• 제목/요약/키워드: Harmonization

검색결과 309건 처리시간 0.027초

의약품 첨가제의 공정서 각조의 국제 규격화 : 그 진행과 문제점 (International Harmonization of Compendium Monographs of Pharmaceutical Excipients: Its Progress and the Matters at Issue)

  • 후지오 세키가와
    • Journal of Pharmaceutical Investigation
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    • 제23권4호
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    • pp.231-254
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    • 1993
  • These days, it is not uncommon that a same kind of drug is circulated globally. However, the qualities of excipients used in the same drug have to be sometimes different depending on the different requirements in the qualities stipulated by each country. For a supplier of pharmaceutical excipients, it is generally necessary to carry out different tests on the same kind of testing criteria depending on the country of destination. Thus, the discrepancies between compendium requirements of pharmaceutical excipients create severe problems in various area of industrial activities. The decision of the United States Pharmacopoeia, European Pharmacopoeia and Japanese Pharmacopoeia Commissions to harmonize the requirements is a unique chance for the industries to overcome these problems. On the other hand, discrepancies of general test methods and requirements in each monograph of pharmaceutical excipient between the compendia valid at present are in most cases extensive. Consequently their harmonization needs a lot of detailed work requiring strong support from the industry. Based on these circumstances, pharmaceutical excipients councils have been established first in U.S.A. and successively in Europe and in Japan to contribute to the harmorization process. We should like to review here the progress since the Orlando Conference in 1991 and comment about the matters at issue with regard to the international harmonization of pharmaceutical excipients.

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Civil legal relations in the context of adaptation of civil legislation to the legislation of the EU countries in the digital age

  • Kizlova, Olena;Safonchyk, Oksana;Hlyniana, Kateryna;Mazurenko, Svetlana
    • International Journal of Computer Science & Network Security
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    • 제21권12spc호
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    • pp.521-525
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    • 2021
  • An essential area is the creation of a single digital market between the EU and Ukraine through information technology. Purpose: to investigate and analyze civil law relations in the field of adaptation of Ukrainian civil law to civil law regulations of the EU. The object of research: Ukrainian civil law and civil law of the EU. The subject of the study is civil law in the context of adaptation of civil law to the legislation of the EU. The following methods of scientific cognition were used during the research: semantic, historical, comparison, analysis and synthesis, generalization. The results of the study show that the harmonization of the legal system of Ukraine with EU law is caused by several goals: successful integration of Ukraine into the EU, legal reforms based on the positive example of EU countries, promoting access of Ukrainian enterprises to the EU market; attracting foreign investment, increasing the welfare of Ukrainian citizens. The adaptation includes three stages, the final of which is the preparation of an expanded program of harmonization of Ukrainian legislation with EU legislation. In the process of adaptation, it is important to take into account the legal history, tradition, features and mentality of Ukraine and before borrowing legal structures to analyze the feasibility of their application in the Ukrainian legal field.

아시아 임상검사실 정도관리 프로그램 (Asian Quality Assurance Survey Program for Clinical Laboratory)

  • 이갑노
    • 한국건강관리협회지
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    • 제4권1호
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    • pp.60-67
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    • 2006
  • Purpose : Asian Quality Assurance Survey program(AQuAS) is and activity of Asian Network for Clinical Laboratory Standardization and Harmonization(ANCLS) which had begun her first colloquium in 1999 in Jakarta, Indonesia by laboratory physicians led by Professors Noriyuki Tatsumi and Yoshinori Funahara with themes of standardization and harmonization of clinical laboratories in Asia. Methods : AQuAS had begun its first survey in July. 2001 and done November and March, three times per year in the fields of Chemistry, Hematology. Coagulation and Urinalysis. As of June 2006 the 15th survey have been completed. Korean Association of Health Promotion(KAHP) had participated in it since July, 2004 in the fields of chemistry, hematology and urinalysis.ゝ⨀

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독일에서의 철도사업 환경영향평가 지침 (Harmonized EIA-Guidelines for German Railways Projects)

