• Title/Summary/Keyword: regulatory science education

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European Regulatory Science and Regulatory Science Expert Training Project (유럽의 규제과학 및 규제과학 인재양성 프로젝트)

  • Shin, Hocheol;Park, Jaehong;Kim, Jiwon;Baek, Dajung;Lee, Yun-ji;Jung, Sun-Young;Kang, Wonku;Kim, Hahyung;Choi, Young Wook;Kim, Eunyoung
    • Korean Journal of Clinical Pharmacy
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    • v.31 no.3
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    • pp.171-179
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    • 2021
  • Background: Need for regulatory science is emerging with the development of pharmaceutical industry. It is essential to train regulatory science experts to meet the needs of technology and regulations to evaluate advanced products. Major regulatory science countries are conducting the regulatory science activities and fostering the experts. Methods: Published literature and the relevant website of European Union (EU) were reviewed and criteria were developed. In particular, we focused on in depth descriptions of the Innovative Medicines Initiative program, which was conducted twice. Results: EU is striving to provide funding and training experts for the development of the regulatory science by horizon 2020 and regulatory science to 2025. Innovative medicines initiative (IMI) is a public-private partnership aimed at the development of the pharmaceutical industry, including the regulatory science. IMI education and training projects have provided various education and training course including short-term curriculum and master and doctoral course. The difference between South Korea's regulatory science expert training project in 2021 and the EU's IMI education and training projects is participation of pharmaceutical companies. While the pharmaceutical companies participate in the IMI project to select project topics and form a community, South Korea's project is focused on the Ministry of Food and Drug Safety and universities. Conclusion: Through successful active networks with regulatory party, pharmaceutical companies, and universities, a great innovative advance of regulatory science in South Korea is expected.

Analysis of Trends in Regulatory Science and Regulatory Science Experts Training Projects: US, Japan, Singapore, and Korea (규제과학 및 규제과학 전문가 양성 프로젝트의 국내외 동향분석: 미국, 일본, 싱가포르, 한국을 중심으로)

  • Park, Jaehong;Shin, Hocheol;Kim, Jiwon;Kim, Minsu;Do, In Gu;Lim, Heeyeon;Lee, Jiwon;Lee, Yun-ji;Jung, Sun-Young;Kang, Wonku;Kim, Hahyung;Choi, Young Wook;Kim, Eunyoung
    • Korean Journal of Clinical Pharmacy
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    • v.31 no.4
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    • pp.257-267
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    • 2021
  • Background: The need for regulatory science development to evaluate advanced regulatory products is gradually increasing without hindering the technological development. Creating a research environment and fostering experts through the establishment of regulatory agency-led policies are essential for the development of regulatory science. Method: This is a comparative study of the United States, Japan, Singapore, and Korea. The literature and websites of each regulatory agency were reviewed, and the focus was on advantages and comparing advantages based on definition, development trends, and expert training projects. Results: The United States is striving to develop regulatory science in response to changes in the new pharmaceutical industry through the regulatory science report, and to foster expert both inside and outside the Food and Drug Administration (FDA). Japan is promoting regulatory science centered on regulatory science centers, and is focusing on researching work-related regulatory science within the Pharmaceuticals and Medical Devices Agency (PMDA) and improving employees' ability to make regulatory decisions. Singapore was aiming to improve Southeast Asia's regulatory capabilities under the leadership of Centre of Regulatory Excellence (CoRE) within Duke-NUS University. In 2021, Korea is in its early stages, starting to run a university's degree program related to regulatory science this year. Conclusion: Regulatory science should be developed with the aim of improving the regulatory ability of the Ministry of Food and Drug Safety with Korea's independent concept of regulatory science.

Effects of Systems Thinking on High School Students' Science Self-Efficacy (시스템 사고가 고등학생의 과학 자기 효능감에 미치는 영향)

  • Lee, Hyundong;Lee, Hyonyong
    • Journal of the Korean earth science society
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    • v.37 no.3
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    • pp.173-185
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    • 2016
  • The purpose of this study is to investigate the effects of systems thinking on high school students' self-regulatory efficacy and self-confidence that constitute science self-efficacy. We set self-regulatory efficacy as a factor of students' systems thinking affects their self-confidence on science through self-regulatory efficacy. A total of 210 students were sampled from general high schools and 188 valid cases were analyzed. The instrument has 39 items that consist of 20 items measuring systems thinking and 19 items of science self-efficacy. The result of the exploratory factor analysis indicated that 20 items for systems thinking, 8 items for self-regulatory efficacy, 4 items for self-confidence are reasonable. Testing the goodness of fit of a structural equation model, it turn out to be appropriate (${\chi}^2$=344.498, df=242, TLI= .921, RMSEA= .044) using 24 items (mental model, personal mastery, systems analysis, self-regulatory efficacy, and self-confidence were constructed). In addition, the mental model, which is one factor of systems thinking, is mediated by self-regulatory efficacy that affects self-confidence directly and/or indirectly. The results suggest that systems thinking affects science self-efficacy directly and indirectly. Utilizing systems thinking in science education can produce a theoretical basis in improving students' confidence and self-efficacy about science.

