Harmonization Of Methodologies Research Articles

Priority areas for the development of the health technology assessment system in Ukraine: survey results

The purpose of the study is to analyze the expert opinion on the priority areas of development of the HTA in Ukraine, taking into account the existing condition, problems and possible prospects for effective development. Materials and methods. The expert survey (online questionnaire) included the preparation of a special questionnaire, targeted selection of experts based on their competence in the field of HTA. Three groups of respondents took part in the survey, including 13 HTA developers, 32 users, and 31 informed persons to ensure the representativeness of the survey results. The following methods were used to process and interpret the results: scientific generalization, mathematical and statistical, analytical, and graphical. Results of the study. Based on the results of the expert survey, the role and place of the HTA in the health care system was determined. Experts see the main purpose of the HTA as preparing the necessary information of the relevant level of evidence for decision-making on the selection of optimal MTs (in particular, for budget procurement, inclusion in regulatory lists for price regulation and reimbursement). The respondents' opinions on the participation of different socio-professional groups in the implementation of the HTA and the use of its results were studied. Thus, according to the results of the survey, HTA experts and scientists can carry out the assessment, and in some cases (mini-HTA, hospital HTA for the formation of local formularies and protocols) – specialists of medical institutions. According to the respondents, it is advisable to expand the use of HTA results for decision-making at the national, regional and local levels. According to the survey, the priority areas for the development of HTA are the creation of a professional environment, adequate logistical and informational support, improvement of legislation, creation of an optimal institutional structure, harmonization of HTA methodology and development of international cooperation. Conclusions. The expert survey allowed us to determine the most likely scenario for the further development of HTA in Ukraine. According to the majority of respondents, the main efforts are currently focused on capacity building, formation of a professional environment, active use of evidence, and infrastructure development.

ImproRisk model, an open access risk assessment tool

Abstract ImproRisk is an open‐access Risk Assessment model, developed in Cyprus, which contributes to the harmonization, standardization and transparency of the Dietary Exposure Assessment methodologies across Europe. It is a simple and transparent tool, built in R, for conducting accurate dietary exposure assessments to chemical substances. Aiming to be established as a standardized Risk Assessment tool at European level, the model has been designed to accept occurrence and consumption data, coded according to the EFSA's food classification and description system version 2 (FoodEx2). ImproRisk users are able to estimate dietary exposure to a chemical substance under study at any level of the EFSA's FoodEx2, considering the FoodEx2 base term and the Process facet (F28). Dietary exposure is estimated at individual level for different population groups and exposure estimates are stratified by different demographic characteristics. ImproRisk is considered as a useful tool both for risk assessors and risk managers, as it facilitates decision making, by providing information regarding the percentage of the population exceeding the relevant health‐based guidance value or reference points for a specific chemical substance.

Using disability-adjusted life years measure for characterization of radiation risk from fluoroscopy

Medical diagnostics procedures involving the use of ionising radiation is one of the most intensively developing areas in medical diagnostics. At the same time, medical exposure of patients has a number of fundamental differences from other routine situations of planned exposure. As a rule, medical exposure is acute, and radiation doses in some types of examinations exceed the level of natural and man-made exposure associated with normal operation of radiation facilities. In such a situation, risk differentiation is of great importance, taking into account the different radiosensitivity of individual sex and age groups of patients. Radiation risks should be taken into account both when prescribing examinations involving the use of ionising radiation and when analysing the benefit-harm ratio associated with their application to specific patients. Another reason why risk assessment is an urgent task is the need to inform patients and/or their legal representatives about the health risks associated with the carrying out of examinations, including radiation risks. Within the framework of the present work, the risks associated with fluoroscopic examinations were assessed. To characterise the risk we used the DALY indicator, which is more and more frequently used in risk assessment, reflecting the possible number of lost years of healthy life as a result of radiation exposure during the study. The aim of the work was to calculate DALY values for different sex and age groups of patients from the Russian population during fluoroscopic examinations. To achieve this aim, the method of estimating the number of healthy life years lost due to exposure to ionising radiation, which was developed in the course of the research work, was used. The paper presents the results of calculating DALY values for three types of fluoroscopic examinations. This work represents the next step in the direction of harmonisation of radiation risk assessment methodology with the methodologies of risk assessment of other nature. One of the directions of using the calculation results is the development of methodological approaches to the calculation of sex- and age-dependent risk coefficients associated with medical exposure of patients. The analysis of the obtained results showed that the contribution of oncological diseases to the total radiation harm in older men was significantly higher than in women.

