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Childhood cancer is a leading cause of death in children, and the increasing availability of digital healthcare data, coupled with rapid progress in artificial intelligence (AI), brings a transformative opportunity to revolutionise its diagnosis, treatment and ultimately improve patient outcomes by leveraging diverse data resources. However, the effective application of AI in childhood cancer requires strict adherence to regulatory and best practice guidelines for patient data preparation and AI model development. Currently, there is a lack of such regulatory and methodological guidance specifically tailored for the paediatric community. This review seeks to address this gap. Beginning with an overview of existing regulatory frameworks, it examines the types of data currently in use or with potential use in developing AI applications for childhood cancer. This encompasses data from traditional sources, such as patient data and electronic health records (EHRs), as well as emerging sources like social media data and social determinants of health. This review also outlines the rules and criteria for collecting, processing, and sharing these data. Informed consent and re-consent are required for data collection and re-use, and data quality, privacy, and security as well as data standardisation, harmonisation and interoperability are important for data processing. Additionally, this review clarifies the essential requirements and methodologies for developing AI models in childhood cancer and healthcare. It also emphasises the importance of AI being trustworthy, protecting privacy, and being accountable and validated in clinical settings. By systematically addressing these key components, this review aims to provide comprehensive knowledge and practical tools for the reliable application and implementation of AI in paediatric cancer to enhance AI acceptance and promote its widespread integration within the childhood cancer community. This, in turn, will lead to improved diagnosis, treatment and outcomes for children with cancer.

This study explores the policy process in the Namibian Electricity Supply Industry in relation to the development of the Modified Single Buyer market model. The research employs the Advocacy Coalition Framework as a theoretical framework wherein actors within a policy subsystem are conceptualized as forming advocacy coalitions based on shared beliefs and engaging in coordinated efforts over time to influence policy direction. The analysis has uncovered the existence of two prominent coalitions: the progressive coalition is advocating for market liberalisation, while the conservative coalition is seeking to preserve the status quo and resist the adoption of the new electricity market model. The study concludes that powerful actors in the Electricity Supply Industry, although equipped with enormous economic resources and strong political ties, could not prevent the regulator from implementing comprehensive changes in the electricity sector. However, the conservative coalition has managed to negotiate for a phased implementation of the policy to ensure minimal disruption in the industry and to guarantee the security of the electricity supply in the long run. The phased implementation also allows sufficient time for this coalition to realign their business strategies within the new regulation policy and maintain their status as relevant and critical actors.

Touristic islands around the world are facing crucial energy challenges, including fossil fuel dependency, high electricity costs, high environmental impact and vulnerability to EU climate change targets and policies. On May 18, 2017, fourteen EU countries signed a “Political declaration on clean energy for EU islands” with the aim of accelerating the clean energy transition on more than 2,700 islands in Europe, supporting islands in reducing their energy import dependency, maximizing distributed energy generation near consumption and adopting innovative energy solutions. However, most of the population on EU islands is concentrated in the Mediterranean Sea, in Spain, Italy and Greece. More specifically, six islands account for the majority of the island's population (approximately 10.78 million): Sicily, Sardinia, the Balearic Islands, the Canary Islands, Crete and Corsica.Realising the importance of the role of local and regional authorities in the islanded Energy Transition, the EU has triggered and supported the creation of the Covenant of Mayors (CoM) for Climate & Energy and the initiative for Clean Energy of EU Islands. These instruments have promoted energy transition awareness among the municipalities and the importance of the bottom-up approach (from local to national). This paper proposes, based on a review of state-of-the-art energy models and methodologies, to identify the main gaps in specific energy indicators capable of easily modelling, assessing and monitoring progress towards the energy transition for policy makers. Furthermore, it presents the main barriers and constraints identified in island areas of Italy, Spain and Greece.

