Global Harmonization Research Articles

Exploring glocalization in the construction and implementation of global curricula.

11020 Background: Despite proposed advantages of global oncology curricular harmonization including physician mobility and improving the quality of care the challenges and unintended consequences require greater study. The aim of this study was to problematize the concept and implementation of global oncology curricula and their relationship to local contexts of power and culture. Methods: Fourteen international participants involved in the development and implementation of global oncology curricula completed in-depth, one-on-one semi-structured interviews lasting 40-60 minutes. Snowball sampling was employed. The participant sample was representative of different geographic regions, genders and professional scopes of practice to ensure diverse perspectives were sought. Through iterative analyses, using an abductive approach, the study team discussed and reviewed the data and made revisions through collaborative analysis to enhance comprehensiveness and to improve credibility. In the final analysis the meaning and implication of the themes were discussed yielding a conceptual analysis. Results: Our data have articulated 5 key challenges for global curricula including 1) Ambiguous or conflicting perspectives on the purpose and scope of Global Oncology Curricula 2) Insufficient representation of diverse perspectives and realities in the creation of the final curricula 3) A rigid conceptualization of competency requirements 4) A mismatch between the curricular requirements and local context and 5) The influence of power relationships and decision makers. Leveraging the strengths of diversity including fostering representation, addressing power differentials and factoring local contexts may be an approach to mitigating these challenges. Conclusions: Global oncology curricula may serve important advocacy roles within the healthcare system. Leveraging diversity may positively impact the common challenges in the construction and implementation of global oncology curricula.

In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, When-Workshop Summary Report.

The pharmaceutical industry and regulatory agencies rely on dissolution similarity testing to make critical product performance decisions as part of drug product life cycle management. Accordingly, the application of mathematical approaches to evaluate dissolution profile similarity is described in regulatory guidance. However, the requirements (e.g., which time points, number of time points, %CV) to apply the widely known similarity factor f2 and other alternative statistical approaches diverge noticeably across regulatory agencies. In an effort to highlight current practices to assess dissolution profile similarity and to strive towards global harmonization, a workshop entitled "in vitro dissolution similarity assessment in support of drug product quality: what, how, when" was held May 21-22, 2019, at the University of Maryland, Baltimore. This article summarizes key points from the podium presentations and breakout (BO) sessions focusing on (1) contrasting the advantages and disadvantages of several statistical methods; (2) the importance of experimental design for successful similarity evaluation; (3) the value of similarity evaluation in light of clinically relevant specifications; and (4) the need for creating a robust and scientifically appropriate path (e.g., non-prescriptive decision tree) for dissolution profile similarity assessment as a stepping stone for global harmonization.

PROSPECTS FOR THE DEVELOPMENT OF FOREIGN ECONOMIC ACTIVITY OF THE ENTERPRISES OF AGRARIAN AND INDUSTRIAL COMPLEX

The article examines the essence of foreign economic activity of enterprises, the features and prospects of its implementation in the field of agrarian and industrial complex. Based on the conducted analysis, it is proved that agrarian export of Ukraine plays a significant role in the formation of the budget and GDP of the country, since its share in 2018 was 14.2% of GDP and 33.4% of the total national exports of goods. The dynamics of export-import operations of the agrarian sector is explored and it is found that it demonstrates a positive trend in contrast to the general foreign trade balance of Ukraine. The analysis of the agrarian exports structure in 2010-2019 confirms the growth of the share of the majority of agrarian products types sold abroad. However, Ukrainian exports are mainly oriented towards raw materials, which, among other reasons, is associated with technological backwardness and the limited ability of domestic agricultural producers to purchase modern equipment and technologies due to theirs low solvency. The commodity orientation of Ukrainian exports makes the competitive position of Ukraine in foreign markets vulnerable, since the demand for commodities is unstable and is characterized by significant price volatility. The geographical structure of foreign trade in agrarian products and the possibilities of its further diversification are investigated. The majority of Ukrainian products in Europe are purchased in Poland, Italy and Germany. Significant connoisseurs of Ukrainian products are also Turkey, China, India, Egypt. Ukrainian exports should be expanded to Asian and Eastern countries. The key problems that put the brakes on the development of the foreign economic activity of the enterprises of agrarian and industrial complex and hinder the competitiveness increase of domestic agrarian products in the international market are identified. A number of measures are proposed to promote the further development of the foreign economic activity of the enterprises of agrarian and industrial complex, including the development of appropriate strategies taking into account global market trends, harmonization and compliance with the quality and safety standards of agrarian products, improving the innovative component, strengthening state support (including financial) of the export-oriented agrarian enterprises, improving the investment climate, and more.