Регіональні рейтинги: статистичні аспекти оцінювання готовності до інтелектуальної автоматизації

The article focuses on the issues of harmonization of the international methodology of the index of readiness of the countries of the world for automation with the specifics of the functioning of the innovative and educational regional environment in Ukraine. The relevance of the chosen topic is substantiated. The problems of breaking the connection between intellectual automation and strategies for the development of education, innovative environment and employment policy in the country are outlined. The need to develop a balanced regional policy based on solving the problem of ensuring constant monitoring of the situation in the field of readiness of regions, territorial communities or cities of Ukraine for future automation is emphasized. In the course of the study, the theoretical and methodological foundations of building the international index of «readiness for automation» of the countries of the world are considered. A similar methodology is used to build the index of «readiness for automation» of the regions of Ukraine. It is also structured as a composite index, and the overall scores for each region are obtained by weighting and combining the three sub-indices corresponding to the components: «Innovation Environment», «Education Policy» and «Labor Market Policy». When combining sub-indices into a general index, weighting coefficients were used to reflect the importance of the relevant component: innovation environment – 40%, educational policy – 40%, labor market policy – 20%. In turn, the estimates of sub-indices are calculated as the weighted average value of normalized estimates of individual indicators. The choice of indicators for the components of the proposed methodology is due to the availability of official data published by the State Statistics Service of Ukraine for 2020 and 2021. The highest level of the overall index of readiness for automation was recorded in the city of Kyiv (92.2), the lowest level (1.82) – in the Chernihiv region. The city of Kyiv stands out as a leader not only in terms of the general index, but also in all sub-indices of readiness for automation, determining its first place in the ranking in terms of the level of development of the innovation environment, education policy and labor market. Dnipropetrovsk region ranks second in the overall ranking of regions of Ukraine in terms of the general index of readiness for automation and all its components.

Specifics of creating clinical abstract of biospecimens

One technology that helps overcome the problem of low research reproducibility is biobanking, which involves maintaining strict quality standards at all stages. In addition to data on the biosample (detailed documentation on sampling, transportation, preparation and subsequent storage), one of the key points is the availability of information about the donor (patient). The aim of this article was to analyze creating clinical abstract of biospecimens, combining data from various biobanks and assessing the possibilities of electronic medical records and other modern technologies for this. The search for publications was carried out in the PUBMED, eLIBRARY.RU, RSCI databases. One approach to creating a clinical description is the targeted collection of information by a specially trained employee. Primary information is most often taken from the individual records of the study participant, which are developed and approved when planning work. An alternative method is the use of electronic medical records and other documents that collect information during the assessment and treatment of patients. There are also mixed types of clinical data collection, a prime example of which is the UK Biobank. Completeness, structure, and standardization are essential characteristics of clinical description associated with biospecimens. Various standards are currently being developed to unify clinical description, making biobanks and collections more available to external researchers and organizations, which is necessary for collaboration and more efficient use of stored biospecimens. Harmonization of clinical description methodology between different biobanks open up broad boundaries for large- scale research within personalized and translational medicine.

Stocktake study of current fertilisation recommendations across Europe and discussion towards a more harmonised approach