Nuclear security has been emphasized to ensure the safety of the environment and humans, as well as to protect nuclear materials and facilities from malicious attacks. With increasing utilization of nuclear energy and emerging potential threats, there has been a renewed focus on nuclear security. Korea has made efforts to enhance the regulatory oversight processes, both for general and specific legislative systems. While Korea has demonstrated effective nuclear security activities, continuous efforts are necessary to maintain a high level of security and to improve regulatory efficiency in alignment with international standards.In this study, the comprehensive regulatory oversight framework for the security of Korean nuclear facilities has been investigated. For reference, the U.S. regulatory oversight frameworks for nuclear facilities, with a focus on nuclear security, and the motivations of changes in regulatory oversight framework have been identified. By comparing these regulatory programs and frameworks, insights and considerations for enhancing nuclear security regulations have been identified. A comprehensive security inspection program tailored for the Korean regulatory oversight framework has been proposed, and has been preliminarily applied to hypothetical conditions for further discussion.

Introduction: A radical shift in energy production is underway worldwide, replacing fossil fuels with renewable sources and causing structural changes in power generation systems. Problem statement: Photovoltaic installations for self-consumption have experienced a steep increase in recent years. They have reached a significant installed capacity to cause a noticeable reduction in consumption from the national grid, which can cause serious management problems. Objectives: In this work, the evolution of the Spanish demand in the last years is analyzed to identify the influence of self-consumption in the overall demand. In addition, a mathematical model is defined to estimate this influence. Methodology: The demand curves of equivalent days in years with high and low installed self-consumption photovoltaic systems have been compared. Then, an estimation of the electricity generated with this source is proposed, with a mathematical model that takes into account data on solar radiation, installed photovoltaic power for self-consumption and other relevant factors. Results: The analysis of the demand has shown a significant reduction of the electricity demand in daylight hours when the number of self-consumption photovoltaic systems increases. Moreover, the proposed model has been able to provide an estimation of the electricity generated with this source. The addition of these estimates to the actual consumption curves of years with a high number of self-consumption installations gives profiles close to those obtained when self-consumption was low. Recommendation: New storage systems need to be implemented and grid management need to be improved to take advantage of the surpluses produced by photovoltaic systems.

In Nigeria, 86 million people lack electricity access, the highest number worldwide, predominantly in rural areas. Despite government efforts, constrained budgets necessitate private investors, who, without adequate incentives, are hesitant to commit capital due to perceived high risks. This study identifies three existing incentive policies—concessionary loans, capital subsidy, and financing productive use equipment—aimed at promoting rural electrification in Nigeria. Employing geospatial and regulatory analyses, we evaluate their impact on electrification planning across 22,696 population clusters. While all incentives encourage mini-grids and stand-alone systems, results show varied impacts, predominantly favouring mini-grids. Under the baseline, grid extension is optimal for 66% of clusters, followed by mini-grids (27%) and stand-alone systems (7%). Concessionary loans boost mini-grid and Stand-Alone Systems shares by 10% and 5%, respectively. Capital subsidies increase the mini-grid share to 41%, surpassing concessional loans (37%). Financing productive equipment enhances Stand-Alone Systems and mini-grid shares to 15% and 43%. Incentives impact LCOE, CAPEX, and OPEX, with average LCOE reducing to 0.31 EUR/kWh (concessionary loans), 0.30 EUR/kWh (capital subsidy), and 0.27 EUR/kWh (financing productive use). Financing productive uses proves decisively more effective in lowering costs for mini-grids and stand-alone systems than loans or capital subsidies. The important policy implications of this study reinforce the need for tailored incentives for distinct electrification options.