Regulations for on-road testing of connected and automated vehicles: Assessing the potential for global safety harmonization

Abstract Although there is great media attention to connected and automated vehicles (CAVs) and strong public interest in the technology, it is still under development. Their deployment to the broader public will require new regulations and road traffic rules that are also under development, and there is not yet a globally harmonized approach. This paper reviews the main safety and liability issues for CAVs with a focus on the rules developed for on-road testing to date in Australia, the United States, and Germany. It also reviews government policies from Victoria, Australia, and California, the United States, and it provides an appendix on European Union (E.U.) regulations. After a review of similarities and differences regarding safety and liability provisions, the study suggests how the current provisions can be brought together toward a globally harmonized approach to safety issues that builds on best practices in the three countries.

The pros and cons of animal health harmonisation.

It has been argued that the global harmonisation of animal health procedures, regulations and responses will improve animal health and provide economic benefits. Harmonisation of regulations can be driven by trade reform, such as multilateral or bilateral agreements, or as a response to private quality assurance programmes. At an international level, trade reform is currently focused on reducing the costs of trading between countries. To achieve this, bilateral agreements, where possible, are harmonising regulations throughout all sectors of the economy. However, as with any new developments, there are both positive and negative outcomes that should be explored to understand the net effect of these changes on animal health, the economy and society. In this article, the authors debate the economic foundations of harmonisation, explore alternative methods to achieve it, and discuss its pros and cons to more fully understand the opportunity costs from countries adopting the same level of risk to animal health.

Exploring Glocalization in the Construction and Implementation of Global Curricula.

Despite proposed advantages of global curricular harmonization including physician mobility and improving the quality of care, the challenges and unintended consequences require greater study. The aim of this study was to problematize the concept and implementation of global oncology curricula and their relationship to local contexts of power and culture. Fourteen international participants involved in the development and implementation of global oncology curricula completed in-depth, one-on-one semi-structured interviews lasting 40-60min. Snowball sampling was employed. Through iterative analyses, using an abductive approach, the study team discussed and reviewed the data and made revisions through collaborative analysis to enhance comprehensiveness and to improve credibility. In the final analysis the meaning and implication of the themes were discussed yielding a conceptual analysis. Our data have articulated 5 key challenges for global curricula including 1) Ambiguous or conflicting perspectives on the purpose and scope of Global Oncology Curricula 2) Insufficient representation of diverse perspectives and realities in the creation of the final curricula 3) A rigid conceptualization of competency requirements 4) A mismatch between the curricular requirements and local context and 5) The influence of power relationships and decision makers. Leveraging the strengths of diversity including fostering representation, addressing power differentials and factoring local contexts may be an approach to mitigating these challenges. Global oncology curricula may serve important advocacy roles within the healthcare system. Leveraging diversity may positively impact the common challenges in the construction and implementation of global oncology curricula.