AbstractThe European Commission has set targets for a reduction in nutrient losses by at least 50% and a reduction in fertiliser use by at least 20% by 2030 while ensuring no deterioration in soil fertility. Within the mandate of the European Joint Programme EJP Soil ‘Towards climate‐smart sustainable management of agricultural soils’, the objective of this study was to assess current fertilisation practices across Europe and discuss the potential for harmonisation of fertilisation methodologies as a strategy to reduce nutrient loss and overall fertiliser use. A stocktake study of current methods of delivering fertilisation advice took place across 23 European countries. The stocktake was in the form of a questionnaire, comprising 46 questions. Information was gathered on a large range of factors, including soil analysis methods, along with soil, crop and climatic factors taken into consideration within fertilisation calculations. The questionnaire was completed by experts, who are involved in compiling fertilisation recommendations within their country. Substantial differences exist in the content, format and delivery of fertilisation guidelines across Europe. The barriers, constraints and potential benefits of a harmonised approach to fertilisation across Europe are discussed. The general consensus from all participating countries was that harmonisation of fertilisation guidelines should be increased, but it was unclear in what format this could be achieved. Shared learning in the delivery and format of fertilisation guidelines and mechanisms to adhere to environmental legislation were viewed as being beneficial. However, it would be very difficult, if not impossible, to harmonise all soil test data and fertilisation methodologies at EU level due to diverse soil types and agro‐ecosystem influences. Nevertheless, increased future collaboration, especially between neighbouring countries within the same environmental zone, was seen as potentially very beneficial. This study is unique in providing current detail on fertilisation practices across European countries in a side‐by‐side comparison. The gathered data can provide a baseline for the development of scientifically based EU policy targets for nutrient loss and soil fertility evaluation.

The green circularity: Life cycle assessments for the space industry

The rapid growth of the global space industry opens the door to an increasing volume and variety of space activities at the same time that companies are increasingly recognizing the value of environmentally responsible business practices. The environmental impacts of space activities are particularly challenging to understand and address given their complexity and distribution across different domains and industries. Multiple key areas still suffer from a lack of research, leaving critical knowledge gaps. Environmental life cycle assessments (E-LCAs) are one tool that can be applied to understand the space sector's cradle-to-grave impacts across space and terrestrial environments. Specifically, an E-LCA can identify circular economy opportunities to reduce waste and pollution by quantifying the environmental impacts of space missions or systems over their entire life cycle.11“Life cycle” as a term is in a state of flux. ISO standardized this term as two words. However, in the United States, this term is still often a single word: “lifecycle.”This paper provides an overview of environmental and sustainability trends and offers options for the U.S. government, and Department of Defense (DOD) in particular, to consider and adopt E-LCAs in space acquisitions. As both DOD and civilian spacefaring agencies seek reduced environmental footprints, E-LCAs can motivate the space industry to improve designs, practices, and realize operational and economic efficiencies.Additionally, the U.S. government is in a strong position, as a large and influential buyer of space systems, to support the harmonization of E-LCA methodologies and frameworks with international partners. Such efforts could catalyze a sustainable space industry while building transparency and trust for all stakeholders.

2022 EULAR points to consider for the measurement, reporting and application of IFN-I pathway activation assays in clinical research and practice

BackgroundType I interferons (IFN-Is) play a role in a broad range of rheumatic and musculoskeletal diseases (RMDs), and compelling evidence suggests that their measurement could have clinical value, although testing...

The pursuit of methodological harmonization within the holistic sustainability assessment of CCU projects: A history and critical review

Environmental sustainability assessments have been conducted around consumer goods since the 1960's, these adopted comparative approaches and followed no accepted methodology. As sustainability assessment rose to prominence, methodological standardization was universally called for. Furthermore, two additional “strands” of sustainability emerged, economic and societal; forming what has recently been termed the “triple helix”. Efforts have been made across the CCU (carbon capture and utilization) community to align, or “harmonize”, the respective assessment formats. Ultimately, targeting enhanced understanding of the interconnections and trade-offs between the three strands, and communication of findings to both industry and policymakers. This review examines key methodologies presented in the field. These were collated through targeted literature searches, focussing on standalone, CCU specific, and harmonized methodologies. Relevant guidance originates with ISO's 2007 standards and terminates in McCord et al's (2021) “triple helix framework”. Other key works reviewed include UNEP / SETAC's S-LCA (social life cycle assessment) guidelines, and GCIs (Global CO2Initiative) integrated LCA and TEA (techno-economic assessment) guidelines. Analysis of the identified methodologies first considers each assessment strand in isolation, subsequently evaluating efforts toward their CDU specific harmonization and integration. Using the collated primary and secondary literature, a taxonomy of assessment methodologies leading to the triple helix framework is produced. Key methodological difficulties and divergent schools of thought are discussed, notably the prescription of system boundaries, impact indicators, and characterization methods. The overarching conclusion of the review is that while a robust combined LCA and TEA assessment methodology has been attained, holistic approaches incorporating social sustainability are still lacking; with substantial problems remaining unsolved. A majority of these originate from SIA's immaturity relative to LCA and TEA, causing issues around data availability and handling methods; exacerbated by the presence of qualitative data. Until a greater degree of maturity is achieved, SIA should be utilized within holistic assessments as a screening tool, determining the suitability of a process or system for more granular assessment.

