Belgian Development Agency

Regulatory evaluation of QT interval prolongation remains central to cardiac safety assessment in drug development. Since the 2015 revision of the ICH E14 Q&A, concentration-QT (C-QT) modelling has been formally recognized as an acceptable alternative to dedicated Thorough QT (TQT) studies, offering ethical and practical advantages. This study aimed to characterize how the European Medicines Agency (EMA) has assessed C-QT modelling approaches over the past five years, with particular focus on regulatory acceptance of TQT waiver requests and the recurring drivers of rejection. A retrospective review was performed of EMA Scientific Advice (SA) documents issued between January 2020 and January 2025. Using the internal text-mining platform Scientific Explorer, 524 SA cases (4,196 applicant questions) were screened for "QT" or "QTc." A custom Python tool extracted relevant discussions, which were subsequently categorized by expert review. Regulatory feedbacks were classified as supportive, conditionally supportive, or unsupportive. Among 110 QT-related requests, 81% sought TQT waivers, most justified by C-QT modelling. Of these, 70% were supported, 9% conditionally endorsed, and 21% rejected. Common rejection drivers included insufficient exposure margins (n = 8), study design limitations (n = 5), data gaps (n = 7), unclear methodological reporting (n = 5), QTc interpretation concerns (n = 5), and additional methodological weaknesses (n = 4). In nine supportive cases, safety margins were endorsed in principle but lacked detailed documentation. C-QT modelling is widely accepted by EMA when adequately supported. However, gaps in exposure justification and reporting continue to challenge regulatory confidence, emphasizing the need for standardized practices in QT risk assessment.

Background: Strengthening digital and pedagogical competence among allied health educators is critical, especially in low-resource settings where digital literacy gaps persist. While faculty development initiatives increasingly explore ICT-enabled teaching, limited research has examined educators’ immediate reflections using video-based methods. Such video-based approaches can capture authentic and spontaneous insights following training. Method: A qualitative descriptive design was used. Reflections from nine educators were captured through a single video-recorded testimonial session after a three-day ICT-focused pedagogical training. These reflections were transcribed and analysed thematically using Braun and Clarke’s reflexive approach. Result: Four themes emerged: 1) enhanced digital competence, 2) first-time exposure and professional growth, 3) application of ICT skills to teaching and supervision, and 4) the need for continued training and adaptation of the use of ICT in teaching and learning. Participants highlighted transferable practical skills and recognised gaps requiring ongoing support. Conclusion: Short-term, contextually relevant training demonstrated transformative potential in building educators’ digital and pedagogical capacity. Video-based evaluation proved effective in capturing authentic reflections, scalability, and informing tailored programme design. Findings are context-specific and not statistically generalizable, but they provide transferable insights for similar low-resource educational settings. However, confidentiality presents a significant challenge in video-based data collection, and appropriate ethical safeguards are necessary to protect participant identity. Recommendation: Institutions should prioritise ongoing ICT-focused faculty development, and future studies should examine sustained impacts on teaching practices and learning outcomes.

Achieving WHO air pollution guidelines is critical to reduce the health burden of air pollution, which disproportionately affects socioeconomically disadvantaged populations and varies by sector, spatial distribution, and seasonal trends. This study explores the implications of sectorial and spatial-seasonal air pollution patterns, socio-economic disparities, and 15-minute communities to achieve (2021) WHO air quality guidelines for PM2.5 and NO2. The study analyses spatial-temporal patterns of air pollution in Belgium. Seasonal air pollution exposure is assessed through summer-to-winter ratios, stratified by land cover, urbanisation, and proximity to roads, and linked to socio-economic disparities using LOESS regression. A case study evaluates the mitigation potential of 15-minute communities for traffic-related air pollution, leveraging the Mobiscore tool to explore the relationship between accessibility and car ownership, a proxy for traffic-related emissions. NO2 and PM2.5 show marked seasonal and spatial variations, with higher concentration ratios in summer near busy roads and urban centres, especially for NO2. In general the NO2 spatial-seasonal pattern is more heterogenous compared to the PM2.5 pattern. Winter pollution exposure significantly hampers meeting WHO health targets, although summer levels of NO2 remain high around major traffic routes. The observed disparities in exposure to NO₂ highlight significant socio-economic inequalities, with the most deprived populations disproportionately burdened by traffic-related air pollution. The results from our case-study to mitigate traffic-related air pollution demonstrate that, up to a Mobiscore of 8.0, car ownership remains constant with increasing availability of services and public transport. From a turning point Mobiscore of 8.0, car ownerships starts to drop significantly, indicating that improving Mobiscores to very high scores ( > = 8.0) may lead to reduced car ownership and lower NO2 and PM2.5 emissions and exposure. Our study highlights important spatial-seasonal patterns in air pollution and their health implications, emphasizing the need for season-specific and structural traffic interventions to meet WHO guidelines for PM2.5 and NO2 exposure. A case study on mitigating traffic-related air pollution identifies a threshold where sufficient public transport and service accessibility lead to a reduction in car ownership. Addressing socio-economic disparities is crucial, as these areas often face greater challenges in meeting WHO air pollution guidelines, particularly for NO₂.

