• Title/Summary/Keyword: regulations.

Search Result 6,452, Processing Time 0.029 seconds

System Dynamics Modeling for FDA Regulation Effect of Pharmaceutical Industry (제약산업에서 FDA규제 영향에 관한 시스템 다이내믹스 모델링: FDA규제가 R&D비용에 미치는 영향을 중심으로)

  • Ko, Seong-Pil;Choi, Jeong-Hwan;Nam, Dong-Wok;Lee, Jeong-Dong
    • Korean System Dynamics Review
    • /
    • v.13 no.4
    • /
    • pp.57-80
    • /
    • 2012
  • This research studies effect of FDA regulations in pharmaceutical industry on new drug development. System dynamics is implemented to demonstrate dynamic relationship between FDA regulations and R&D costs, firm's profits, sales. This research is focused on clinical trials of new medical entity process 50~60% portion of total development cost. Simulation results say that firm's profit is more sensitive to increasing the regulation than alleviating the regulation and effect of regulation policy make different result depending on the intensity of regulation and policy direction. Our simulation model provides the instrumental means for the policy makers and strategic decision in pharmaceutical industry.

  • PDF

A Study on the Actual Pronunciation of the Words of Foreign Origin and the Related Rules (외래어의 발음 실태와 발음 규정)

  • Cha Jae-Eun
    • Proceedings of the KSPS conference
    • /
    • 2006.05a
    • /
    • pp.17-20
    • /
    • 2006
  • The purpose of this paper is to investigate the actual pronunciation of the words of foreign origin on TV news programs, and to review the regulations related to it. To investigate the actual pronunciation of the foreign words, the frequency data of the National Korean Language Institute is used as the subject of investigation. There is a big gap between the actual pronunciation and the orthography of the words of foreign origin. And received pronunciation of foreign words is need to teach or learn Korean efficiently. I suggest the pronunciation of foreign words is marked on Korean dictionary instead of revising the related regulations.

  • PDF

Chemical Residues in Edible Tissues of Animals and Control Measures (축산식품의 유해물질 잔류와 그 관리방안)

  • 박종명;박근식
    • Journal of Food Hygiene and Safety
    • /
    • v.6 no.2
    • /
    • pp.17-22
    • /
    • 1991
  • Great attention form a public health aspect has centered on the safety of tissues residues of veterinary drugs and environmental contaminants, with intensification of animal husbandry, the use of veterinary drugs will become increasingly important. Heavy responsibility is placed on the veterinarian and livestock producer to observe the period for withdrawal of drug prior to slaughter to assure that illegal concentrations of drug residues in meat, milk and egg do not occur. Every nation has their own regulations in relation to the residues and the guidelines on the use of veterinary drugs to fulfil the regulations, and their own national residue programs to monitoring and eliminate illegal products. Good practice of veterinary drug by users and governmental surveillance programs are very important to ensure animal food safety.

  • PDF

A Study on the Standard Provisions of International Franchising Contracts and Unfair Trade Acts (국제프랜차이즈계약의 표준조항과 불공정거래행위)

  • Seo, Jung-Doo
    • Journal of Arbitration Studies
    • /
    • v.22 no.3
    • /
    • pp.165-185
    • /
    • 2012
  • Franchising has proved over many years to be a successful commercial vehicle for the international distribution of products and services. However, there has long been missing a user-friendly model contract that would reflect the diversity of international franchising contracts. Because the ICC has drafted a model form of international franchising contracts, taking into account the most commonly encountered clauses in franchising agreements, their model could be used as a checklist of the core obligations of a cross-border franchise contract. Because there is no internationally agreed-upon uniform legislation on franchising, parties must rely on national laws and regulations applicable to the international franchise (when such laws and regulations exist) and should therefore very carefully draft stipulations for the legal status of the contract. This study has been intended to cite some provisions for striking a fair balance between the interests of the franchisor and those of the franchisee and for avoiding unfair trade acts in international franchising contracts.

  • PDF

A Comparative Study of Radiation and Gas Sterilization. (방사선항균법과 개스항균법의 비교연구)

  • 정해원;유영수
    • Journal of Environmental Health Sciences
    • /
    • v.8 no.1
    • /
    • pp.81-97
    • /
    • 1982
  • Ethylene oxide gas has been used as a cold sterilant for heat-sensitive medical equipments and as a fumigant for food for more than 30 years, and it is used more widely than radiation although radiation sterilization has made significant inroads in recent years. But according to recent studies of toxicities such as mutagenicity, haemolytic effect and possible carcinogenicity of Ethylene oxide (ETO) and its two main reaction products, Ethylene chlorohydrin (ETCH) and Ethylene glycol (ETG), Environmental Protection Agency in U.S.A. has suggested some regulations on residual gas in drug products and medical devices for human use. The mutagenic activity of ETO compared with that of X-ray has an equivalency of 1 ppm/hr for ETO as compared to 20 mrad for X-ray, and one could suggest the present maximum allowable concentration for ETO (50 ppm) should be 400 times lower than the radiation standard (2.5 mrad/hr). Although radiation sterilization has advantages of simplicity of operation and complete reliability, changes of physico-chemical properties with possible formation of toxic substances may occur. It is therefore necessary to make some regulations of our own for residual toxicities orginated from each sterilization method.