Conceptual study of the difference between the money market and the capital market

The article is devoted to the research of theoretical principles of development of such components of the financial market as the money market and the capital market, identification of key differences between them on the basis of the analysis of scientific professional literature and key provisions of the legislative framework, substantiation of the general interpretation of their essence that could be used in international practice. The article analyzes the peculiarities of formation and functioning of each type of markets, traditional differences between them, examines international practice and statistics on the use of these terms by economic agents, defines the legal basis for understanding their essence and the legal basis for the delineation of these two types of markets. It is proved that a thorough analysis of the peculiarities of the functioning of individual markets, the frequency, and popularity of the use of their definitions in economic practice, the definition of users of these types of markets and their functions, form the prerequisites for clarifying the definitions of the essence of each of these markets, with their further global harmonization. The result of the research is the authors’ own interpretations of the concepts of the “money market” and “capital market”. The money market offers an understanding of the transaction system for the purchase and sale of liquid cash or other short-term financial assets, which typically include short-term financial liabilities (up to one year), the purpose of which is usually to provide financing for current operations, short-term profit or financial risk management in the short-term. The capital market is defined in the article as a system of transactions for the purchase and sale of financial assets, which include securities, derivatives, or financial transactions, which usually involve long-term financial liabilities, the purpose of which is to satisfy capital requirements or increase capital. Keywords: money market; capital market; financial market; legal basis; international practice, definitions.

Laser Light-Based Opacitometer ‘Peira LLBO 180’: A new and validated opacitometer for use in the Bovine Corneal Opacity and Permeability (BCOP) eye irritation test method

The “Peira LLBO 180” is a Laser Light-Based Opacitometer that can be used as an alternative for the standard OP-KIT device in the Bovine Corneal Opacity and Permeability (BCOP) test Organisation for Economic Co-operation and Development (OECD) Test Guideline (TG) 437 to identify chemicals inducing serious eye damage as defined by United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS), i.e. chemicals to be classified as UN GHS Category 1 and chemicals not requiring classification for eye irritation or serious eye damage under the UN GHS classification system (No Category).• The Peira LLBO 180 offers the advantage of analysing the complete corneal surface and is therefore able to detect more efficiently opaque spots located around the periphery of the excised corneas.• This new device will allow not only a more accurate definition of the eye irritating potential of compounds, but also a more precise ranking of moderate to mild and non-irritating compounds.• The value of Peira LLBO 180 is confirmed during in-house and multi-laboratory evaluation studies and is now included in the updated OECD TG 437, dated 26th of June 2020.The results demonstrate that the presented methodology is an improved new approach methodology (NAM) for ocular irritation testing of liquids and solids.

Intraocular devices associated adverse events reporting system in India.

Intraocular devices associated adverse events reporting system in India.

Terror of 10 MB, a cross-sectional study investigates the regulation to the prospective of medical device

An instrument, apparatus, implement, machine, implant, in vitro reagent, a component part or accessory which Intended for use in diagnosis of disease or other condition, or in the cure, mitigation and treatment or prevention of disease is called medical devices. Medical devices under new rule classified as Class A (low risk), Class B (low moderate risk), Class C (moderate high risk), and Class D (high risk) commemorating the notification of January 31, 2017 of Ministry of Health and Family Welfare which is conformity with Global Harmonisation Task Force framework. As per make in India program, the industry of medical devices is USD 5.2 billion and is contributing 4%–5% to the USD 96.7 billion Indian health-care industry. A total of 750–800 medical device manufacturers in India, an average investment of Rs 170–200 million and an average turnover of Rs 450–500 million. An online licensing portal of the Central Drugs Standard Control Organization (CDSCO) called “Sugam portal” has been launched on November 14, 2015, to file application and grant permission of registration exclusively for Medical Device CDSCO MD Online portal. By making the document submission easier, there are lot of challenges also present in “Sugam-online Portal.” One of the main challenges in Sugam Portal is that there is no provision to upload files greater than 10MB file size. The current study addresses the issues and challenges faced by medical device industry and regulators with their potential solutions and recommendations.