This study uses various models to address network traffic classification, categorizing traffic into web, browsing, IPSec, backup, and email. We collected a comprehensive dataset from Arbor Edge Defender (AED) devices, comprising of 30,959 observations and 19 features. Multiple models were evaluated, including Naive Bayes, Decision Tree, Random Forest, Gradient Boosting, XGBoost, Deep Neural Networks (DNN), Transformer, and two Large Language Models (LLMs) including GPT-4o and Gemini with zero- and few-shot learning. Transformer and XGBoost showed the best performance, achieving the highest accuracy of 98.95 and 97.56%, respectively. GPT-4o and Gemini showed promising results with few-shot learning, improving accuracy significantly from initial zero-shot performance. While Gemini Few-Shot and GPT-4o Few-Shot performed well in categories like Web and Email, misclassifications occurred in more complex categories like IPSec and Backup. The study highlights the importance of model selection, fine-tuning, and the balance between training data size and model complexity for achieving reliable classification results.

Air Quality (AQ) monitoring in Belgium has hitherto been relying mostly on in-situ measurements of surface concentration, with geographical gaps between observations filled in with numerical modelling ingesting (proxies for) bottom-up emission estimates.   However, a new generation of satellite sounders on sun-synchronous Low Earth Orbits (LEO) – like the Copernicus Sentinel-5(p) series – performs now daily global mapping of atmospheric composition down to the 3-km scale. Soon this daily global mapping will be complemented with geostationary instruments (GEO, e.g. Sentinel-4) observing the diurnal cycle in trace gas concentrations, although over the limited geographical area accessible from a geostationary viewpoint. This new constellation of satellite sounders is built to support detailed monitoring of AQ on the different relevant scales: from point-like emissions to intercontinental transport, and from city-level to international regulations established by public authorities to manage AQ in their area of responsibility. Nevertheless, uptake of these new satellite AQ data by the various Belgian stakeholders is not guaranteed.  Indeed, to realize the full complementary impact of this constellation of LEO and GEO satellites, i.e. to make their observations fit-for-purpose for air quality applications at the different scales, several challenges need to be addressed. These include (1) the need to enhance to sub-city scales the resolution of satellite data to make them better suited for the monitoring of e.g. the impact of the Low Emission Zones enforced in several European cities, (2) to characterize the non-trivial relation between the column amount of the pollutant measured by a satellite and the near-surface concentrations measured by in-situ networks, and (3) to determine how the different LEO and GEO vantage points lead to a different perception of atmospheric and surface details and how we can benefit from - or correct for - these differences.Work on these challenges is taking place in the dedicated Belgian federal research project LEGO-BEL-AQ (2020-2023, https://lego-bel-aq.aeronomie.be/index.php) funded by BELSPO, with a particular focus on AQ in Belgium.  In this contribution, we demonstrate that a combination of temporal aggregation, careful data selection, and horizontal oversampling can produce a meaningful increase in horizontal resolution in S5P tropospheric NO2 column maps, revealing policy-relevant features in the NO2 distribution over Belgium’s major cities. Comparisons between our high-resolution S5P NO2 maps and the near-surface in-situ observations as procured by the Belgian authorities, reveal high correlation when considering longer time scales (seasonal and annual), allowing a pragmatic conversion from tropospheric columns to near-surface concentrations over the complete Belgian domain, and consequently also a confrontation to WHO annual thresholds at the level of individual Belgian municipalities.Acknowledgements This work has been supported by the BELSPO BRAIN-be 2.0 project LEGO-BEL-AQ (https://lego-bel-aq.aeronomie.be)

Epidemic-prone diseases have high adverse impacts and pose important threats to global health security. This study aimed to assess levels of health facility preparedness and response to the COVID-19 pandemic in Guinea. This was a cross-sectional study in public and private health facilities/services across 13 Guinean health districts. Managers and healthcare workers (HCWs) from departments in each facility/service were interviewed. Descriptive statistics and comparisons were presented using Pearson’s Chi-Squared Test or Fischer exact test. Totally, 197 managers and 1020 HCWs participated in the study. Guidance documents and dedicated spaces for management/isolation of suspected COVID-19 cases were available only in 29% and 26% of facilities, respectively. Capacities to collect (9%) and safely transport (14%) samples were low. Intensive care units (5%), dedicated patient beds (3%), oxygenators (2%), and respirators (0.6%) were almost lacking. While 36% of facilities/services had received infection prevention and control supplies, only 20% had supplies sufficient for 30 days. Moreover, only 9% of HCWs had received formal training on COVID-19. The main sources of information for HCWs were the media (90%) and the internet (58%). Only 30% of HCWs had received personal protective equipment, more in the public sector (p<0.001) and in Conakry (p=0.022). This study showed low levels of preparedness of health facilities/services in Guinea and highlighted a lack of confidence among HCWs who felt unsafe at their workplace. Better governance to improve and maintain the capacity of the Guinean health system to respond to current and future epidemics is needed.

This study documents the setup and roll-out of a Computerized Maintenance Management System (CMMS) in Burundi’s resource constrained health care system between 1/04/2017 and 31/03/2020. First, in 2017 a biomedical assets ontology was created, tailored to the local health system and progressively mapped on international GMDN (Global Medical Devices Nomenclature) and ICMD (International Classification and Nomenclature of Medical Devices) classifications. This ontology was the cornerstone of a web-based CMMS, deployed in the Kirundo and Muramvya provinces (6 health districts, 4 hospitals and 73 health centers).During the study period, the total number of biomedical maintenance interventions increased from 4 to 350 per month, average corrective maintenance delays were reduced from 106 to 26 days and the proportion of functional medical assets grew from 88 to 91%.This study proves that a sustainable implementation of a CMMS is feasible and highly useful in low resource settings, if (i) the implementation is done in a conducive technical environment with correct workshops and maintenance equipment, (ii) the active cooperation of the administrative authorities is ensured, (iii) sufficient training efforts are made, (iv) necessary hardware and internet connectivity is available and (v) adequate local technical support can be provided.