  • PDF

A Evaluation of Office Environment in Universal Design (유니버설 디자인 관점에서의 오피스환경 평가 연구)

  • 구아현;하미경
    • Proceedings of the Korean Institute of Interior Design Conference
    • /
    • 1999.04a
    • /
    • pp.49-52
    • /
    • 1999
  • The purpose of this research is providing the fundamental data for the effective workplace design, so that employees are not suffered from physical barrier. This research based on literature review. And then gain actual data by auditing buildings and data have been analyzed by percentage. The results and conclusions of research are the follow: In order to evaluate the law-abiding levels of office buildings, classifying the sources as the three levels. Just 44.2 percentage of building were marked on 'compliance' level. And also the 24% was 'not compliance' 31.8% was 'not accommodation'. The actual office building was out of the allowance of regulations so the regulations should be added both about new building and ready-built buildings.

  • PDF

A Evaluation of Office Environment in Universal Design-by related laws- (유니버설 디자인 관점에서의 업무시설환경평가연구-관련법규를 중심으로-)

  • 하미경;구아현
    • Korean Institute of Interior Design Journal
    • /
    • no.22
    • /
    • pp.117-122
    • /
    • 2000
  • The purpose of this research is to provide the fundamental information for the effective workplace design, so that employees are not suffered from physical barriers. This research based on literature review; and then gain actual data by auditing buildings and data have been analyzed by percentage. The results and conclusions of research are the follow : In order to evaluate the law-abiding levels of office buildings, classifying the sources as the three levels. Just 44.2 percentage of building were marked on 'compliance' level. And also the 24% was 'not compliance' 31.8% was 'not accommodation'. The actual office building was out of the allowance of regulations, so the regulations should be added both about new building and ready built buildings.

  • PDF

A Study of Heat Stress Characteristics on Workers in Hot Workplace by WBGT Index (WBGT지수를 이용한 온열작업장 근로자의 열피로특성에 관한 연구)

  • 마성준;이내우;설수덕;이진우
    • Journal of the Korean Society of Safety
    • /
    • v.15 no.1
    • /
    • pp.112-120
    • /
    • 2000
  • We have compared the regulations of hot environment workpaces between Korea and ACGIH, then pointed out some insufficiences of Korean regulations for occupational hygiene and safety. And investigated the heat stress characteristics of laboratory, lathe and foundry working. The metabolic heat loads of those workplaces were obtained as 120, 300 및 660 kcal/hr based on WBGT index. WBGT index could be depended on weather condition, therefore useful for controlling working and rest times etc, but Belding-hatch index was represented by strength of working, definitely this would be convinient result for arranging countermeasures of workers in hot environments by estimating metabolic heat and signs of fatigue.

  • PDF

Effectiveness and Balance of Compulsory and Voluntary Safety Certification of Industrial Machines and Devices (산업용 위험기계·기구 의무 및 임의 안전인증의 효과 및 균형)

  • Choi, Gi Heung
    • Journal of the Korean Society of Safety
    • /
    • v.31 no.1
    • /
    • pp.7-12
    • /
    • 2016
  • This study first focuses on the quantitative evaluation of both compulsory and voluntary safety certification of industrial machines and devices. Based on the results of statistical analysis, effectiveness of those safety certifications were confirmed. In order to reduce both the frequency and the strength of industrial accidents associated with industrial machines and devices, major target of safety regulations needs to be shifted from users to manufacturers. Adjustment of industrial machines and devices which are subject to compulsory safety certification and implementation of risk assessment are further suggested. As for the voluntary certification, reestablishment of the concept of voluntary safety certification and balance between compulsory and voluntary certifications is discussed. Voluntary safety certification is further suggested as a mean to manage safety of industrial machines and devices which are not subject to any safety regulations.

Cause Analysis of Accidents Associated with Industrial Machines and Devices (산업용 기계 및 기구 관련 산업재해 원인분석)

  • Choi, Gi Heung
    • Journal of the Korean Society of Safety
    • /
    • v.33 no.1
    • /
    • pp.16-21
    • /
    • 2018
  • Cause analysis of accidents associated with industrial machines and devices is essential to improve the effectiveness and the efficiency of industrial safety system in Korea. This study focuses on cause analysis of accidents associated with industrial machines and devices. In particular, analysis of abstracts of accidents which are written in descriptive format and, therefore, inherently unstructured and exhibits characteristics of big data is suggested and tested. Automatic analysis of such big data performed in this study reveals the consistent results with the manual analysis results in previous studies. Analysis results also suggest that incorporating transition from the current user-oriented indirect regulations to more manufacturer and user balanced direct regulations will guarantee more effective prevention of industrial accidents at the early stage of generation of danger.