Grid-connected renewable energy sources: Review of the recent integration requirements and control methods

Abstract The growing of renewable power generation and integration into the utility grid has started to touch on the security and stability of the power system operation. Hence, the grid integration requirements have become the major concern as renewable energy sources (RESs) such as wind and solar photovoltaic (PV) started to replace the conventional power plant slowly. In line with this, some of the new requirements and technical regulations have been established to ensure grid stability. This study aims to fill the gap and conduct an updating review of the recent integration requirements and compliance control methods regarding the penetration of renewable power plants to the power grid. The review is conducted by a comparing of the key requirements related to voltage stability, frequency stability, voltage ride-through (VRT), power quality, active and reactive power regulations towards grid stability. In order to fulfill these requirements, different control methods have been recently proposed. Accordingly, this paper compares and reviews the state-of-the-art solutions for compliance technology and control methods. Furthermore, a broad discussion on the global harmonization of the integration requirements, challenges, advantages and disadvantages is also highlighted. The rigorous review indicates that although the recent integration requirements can improve the grid operation, stability, security, and reliability, further improvements are still required with respect to protective regulations, global harmonization, and control optimization. Various recommendations for future research related to the integration and technical regulations of RESs are then presented. In sum, the insights provided by this review may aid the development of smooth and stable grid integration of RESs, help developers and researchers to develop the design and control strategies in the sense of current requirements. Additionally, assist power system operators in establishing or improving their own requirements in comparison with the remaining international requirements.

Current legislations in nutrition and issues requiring global harmonisation

This article describes an overview of the current trends on international regulations on nutrition as well as global nutrition policies. We present recommendations for harmonisation of dietary guidelines, and nutrition and health claims starting with the societal needs driving this perspective. These recommendations also are proposed within the framework of objectives and actions by the Nutrition Working Group of the Global Harmonization Initiative (GHI). In all reviews to date, reports and critical point of views, the common conclusion is that harmonisation is the key to improving global legislation, which would benefit consumers, food quality and fair trade. The differences existing between global regulations regarding the main nutrition issues and the gap existing for the Nutrient Reference Value (NRV), daily energy value and intake, have made global harmonisation a vital initiative. Harmonised criteria checklists for food nutrition and health claims are proposed in this article, within the framework of general principle of harmonisation. These are strictly based on proven relationship(s) between food compounds and beneficial effects on nutrition or health.

International Consortium of Vascular Registries Consensus Recommendations for Peripheral Revascularization Registry Data Collection

Introduction - To achieve consensus on the minimal core data set for evaluation of peripheral arterial revascularization outcomes and enable collaboration among international registries. Methods - A modified Delphi approach was used to achieve consensus among international vascular surgeons and registry members of the International Consortium of Vascular Registries (ICVR). Variables, including definitions, from registries covering open and endovascular surgery, representing 14 countries in ICVR, were collected and analyzed to define a minimal core data set and to develop an optimal data set for registries. Up to three different levels of variable specification were suggested to allow inclusion of registries desiring simpler vs. complex data capture, while still allowing for data aggregation based on harmonized core definitions. Results - Among 31 invited experts, 25 completed five Delphi rounds via Internet exchange and face-to-face discussions. In total, 187 different items from the various registry data forms were identified for potential inclusion in the recommended dataset. Ultimately, 79 items were recommended for inclusion in minimal core data sets, including 65 items in the Level 1 dataset, and an additional 14 items in the more specific Level 2 and 3 recommended data sets. Data elements were broadly divided into 1) patient characteristics, 2) co-morbidities, 3) current medications, 4) lesion treated, 5) procedure, 6) bypass, 7) endarterectomy, 8) catheter-based intervention, 9) complications, and 10) follow-up. Conclusion - A modified Delphi study allowed 25 international vascular registry experts to achieve a consensus recommendation for a minimal core data set and an optimal dataset for peripheral arterial revascularization registries. Continued global harmonization of registry infrastructure and definition of items will overcome limitations related to single-country investigations and enhance the development of real world evidence.

Analysis of the Regulatory Divergence of Comparative Dissolution Requirements for Post-Approval Manufacturing Changes of Modified Release Solid Oral Dosage Forms.

