Abstract. Droughts in Europe are becoming increasingly frequent and severe, with the 2022 drought surpassing previous records and causing widespread socio-economic impacts. Using a Europe-wide survey (n = 481 across 30 countries) combined with hydroclimatic data (i.e., Standardized Precipitation Evapotranspiration Index; SPEI), we quantify how forecasting systems and Drought Management Plans (DMPs) affected response timing and perceived effectiveness. It specifically assesses the role of forecasting systems and Drought Management Plans (DMPs) in improving preparedness and in facilitating more effective and timely responses. Our findings show that organisations with forecasting systems or DMPs in place implemented drought response measures on average two and one months earlier respectively than those without, and rated their effectiveness higher. Additionally, the study investigates how drought management practices and awareness have evolved as a consequence of the 2018 European drought and how recent experiences shape water managers' perceptions, with 35 % of the respondents indicating introducing or updating their DMPs after the 2018 drought. The findings emphasize the necessity of a standardized, continent-wide drought risk management coordination to address the multifaceted nature of drought risk by integrating climatic and societal factors, and advocates for a Drought Directive as a means to achieve this. This research aims to inform policy development towards sustainable and holistic drought risk management, highlighting the crucial roles of preparedness, awareness, and adaptive strategies in mitigating future drought impacts. This study and its companion paper The 2022 drought needs to be a turning point for European drought risk management are the result of a study carried out by the Drought in the Anthropocene (DitA) network, an IAHS initiative.

ABSTRACT The European Union recently approved and adopted a new regulation for artificial intelligence (AI) that represents a watershed approach. It is the first regulation valid for all Member States, also affecting providers of AI operating outside Europe but providing AI services/applications for the EU market. The regulation, to be adopted within 2 years by the Member States, outlines a new regulatory apparatus based on a risk management approach, with high‐level principles such as human centricity, and at the same time, very specific technical requirements to manage future risks. However, AI applications are malleable and evolving. Moreover, an original AI application can be taken and used to build another application, thereby continually expanding AI tools and reach. In this article, we focus on the challenges for the public sector, ostensibly the orchestrator of regulatory apparatus implementation proceeding at the time of this article. This article's specific focus is on risk management and the emergence of another malleable concept—trustworthiness. It offers insights and guidance for public sector researchers and policymakers, highlighting the distinctive characteristics of AI and the European AI Act and warning of the danger that the apparatus could become an iron cage of specific requirements that fail to contain AI, which can behave like water unconstrained by a regulatory iron cage.

Abstract. The 2022 European drought has underscored critical deficiencies in European water management. This paper explores these shortcomings and suggests a way forward for European drought risk management. In particular, we focus on four key aspects: the increasing drought risk, its spatial and temporal impacts, current management approaches, and how these differ across Europe. We base our findings on a continent-wide survey of water managers involved in responding to the 2022 drought. The survey collected 481 responses from 30 European countries and contained 19 questions on perceived sectorial impacts and the drought risk management practices implemented by the respondents' organizations. Information from the survey was supported with climate-related data on drought severity as quantified by the Standardised Precipitation Evapotranspiration Index, to offer a comprehensive overview of how extreme historical droughts are managed across Europe. Our findings reveal a consensus on the growing risk of drought, driven by droughts' rising frequency and intensity. While the 2022 event affected most of the continent, our findings show significant regional disparities in management capacity. In many countries – particularly those with agriculture-dominated economies – drought responses remain short-term and reactive, often leading to potentially maladaptive practices. Despite these challenges, we also observe a positive shift, with organizations showing increased awareness and preparedness. Hence, the lessons learnt from the 2022 event may provide an ideal opportunity to mainstream European-wide drought risk management. To seize this opportunity, we advocate for a European Drought Directive, to harmonize and enforce risk management policies across the continent. This directive should promote a systemic, integrated, and long-term risk management perspective. It should also set clear guidelines at the national and sub-national level, and for cross-boundary drought collaboration. This study and its companion paper, “From Crisis to Capacity: Institutional Preparedness and Response During the 2022 European Drought”, result from work carried out by the Drought in the Anthropocene network, an initiative of the International Association of Hydrological Sciences (IAHS).

