Global Reflections on Pharmacovigilance: A Europe-Africa Roundtable on Regulation, Culture, and Practice

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Hosted by the UiO-coordinated-EDCTP3 project, AccessAfrica2, in coordination with Gispen4Regulatory Science, with additional funding from the Norwegian Research Council.  The event fosters critical discussion on real-world safety monitoring, regulatory practices, and health system differences through short, problem-focused presentations based on active research and field practice.

Topics include unintended regulatory effects, cross-cultural practices, clinical trial surveillance, patient engagement, and vaccine safety during pandemics. 

Participants include regulators, researchers, and policy experts from institutions such as the European Medicines Agency, Norwegian Medicines Agency, Dutch Medicines Evaluation Board; Gispen4Regulatory Science; Welfare and Sport, Africa CDC, AUDA-NEPAD, national regulators across Europe and East Africa, Concilium (UK), Pharmacy and poisons board (Kenya), Tanzania, Medicines and Medical Devices Authority, Uganda National Drug Authority, Rwanda Foods and Drugs Authority, Utrecht Centre for Pharmaceutical Policy and Regulation and the Julius Centre for Health Sciences.

The roundtable prioritizes reflection and practical insights over formal presentations, encouraging joint learning and collaboration to shape future pharmacovigilance priorities.  

Language: English

Abstracts from speakers:

Anne Moen: Patient and their support network contributions to pharmacovigilance and safer use of medicines. Perspectives from Gravitate-Health Public-Private Partnership

Gravitate-Health is a digital health information initiative aimed at empowering individuals through understandable, reliable, and evidence-based tools that enhance patient engagement and support safe medicine use. Central to this is the Gravitate Lens (G-lens), which presents approved electronic product information in a user-centric way without filtering content. By improving access to trusted health information via an open-source platform, the project seeks to boost treatment adherence, promote pharmacovigilance, and achieve better health outcomes through personalized, informed decision-making.

Amos Jong: Regulatory perspectives on innovative trial approaches: focus on decentralized trials and platform trials

This presentation explores innovative clinical trial models—specifically decentralized clinical trials (DCTs) and platform trials (PTs)—as solutions to persistent challenges in traditional trial conduct, such as low recruitment and complex regulations. DCTs shift trial activities to participants’ homes, while PTs enable ongoing evaluation of multiple interventions, enhancing efficiency. The session will cover definitions, regulatory considerations, and recent DCT case studies, aiming to provoke discussion on how regulatory frameworks can evolve to support these innovations while maintaining participant safety and data quality.

Christine Gispen: Balancing safety and efficacy in drug regulation

Drug approval decisions by FDA and EMA weigh a new drug’s efficacy against its (manageable) safety profile, considering disease type, patient population, and treatment alternatives. Case examples like aducanumab and amylyx show differing regulatory conclusions based on this risk-benefit balance, which evolves post-approval through ongoing safety surveillance. The Round Table Workshop will explore how this dynamic process is adapting globally amid innovations like home-based trials, digital measures, and AI, while recognizing that market withdrawal decisions also involve complex trade-offs.

Sabine Straus: Risk Management Plan at the time of authorization and post authorization period.

In the EU, all authorized medicines are assessed for quality, safety, efficacy, and benefit-risk balance at approval, but clinical trials have limitations, and safety profiles evolve post-authorization. The Pharmacovigilance Risk Assessment Committee (PRAC) ensures ongoing safety through tools like Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), Post-Authorization Safety Studies (PASS), and signal detection. These tools help identify, evaluate, and manage risks, enabling timely regulatory actions and informed decisions. This process ensures medicines remain safe and effective throughout their lifecycle and supports public health and trust. The event will explore these tools, challenges, and opportunities in pharmacovigilance.

Marie Louise De Bruin: Unintended consequences of regulatory interventions

Pharmacovigilance systems implement regulatory interventions, such as safety communications and risk minimisation measures (RMMs), throughout a medicine's life cycle with the goal of protecting and promoting public health. However, evaluating the real-world impact of these interventions is a significant challenge.

Studies attempting to measure the association between interventions and changes in drug use, like prescribing patterns, show results that are moderate on average but highly variable. Concerningly, some interventions appear to have little to no effect, or even the opposite of the intended outcome.

A key area of difficulty lies in assessing the effectiveness of RMMs, often through industry-sponsored post-authorisation safety studies (PASS). Many of these studies are inconclusive, unable to definitively show if the RMMs worked as intended, partly due to limitations in study design. Research indicates that the duration of these RMM effectiveness PASS from regulatory request to completion can be quite long, often exceeding four years. Despite these challenges, regulatory bodies frequently mandate RMMs; for example, the vast majority of Advanced Therapy Medicinal Products (ATMPs) authorised in the EU are introduced with additional RMMs like extensive educational materials and controlled access programs to manage their specific risks.

Furthermore, the evaluation of the unintended consequences of these interventions, such as patients switching to potentially less safe alternative therapies, is often overlooked in impact studies.

Rob Hemmings: Using clinical trials to learn about drug safety: potentials and pitfalls.

I will review objectives, data collection, statistical analysis and interpretation of safety data in clinical trials, with a focus on different types of randomised controlled trial and open-label extensions.  The talk will look at some of the techniques used by sponsors to present safety data in the most favourable light, including lumping vs splitting of AE types and (mis-)using exposure-adjusted incidence rates.  The talk will consider the benefits and limitations of generating data in a randomised study, comparing and contrasting analysis and interpretation of safety data in an RCT with data from an observational study.  Finally, some innovations in clinical trial design and analysis will be reviewed and the impact on generation and interpretation of safety data discussed. 

Agenda: Pharmacovigilance RoundTable Discussions 5th and 6th June 2025

DAY 1 

DAY 2