Global Harmonization Research Articles

Territoriality in Intellectual Property Law: Examining the Tension between Securing Societal Goals and Treating Intellectual Property as an Investment Asset

By Emmanuel Kolawole Oke. The principle of territoriality is one of the foundational principles of International Intellectual Property Law. This principle allows countries to design their intellectual property laws in a manner that facilitates the achievement of specific societal goals. However, while it is true that this principle has managed to survive the incorporation of intellectual property into the international trade law system (via the WTO’s TRIPS Agreement), some scholars have expressed concern that the incorporation of intellectual property into the international investment law system via investment agreements (such as bilateral investment treaties) constitutes a potential threat to the principle of territoriality in the international intellectual property system. This paper will investigate the tension between the principle of territoriality and the global harmonisation of intellectual property standards in the context of the current iteration of intellectual property as an asset in investment agreements. Specifically, it will critically examine how this tension was resolved in two recent investment arbitration disputes. The first is the dispute between Philip Morris and Uruguay which concerned the latter’s implementation of certain measures to curb the consumption of tobacco products in its country but which Philip Morris construed as an expropriation of its trademarks. The second is the dispute between Eli Lilly and Canada which concerned the interpretation of the utility requirement under Canadian patent law. These cases will be used to assess whether there is still scope for the preservation of the principle of territoriality within the investor-state dispute settlement system.

Occupational health and safety in cannabis production: an Australian perspective.

The legal Australian cannabis industry has been rapidly expanding due to increased awareness of the plant's therapeutic potential, as well its diverse range of applications including biofuel, textiles, building materials, food, nutritional supplement, and animal feed. The objective of this paper is to describe the current landscape of the commercial Australian cannabis industry, summarise occupational health and safety (OHS) hazards in cannabis-related working environments, and provide suggestions for safeguarding worker health and well-being in this emerging industry. A comprehensive search of peer-reviewed and grey literature published between 1900 and 2017 was undertaken to identify case studies and original epidemiological research on OHS hazards associated with the cannabis cultivation and the manufacture of cannabis-based products. The review found that the majority of OHS studies were undertaken in the hemp textile industry during the late twentieth century, with a small number of articles published from a variety of occupational environments including forensic laboratories and recreational marijuana farms. Cannabis harvesting and initial processing is labour intensive, and presents a physical hazard Depending on the operation, workers may also be exposed to a variety of biological, chemical, and physical hazards including: organic dusts, bioaerosols, pollen/allergens, volatile organic compounds, psychoactive substances (tetrahydrocannabinol [THC])), noise, and ultraviolet radiation. Little research has been undertaken on the exposure to inhalable organic dust and other bioaerosols during the commercial cultivation and manufacture of cannabis-based products. Furthermore, there is an absence of Australian-based research and OHS guidance materials to help professionals develop risk management strategies in this evolving industry. It is recommended that: Investigation into the toxicological properties of cannabis dusts, specifically in relation to potential occupational exposures during cultivation and manufacture, should be a priority. The interim adoption of the respirable cotton dust exposure standard of 0.2mg/m3 for workplace exposure in hemp facilities until a cannabis workplace exposure standard is developed, and that exposure to medicinal cannabis containing THC are kept as low as reasonably practicable. An industry partnership be established for the development of an Australian health and safety guideline for the production of medicinal cannabis and hemp. A classification to meet the requirements of the Global Harmonization Scheme should be undertaken to ensure consistency in the use of safety and risk phrases in cannabis-related industries.

International Financial Standards: An Argument for Discernment

Multiple shocks have led regulators and policy makers to put increasing faith in the diagnostic and prophylactic powers of international financial standards, but the nature, appropriateness and normative force of such standards varies. As a standard setter, the International Organization of Securities Commissions (IOSCO) has pursued global consensus, harmonization and international best practices for many years. International standards, however, are often created under suboptimal conditions by actors with a broad range of motivations, assumptions and biases. Frictions between state-level regulation and international standards can undermine their effectiveness. This policy brief examines the process of standard setting and two very different sets of standards and their standard setters to illustrate some of the anomalies associated with them. The process has become more complex, more compromised and more politicized, leading in some cases to “pseudo-international” standards or a riot of diverse viewpoints, of limited practical use. The danger lies in major economies walking away from international standards which no longer demonstrate pertinence or credibility. Greater discernment should be exercised by state-level policy makers, international financial institutions and the international organizations themselves in proposing, deploying and implementing international standards.