The Effect of Color on Perceived Price Attractiveness: Interaction of Regulatory Focus and Involvement (가격 매력도 지각에 대한 가격 색상의 영향: 조절초점과 관여도와의 상호작용을 중심으로)

  • Park, Eun-Young;Lee, Eun-Young
    • Journal of Distribution Science
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    • v.14 no.10
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    • pp.117-126
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    • 2016
  • Purpose - Color is perceived to have an effect on humans' cognition and behavior because of its association with specific concepts. Since there are few studies linking color and price presentation, we investigated a constrained condition of consumers' regulatory focus and involvement. Research design, data, and methodology - We performed a 2 (color: red vs. black) × 2 (regulatory focus: prevention vs. promotion) × 2 (involvement: high vs. low) test of our hypothesis. The target product was a portable data storage device (USB) and data from 165 respondents were analyzed. Each condition had two stages. In the first, product information and price were presented. After reviewing the product information, respondents evaluated price attractiveness. In the second stage, respondents filled out regulatory focus and involvement questionnaires. The main variables were color, regulatory focus, and involvement. Therefore, we ran a three-way ANOVA (Analysis of Variance) to test our hypothesis. Results - When the price was red (vs. black), consumers perceived the red price as more attractive than the black price. However, this effect varied by situation. Specifically, in the low involvement condition among prevention-focused consumers, when the price was in red, price attractiveness was higher than when the price was in black. However, for promotion-focused consumers, there was no difference in the price color effect. In the high involvement condition, promotion-focused consumers showed stronger price attractiveness for the red price than the black price. However, the effect of price color diminished for prevention-focused consumers. That is, prevention-focused consumers did not reveal a different price perception between red versus black in the high involvement condition. Conclusions - This research contributes by academically linking the effects of color to price attractiveness, and focusing on the interaction of regulatory focus and involvement. When involvement is low, the effect of red disappeared for promotion-focused consumers, whereas the same happened for prevention-focused consumers under the condition of high involvement.

Priorities And Problems In The Development Of Modern Information Technologies In Education

  • Prykhodkina, Nataliia;Tymoshko, Hanna;Zuieva, Alona;Sholokh, Olena;Noskova, Margaryta;Lebid, Yuliia
    • International Journal of Computer Science & Network Security
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    • v.21 no.6
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    • pp.231-236
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    • 2021
  • The article assesses the functioning of the DE system or a separate educational institution, where it can be carried out on the basis of developed criteria or on a regulatory basis. The assessment was carried out on the basis of a qualitative and quantitative nature by comparing the actual state of affairs with a certain "ideal" (educational standard), which must be defined and used as a kind of benchmark against which the assessment is made. Conducted an assessment based on a regulatory framework that represents an alternative approach. It has been emphasized that the exceptional difficulty in determining the ideal indicators (norms) of the activities of universities, it has been found that the normative approach, in which the activities of traditional and open universities are compared, taking into account the differences in social, cultural and economic conditions, is the most acceptable.

Pedagogical Conditions And Technology Of Formation Of Management Competencies Of Future Specialists Of The System Of Higher Education Institutions

  • Rebryna, Anatolii;Kukin, Igor;Soltyk, Oleksandr;Tashmatov, Viacheslav;Bilanych, Halyna;Kramarenko, Iryna
    • International Journal of Computer Science & Network Security
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    • v.22 no.8
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    • pp.217-221
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    • 2022
  • The article analyzes the main theoretical approaches to the formation of managerial competencies and establishes the degree of development of the problem. The content of the concept of "managerial competence" has been clarified, to determine the structure of managerial competencies of a future specialist in the education system and indicators of the formation of managerial competencies. The organizational and pedagogical conditions necessary for the effective process of forming the managerial competencies of future specialists are revealed. The following research methods were used in the work: theoretical (analysis of regulatory documents and scientific literature on the problem under study, comparison, generalization, modeling), empirical (diagnostics of the level of formation of managerial competencies of students of the system, questioning, observation, peer review, comparative qualitative and quantitative analysis of diagnostic results the level of formation of managerial competencies).