Objective Vortioxetine is a multimodal antidepressant approved for the treatment of major depressive episodes. As part of the overall European risk-management plan, we aimed to fill data gaps on relevant missing information such as the extent of vortioxetine use in special populations and assessment of selected potential risks. Methods This non-interventional post-authorization safety study used longitudinal administrative claims/medical records data from 10,358 patients newly prescribed vortioxetine in Finland, Spain, and the Netherlands (EU-PAS register: EUPAS19199). Results Elderly patients (≥75 years) accounted for 3–14% of the assessed populations, while off-label pediatric prescribing was low (0.1–0.5%). Patients with a comorbid diagnosis of mania/hypomania accounted for 0.4–10% of the population, while patients with comorbid neurological conditions accounted for ≤3% of patients. The median prescribed daily vortioxetine dose was 10 mg and mean exposure was 72–238 days. The proportions of patients who had one of the events of interest (suicidal events, epilepsy, convulsions/seizures, severe renal or hepatic events) recorded during vortioxetine exposure were all ≤1%. Conclusion In this European healthcare database study, the extent and characteristics of vortioxetine use were in line with clinical trial experience and the current label. Analyses of events, including those of special interest, did not raise any new safety concerns.

Abstract. The European Commission Disaster Risk Management Knowledge Centre (DRMKC) has developed and hosts a web platform, the Risk Data Hub (RDH), designed to facilitate access to and sharing of curated, EU-wide risk data, tools, and methodologies, ultimately supporting disaster risk management (DRM) initiatives. Based on the RDH data, we propose a methodology for the identification of regions with multi-hazard exposure at the pan-European level (EU27+UK). This methodology aims to support disaster risk management (DRM) decision-making processes at both national and subnational levels in the EU. By employing a meta-analysis approach and aggregating the hotspots of exposure to single hazards, we provide an objective, statistically robust assessment of the European multi-hazard landscape at the finest spatial subdivision level, local administrative units (LAUs). Our results suggest that 21.4 % of European LAUs are exposed to multiple natural hazards, affecting around 87 million people (18.8 % of the European population). Furthermore, nearly half this population is exposed to more than three hazards. We find that beyond population density, the income level (i.e. high, medium, low) is the primary driver that influences risk status at the local level, within both rural and urban areas. On average, we find higher multi-hazard exposure for people living in high-income urban areas or low-income rural areas. We further validate our results by comparing them with empirical data on fatalities and disaster events, revealing a relatively high correlation between statistically significant multi-hazard hotspots and fatalities (r=0.59). By providing a detailed assessment of multi-hazard exposure at the pan-European scale, this study contributes to a better integration of multi-hazard risks in European disaster risk management plans.

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Teratogenicity: analysis of European risk management plan summaries.

Assessing the risk of induction of skin sensitization to plant protection products: A quantitative approach

As part of the European risk management plan of a 91-day extended levonorgestrel-containing combined oral contraceptive (COCLNG ), a study was performed to assess its safety. This analysis was conducted to examine delayed pregnancy detection and return to fertility with extended combined oral contraceptives (COC). We conducted a retrospective cohort study in new users of 91-day COCLNG or 28-day COCLNG within a US-based healthcare claims database from 2006 to 2017. Delayed pregnancy detection during current COCLNG exposure was defined as the time between estimated pregnancy start and first prenatal care encounter. Additionally, the time between estimated pregnancy start and COCLNG discontinuation was measured. To measure return to fertility, pregnancy rates were estimated among females who discontinued treatment. 91-day COCLNG users were propensity score-matched to 28-day COCLNG users. Hazard ratio for pregnancy was calculated using Cox proportional hazards models. The 91-day and 28-day COCLNG users had 25 593 and 76 586 treatment episodes, respectively. The median time to pregnancy detection was 64.5 and 61.0 days (p= 0.24) in users of 91-day COCLNG and 28-day COCLNG . The median exposure time to treatment after estimated pregnancy start was 54.0 and 38.0 days (p< 0.01). In the fertility analysis, pregnancy rates were 54.82 (95% CI, 50.05-59.93) and 69.30 (95% CI, 64.98-73.82) per 1000 person-years in extended COCLNG discontinuers and 28-day COCLNG discontinuers. The adjusted hazard ratio of pregnancy was 0.77 (95% CI, 0.69-0.85). Small differences were observed for pregnancy rates and delayed pregnancy detection between 91-day extended COCLNG and 28-day COCLNG , which may be related to the longer days' supply of extended COCLNG . Differences in the fertility analysis may be related to unmeasured residual confounding.