Think positive: Proposal of a simple method to create reference materials in the frame of microplastics research

In the context of the harmonization of methodologies employed to isolate and count microplastics in samples or to organize ring trials tests, the use of reference materials, i.e. samples with controlled amount of particles is required. The method proposed here uses transparent, sealed capsules containing in-house generated microplastics as a convenient way to generate microplastic reference materials. This method is a simple approach for adding particles to samples without risk of loss during particle extraction or transporting/handling.•Low-cost and easy-to-use preparation of heterogeneous mix of microplastic reference particles•Possibility to control microplastic size, shape, and polymeric composition•Applicable to many protocols and wide range of applications on water, sediments and biota.

WHO cone bioassay boards with or without holes: relevance for bioassay outcomes in long-lasting insecticidal net studies

BackgroundThe World Health Organization (WHO) cone bioassay is a key method used to evaluate the bioefficacy of long-lasting insecticidal nets (LLINs) used for malaria control. These tests also play an important role in LLIN product prequalification and longitudinal monitoring. Standardization of these assays is therefore important. While many parameters for WHO cone bioassays are defined in the respective WHO guidelines, others are not. One of these undefined parameters is the exact configuration of the bioassay boards. In cone bioassays, LLIN samples are pinned onto a bioassay board for testing. Anecdotal evidence suggests that bioassay boards with holes behind the LLIN samples lead to greater exposure to insecticide, as the mosquitoes are ‘forced to stand on the net material’. This may increase the key assay outcomes of 60 min knockdown (KD60) and 24 h mortality (M24). The present study tested this hypothesis in two facilities using two fully susceptible mosquito colonies.MethodsWHO cone bioassays were performed using bioassay boards with holes and boards without holes in parallel, following WHO guidelines. Five brands of LLINs with four new and unwashed whole net samples per brand were used (total of n = 20 whole nets). Five pieces per whole net sample were prepared in duplicate resulting in a total of n = 100 pairs.Knock-down (KD) was recorded in 10 min intervals within the first hour after exposure and mortality was recorded at 24 h. Assays with Anopheles farauti were done at the Papua New Guinea Institute of Medical Research (PNGIMR) and assays with Aedes aegypti were done at James Cook University, Australia.ResultsResults varied not only with bioassay board configuration but also with mosquito colony. In particular, with An. farauti, a significantly higher M24 was observed when boards with holes were used, while this was not observed with Ae. aegypti. WHO cone bioassay results were systematically biased between the two facilities such that the use of An. farauti at PNGIMR predicted higher KD60 and M24.ConclusionThe present study highlights the need for further harmonization of WHO cone bioassay methodology. Parameters such as bioassay board configuration and mosquito species systematically affect the observations, which impedes generalizability of WHO cone bioassay outcomes.

The outcome of early life status epilepticus-lessons from laboratory animals.

Status epilepticus (SE) is the most common neurologic emergency in children. Both clinical and laboratory studies have demonstrated that SE in early life can cause brain damage and permanent behavioral abnormalities, trigger epileptogenesis, and interfere with normal brain development. In experimental rodent models, the consequences of seizures are dependent upon age, the model used, and seizure duration. In studies involving neonatal and infantile animals, the model used, experimental design, conditions during the experiment, and manipulation of animals can significantly affect the course of the experiments as well as the results obtained. Standardization of laboratory approaches, harmonization of scientific methodology, and improvement in data collection can improve the comparability of data among laboratories.