Resumen: En una empresa de servicios altamente especializados y cambiantes en el curso de una vida laboral, como son los servicios de salud gestionados directamente por las Administraciones públicas (SNS-GD), las cuestiones relativas al reclutamiento, la selección y la retención de profesionales deberían recibir una atención mucho mayor que la que ahora se les presta. Desde hace demasiado tiempo el SNS-GD trabaja solo la resolución de los problemas que afectan a la organización, con enorme desatención de los que sufren los destinatarios de sus servicios, la población real a la que presta asistencia. La administración —más que gestión— de los recursos humanos está circunscrita por los contornos del Estatuto marco y sus normas y sentencias de desarrollo. Es este un instrumento inadecuado, tanto empíricamente, a la vista de los resultados cosechados (un 50% de temporalidad entre los profesionales trabajando en el SNS), como conceptualmente, pues incumple las razones que normativamente justifican su existencia: «que su régimen jurídico se adapte a las específicas características del ejercicio de las profesiones sanitarias, así como a las peculiaridades organizativas del Sistema Nacional de Salud». Se describen las características de la regulación estatutaria y se repasa cómo afectan las restricciones normativas a las políticas de reclutamiento, selección y retención. Finalmente, se plantean las alternativas verosímiles para disponer de políticas coherentes y racionales de dotación de efectivos de carácter permanente que cubran las necesidades reales de los servicios. Abstract: In an organization with highly specialized and changing services over the course of a working life, such as health services managed directly by public administrations (DM-NHS) are, the issues related to the recruitment, selection and retention of professionals should receive special attention. much larger than what is provided. For too long, the DM-NHS has mainly been working to resolve the problems that affect the organization, with enormous disregard for those suffer by the recipients of its services, the real population to which it provides assistance. In the DM-NHS, its administration (rather than management) of human resources is circumscribed by the contours of the Framework Statute and its implementing regulations and rulings. This is an inadequate instrument, both empirically in view of the results obtained (50% temporary employment among professionals working in the NHS), and conceptually, since it fails to comply with the reasons that normatively justify its existence: “that its legal regime is adapts to the specific characteristics of the practice of health professions, as well as the organizational peculiarities of the National Health System”. The text describes the characteristics of statutory regulation and reviews how regulatory restrictions affect recruitment, selection and retention policies. Finally, possible alternatives are proposed to have coherent and rational permanent staffing policies that cover the real needs of the health services.

The growth of commercial air transport arguably translates into more aging passenger aircraft queuing up for major maintenance, modifications, and/or freighter conversion with the aircraft maintenance industry. In the competitive business environment, this increased maintenance demand possesses the potential to stress the industry and make safety vulnerable. In the aircraft maintenance industry, several aircraft accidents and incidents have resulted from organizational failure to learn from the past. To address this chronic problem, this study aims to (a) establish a learning process model for the aircraft maintenance industry, (b) identify the factors that influence learning, and (c) determine the effect of identified factors on learning from the past. A review of scholarly articles and regulatory publications enabled the development of learning from the past process model and a data collection tool, followed by structural equation modeling to quantify the relationship among influencing factors. The study was conducted in the Indian aircraft maintenance environment and is based on the perspective of the front-line maintenance staff. The study found that safety communication is the decisive stage for learning from the past. Contextualization of the safety information and evaluating the lessons learned during safety communication strongly impact learning from the past, for which existing regulatory provisions are vulnerable. The findings of this study are meant to assist State regulators and management of the aircraft maintenance industry; nevertheless, safety managers and practitioners in other ultra-safe, high-risk sectors may also apply the results in compliance with the respective regulatory guidelines.

This paper provides a comprehensive review of the current state and planned developments in the electricity sectors across eight countries in South East Europe (SEE). It highlights positive examples as well as barriers to efficient market operation and regional market integration. Progress is evaluated in terms of the level of implementation of required legislation, and the efficacy of regulatory frameworks to facilitate market integration of renewables, emerging technologies, and active demand participation. The observations are based on exhaustive research into European Union (EU) and national legislation, as well as a questionnaire taken by industry experts from the corresponding Transmission System Operators offering first-hand insights into the electricity sectors in the region. The conducted investigation demonstrates that SEE countries are at different stages in market opening and compliance with EU energy policy but show unity in the aim of integrating into the EU internal electricity market. The harmonization of legislation and technical requirements is highlighted as a precondition to this goal as it would facilitate cross-border trade, increase efficiency through the shared use of resources, and incentivize infrastructure investments. The analyses show that there is a continuous progress in development of wholesale and balancing markets in the region, but problems with liquidity and incumbents impede the process. The progress towards renewable generation targets varies between the countries, however, the region is committed to electricity sector decarbonization and digitalization in the future. Finally, the paper presents potential directions for regional power sector developments in response to the challenges in electricity market design for a low-carbon future.