IntroductionThe European Risk Management Plan (EU-RMP) is a proactive planning tool for identification, characterisation and management of important risks and missing information throughout the lifecycle of a medicinal product. Over the past 15 years the EU-RMP has been a part of the pharmacovigilance practice in Europe, but there are no published studies assessing impact of the growing experience and evolving regulatory framework on the content and focus of the EU-RMP.ObjectivesThe objectives were to study the real-world impact of evolving pharmacovigilance guidelines on the proactive lifecycle management of important risks and missing information through EU-RMPs, and to further explore the impact of different resources on the management of the benefit-risk profile.MethodsA retrospective study based on the review of 64 EU-RMPs dated between 01 January 2006 and 01 October 2020 for seven human medicinal products for which Boehringer Ingelheim holds the Marketing Authorisation in the European Union. Data on the timing and rational behind changes (i.e., inclusion, reclassification, removal) to the safety concerns (Important Identified Risks, Important Potential Risks, Missing Information) and associated additional Pharmacovigilance activities and/or Risk Minimisation measures were collected and assessed.ResultsThe analysed EU-RMPs included a total of 197 safety concerns, 129 of which were removed and 19 were reclassified during the observation period. The implementation of the Guidelines on Good Pharmacovigilance Practices Module V in 2012 and Revision 2 in 2017 resulted in a noticeable decrease in the number of safety concerns. Clinical trial, non-clinical and routine post-marketing data were common sources that influenced the safety concern dynamics, and results from dedicated post-authorisation studies lead to the removal of 21 important risks and missing information. Many safety concerns were related to pharmacological class effect (n = 55) and target population characteristics (n = 37).ConclusionsThis study demonstrated that the growing knowledge regarding benefit-risk of approved products and the introduction of new or revised regulatory guidelines influenced the EU-RMP lifecycle of safety concerns, and moreover, the results emphasise that exchange of knowledge about the pharmacological class and target population between stakeholders are important for keeping an up-to-date understanding of a medicinal product’s safety profile. The aim of improving the efficiency of risk management has leveraged the accumulation of knowledge leading to revision of regulatory guidelines and increasingly, proactive Risk Management Plans focused on safety concerns that are important for patients and public health.

В статье рассматриваются методика оценки рисков перевода бизнеса или его части на аутсорсинг с применением стандарта FERMA (Federation of European Risk Management Association) с точки зрения построения стратегических альтернативных моделей предприятий и организаций в том числе банков, совершенствования их управленческой деятельности в процессе реализации национальной программы «цифровая экономика», в контексте принятия управленческих решений о применении аутсорсинга. The article discusses the methodology for assessing the risks of transferring a business or its part to outsourcing using the FERMA (Federation of European Risk Management Association) standard from the point of view of building strategic alternative models of enterprises and organizations, including banks, improving their management activities in the process of implementing the national program " digital economy ", in the context of making management decisions on the use of outsourcing.

One of the effects of climate change is an increasing frequency of heavy rainfall events, which in turn leads to increased flooding damage in urban areas. The purpose of this study was to develop a tool for dynamic risk evaluation that can be used to fulfil several of the goals in the European Flood Risk Management Directive. Flood risk analysis was performed as a spatial GIS analysis with the FME software. The primary data source for the analysis was a 1D/2D model calculation, wherein 1D models described the pipeline network and the watercourses and a 2D model described surface runoff. An ArcGIS online platform was developed to visualize the results in a format understandable for decision makers. The method and tool were tested for the Norwegian capital of Oslo. The tool developed in the study enabled the efficient analysis of consequences for various precipitation scenarios. Results could be used to identify the areas most vulnerable to flooding and prioritize areas in which measures need to be implemented. The study showed that for urban areas in steep terrain, it is essential to include water velocity and depth-integrated velocity in risk analysis in addition to water depths and pipe network capacity.

