• Title/Summary/Keyword: policy management

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The Study of Comparative Legal Review According to Data Exclusivity of Pharmaceutical Marketing Authorization - In preparation for the development of drugs and vaccine of COVID-19 - (의약품 자료독점권(Data Exclusivity)에 대한 비교법적 고찰 - COVID-19 치료제 및 백신 개발을 대비하여 -)

  • Park, Jeehye
    • The Korean Society of Law and Medicine
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    • v.21 no.1
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    • pp.223-259
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    • 2020
  • With COVID-19 spreading rapidly around the world, research and development issues on treatments and vaccines for the virus are of high interest. Among them, Remdesivir was the first to show noticeable therapeutic effects and began clinical trials, with each country authorizing the use of the drug through emergency approval. However, Gilead Co., Ltd., the developer of Remdesivir, received a lot of criticism from civic groups for submitting the application for the marketing authorization as an orphan drug. This is because when a new drug got a marketing authorization as an orphan drug could be granted an exclusive status for seven year. The long-term exclusive status of an orphan drug comes from the policy purpose of motivating pharmaceutical companies to develop treatment opportunities for patients suffering from rare diseases, which was not appropriate to apply to infectious disease treatments. This paper provides a review of the problems and improvement directions of the domestic system through comparative legal consideration against the United States, Europe and Japan for the statutes which give exclusive status to medicines. The domestic system has a fundamental problem that it does not have explicit provisions in the statute in the manner of granting exclusive status, and that it uses the review system to give it exclusive status indirectly. In addition, in the case of orphan drugs, the "Rare Diseases Management Act" and the "Regulations on Examination of Items Permission and Reporting of Drugs" provide overlapping review periods, and despite the relatively long monopoly period, there seems to be no check clause to recover exclusive status in the event of a change in circumstances. Given that biopharmaceuticals are difficult to obtain patents, the lack of such provisions is a pity of domestic legislation, although granting exclusive rights may be a great motivation to induce drug development. In the United States, given that the first biosimilar also has a one-year monopoly period, it can be interpreted that domestic legislation is quite strictly limited to granting exclusive status to biopharmaceuticals. The need for improvement of the domestic system will be recognized in that it could undermine local pharmaceutical companies' willingness to develop biopharmaceuticals in the future, and in that it is also necessary to harmonize international regulations. Taking advantage of the emergence of COVID-19 as an opportunity, we look again at the problems of the domestic system that grants exclusive rights to medicines and hope that an overall revision of the relevant legislation will be made to establish a unified legal basis.

A Model to Measure the Success of a Web-based Information System at a Government Agency - the Chungwadae Case (공공기관 업무관리시스템 성과평가 모형 개발에 관한 연구: 청와대 업무관리시스템(e지원시스템)을 중심으로)

