• Title/Summary/Keyword: regulatory standards

Search Result 237, Processing Time 0.028 seconds

Model of The Korea Regulatory Body of Advanced Practice Registered Nurse (전문간호사 자격관리 전문기관의 조직 및 운영(안))

  • Cho, Jae-Hyun;Kim, Ki-Kyong
    • Journal of Korean Academy of Nursing Administration
    • /
    • v.10 no.4
    • /
    • pp.437-448
    • /
    • 2004
  • Purpose: The study was done to develop the model of regulatory body of advanced practice registered nurse. Method: This was a descriptive study adopted a method of comparison and construction of laws. Result: The type of partnership of government and people were privatization, negotiated rule-making, standard-setting authority, self-regulation. The pattern of partnership were applied to the regulatory body's role; administration of certification and examination, setting standards for nursing education programs and approval nursing programs. The regulatory body of advanced practice registered nurse was organized according to it's role. Conclusions: It is needed to proceed to self-regulation step by step.

  • PDF

The Importance of Qualitative Approach to Managing the Regulatory Lag of Convergence New Products: Focusing on the Certification of Compliance of New Products of Industrial Convergence (융합 신제품 규제 시차 관리를 위한 정성적 접근의 중요성: '산업융합 신제품의 적합성 인증제도'를 중심으로)

  • Kim, Hyung-Jin
    • Informatization Policy
    • /
    • v.29 no.3
    • /
    • pp.26-47
    • /
    • 2022
  • "The certification of compliance of new products of industrial convergence" (hereinafter referred to as "certification of compliance") is a legal certification system in accordance with the Industrial Convergence Promotion Act through which a convergence new product can be officially certified without legislation when the certification standards applicable to the product are not yet provided. Unlike other certification systems, the certification of compliance is characterized by the role of resolving the certification difficulties driven by the regulatory lag of convergence new products. Nevertheless, studies that analyzed the certification of compliance in detail from the viewpoint of regulatory improvement were surprisingly rare. Through the sequential matching of the steps of certification of compliance with the process from the occurrence of a regulatory problem to resolution, our study provided clear understanding as to how the regulatory lag could be reduced by the procedure for certification of compliance. Furthermore, we divided the perspective on regulatory lag management into quantitative and qualitative, and the structures and practices of certification of compliance were then analyzed from the two perspectives. By doing this, the present study emphasized that the fundamental reason the certification of compliance could effectively solve the regulatory lag problem of convergence new products was not only the quantitative elements such as legal deadlines for each step but also several qualitative approaches to securing the quality of every stage.

Comparison of Off-site Radiological Dose Due to the Routine Release of Gaseous Radioactive Effluents Based on the Korean and Japanese Regulatory Recommendations

  • Hwang, Won Tae;Kim, Chang Lak;Lee, Cheol-Woo;Han, Moon Hee
    • Journal of Radiation Protection and Research
    • /
    • v.44 no.4
    • /
    • pp.161-165
    • /
    • 2019
  • Background: Not only regulatory framework including radiation protection quantities and regulatory standards, but also methodology for regulatory compliance may be different in each country due to inherent philosophy for radiation protection. Materials and Methods: Based on the Korean regulatory models, off-site radiological dose resulting from the routine releases of gaseous radioactive effluents was calculated by applying the parameter values and assumptions recommended in the Korean and Japanese regulations. Results and Discussion: Effective dose for adult based on the Korean recommendation were 17.5 and 1.6 times higher than those of Japanese recommendation for 131I and 133I, respectively, for the same atmosphere dispersion and ground deposition factors. Conclusion: It was due to different parameter values and assumptions recommended for the purpose of evaluating compliance with dose criteria for the radiation protection of the public in each country.

OTC Drug Regulatory System of Korea Comparing to Other Countries (일반의약품 허가제도의 국가간 비교 및 발전 방향)

  • Sohn, Hyun-Soon;Shin, Hyun-Taek
    • Korean Journal of Clinical Pharmacy
    • /
    • v.15 no.2
    • /
    • pp.127-138
    • /
    • 2005
  • This is to examine the OTC regulatory system of Korea in comparison with those of Japan, UK and US, and suggest the possible regulatory actions to harmonize it to international standards. Individual countries have their own regulatory requirements and processes far OTC application based on established drug monographs and safety profiles from clinical experiences. Categories of OTC drug monographs are being expanded with transparent establishment procedure according to detailed guidelines, and public opinions as well as professional experts for assessing appropriateness of wide usage without physician's prescription. In line with trend of self-medication worldwide, the number of OTC drugs is increasing and more efficient and professional drug review is underway in the separate OTC division in regulatory agency. For improving OTC regulatory system in Korea, settlement of optimal drug classification policy and management for encouraging OTC drug use, development of more detailed and specific guidelines for OTC drug application, expansion of OTC drug monographs, transparent process for OTC monographs establishment, and establishment of OTC division in health authority, are suggested.