Composition and chemical health hazards of the most common electronic cigarette liquids in nine European countries

Background: The aim of the present study was to identify the composition and reported chemical health hazards of the most common electronic cigarette liquids (e-liquids) in nine European Union (EU) Member States (MS) prior to adoption of the Tobacco Product Directive (TPD).Materials and methods: Within the Horizon2020, EUREST-PLUS study, 122 of the most commonly sold e-liquids in 9 EU MS were randomly selected and purchased. A quantitative and qualitative chemical analysis was performed using a previously validated based gas chromatography–mass spectrometry and liquid chromatography–mass spectrometry method. The most commonly detected compounds were then divided according to the Danger Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and Warning GHS codes.Results: Within our qualitative analysis, 171 different compounds were detected. Discrepancies in measured versus reported nicotine concentration were identified. Forty-one (85.4%) of the most commonly detected compounds were registered with Warning GHS codes, 11 with Danger GHS codes and 9 with both codes. Of the total number of the detected compounds, 293 were attributable to fruits flavor, followed by tobacco flavor (204), nonalcoholic drinks (n = 64), desserts–sweets (n = 50), menthol – mint (n = 42) and alcohol (n = 39). Menthol which is classified as a strong irritant to skin and eye was the most frequently detected compound.Conclusion: A large plethora of compounds with varying warning codes was identified in e-cigarette samples. The systematic monitoring and chemical evaluation of e-liquids are warranted, so as to ensure consumer protection.

Fundamental pharmacological expressions on ocular exposure to capsaicin, the principal constituent in pepper sprays

Eye irritation assessment is compulsory to anticipate health risks in military personnel exposed to riot control agents such as capsaicin, the principal constituent of oleoresin capsicum, or pepper sprays. The present work investigates certain fundamental yet unaddressed pharmacological manifestations on ocular exposure to capsaicin. Ocular pharmacology of capsaicin was studied using acute eye irritation (AEI), bovine corneal opacity and permeability (BCOP) assay, corneal fluorescein staining and indirect ophthalmoscopy studies, transcorneal permeation, Schirmer tear secretion test, nerve conduction velocity study and enzyme-linked immunosorbent assay (ELISA). Additionally, histopathology and scanning electron microscopy (SEM) of bovine corneas and rat optic nerves were done to further estimate capsaicin induced morphological variations. Our findings demonstrated that AEI, BCOP, corneal fluorescein staining and indirect ophthalmoscopy were useful in assessing capsaicin induced ocular irritation; AEI and BCOP also contributed towards indicating the eye irritation potential of capsaicin as per the United Nations Globally Harmonized System of Classification and Labelling of Chemicals categorization. Additional experimental observations include considerable transcorneal permeation of capsaicin, capsaicin induced reduction in tear secretions and nerve conduction velocity and increased expression of proinflammatory cytokines by ELISA. Histopathology and SEM were favourable techniques for the detection of capsaicin induced ocular physiological modifications.

Consistency of listed indications and contraindications between the U.S., the U.K., Japan, and Korea on prescription drug labels

Inclusion of indications and contraindications in drug labeling is essential for drug approval. Little is known regarding how well new drug information labels agree across countries. To compare the number of indications and contraindications on the labels of drugs in the U.S., U.K., Japan, and Korea, we selected 81 new drugs approved in these countries between 2008 and 2016 and assessed the number of indications and contraindications on each label. Average and median numbers with standard deviations were presented for the 81-drug set, and for subsets grouped according to drug class. Correlation analyses were conducted to estimate Pearson and concordance correlation coefficients. No significant difference was observed across countries in the number of indications, the average being 1.69, 1.67, 1.54, and 1.51 in the U.S., the U.K., Korea, and Japan (p = 0.31), respectively. By contrast, substantial variation was observed in the number of contraindications, the average being 1.54, 2.42, 3.53, and 3.00 in the U.S., the U.K., Korea, and Japan (p < 0.001), respectively. Pearson correlation coefficients comparing contraindications were 0.40, 0.48, and 0.47 for U.S.-U.K., U.S.-Korea, and U.S.-Japan, but 0.83, 0.73, and 0.71 for U.K.-Korea, U.K.-Japan, and Korea-Japan, respectively (p < 0.01). There is consistency in the number of indications, but a substantial discrepancy in contraindications listed in drug labeling across countries. Further study is warranted to improve global harmonization of contraindication listings.