  • Bae, Lee-Chul;Hong, Il-Yoo
    • Asia pacific journal of information systems
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    • v.18 no.1
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    • pp.97-115
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    • 2008
  • Introduction The e-government is concerned with using Internet and Web technologies to exchange information and services with citizens, businesses and other related organizations, and it centers on three functions, namely informational, interactive, and transactional [UN, 2001]. Many developed countries like the U.S. have been actively involved in e-government projects, since they enable both more effective public services for citizens and more efficient internal operations. Korea is among these leading countries that are planning to leverage computer and communication technologies to provide for integration of work processes and information as well as convenient access to information and services. For this reason, evaluating e-government projects is becoming a crucial issue for both researchers and policy-makers. However, most research to date has primarily focused on a model of success of an e-government system designed for citizens, overlooking internal systems specifically created for employees working in a public organization. This paper is intended to propose a model to measure the success of a Web-based information system designed for use by internal users at Chungwadae, the executive branch of Korea's central government. The paper is also aimed at applying the model to the assessment of the present system being used at Chungwadae in comparison with the preceding system. Evaluating an e-Government System The most widely cited model of information systems success today is that of DeLone and McLean[1992, 2003, 2004]. The original model states that the success of an information system can be measured using six dimensions, including system quality, information quality, use, user satisfaction, individual impact, and organizational impact. Although the ultimate success of an information system may be reflected in the impact that the system has upon individuals as well as an organization, aspects of using the system such as system use and user satisfaction can play an important role in determining the system success, because the system would be a sheer failure if users don't like and use the system. As a response to criticisms given by numerous researchers, the authors adapted their model to fit the emerging Web-based environment. The revised model[DeLone and McLean, 2003] they offered included an additional quality dimension, namely service quality, and combined individual and organizational impacts into net benefits which can also influence user satisfaction. The e-government system success model can be built around this updated model. Our model incorporates information quality, system quality, and service quality as in the DeLone and McLean model. However, the 'system use' dimension has been replaced by perceived usefulness, as suggested by Seddon[1998]. In addition, because the e-government systems that this paper focuses on are internal public systems used in government agencies, the 'net benefits' dimension has been replaced by perceived work efficiency. Based on the proposed model, a total of nine hypotheses have been formulated which we tested using an empirical analysis. Methods A questionnaire form has been created with items that are designed to examine the relationships among the variables in the model. The questionnaire has been handed over, in person, to 65 members of Chungwadae staff who are now actively using the E-Support System, the present information system created to support internal work at Chungwadae. We made arrangements to meet with each individual who agreed to participate in our survey, and helped to fill out the survey form with explanations. Of the 65 copies that were delivered, only 33 were returned, and 30 responses of these have been adopted for our analysis, since three were not valid. The extremely small sample size was due to the limited number of staff members who had adequate experience required of this study. Results We gathered data from the questionnaire survey and analyzed them using a regression analysis to test the hypotheses. As shown in the table below, the results indicated that all three dimensions of an information system’s quality are positively related to user satisfaction. However, information quality and system quality were found to be positively related to perceived usefulness, while service quality was not. In addition, perceived usefulness is not positively related to user satisfaction, implying that a user may find a system useful, but may not be satisfied with it. Finally, user satisfaction and perceived usefulness both are positively related to perceived work efficiency. This suggests that workers' positive experience with the system is important to guarantee favorable work efficiency. Conclusions We conclude that the proposed model proved useful in measuring the success of an internal information system used by a government agency. To demonstrate the applicability and usefulness of the model in the paper, we applied the model to the assessment of the present internal system used at Chungwadae in comparison with the preceding system. The results showed that the present system outperforms the preceding one in a statistically significant way. Future research will have to focus on applying the model to Korea's governmental agencies other than Chungwadae and examine whether it proves applicable in different types of governmental organizations.

Wetland Function Evaluation and Expert Assessment of Organic Rice-Fish Mixed Farming System (유기농 벼-담수어 복합영농의 습지기능평가 및 전문가 조사)

  • Nam, Hongsik;Park, Kwanglai;An, Nanhee;Lee, Sangmin;Cho, Junglai;Kim, Bongrae;Lim, Jongahk;Lee, Changwon;Choi, Seonu;Kim, Changhyun;Kong, Minjae;Son, Jinkwan
    • Journal of Wetlands Research
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    • v.20 no.2
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    • pp.161-172
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    • 2018
  • A mixed farming system that includes organic rice production and freshwater fish farming is being called into attention in Korean agricultural industry and rural areas in order to improve farm management and environmental conservation. This study was conducted to evaluate the environmental and ecological value of such mixed farming practices. Expert assessment and rapid assessment method (RAM) of wetland evaluation were employed for this study. Experts have responded that biodiversity conservation including amphibian and reptile habitat (2.39), aquatic insect habitat (2.36), Fishery habitat (2.34), vegetation diversity (2.13), avian habitat (2.05), and experience and education were the most important function of mixed farming. The wetland function evaluation conducted using modified RAM indicated that rice-fish mixed system showed improvements in most of the evaluated functions, compared to the conventional rice paddies. The overall wetland function of rice paddies in rice-fish mixed system was greatly improved as compared with the conventional rice paddies. Rice paddies are known to play an important role in biodiversity maintenance, and provide ecosystem services such as climate modulation and carbon reduction. Rice-fish mixed system of farming may not only improve various ecosystem services of rice paddies, but may increase farm income through value added fish farming, as well as promotion of social services such as education and maintenance of tradition. Additional research is needed for quantitative analysis of the values gained from the most improved wetland function when mixed farming system is actually put into practice, and to utilize the results in advertising of the organic rice, and in various sectors such as food, education and direct payment policy.