  • PDF

Disciplines on Telecom Standards in US' FTAs : Main Features and Implications (미국 FTA의 통신기술표준 규범 : 특징 및 시사점)

  • Lie, Han-Young
    • International Commerce and Information Review
    • /
    • v.8 no.1
    • /
    • pp.337-356
    • /
    • 2006
  • The Korea-US dispute on telecom standards has shown the inability of existing trade rules that can be applicable to standardization policy in telecom services sector. It has entailed plenty of dissenting but unsolved trade issues, including legal jurisdiction over technical standards on telecom services and their compatibility with WTO agreements. Question remains how US will cope with this tricky trade puzzle. This paper points out that Korea-US negotiations on telecom standards have provided US with a momentum to think seriously over the necessity of further rule-setting on telecom standards, and FTAs are the rescue train for US to ride on for that purpose. That is to say, US is taking advantage of FTA as a means to promote its national commercial goals by creating trade rules, which seek to deprive its trading partners of regulatory autonomy in telecom standardization. Based upon the research output, it is very important for Korean government in the upcoming Korea-US FTA negotiations to ensure facilitating public policy objectives in telecom standardization as possible as it can, and not to adopt the provision of international standards in the existing US' FTAs.

  • PDF

Guidelines for Manufacturing and Application of Organoids: Heart

  • Hyang-Ae Lee;Dong-Hun Woo;Do-Sun Lim;Jisun Oh;C-Yoon Kim;Ok-Nam Bae;Sun-Ju Ahn
    • International Journal of Stem Cells
    • /
    • v.17 no.2
    • /
    • pp.130-140
    • /
    • 2024
  • Cardiac organoids have emerged as invaluable tools for assessing the impact of diverse substances on heart function. This report introduces guidelines for general requirements for manufacturing cardiac organoids and conducting cardiac organoid-based assays, encompassing protocols, analytical methodologies, and ethical considerations. In the quest to employ recently developed three-dimensional cardiac organoid models as substitutes for animal testing, it becomes imperative to establish robust criteria for evaluating organoid quality and conducting toxicity assessments. This guideline addresses this need, catering to regulatory requirements, and describes common standards for organoid quality and toxicity assessment methodologies, commensurate with current technological capabilities. While acknowledging the dynamic nature of technological progress and the potential for future comparative studies, this guideline serves as a foundational framework. It offers a comprehensive approach to standardized cardiac organoid testing, ensuring scientific rigor, reproducibility, and ethical integrity in investigations of cardiotoxicity, particularly through the utilization of human pluripotent stem cell-derived cardiac organoids.

환경보전 정책에 관한 제 방법의 상대적 효율성 연구 - 판매가능한 배출허용권제도를 중심으로 -

  • Lee, Seon;No, Gong-Gyun;Lee, Jae-Geun
    • Environmental and Resource Economics Review
    • /
    • v.1 no.1
    • /
    • pp.115-149
    • /
    • 1991
  • In evaluating current environmental protection policy, economists often note that current regulations are more costly than necessary to meet environmental quality standards. While the a priori case can be made that current regulatory approaches entail higher-than-necessary costs to attain environmental standards, there is relatively little empirical evidence to support this claim in Korea. The purpose of this analysis is to supply some of the missing evidence by presenting the results of one study that assesses some of the potential savings associated with implementing economic, rather than command-and-control regulatory approaches to abate one type of air pollution in one region, in Korea, Specifically, the analysis examine the costs of meeting a long-term standard for TSP under the alternative control strategies for stationary sources of TSP in Ulsan Industrial Complex region. The alternative strategies that are considered are current command-and-control and various marketable permit designs. The analysis shows that the most efficient policy of emissions control is economic approaches, supporting results of previous empirical studies conducted in other countries.

  • PDF

A Study on the improvement plan of regulatory standard for construction noise and vibration (공사장 소음진동 규제기준 개선방안에 관한 연구)

  • Park, Young-Min;Kim, Kyoung-Min
    • Journal of Environmental Impact Assessment
    • /
    • v.22 no.4
    • /
    • pp.369-379
    • /
    • 2013
  • Noise and vibration problems at the construction site, expansion of construction scale and frequency of urban construction is increased, has given the damage to local residents. Also, the result of civil complaint about noise and vibration that occurred in 2011 was 56,244; it is showing an increasing trend of more than 4% annually. In particular, the construction noise and vibration, the civil complaints of around construction site accounts for 64.6%(36,353), are harmful to the tranquility of living environment. As a result, the government has managed to strengthen the regulatory standard of construction noise (65dB(A), Day-time) from 2011. However, the regulatory standard of construction noise and vibration does not meet and also complaints related the construction noise and vibration not decreased. Because the management system can be applied to the construction site is insufficient and a shortage of manpower. In this study, investigated the status and problems of the regulatory standards related to construction noise and vibration, we propose an efficient management plan of construction noise and vibration.