Discrepancies in the Evidence and Recommendation Levels of Pregnancy Information in Prescription Drug Labeling in the United States, United Kingdom, Japan, and Korea.

To compare the evidence-of-risk and recommendation levels of new drugs' label information in pregnancy among US, UK, Japan, and Korea. Despite the importance of drug labels in guiding decisions, officially approved prescribing information in drug labels is often inconsistent across countries and contains misleading content. Women are unintentionally exposed to drugs during early stages of unplanned or unrecognized pregnancies when treated for medical conditions. We selected 81 drugs approved in all 4 countries mentioned above from 2008 to 2016. Evidence level was classified into five categories ("Definite," "Probable," "Possible," "Unlikely," and "Unclassified"), and recommendation level was classified into four categories ("Contraindicated," "Cautious," "Compatible," and "Unclassified"). We calculated kappa coefficient with 95% confidence intervals (CIs) to estimate the agreement of each category. For evidence level, "Unclassified" was the highest in Japan (33.3%), while representing a much smaller proportion in US (2.5%), UK (6.2%), and Korea (6.2%; p < 0.01). For recommendation level, "Contraindicated" was the lowest in US (9.9%), while it was greater in UK (50.6%), Japan (50.6%), and Korea (42.0%; p < 0.01). Korea-UK presented substantial agreement for both evidence-of-risk (kappa = 0.80, 95% CI: 0.67-0.94) and recommendation level (kappa = 0.64, 95% CI: 0.46-0.82), while Korea-Japan and Korea-US were in fair or moderate agreement. Label information in pregnancy was discrepant among the four countries. Discrepancies in labeling information among countries may cause confusion to patients and healthcare professionals alike. To better assist healthcare professionals and patients in the use of prescription drugs, global harmonization of safety information is needed to minimize confusion with potential risk.

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

To achieve consensus on the minimum core data set for evaluation of peripheral arterial revascularisation outcomes and enable collaboration among international registries. 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 analysed to define a minimum core data set and to develop an optimum data set for registries. Up to three different levels of variable specification were suggested to allow inclusion of registries with simpler versus more complex data capture, while still allowing for data aggregation based on harmonised core definitions. 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 data set. Ultimately, 79 items were recommended for inclusion in minimum core data sets, including 65 items in the level 1 data set, and an additional 14 items in the more specific level 2 and 3 recommended data sets. Data elements were broadly divided into (i) patient characteristics; (ii) comorbidities; (iii) current medications; (iv) lesion treated; (v) procedure; (vi) bypass; (vii) endarterectomy (viii) catheter based intervention; (ix) complications; and (x) follow up. A modified Delphi study allowed 25 international vascular registry experts to achieve a consensus recommendation for a minimum core data set and an optimum data set for peripheral arterial revascularisation registries. Continued global harmonisation of registry infrastructure and definition of items will overcome limitations related to single country investigations and enhance the development of real world evidence.

Prioritization of reproductive toxicants in unconventional oil and gas operations using a multi-country regulatory data-driven hazard assessment

BackgroundRecent trends have witnessed the global growth of unconventional oil and gas (UOG) production. Epidemiologic studies have suggested associations between proximity to UOG operations with increased adverse birth outcomes and cancer, though specific potential etiologic agents have not yet been identified. To perform effective risk assessment of chemicals used in UOG production, the first step of hazard identification followed by prioritization specifically for reproductive toxicity, carcinogenicity and mutagenicity is crucial in an evidence-based risk assessment approach. To date, there is no single hazard classification list based on the United Nations Globally Harmonized System (GHS), with countries applying the GHS standards to generate their own chemical hazard classification lists. A current challenge for chemical prioritization, particularly for a multi-national industry, is inconsistent hazard classification which may result in misjudgment of the potential public health risks. We present a novel approach for hazard identification followed by prioritization of reproductive toxicants found in UOG operations using publicly available regulatory databases. MethodsGHS classification for reproductive toxicity of 157 UOG-related chemicals identified as potential reproductive or developmental toxicants in a previous publication was assessed using eleven governmental regulatory agency databases. If there was discordance in classifications across agencies, the most stringent classification was assigned. Chemicals in the category of known or presumed human reproductive toxicants were further evaluated for carcinogenicity and germ cell mutagenicity based on government classifications. A scoring system was utilized to assign numerical values for reproductive health, cancer and germ cell mutation hazard endpoints. Using a Cytoscape analysis, both qualitative and quantitative results were presented visually to readily identify high priority UOG chemicals with evidence of multiple adverse effects. ResultsWe observed substantial inconsistencies in classification among the 11 databases. By adopting the most stringent classification within and across countries, 43 chemicals were classified as known or presumed human reproductive toxicants (GHS Category 1), while 31 chemicals were classified as suspected human reproductive toxicants (GHS Category 2). The 43 reproductive toxicants were further subjected to analysis for carcinogenic and mutagenic properties. Calculated hazard scores and Cytoscape visualization yielded several high priority chemicals including potassium dichromate, cadmium, benzene and ethylene oxide. ConclusionsOur findings reveal diverging GHS classification outcomes for UOG chemicals across regulatory agencies. Adoption of the most stringent classification with application of hazard scores provides a useful approach to prioritize reproductive toxicants in UOG and other industries for exposure assessments and selection of safer alternatives.