Consumers are increasingly aware of the importance of diet in human health and they preferably choose functional food products. The present work is focused on describing the current status of the international regulatory framework for health-related claims in functional food products and the state of the art regarding these products market focusing on those with health-related claims. Specific regulation must control the use of these claims in the labeling of functional products. Although the European, American and Japanese claims are partly similar in nature, but the approval and use procedures and the regulatory framework are different. Consumers generally accept functional products with health-related claims, and most of them include more than one claim. This review could help consumers for making better-informed food decisions; food industry in marketing its products with a focus on international trade; and scientists in order to put in value their research work.

Background Aims: Advanced therapy medicinal products (ATMPs) are a class of biological products for human use that are based on gene, tissues or cells. ATMPs have peculiar characteristics when compared with traditional medicines. In this regard, long-term safety and efficacy follow-up systems of individuals treated with ATMPs have become necessary and may present unique challenges, because unlike conventional drugs and biologics, these products can exert their effects for years after administration. This work seeks to assess the requirements foreseen in the regulatory frameworks for the post-marketing authorization safety and efficacy surveillance for ATMPs in Brazil, European Union (EU), Japan and United States, which are some of the members of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use., Methods: We reviewed the scientific literature and official documents of regulatory agencies (RAs) in Brazil, the EU, Japan and the United States., Results and Conclusions: RAs in the EU, US and Japan have developed regulatory guidelines for the post-marketing surveillance of ATMPs. These guidelines aim at implementing surveillance plans for monitoring adverse events, including late ones, after marketing authorization. All the ATMPs authorized by the RAs studied, submitted some type of post-marketing requirement to supplement safety and efficacy data, according to the regulations and terminology used by those jurisdictions., Competing Interests: Declaration of Competing Interest The authors have no commercial, proprietary or financial interest in the products or companies described in this article., (Copyright © 2023 International Society for Cell & Gene Therapy. Published by Elsevier Inc. All rights reserved.)

Whole slide imaging (WSI) scanners and automatic image analysis algorithms, in order to be used for clinical applications, including primary diagnosis in pathology, are subject to specific regulatory frameworks in each country. Until May 25, 2018, in the European Union (EU), in vitro diagnostic (IVD) medical devices were regulated by directive 98/79/EC (in vitro diagnostic medical device directive [IVDD]). Main scanner vendors have obtained a Conformité Européenne mark of their products that in Europe were classified as General Class IVDD, so that conformity is only based on a self-declaration of the manufacturer. This contrasts with the initial classification of the US Food and Drug Administration (FDA) of WSI system as Class III medical devices, although the first digital pathology WSI system to be cleared by FDA was classified as Class II, with special controls. Other digital pathology solutions (automated cervical cytology slide reader) are considered of higher risk by US and European regulations. There is also some disparity in the classification of image analysis solutions between Europe and the United States. All IVD-MDs must be approved under the new European regulation (in vitro diagnostic medical device regulation) 2017/746 after May 26, 2024. This means the need of a performance evaluation, including a scientific validity report, an analytical performance report, and a clinical performance report. According to its clinical use (e.g., screening, diagnosis, or staging of cancer), a WSI slide scanner can be now classified as Class C device. A special regulation is applied to companion diagnostics. The new EU regulation 2017/746 contemplates the use of standard unique identifiers for medical devices and the creation of a European database on medical devices (Eudamed). Existing validation studies and clinical guidelines already available in the literature are a sound basis to avoid that this new regulation becomes a barrier for digital pathology development in Europe.