Pasture areas in the Gran Paradiso National Park

ABSTRACT Mountain pastures are essential for maintainig biodiversity and local economies. Despite the great value and fragility of these ecosystems, an up-to-date overview of extent and type of alpine pastures is lacking in many areas of the Alps. In this study, the interpretation of ancillary information combined with expeditious field campaigns, and the harmonization of classification methodologies allowed us to: (1) define the spatial extent of mountain pastures; (2) identify the non-grazeable percentage in these areas; (3) Characterize and map pasture types within the Gran Paradiso National Park (Italy), where 4596 ha of grazeable areas were mapped. Among the 13 categories identified, the three most represented in the park are Bare thermophile grasslands (38%), Nardus swards (20%), and Alpine intermediate grasslands (18%). The maps obtained in this study are useful for animal management during the grazing season, and have the capability of geographically assessing potential forage avaibility through modeling and remote sensing data.

Five Percent Variant Allele Frequency Is a Reliable Reporting Threshold for TP53 Variants Detected by Next Generation Sequencing in Chronic Lymphocytic Leukemia in the Clinical Setting.

The clinical significance of small TP53 clones detected with next generation sequencing (NGS) in chronic lymphocytic leukemia is an issue of active debate. According to the official guidelines, treatment decisions should be guided only by variants with variant allele frequency (VAF) ≥10%. We present data on 325 consecutive patients with chronic lymphocytic leukemia analyzed with NGS. In total 47 pathogenic/likely pathogenic (P/LP), TP53 variants were detected in 26 patients (8%). Eleven of these (23%) were in the 5% to 10% VAF range and reported according to our institutional policy. All TP53 variants in the 5% to 10% VAF range were confirmed (100% concordance) with a second NGS panel. Our results where further validated with the performance of Sanger sequencing and digital droplet PCR (ddPCR). In 12 patients with available fluorescence in situ hybridization data and TP53 mutations within 5% to 10% VAF, deletion of chromosome 17p (del(17p)) was detectable in only 1 patient. We propose a robust diagnostic algorithm, which allows the safe detection and reporting of TP53 variants with VAF down to 5% in the clinical setting. Our study provides evidence that NGS is equally potent to detect variants with VAF 5% to 10% compared to those with VAF 10% to 15%, highlighting the urgent need for harmonization of NGS methodologies across diagnostic laboratories.

Evaluation of EFSA training courses on principles in chemical and biological risk assessment

This report evaluates the training courses delivered under the contract OC/EFSA/SCER/2017/01 - Lot 1. Within the period of January 2018 to February 2022 a total of 21 training courses were provided, eight on-site training courses in Parma at EFSA, six virtual training courses during the Covid-19 pandemic and seven eLearning courses comprising various numbers of modules. The courses covered different aspects of chemical and biological risk assessment and related tools, namely i) harmonisation of risk assessment methodologies for human health and ecological risk assessment of combined exposure to multiple chemicals (mixture assessment), ii) risk assessment of the application of nanoscience and nanotechnologies in agro/food/feed (nanotoxicity); iii) science-based criteria for identifying endocrine disruptors in the context of EU legislation on pesticides and biocides (endocrine disruption); iv) principles on genotoxicity on scientific assessment (genotoxicity) and v) computational toxicology approaches and tools (in silico). All tutors were experts in their field and had previously performed training courses on these topics. The target participants of the training courses were members of EFSA’s Scientific Committee/Panels and their working groups as well as employees from national and international regulatory agencies associated with risk assessment of feed and food compounds. Members of the EFSA Networks as well as EFSA scientific staff also participated in the training courses. Courses were evaluated based on the feedback of participants and continuously improved also by integrating updated or new EFSA guidance documents.