Removing barriers to the movement of food accross borders

Always when I receive the announcement of a new issue of AJFAND, I immediately read the editorial and then look up the articles that are of interest to me or I feel should have the interest of colleagues, whom I subsequently alert about it. AJFAND is certainly a journal of high quality and many of the articles are not only of interest to Africa. When invited to write a guest editorial, about a topic of my choice, logically I accepted, but I had no clue yet about the subject of the editorial. If I write an article, I feel it should have contents that matter and will help at least a few readers a little ahead in their endeavours. As the highest priority of my activities is with the Global Harmonization Initiative (GHI) whose goal it is to achieve consensus on the science of food regulations and legislation to ensure global availability of safe and wholesome food products for all consumers, I felt I should focus on the availability of safe food in Africa, remembering the many famines in several parts of Africa in the past decades

The Mycotox Charter: Increasing Awareness of, and Concerted Action for, Minimizing Mycotoxin Exposure Worldwide.

Mycotoxins are major food contaminants affecting global food security, especially in low and middle-income countries. The European Union (EU) funded project, MycoKey, focuses on “Integrated and innovative key actions for mycotoxin management in the food and feed chains” and the right to safe food through mycotoxin management strategies and regulation, which are fundamental to minimizing the unequal access to safe and sufficient food worldwide. As part of the MycoKey project, a Mycotoxin Charter (charter.mycokey.eu) was launched to share the need for global harmonization of mycotoxin legislation and policies and to minimize human and animal exposure worldwide, with particular attention to less developed countries that lack effective legislation. This document is in response to a demand that has built through previous European Framework Projects—MycoGlobe and MycoRed—in the previous decade to control and reduce mycotoxin contamination worldwide. All suppliers, participants and beneficiaries of the food supply chain, for example, farmers, consumers, stakeholders, researchers, members of civil society and government and so forth, are invited to sign this charter and to support this initiative.

EP-2206: Global findings of remote beam output audits; a review by the Global Harmonisation Group

EP-2206: Global findings of remote beam output audits; a review by the Global Harmonisation Group

Transformation/dissolution characterization of tungsten and tungsten compounds for aquatic hazard classification.

The transformation/dissolution protocol (T/DP) for metals and sparingly soluble metal compounds was applied to determine the transformation/dissolution (T/D) characteristics of yellow tungsten trioxide, WO3 ; blue tungsten oxide, WOx, x taken as 2.9; tungsten disulphide, WS2 ; tungsten metal, W; 3 samples of tungsten carbide, WC; sodium tungstate, Na2 WO4 · 2H2 O; ammonium paratungstate (APT), (NH4 )10 (H2 W12 O42 ) · 4H2 O; and ammonium metatungstate (AMT) (NH4 )6 (H2 W12 O40 ) · 3H2 O. The T/D data were used to derive aquatic hazard classification outcomes under the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS) and European Union Classification, Labelling and Packaging of Substances and Mixtures (EU CLP) schemes by comparing the data with selected acute and chronic ecotoxicity reference values (ERVs) of 31 and 3.37 mg W/L, respectively. In addition to the concentration of total dissolved tungsten (W), the T/D solutions were analyzed for the concentration of the tungstate anion, because speciation can be an important factor in establishing the ecotoxicity of dissolved metals. Results show that the tungstate anion was the predominant W-bearing species in solution for all substances examined at pH 6 and 8.5. It was found that the 100 mg/L loadings of both the yellow WO3 and the blue WOx exceeded the 31 mg/L acute ERV, so they would classify as Acute 3-Chronic 3 under the UN GHS scheme but they would not classify under the EU CLP. An effect of pH on the reactivity of the W metal was observed with 3% and 16% W dissolution at pH 6 and 8.5, respectively. Tungsten metal would not classify under either the UN GHS or EU CLP schemes nor would the WS2 . The WCs were the least reactive in terms of the 1% or less dissolution of the contained W at pH 6. A critical surface area for WC was calculated. The sodium tungstate, APT and the AMT all yielded, at pH 8.5, total dissolved W concentrations that would result in UN GHS Acute 3-Chronic 3 classifications. Integr Environ Assess Manag 2018;14:498-508. © 2018 Her Majesty the Queen in Right of Canada. Integrated Environmental Assessment and Management © 2018 SETAC.