The European Union thorough the European Ceramic Industries association, CERAME-UNIE, elaborate since 2004 a sectorial diagnostic and the published draft (9-09-2006) was transcribed in the Boletin Sociedad Española Ceramica y Vidrio issue 1 of 2007. This draft is a preliminary document that consisted in an instrument to initiate the mandatory debate in order to confront the sector expectation in the conference of the Parliament an the European Union that will be held in 2008. On behalf of the importance of the Spain Ceramic industry with a turnover of 6.000 M€ in the context of 27.000 M€ of the total of the European Ceramic industries, and due to the relevance of such spanish turnover on the Gross Domestic Product, it must necessary to analyze their own future strategy.La Unión Europea, a través de la asociación europea de fabricantes de cerámica CERAME-UNIE, lleva elaborando desde 2004 un diagnostico del sector, cuyo borrador (26-0/9-2006) se publica en el número 1 del año 2007 del Boletín de la Sociedad Española de Cerámica y Vidrio. Este borrador es un documento muy preliminar, pero en todo caso va a permitir disponer de un instrumento para un debate necesario, que afrontará las perspectivas del sector ante la conferencia que tendrá lugar en el 2008, organizada por el Parlamento y la Comisión Europea. Dado el elevado peso de la industria cerámica española en el contexto europeo, 6.000 M€ sobre un total de 27. 000 M€, y la importancia de su aportación al Producto Interior Bruto nacional, sería conveniente que el entorno productivo aproveche la oportunidad para analizar la estrategia de futuro.

Background Aims: Advanced therapy medicinal products (ATMPs) are a class of biological products for human use that are based on genes, cells and tissues. The first ATMP received marketing authorization in Europe in 2009, whereas Brazil granted the first authorization in 2020. The objective of this study was to compare the regulatory models adopted by Brazil, the USA, Japan and the European Union, which comprise the member countries of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, with regard to the marketing authorization of ATMPs., Methods: The authors performed a review of the scientific literature and official documents of the regulatory agencies in the aforementioned countries., Results: The legislation and regulatory guidelines adopted by the regulatory agencies exhibit similarities and differences. It was not possible to assess whether these differences can be translated into divergent final recommendations by regulatory authorities upon a request for marketing authorization., Conclusions: In the future, it will be appropriate to start a progressive process of harmonization between these agencies in terms of terminology, legal recommendations and characterization requirements. This is particularly important for emerging countries such as Brazil. In this sense, some measures can be taken to achieve alignment between regulators., (Copyright © 2022 International Society for Cell & Gene Therapy. Published by Elsevier Inc. All rights reserved.)

Background Aims: Cell and gene therapy products (CGTPs) are anticipated to bring many benefits for the treatment of conditions with limited or no satisfactory treatment options. However, they are associated with concerns of potential safety risks because of their high complexity. The National Pharmaceutical Regulatory Agency (NPRA) of Malaysia took the first step toward the regulation of CGTPs by publishing the Malaysian Guidance Document and Guidelines for CGTPs in 2016. As mandatory registration and enforcement of CGTPs were scheduled to begin January 1, 2021, the aim of this study was to ascertain the industry's readiness for the regulation of CGTPs in terms of awareness of the guidelines, challenges and acceptance of the regulatory requirements., Methods: The authors invited 48 CGTP companies to participate in the survey between October 2019 and June 2020, and 30 companies responded., Results: The majority of respondents were aware of the mandatory CGTP regulatory control and the availability of the guidelines. Many CGTPs were in the early development phase, and the most difficult registration barriers were dossier preparation and compliance with the pre-clinical and clinical requirements., Conclusions: These findings represent the current CGTP landscape in Malaysia from the industry's viewpoint, enabling the NPRA to implement initiatives to facilitate registration and enforcement., (Copyright © 2021 International Society for Cell & Gene Therapy. Published by Elsevier Inc. All rights reserved.)

The South African population is highly diverse, both ethnically and genetically. This diversity is particularly true for the African ancestry and various mixed ancestry population groups. These groups are under-represented in national and international bone marrow and peripheral blood donor registries, making it challenging to identify HLA-matched and mismatched unrelated donors when patients from these groups require allogeneic hematopoietic stem and progenitor cell transplantation. In most high-income countries, banked cord blood (CB) units provide an attractive source of hematopoietic progenitor cells for genetically diverse populations. SA does not have a public CB inventory, leaving many patients without access to this important treatment modality. Haploidentical transplantation provides an alternative. In recent years, the use of post-transplant cyclophosphamide has significantly reduced the incidence of graft-versus-host disease after haploidentical transplantation and has improved transplantation outcomes. However, it is difficult to identify suitable haploidentical donors in SA because of family disruption and a high prevalence of HIV. Here the authors provide a brief historical overview of the ethnic and genetic diversity of the country and region. The authors provide a southern African perspective on HLA diversity, consider the allogeneic hematopoietic stem and progenitor cell transplantation landscape and explore the need to establish a public CB bank (CBB) in SA. The health policy and regulatory frameworks that will impact on a CBB in the country SA are also explored. Finally, the authors discuss several matters we believe require attention when considering the establishment of a sustainable public CBB in the South African context., (Copyright © 2021. Published by Elsevier Inc.)