CONVERGENCE OF PROJECT MANAGERS COMPETENCIES IN HYBRID WORLD

Global trends that occur in various fields of knowledge with a significant acceleration affect the development of information technology and project management competencies, programs, and project portfolios. The paper aims to develop and study information technology and mechanisms for assessing the competencies of project managers for their development based on current trends and flexible methodology of Agile in project management in creating modern information and communication technologies in project management. Global trends that challenge the development of project management competencies and programs are related to global acceleration, digitalization of society, development of blockchain, cloud and fog technologies, active introduction of smart systems, the transition from “Rational economy” to “Behavioral economy”, “Green economy”, “Sustainable development economy” and “Circular economy”. The convergence of these trends creates a new platform for the effective application of existing methodologies, knowledge systems, and methods of assessing the competence of project managers. Based on convergence, integration, and harmonization of project and program management methodologies, step-by-step research methods have been identified. The formation of an updated system of competencies lies in the change of paradigms from the traditional waterfall life cycle model to the Agile life cycle models of the projects. Decisionmaking in conditions of uncertainty based on data mining, from rational to irrational forms. The article examines modern hybrid information models of projects and programs that change the competency systems of project managers, convergent models and methods of decision making. At the same time, the change in competencies as actions or functions to be performed by project managers affects the competency model and evaluation system, including key competency indicators. A meaningful model of diagnostics of application of competence models and methods of project management in the digital and “behavioral economy” based on flexible methodologies is given. Some key competency indicators that are used in assessing the competence of a project manager based on his competencies in working in a project team are identified. Patterns of behavior of project managers in project product creation and project management are studied. The patterns allowed the authors to identify bottlenecks in the application of Agile project management methodologies in the convergence of trend information models and technologies. An example of information technology for managing the assessment of competence of project managers according to the IPMA Agile ICB model is given.

An Analysis of the International Law on Waste Statistics

The article contains an analytical review of the regulatory framework in the waste statistics. By summing up documentary evidences (conventions on protection of the population health and environment, objectives and indicators of Sustainable Development Goals, related with waste), it is demonstrated that waste statistics plays important role in identifying waste-specific problems, priority setting in waste management, formulating and implementing policy goals in waste management. 
 It is shown that the waste statistics is collected by various international entities, and reports on waste generated in the process of economic activities are made up using two main classifications: International Standard Industrial Classification of All Economic Activities (ISIC), and Statistical Classification of Economic Activities in the European Community (NACE). The EU practices in the waste statistics are highlighted. The EU approach to waste treatment is based on “waste hierarchy”. In practice, a major part of EU countries collects the data on waste types by the List of Waste. After that, the conformity between the types of waste and EWC-Stat is set using the translation table given in Annex III to the Waste Statistics Regulation. Only several countries collect data by the reliance on EWC-Stat.
 Problems faced by the waste statistics are discussed (inadequate comparability of waste statistics due to different methods and definitions used in the data production; incomplete coverage of waste-specific issues by the official waste statistics), sources of these problems are determined. 
 The analysis demonstrates that the waste statistics is a rather new field in EU, which evidence is the ongoing change in the EU regulatory framework. The countries producing waste data with reference to it or implementing it should do it by taking account for the most recent change. The need for harmonization of national methodologies in the waste statistics is highlighted.

Imaging Quality Control, Methodology Harmonization and Clinical Data Management in Stress Echo 2030

Stress echo (SE) 2030 study is an international, prospective, multicenter cohort study that will include >10,000 patients from ≥20 centers from ≥10 countries. It represents the logical and chronological continuation of the SE 2020 study, which developed, validated, and disseminated the “ABCDE protocol” of SE, more suitable than conventional SE to describe the complex vulnerabilities of the contemporary patient within and beyond coronary artery disease. SE2030 was started with a recruitment plan from 2021 to 2025 (and follow-up to 2030) with 12 subprojects (ranging from coronary artery disease to valvular and post-COVID-19 patients). With these features, the study poses particular challenges on quality control assurance, methodological harmonization, and data management. One of the significant upgrades of SE2030 compared to SE2020 was developing and implementing a Research Electronic Data Capture (REDCap)-based infrastructure for interactive and entirely web-based data management to integrate and optimize reproducible clinical research data. The purposes of our paper were: first, to describe the methodology used for quality control of imaging data, and second, to present the informatic infrastructure developed on RedCap platform for data entry, storage, and management in a large-scale multicenter study.

The needs-based health workforce planning method: a systematic scoping review of analytical applications.