Ecodesign of cosmetic formulae: methodology and application.

This article describes an easy-to-use ecodesign methodology developed and applied since 2014 by the L'Oréal Group to improve the sustainable performance of its new products without any compromise on their cosmetic efficacy. Cosmetic products, after being used, are often discharged into the sewers and the aquatic compartment. This discharge is considered as dispersive and continuous. A consistent progress in reducing the environmental impact of cosmetic products can be achieved through focusing upon three strategic indicators: biodegradability, grey water footprint adapted for ecodesign (GWFE) and a global indicator, complementary to these two endpoints. Biodegradability represents the key process in the removal of organic ingredients from the environment. GWFE is defined herein as the theoretical volume of natural freshwater required to dilute a cosmetic formula after being used by the consumer, down to a concentration without any foreseeable toxic effects upon aquatic species. Finally, the complementary indicator highlights a possible alert on formula ingredients due to an unfavourable environmental profile based on hazard properties: for example Global Harmonization System/Classification, Labelling and Packaging (GHS/CLP) H410 classification or potential very persistent and very bioaccumulative (vPvB) classification. The ecodesign of a new cosmetic product can be a challenge as the cosmetic properties and quality of this new product should at least match the benchmark reference. As shown in the case studies described herein, new methodologies have been developed to maximize the biodegradability of cosmetic formulae, to minimize their GWFE and to limit the use of ingredients that present an unfavourable environmental profile, while reaching the highest standards in terms of cosmetic efficacy. By applying these methodologies, highly biodegradable products (≥ 95% based on ingredient composition) have been developed and marketed, with a low GWFE. This new ecodesign approach shows that embedding sustainability in developing new cosmetic products can also open up new innovative opportunities.

In vitro SAFETY EVALUATION OF PALM TOCOTRIENOL-RICH FRACTION NANOEMULSION FOR TOPICAL APPLICATION

The application of nanotechnologies in cosmetics industry has resulted in the introduction of new nanomaterials for topical applications. Nanomaterial overcomes issues of limited penetration and low bioavailability of non-soluble bioactive agents. While there are many advantages of using nanomaterials, recent development in using submicron particles for enhance skin penetration has raised the concern of safety including the increase potential to induce skin irritation and allergic reactions on the skin. The studies on irritation potential of palm tocotrienol-rich fraction (TRF) nanoemulsion using in vitro ocular and dermal irritection assays, reconstructed human epidermis and human corneal epithelium tests were investigated. Palm TRF nanoemulsion did not exhibit any potential skin irritation in the in vitro ocular and dermal irritation assessment. The studies showed that when reconstructed human corneal epithelium and human epidermis models were treated with the tocotrienol macroemulsion and nanoemulsions, no indication of irritancy to the eyes or dermal tissues were observed giving a mean tissue viability of more than 60% and 50%, respectively. The non-irritant category is classified as Category 1 according to United Nations Globally Harmonised System of Classification and Labelling of Chemicals. In vitro studies showed no ocular or dermal irritation potential indicating possible topical application of palm TRF nanoemulsion.

Culture, Economics, and Antitrust

What role do cultural dimensions of cooperation and competition play in economic life? Taking a multidisciplinary perspective, this essay uses the example of the concept of trust to consider some implications for competition policy. The author suggests that the field of competition policy is at core about the authoritative allocation of categories of economic activity along a spectrum with individualism and competition at one end and collectivism and cooperation at the other. The allocation is a function of the state, made on the basis of a variety of imprecise inputs—cultural, political, historic, economic, and institutional—and not merely neoclassical economic theory. Sensitivity to the cultural aspects of competition and cooperation places constraints on overly optimistic expectations for global harmonization of antitrust enforcement.