This manuscript discusses global regulatory divergence of dissolution requirements for modified release solid oral dosage forms and the obstacles that must be addressed to be compliant with evolving guidance and legislation. The proliferation of local guidance documents, changing regulatory expectations, and increased legal enforcement has resulted in mismatched country-specific dissolution testing requirements and similarity criteria, and heightens industry's challenges with registration of modified release solid oral dosage forms. The lack of global harmonization and the complexity added by minor regional adaptations contributes to inefficiencies and hinders industry's goal of developing and delivering medicines. Awareness of country-specific similarity requirements and alignment between industry leaders and regulators is needed to facilitate global harmonization which will enable delivering new and improved medicines. The purpose of this manuscript is to compare and contrast in vitro conditions stated in local regulatory guidelines, raise awareness of the need to work toward harmonization of global requirements, and propose an initial study design toward that aspiration.

PNS138 TRANSNATIONAL COLLABORATIONS AMONG DRUG REGULATORY AGENCIES: TRENDS AND FUTURE PERSPECTIVES

Diversity in regulatory standards globally makes the drug development complex. Different international initiatives were put in place to support the harmonization in drug regulation to optimize drug development and drug authorization. Study aim was to evaluate the trends in the transnational collaborations between drug regulatory agencies and future perspectives. A comprehensive literature review was conducted in websites of regulatory agencies (EMA, US FDA, TGA and Health Canada), websites of International Council for Harmonization (ICH), International Coalition of Medicines Regulatory Authorities (ICMRA), International Pharmaceutical Regulators Programme (IPRP), as well as in PubMed database and in grey literature. Global harmonization in the criteria for quality, safety and efficacy are promoted intensively through the ICH, ICMRA and IPRP initiatives since 1995. EMA was established in 1995 aiming to centralize drug authorization in Europe. EMA/ US FDA collaboration formally started in 2003 in various areas such as mutual recognition agreement on pharmaceutical inspections on good manufacturing practices, parallel EMA/FDA scientific advice or FDA/EMA patient engagement cluster. Most recently EMA and US FDA collaborated on a common scientific approach for advanced therapies to facilitate their development, on streamlining scientific requirements for hybrids applications, and on real-world evidence methodologies to optimize use to support regulatory decision-making. Both Agencies are considering also the initiation of pilot program in the field of oncology for medicinal products eligible for breakthrough therapy program (FDA) and the priority medicines scheme (EMA). ACSS Consortium (Australia, Canada, Singapore and Switzerland) recently initiated a joint assessment procedure for new chemical entities applications by Health Canada and TGA; however, marketing authorization is still remaining country-specific decision. Several transnational collaboration are seen among drug regulatory agencies Such collaborations are growing, including also HTA bodies, while more and more innovative products are launched and complex decisions to be made by decision-makers to ensure fast patient access.

Physical Macroeconomics: Part XI – Harmonization of the Global Economy

Some of the topical problems of the harmonization of the global economy are outlined. Harmony is treated in Physical Macroeconomics as a dynamic balance of all energy and informational factors. Harmony is an objective property of the sustainable development of all living systems. Primarily, harmonious economic development means a balanced distribution of world GDP, which includes useful energy and information components. The information component of GDP is increased at the expense of the increased entropy of the environment. Hence, the rapidly growing information potential of the global economy should be primarily directed to the solution of ecological problems (e.g. using increasing information to understand how to deal with such problems). The highest stage of biological evolution was the creation of the human brain, which made it possible for people to feel a sense of harmony. Perhaps the electromagnetic oscillations in the brain that reflect harmony of the surrounding world in an encoded form can be decoded in future large-scale brain studies; then this will be a fundamental step towards global harmonization.

Physical Macroeconomics: Part IX – GDP Distribution and Economic Stability

The relationship between the distribution of GDP and sustainable economic development is considered. The main objective of the global economy harmonization is to ensure a balanced distribution of the world GDP. The growing economic inequality, financial and social crises as well as environmental destruction are the consequences of the GDP distribution imbalance. An important contribution to the solution of this problem would be an introduction of the dynamic added value taxation (DAVT), instead of a static VAT which is a destabilizing factor in the economy which could eventually become a universal tax. The distribution of free energy in biological systems is balanced due to stabilizing negative feedback – nutritional and metabolic feedback. The distribution of the global economy working potential (world GDP) is unbalanced, and this imbalance is the main cause of crises and social instability. Unbalanced GDP distribution leads to excessive income and tax inequality, which slows economic growth. The current static tax system is a destabilizing factor because it does not provide a balanced distribution of GDP. The solution to the problem is to replace the static VAT with a dynamic added value tax (DAVT). The DAVT theory is presented.