Component, Formulation and Regulatory of Sunscreen Materials: A Brief Review

  • Firi Oktavia Hariani;Mohammad Adam Jerusalem;Iqmal Tahir;Maisari Utami;Won-Chun Oh;Karna Wijaya
    • Korean Journal of Materials Research
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    • v.33 no.3
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    • pp.87-94
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    • 2023
  • Exposure to ultraviolet (UV) light is often associated with skin damage, sometimes very serious, and in recent times has received particular attention as a health risk. As a result, the proper use of sunscreen has long been recommended to protect against skin damage. The continued increase in the use of sunscreen may be linked to increased information about the risk of melanoma and non-melanoma skin cancer caused by prolonged exposure to ultraviolet rays. Natural and harmless materials that block and prevent UV light have emerged as essential household items in the field of skin beauty. New materials need to be considered and evaluated in relation to ultraviolet rays and their harmful effects. This study aims to explain the effect of UV exposure on human skin, the classification of sunscreens, the application of zeolite, nano clay, and LDH in sunscreen formulations, as well as the regulation of this service in various countries around the world.

Production of Human Serum Albumin in Chloroplast-Transformed Tobacco Plants

  • Ko, Suk-Min;Kim, Hyun-Chul;Yoo, Byung-Ho;Woo, Je-Wook;Chung, Hwa-Jee;Choi, Dong-Woog;Liu, Jang-R.
    • Journal of Plant Biotechnology
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    • v.33 no.4
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    • pp.233-236
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    • 2006
  • Human serum albumin (HSA) is the most abundant protein in plasma and is the most often used intravenous protein in many human therapies. However, HSA is currently extracted only from plasma because commercially feasible recombinant expression systems are not available. This study attempted to develop an efficient system for recombinant HSA production by chloroplast transformation of tobacco. A HSA cDNA was isolated from a cDNA library constructed with human liver tissue. Chloroplast transformation vectors were constructed by introducing various regulatory elements to HSA regulatory sequences. Vectors were delivered by particle bombardment into leaf explants and chloroplast-transformed plants were subsequently regenerated into whole plants. Southern blot analysis confirmed that the HSA cDNA was incorporated between rps12 and orf70B of the chloroplast genome as designed. Western blot analysis revealed that hyper-expression and increasing the stability of HSA were achieved by modification of the regulatory sequences using the psbA5'UTRs in combination with elements of the 14 N-terminal amino acids of the GFP and the FLAG tag. However, only plants transformed with the vector containing all of these elements were able to accumulate HSA.

Current Status and the Future of Occupational Safety and Health Legislation in Low- and Middle-Income Countries

  • Ncube, France;Kanda, Artwell
    • Safety and Health at Work
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    • v.9 no.4
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    • pp.365-371
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    • 2018
  • This article addresses three key issues. First, the commonalities, differences, strengths, and limitations of existing occupational safety and health (OSH) legislation of low- and middle-income countries were determined. Second, required revisions were identified and discussed to strengthen the laws in accordance with the best international practice. Finally, proposals for additional OSH laws and interventions were suggested. A literature search of OSH laws of 10 selected low- and middle-income countries was carried out. The laws were subjected to uniform review criteria. Although the agricultural sector employs more than 70% of the population, most of the reviewed countries lack OSH legislation on the sector. Existing OSH laws are gender insensitive, fragmented among various government departments, insufficient, outdated, and nondeterrent to perpetrators and lack incentives for compliance. Conclusively, the legal frameworks require reformation and harmonization for the collective benefit to employees, employers, and regulatory authorities. New OSH legislation for the agricultural sector is required.

A Study on Legal and Regulatory Improvement of Telemedicine Service (원격의료 서비스의 규제개선에 관한 연구)

  • Kwon, Jun Cheol;Choi, Yong Jeon;Jung, Yong Gyu
    • Journal of Service Research and Studies
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    • v.4 no.1
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    • pp.83-93
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    • 2014
  • Telemedicine is performed at a place far away from medical practice with physicians and patients by the means of communication appropriately. It will be identified in general the remote medical service to deliver the medical information and also defined as any action by interactive information communication technology. Medical services can be said to be fused as television, communication, computer, engineering of various technologies of information and communication applications. If doctors can not be reached due to distances away from the patient, Information technologies could be used to get medical information and to give expert advice provided by the system remotely. And it could be used patient care as well as medical administration, medical education, professional advice and consulting. In this paper, we take a look at the legal requirements of telemedicine for improving regulatory in the current law to investigate the matter.

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