Asymmetric-flow field-flow fractionation (AF4) has been recognized as an invaluable tool for the characterisation of particle size, polydispersity, drug loading and stability of nanopharmaceuticals. However, the application of robust and high quality standard operating procedures (SOPs) is critical for accurate measurements, especially as these complex drug nanoformulations are most often inherently polydisperse. In this review we describe a unique international collaboration that lead to the development of a robust SOP for the measurement of physical-chemical properties of nanopharmaceuticals by multi-detector AF4 (MD-AF4) involving two state of the art infrastructures in the field of nanomedicine, the European Union Nanomedicine Characterization Laboratory (EUNCL) and the National Cancer Institute-Nanotechnology Characterisation Laboratory (NCI-NCL). We present examples of how MD-AF4 has been used for the analysis of key quality attributes, such as particle size, shape, drug loading and stability of complex nanomedicine formulations. The results highlight that MD-AF4 is a very versatile analytical technique to obtain critical information on a material particle size distribution, polydispersity and qualitative information on drug loading. The ability to conduct analysis in complex physiological matrices is an additional very important advantage of MD-AF4 over many other analytical techniques used in the field for stability studies. Overall, the joint NCI-NCL/EUNCL experience demonstrates the ability to implement a powerful and highly complex analytical technique such as MD-AF4 to the demanding quality standards set by the regulatory authorities for the pre-clinical safety characterization of nanomedicines., Competing Interests: Declaration of Competing Interest The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2020. Published by Elsevier B.V.)

Introduction: Regenerative medicine offers innovative approaches to restore damaged tissues on the basis of tissue engineering (TE). Although research on advanced therapy medicinal products (ATMPs) has been very active in recent years, the number of licensed products remains surprisingly low and restricted to the treatment of severe, incurable diseases., Methods: This paper provides a critical review of current literature on the regulatory, clinical, and commercial status of ATMP-based therapies in the EU and worldwide and the hurdles to overcome for their broader application in Regenerative Dentistry., Results: Competent authorities have focused on developing regulatory pathways to address unmet patient needs. Oncology represents the dominating field, followed by cardiovascular, musculoskeletal, neurodegenerative, immunologic, and inherited diseases. Yet, the status remains in early development, and scientific, regulatory, and cost-effectiveness issues impose considerable hurdles toward marketing authorization, technology adoption, and patient accessibility. In this context, although regenerative dentistry has achieved breakthrough innovations in TE of several dental/oral tissues in preclinical models, it has hardly harnessed research progress to integrate innovative regenerative treatments into clinical practice., Conclusion: Global demographic changes, which demonstrate a steady increase of the aging population, highlight the societal need for the application of ATMP-based therapies in the treatment of noncommunicable diseases (NCDs). Although oral diseases, as an integral part of NCDs, are not life-threatening and largely preventable, they sustain high prevalence, with severe burden on economy and quality of life. In this perspective, the urgent request to ultimately translate draining research in dental TE conducted during the last decades into innovative treatments brought safely and cost-effectively into society at large still holds the stage. This review provides an overview of the regulatory, clinical, and commercial status of ATMP-based therapies in the European Union and worldwide and the hurdles to overcome for their broader application in regenerative dentistry., (Copyright © 2020 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.)