The ongoing COVID-19 crisis has redirected attention to the importance of robust risk management practices and well-established risk management cultures within financial institutions. Various studies have highlighted the positive implications of strong risk management practices on performance and market rewards during a single-wave crisis. Are these findings, however, consistent also across a multiple-wave prolonged crisis? To answer this, the authors analyse a prolonged crisis period ranging from 2008 to 2011 using a dataset comprising of 13 systemically important European banks. This study further analyses whether a prolonged crisis period encourages banks to permanently strengthen their risk management practices during or post-crisis turmoil, potentially capturing elements of bank risk culture. The authors find that higher levels of risk management contribute to better bank performance measured through the return on assets (ROA) and annual returns. Unlike in a single-wave crisis period, however, the results show that banks having in place stronger risk management practices do not benefit from superior bank performance and market rewards during a multiple-wave crisis period. The authors also find that banks which perform worse during a multiple-wave crisis period fail to later improve their risk management practices. The study concludes by providing insightful guidance to policy makers aiming to contribute towards enhancing bank risk management in response to the COVID-19 crisis.

Risk of bradyarrhythmia related to ticagrelor: A systematic review and meta-analysis

The aim of the study is to identify how we can use some methods of environmental risk management at the macro, meso and micro levels. It is necessary for minimizing and reducing the consequences of environmental disasters; identify opportunities and practical tools for neutralizing environmental risks and threats. The general scientific and special methods, such ascontent analysis method, system analysis method, retrospective analysis method, statistical survey methods, benchmarking were chosen and used as the scientific tools for this study. The research was informed by analytical developments of the Federation of European Risk Management Associations (FERMA), The Committee of Sponsoring Organizations of the Treadway Commission (COSO), the Federal State Statistics Service. The works of researchers in sustainable development, green economy and risk management filds were used as the theoretical and methodological basis of the study. The definitions of environmental management and sustainable development were the basis of the study. The development of an integrated approach to environmental risk management at all levels of the economy is the result of research. The integration of risk management helps to increase adaptability to the risks resulting from change. Some practices of implementing a risk-oriented approach in solving environmental problems at the state, regional and urban, enterprise and individual levels are un the article. Strategic development programmes, national projects and programmes are the practices at the state level; technological and digital innovation are the practices at the regional and urban levels; environmental compliance and environmental due diligence are the practices at the enterprise level; environmental thinking and culture is to form at the individual level. As an issue to be debated, the author considers the application of the acceptable risk principle (the assessment of environmental risks as «cost-benefit-risk»), and identifies the need to apply the zero environmental risk principle everywhere.

Harmonized mapping of forests with a protection function against rockfalls over European Alpine countries

Awareness of the need for effective risk management is gaining ground, both among business organizations and in scientific publications in the field. The prospects for development in risk management must be tailored to the growing and transformative needs of Industry 4.0. The paper focuses on different directions, priorities of the Federation of European Riskmanagement Associations (Ferma). The main subject of research is placed on risk management through artificial intelligence. Both the risks of its introduction and the benefits of it have been identified.

Turkey has made great strides towards increasing international competitiveness and aims to adapt to the international risk management platforms to further its national economic policy. Risk management would serve to the corporates to run their business in optimum level, to reduce the chance of the hazards, to protect the resources and to improve the image. The purpose of this study is to investigate the inherent risks plaguing non-financial companies in Turkey and the risk management behavior and insurance approach undertaken in order to combat these important risks. The analysis consists of survey questions generated via appropriate risk management literature and reports from the Federation of European Risk Management Associations and Risk &amp; Insurance Management Society. The sample consisted of 59 high level Risk Managers from publicly available non-financial firms on BIST, 20 of which were included under top 100 of ISO 500 by 2017.