Regulatory Harmonization:A View from India

For any drug to be marketed in a country, it must be passed by the local regulatory authorities. Different regulators have different criteria for passing a drug. Zerhouni and Hamburg in an editorial have urged greater global harmonization in the matter of drug regulations ( Sci. Transl. Med. , 2016, 8, 338ed6). At the time of writing their Editorial, Zerhouni was – and continues to be – head of R&amp;D at the large pharma company Sanofi and a former head of the National Institutes of Health, USA and Hamburg was the immediate past Commissioner of the US Food and Drug Administration (USFDA). One can see that the editorial reflected Zerhouni’s current – and perhaps Hamburg’s former – problems. Given the authors’ current or past affiliations, one can also assume that their comments were somewhat US-centric.

Vehicle Accident Databases: Correctness Checks for Accident Kinematic Data

(1) Background: Data collection procedures allow to obtain harmonization of in-depth road accident databases. Plausibility of calculable accident-related kinematic parameters depends on the constraints imposed on calculation, making their uncertainty degree higher than the one for measurable parameters (i.e., traces, airbag activation, etc.). Uncertainty translates in information loss, making the statistics based on databases analysis less consistent. Since kinematic parameters describe the global accident dynamics, their correctness assessment has a fundamental importance; (2) Methods: the paper takes as reference data collected in the Initiative for the GLobal harmonisation of Accident Data (IGLAD) database for vehicle-to-vehicle crashes. The procedure, however, has general nature and applies identically for other databases and multiple impacts between vehicles. To highlight issues which can arise in accident-related data collection, 3 different checks are proposed for parameters correctness assessment; (3) Results: by 4 examples, 1 with correct and 3 with incorrect parameters reported, the paper demonstrates that errors can go beyond simple calculation uncertainty, implying that a deeper analysis is desirable in data collection; (4) Conclusions: the step-by-step guidelines described in this paper will help in increasing goodness of collected data, providing for a methodology which can be used by each individual involved in accident data collection, both for collection itself and subsequent verification analysis.

Grid-connected photovoltaic power plants: A review of the recent integration requirements in modern grid codes

The high integration of photovoltaic power plants (PVPPs) has started to affect the operation, stability, and security of utility grids. Thus, many countries have established new requirements for grid integration of solar photovoltaics to address the issues in stability and security of the power grid. In this paper, a comprehensive study of the recent international grid codes requirement concerning the penetration of PVPPs into electrical grids is provided. Firstly, the paper discusses the trends of PVPPs worldwide and the significance of improving grid codes' requirements. In addition, the comparison of common requirements covered in the majority of international grid codes considers high‐ and low‐voltage ride‐through capabilities, voltage and frequency regulation, and active and reactive power support requirements. Finally, a broad discussion on the compliance technology challenges and global harmonization of international grid codes that the PVPPs have to address is presented. The study summarizes the most recent international regulation regarding photovoltaic integration and research findings on the compliance of these regulations and proposed recommendations for future research. It also can assist power system operators to compare their existing requirements with other universal operators or establish their own regulations for the first time. Additionally, this research assists photovoltaic manufacturers and developers to get more accurate understanding from the recent global requirements enforced by the modern grid codes.

ЛОГІКА ВИКОРИСТАННЯ ПОРТФОЛІО В ЗАБЕЗПЕЧЕННІ ЯКОСТІ ПІСЛЯДИПЛОМНОЇ МЕДИЧНОЇ ОСВІТИ ТА БЕЗПЕРЕРВНОГО ПРОФЕСІЙНОГО РОЗВИТКУ ЛІКАРЯ. АНАЛІТИЧНИЙ ОГЛЯД

The problem of using the portfolio as a personal oriented technology for improving the quality of medical education is considered. It is emphasized that the "Portfolio" is currently an effective tool for objectifying and quantifying educational and professional growth in education and continuous professional development of the doctor. It can also be used to assess social relations and competencies that are difficult to assess in other ways. Portfolio can be widely used to demonstrate the acquisition of competences in interdisciplinary and transdisciplinary areas of medicine, as well as the development of non-clinical skills.Attention is also focused on the fact that the portfolio in postgraduate medical education is applicable to support the physician's reflexive practice, knowledge management and knowledge transfer management at the organizational and individual levels. However, the creation of an e-portfolio requires a global harmonization of the content of training, professional activity and assessment of the improvement of the doctor in professional conditions.