of registry data turning into regulatory actions will be discussed. With registries becoming more frequent worldwide, they will be a major potential source for early detection of new signals. Key experiences from the examples will be outlined for future considerations.

Drug Safety information from clinical trials and marketed products is predominantly processed by manual methods, with some basic means of scripted automation that basically has been available for the last 20 years. Equally, signal detection technology and methodologies, to detect or defer concerns / potential risks seen with a drug, have been fairly stagnated for many years. With the wealth of cutting edge technologies available today, including Artificial Intelligence / Machine Learning and Big Data Analytics on vast healthcare data, could we do something more profound to change how we analyze and extract knowledge?

This session will explore the potential and pitfalls of introducing these new technologies and data sources to signal detection and also reflect on recent advancements in the area. Fundamental questions are to be answered: What are the potential gains in terms of patient safety? How would this work in practice and how mature is the technology for safety signal detection? Will it provide efficiency gains / is there a positive return on investment? Or will this lead to far more work in Industry?

In this presentation the implementation of the ccAI project in Novo Nordisk Global Safety Customer Complaint Center is described. The aim of the project is to automate parts of the device complaint Triage process, by using emerging technologies.

We will describe the technologies used and the underlying theories. We will explain which technology has been chosen for implementation, its limitations and where we have combined the technology with other techniques in order to handle the business needs.

Using machine learning introduces a new set of concepts and questions that needs to be tackled:

– Designing processes that take erroneous machine decisions into account.
– What accuracy and error rates are acceptable?
– When and how often will we need to re-train the machine learning system.

These concepts and questions will be discussed as seen from a PV business perspective, and if possible then we will present the results from the AI design (project is not scheduled to be concluded by October 2020).