  • Ch. Ufer, J. Koppel
    • 환경영향평가
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    • 제2권2호
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    • pp.55-58
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    • 1993
  • After establishing the EIA(Environmental Impact Assessment) act in the Federal Republic of Germany there still remain methodical and substantial deficits. So nearly every environmental impact study went to be a matter of experiments. The requirement for standardization of data sampling and evaluation has permanently been increasing. This is meant to ensure quality standards for the assessment of environmental impacts as well as to maintain reliability required by the projecting company. Such a harmonization is of special importance because of the strongly accelerated expansion of traffic infrastructure caused by the reunification of Germany. That is why the guideline "EIA carried out" for the German Railways company is in process of development This guideline, focussing on practical demands, comprises impacts of railways, adequate sets of indicators, feasible tools for the prognosis and evaluation of environmental reactions. "EIA carried out" will be introduced not only as a manual but also through workshops and pilot studies.

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태양광발전 에너지 시스템의 표준 및 인증제도 (Standards and Certification Scheme of Solar Photovoltaic Energy Systems)

  • 신성호
    • 한국신재생에너지학회:학술대회논문집
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    • 한국신재생에너지학회 2005년도 춘계학술대회
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    • pp.142-146
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    • 2005
  • Standards are increasing of importance for photovoltaics. The rapid growth of production is one reason for this but standards are equally important in ensuring the quality and reliability of installed PV systems. which have a propound impact on acceptance of the technology in the expanding marketplace. Korea government (Korean Agency for Technology and Standards. KATS)make and implement a five year plans for promotion of international standardization of this field from 2004. Through these works and harmonization of PV Korea standards with international standards(international electrotechnical commission. IEC). KATS leads the technology innovations and eventually increases the international Competitiveness. Strategic collaboration with other countries is also strengthened through Korea's participation in IECEE(IEC system for conformity and certification of electrical equipment) on standards and conformity assessment. One of the major goals of the Plan is to facilitate trade between Korea and its trading partners by emphasizing harmonization of its national conformity assessment system with international norms

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멀티미디어 서비스에서 연관 QoS 지원을 위한 트래픽 기술자 (Additional Traffic Descriptors for Associatiove QoS Parameters in a Multimedia Service)

  • 김지영;이상목최봉근이상홍
    • 대한전자공학회:학술대회논문집
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    • 대한전자공학회 1998년도 하계종합학술대회논문집
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    • pp.86-89
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    • 1998
  • Multiple types of information in a multimedia service are delivered though multiple virtual connections on ATM network, while each virtual connection may be controlled independently. A multimedia service requires an associative relationship among multiple information streams to provide required harmonization. There may be required additional traffic descriptors to guarantee the required harmonization among multiple information streams in a multimedia service. For buffering of large bandwidth information stream(e.g., video), extremely large buffer size is necessary, but this approach should not be efficient way to compensate a severely delayed cells/blocks experienced at network. The best way to solve this problem will be minimization of relative-delayed-transfer of cells/blocks to application processes through ATM network control. To minimize a delayed transfer the mapping between relative delay parameter(i.e., associative Group QoS parameters) and per-VC traffic descriptor will be necessary. This paper is present additional functions and parameters to interpret the mapping between relative delay parameters(i.e., associative Group QoS parameters) and per-VC traffic descriptors in ATM API for multimedia application services.

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건축음향관련 KS규격의 개정 및 제정에 관한 고찰 (A Consideration on the Revision and Establishment of KS - For Building Acoustics -)

  • 송민정;이주엽;정진연;장길수;김선우
    • 한국소음진동공학회:학술대회논문집
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    • 한국소음진동공학회 2000년도 춘계학술대회논문집
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    • pp.197-201
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    • 2000
  • For building acoustics, the revision and establishment of ISO JIS were carried out actively in the direction of international harmonization recently. In this consideration, the trends of the ISO and JIS were reviewed and the establishment process of KS was introduced. As a result of this consideration, it is thought to be that 'International Harmonization' should be a base for KS and the speciality of domestic characteristics should be attached to annex.

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