Although the theoretical underpinnings and analytical framework for needs-based health workforce planning are well developed and tested, its uptake in national planning processes is still limited. Towards the development of open-access needs-based planning model for national workforce planning, we conducted a systematic scoping review of analytical applications of needs-based health workforce models. Guided by the Preferred Reporting Items for Systematic reviews and Meta-Analyses-extension for Scoping Reviews (PRISMA-ScR) checklist, a systematic scoping review was conducted. A systematic search of peer-reviewed literature published in English was undertaken across several databases. Papers retrieved were assessed against predefined inclusion criteria, critically appraised, extracted and synthesized. Twenty-five papers were included, which showed increasing uptake of the needs-based health workforce modelling, with 84% of the studies published within the last decade (2010-20). Three countries (Canada, Australia and England) accounted for 48% of the publications included whilst four studies (16%) were based on low-and-middle-income countries. Only three of the studies were conducted in sub-Saharan Africa. Most of the studies (36%) reported analytical applications for specific disease areas/programs at sub-national levels; 20% focused on the health system need for particular categories of health workers, and only two (8%) reported the analytical application of the needs-based health workforce approach at the level of a national health system across several disease areas/programs. Amongst the studies that conducted long-term projections, the time horizon of the projection was an average of 17 years, ranging from 3 to 33 years. Most of these studies had a minimum time horizon of 10 years. Across the studies, we synthesized six typical methodological considerations for advancing needs-based health workforce modelling. As countries aspire to align health workforce investments with population health needs, the need for some level of methodological harmonization, open-access needs-based models and guidelines for policy-oriented country-level use is not only imperative but urgent.

Regulatory landscape of nanotechnology and nanoplastics from a global perspective

Nanotechnology and more particularly nanotechnology-based products and materials have provided a huge potential for novel solutions to many of the current challenges society is facing. However, nanotechnology is also an area of product innovation that is sometimes developing faster than regulatory frameworks. This is due to the high complexity of some nanomaterials, the lack of a globally harmonised regulatory definition and the different scopes of regulation at a global level. Research organisations and regulatory bodies have spent many efforts in the last two decades to cope with these challenges. Although there has been a significant advancement related to analytical approaches for labelling purposes as well as to the development of suitable test guidelines for nanomaterials and their safety assessment, there is a still a need for greater global collaboration and consensus in the regulatory field. Furthermore, with growing societal concerns on plastic litter and tiny debris produced by degradation of littered plastic objects, the impact of micro- and nanoplastics on humans and the environment is an emerging issue. Despite increasing research and initial regulatory discussions on micro- and nanoplastics, there are still knowledge gaps and thus an urgent need for action. As nanoplastics can be classified as a specific type of incidental nanomaterials, current and future scientific investigations should take into account the existing profound knowledge on nanotechnology/nanomaterials when discussing issues around nanoplastics.This review was conceived at the 2019 Global Summit on Regulatory Sciences that took place in Stresa, Italy, on 24–26 September 2019 (GSRS 2019) and which was co-organised by the Global Coalition for Regulatory Science Research (GCRSR) and the European Commission's (EC) Joint Research Centre (JRC). The GCRSR consists of regulatory bodies from various countries around the globe including EU bodies. The 2019 Global Summit provided an excellent platform to exchange the latest information on activities carried out by regulatory bodies with a focus on the application of nanotechnology in the agriculture/food sector, on nanoplastics and on nanomedicines, including taking stock and promoting further collaboration. Recently, the topic of micro- and nanoplastics has become a new focus of the GCRSR. Besides discussing the challenges and needs, some future directions on how new tools and methodologies can improve the regulatory science were elaborated by summarising a significant portion of discussions during the summit. It has been revealed that there are still some uncertainties and knowledge gaps with regard to physicochemical properties, environmental behaviour and toxicological effects, especially as testing described in the dossiers is often done early in the product development process, and the material in the final product may behave differently. The harmonisation of methodologies for quantification and risk assessment of nanomaterials and micro/nanoplastics, the documentation of regulatory science studies and the need for sharing databases were highlighted as important aspects to look at.