A Case study on the utility of predictive toxicology tools in alternatives assessments for hazardous chemicals in children's consumer products.

Children’s consumer products represent an important exposure source for many toxicants. Chemicals of high concern, as designated by the Washington State Child Safe Product Act include phthalates, Bisphenol A (BPA) and parabens, among others. As regulation and reporting requirements increase, so has demand for safer alternatives. This project examines how predictive toxicology and exposure comparison tools can fill gaps in alternatives assessments for hazardous chemicals found in children’s products. Phthalates, parabens, BPA and their alternatives were assessed for endocrine disruption and reproductive toxicity using authoritative lists and US Environmental Protection Agency’s (EPA) predictive toxicology and exposure comparison tools. Resources included the European Chemical Agency’s Endocrine Disruptor Substances of Concern database, Global Harmonization System and Classification of Labeling Chemicals, Quantitative Structural Activity Relationships from the Toxicity Estimation Software Tool, the Toxicological Prioritization Index (ToxPi) score calculated from the ToxCast Database, and No Observable Adverse Effects Levels (NOAELs)/Highest No Effects Levels (HNEL) from animal studies found in the CompTox Chemistry Dashboard. Exposure was assessed using ExpoCast predictions. Though alternatives were rarely included in authoritative lists, predictive toxicology tools suggested that BPA alternatives may not be safer but paraben and phthalate alternatives may be safer. All four paraben and no bisphenol or phthalate alternatives were listed on EPA’s Safer Chemical Ingredients List. Overall, we found that predictive toxicology tools help fill gaps for alternatives assessments when existing classifications are incomplete.

Globalised student achievement? A longitudinal and cross-country analysis of convergence in mathematics performance

ABSTRACTWith the aid of longitudinal country-level data from five IEA TIMSS assessments (1995–2011), the current study addresses the issue of the globalisation of curricula and achievement. To explore the hypothesis of global convergence, we study performance in four subdomains of mathematics. Using regression with fixed effects for countries, we consider whether the variation of subdomain scores decreases globally over time. Additionally, we explore qualitative differences in performance profiles using latent class analysis. Our results provide little evidence for a global harmonisation of student achievement. Rather, for regions with a similar language and culture, we observe similar strengths and weaknesses in mathematics content areas. Furthermore, these patterns remain stable over time. Directions for future research include the exploration of global trends in aspects of attained curricula for other subjects, and the use of information on school achievement.

Comparison of approval procedures for medical devices in Europe and the USA

Abstract Important achievements such as the discovery of penicillin increased life expectancy in the 19th century. At the beginning of the 20th century, the influence of technical equipment and biomedical research led to a further leap in life expectancy. The use of computer devices with sophisticated software also improved the quality of life. This is linked to the fact that all these achievements have now led to the emergence of one of the largest import and export markets in the USA, alongside the european union (EU), which is an association of European states. In order to guarantee a uniform quality of this abundance of different products and therapies, there are worldwide corresponding regulations, to which all manufacturers must adhere. The entry into force of these regulations, with the associated approval and testing obligations for each individual medical device, ensures that a consistently high quality of products is used on patients. Of course, high quality as well as high functionality and safety levels of medical products are a must. However, the implementation of these regulations is realized differently in the various markets, as there is no global harmonization. This work focuses on approval procedures for medical devices in Europe (EU) and the USA and compares significant differences in the approval procedures, which are shown as a graphical comparison. An example is an approval of medical devices by the U.S. Food and Drug Administration (FDA), which is an US government agency. In Europe (EU) there is a manufacturer’s declaration of conformity for the approval.