In recent years, remarkable progress has been made in the fundamental research and on clinical development of cell therapy. Although China has launched a series of regulations to establish a proper regulatory framework that facilitates the development of cell therapy products, the regulatory framework has not been able to meet the country's regulatory requirements. This article introduced the development of regulation and current regulatory pathways for cell therapy in China and identified the main challenges in clinical studies. China has recently tightened its policy on cell therapy clinical studies after medical chaos occurred in the area of cell therapy over the past few years. Currently the regulatory jurisdiction between NMPA and NHC are not very clear, especially for clinical somatic cell research, further efforts are necessary to establish a legislative system with a clear and functional regulatory framework for cell therapy., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Biotherapeutics dominate the pipelines of pharmaceutical companies across the world today with products ranging from hormones, immune-modulators, monoclonal antibodies (mAbs), blood coagulation factors, enzymes and vaccines. However, they are considerably more expensive than their small molecule counterparts (pharmaceuticals) and as a result their contribution to the already unacceptably high healthcare costs in the developed economies (Europe, United States, Japan, Canada and South Korea) has been in the limelight in the last decade. This has resulted in the rise of biosimilars, seen as the affordable versions of innovator biotherapeutics. As the developed economies form the majority of the global sales of biotherapeutics, they are an attractive market for the biosimilars as well. Regulatory considerations for approval of biosimilars in these jurisdictions is likely to have a major impact on the adoption of biosimilars. In this paper, we offer a perspective on this topic while focusing on the developed markets. This article summarizes the main regulatory requirements for approval of biosimilars in Europe, United States, Japan, Canada, and South Korea. An overview on current biosimilars status and market in the aforesaid countries has also been included., (Copyright © 2019 Elsevier Inc. All rights reserved.)

In China, child and adolescent pediatricians often face challenges in treating children with the appropriate medications. Within the last 8 years, the Chinese government has already initiated a series of policies to promote development of age-appropriate medicines for children. In this study,we introduced the current status of pediatric drugs, obstacles for pediatric drugs development and regulatory reforms in China. The lack of label information in drugs for children, inadequacy of age-appropriate dosage forms and strengths, and shortage of pediatric drugs are some of the problems commonly faced. There exists neither mandatory requirements nor enough financial drivers for development of pediatric medicines. Though some progress in terms of pediatric drugs development as well as distribution have been made by Chinese government over past years, further efforts are necessary to improve availability of pediatric medications., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

The vision of a sustainable and safe use of chemicals to protect human health, preserve the environment and maintain the ecosystem requires innovative and more holistic approaches to risk assessment (RA) in order to better inform decision making. Integrated risk assessment (IRA) has been proposed as a solution to current scientific, societal and policy needs. It is defined as the mutual exploitation of environmental risk assessment (ERA) for human health risk assessment (HHRA) and vice versa in order to coherently and more efficiently characterize an overall risk to humans and the environment for better informing the risk analysis process. Extrapolating between species which are relevant for HHRA and ERA requires a detailed understanding of pathways of toxicity/modes of action (MoA) for the various toxicological endpoints. Significant scientific advances, changes in chemical legislation, and increasing environmental consciousness have created a favourable scientific and regulatory environment to develop and promote the concept and vision of IRA. An initial proof of concept is needed to foster the incorporation of IRA approaches into different chemical sectorial regulations and demonstrate their reliability for regulatory purposes. More familiarity and confidence with IRA will ultimately contribute to an overall reduction in in vivo toxicity testing requirements. However, significant progress will only be made if long-term support for MoA-related research is secured. In the short term, further exchange and harmonization of RA terminology, models and methodologies across chemical categories and regulatory agencies will support these efforts. Since societal values, public perceptions and cultural factors are of increasing importance for the acceptance of risk analysis and successful implementation of risk mitigation measures, the integration of socio-economic analysis and socio-behavioural considerations into the risk analysis process may help to produce a more effective risk evaluation and consideration of the risks and benefits associated with the use of chemicals., (Copyright © 2015 Elsevier B.V. All rights reserved.)

This proceedings report presents the outcomes from an international Workshop designed to establish consensus on the professional status of the Clinical Embryologist, and then to work towards creating international standards that can be referenced by regulators and professional societies around the world. The participants represented a total of 20 countries (Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Finland, France, Germany, Ireland, Italy, the Netherlands, Russia, South Africa, Spain, Sweden, Turkey, UK and USA) and 18 national and regional societies (as presented in the list of participants). This report includes general presentations about current practice, and factors for consideration in the development of a competency-based framework for certification of Clinical Embryologists., (Copyright © 2015 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.)