Abstract The increase of pluvial flooding has long been discussed to be a most probable outcome of climate change. This has raised the question of necessary consequences in the design of urban drainage systems in order to secure adequate flood protection and resilience. Due to the uncertainties in future trends of heavy rainfall events, the awareness of remaining risks of extreme pluvial flooding needs to be roused at responsible decision makers and the public as well leading to the implementation of pluvial flood risk management (PFRM) concepts. The state of two core elements of PFRM in Germany are described here: flood hazard and risk evaluation and risk communication. In 2016 the guideline DWA‐M 119 has been published to establish city‐based PFRM concepts in specification of the European Flood Risk Management Directive (EU 2007). As core elements, the guidelines recommend a site‐specific analysis and evaluation of flood hazards and potentials of flood damages to create flood hazard and flood risk maps. In the long run, PFRM needs to be established as a joint community effort and a requirement for more flood resilience. The risk communication within the administration and in the public requires a comprehensible characterization and classification of heavy rainfall to illustrate event extremity. The concept of a rainstorm severity index (RSI) instead of statistical rainfall parameters appears to be promising to gain a better perception by affected citizens and non‐hydrology‐experts as well. A methodical approach is described to specify and assign site‐specific rainfall depths within the severity index scheme RSI12.This article is categorized under: Engineering Water &gt; Sustainable Engineering of Water Engineering Water &gt; Planning Water Engineering Water &gt; Methods

BackgroundAgomelatine is a melatonin receptor agonist and serotonin 5-HT2C receptor antagonist indicated for depression in adults. Hepatotoxic reactions like acute liver injury (ALI) are an identified risk in the European risk management plan for agomelatine. Hepatotoxic reactions have been reported for other antidepressants, but population studies quantifying these risks are scarce. Antidepressants are widely prescribed, and users often have risk factors for ALI (e.g. metabolic syndrome).ObjectiveThe goal was to estimate the risk of ALI associated with agomelatine and other antidepressants (fluoxetine, paroxetine, sertraline, escitalopram, mirtazapine, venlafaxine, duloxetine, and amitriptyline) when compared with citalopram in routine clinical practice.MethodA nested case–control study was conducted using data sources in Denmark, Germany, Spain, and Sweden (study period 2009–2014). Three ALI endpoints were defined using International Classification of Diseases (ICD) codes: primary (specific codes) and secondary (all codes) endpoints used only hospital discharge codes; the tertiary endpoint included both inpatient and outpatient settings (all codes). Validation of endpoints was implemented. Adjusted odds ratios (ORs) and 95% confidence intervals (CIs) for current use were estimated for each data source and combined.ResultsWe evaluated 3,238,495 new antidepressant and 74,440 agomelatine users. For the primary endpoint, the OR for agomelatine versus citalopram was 0.48 (CI 0.13–1.71). Results were also < 1 when no exclusion criteria were applied (OR 0.37; CI 0.19–0.74), when all exclusion criteria except alcohol and drug abuse were applied (OR 0.47; CI 0.20–1.07), and for the secondary (OR 0.40; CI 0.05–3.11) and tertiary (OR 0.79; CI 0.50–1.25) endpoints. Regarding other antidepressants versus citalopram, most OR point estimates were also below one, although with varying widths of the 95% CIs. The result of the tertiary endpoint and the sensitivity analyses of the primary endpoint were the most precise.ConclusionIn this study, using citalopram as a comparator, agomelatine was not associated with an increased risk of ALI hospitalisation. The results for agomelatine should be interpreted in the context of the European risk minimisation measures in place. Those measures may have induced selective prescribing and could explain the lower risk of ALI for agomelatine when compared with citalopram. Most other antidepressants evaluated had ORs suggesting a lower risk than citalopram, but additional studies are required to confirm or refute these results.Electronic supplementary materialThe online version of this article (10.1007/s40263-019-00611-9) contains supplementary material, which is available to authorized users.