The Social and Economic Impact of the Urban Regeneration Project in Jeonju Hanok Village Area (전주 한옥마을의 도시재생사업이 지역변화에 미친 영향)

  • Kim, Ju-Young;Heo, Sun-Young;Moon, Tae-Heon
    • Journal of the Korean association of regional geographers
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    • v.23 no.1
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    • pp.106-117
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    • 2017
  • Recently, urban regeneration is being actively promoted in Korea and among those Jeonju Hanok Village is the major project which is the most consistently promoted. For this, visitors of Jeonju Hanok Village are skyrocketing. However, due to this condition, various problems are occurring, especially about commercialization. In this regard, this study is to suggest management of the Jeonju Hanok Village and new orientation in the policy, by analyzing physical, economic, and social status due to urban regeneration for Jeonju Hanok Village which has lost its identity and been commercialized. For this, the study analyzed changes in land usage and real transaction price, SNS data. Firstly, in the physical analysis, the study realized that there is commercialization going around the main streets of Jeonju Hanok Village. Due to the rapid commercialization, living spaces for locals are replaced to commercial spaces for tourists, and the emigration of locals is caused by economic/environmental damages with the degradation of housing environments. Secondly, in the economic analysis, there was no gap in real transactions among streets in 2010 but has shown a valid gap in 2016. The traffic of tourists is heavy and the real transaction prices of streets that are adjacent to major tourist sights rose the most. Rising real transaction prices are a positive phenomenon in the aspect of the city regeneration but it is concerned that they can be perceived as investment subjects. Thirdly, in the social analysis, tourists are using commercial aspects more than historical or cultural sites, and have lots of interest on those. However, because there are also lots of opinions about the commercialization of Hanok Village, we think the plans which can establish the identity of Hanok Village should be prepared. The study has its meaning on analyzing reality based on the land usage, real transaction, SNS data and suggesting political implications.

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International Case Studies on the Eco-friendly Energy Towns with Hybrid Thermal Energy Supply System and Borehole Thermal Energy Storage (BTES) (친환경에너지타운에서 보어홀지중열 저장(BTES) 활용 융복합 열에너지 공급 시스템 사례 연구)

  • Shim, Byoung Ohan
    • Economic and Environmental Geology
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    • v.51 no.1
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    • pp.67-76
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    • 2018
  • This study reviews three eco-friendly energy towns with hybrid thermal energy supply systems and borehole thermal energy storage (BTES) in Canada and Denmark. The district heating and cooling systems were designed by using multi-source energy for the higher efficiency and reliability as well as environment. ADEU (Alexandra District Energy Utility) located at the developing area in the city of Richmond, Canada was designed to supply district energy with the installation of 726 borehole heat exchangers (BHEs) and a backup boiler using natural gas. DLSC (Drake Landing Solar Community) located in the town of Okotoks, Canada is a district system to store solar thermal energy underground during the summer season by seasonal BTES with 144 BHEs. Brædstrup Solpark district heating system located in Denmark has been conducted energy supply from multiple energy sources of solar thermal, heat pump, boiler plants and seasonal BTES with 48 BHEs. These systems are designed based on social and economic benefits as well as nature-friendly living space according to the city based energy perspective. Each system has the energy center which distribute the stored thermal energy to each house for heating during the winter season. The BHE depth and ground thermal storage volume are designed by the heating and cooling load as well as the condition of ground water flow and thermophysical properties of the ground. These systems have been proved the reliance and economic benefits by providing consistent energy supply with competitive energy price for many years. In addition, the several expansions of the service area in ADEU and Brædstrup Solpark have been processed based on energy supply master plan. In order to implement this kind of project in our country, the regulation and policy support of government or related federal organization are required. As well as the government have to make a energy management agency associated with long-term supply energy plan.

ICU nurses' ethical attitudes about DNR (중환자실 간호사들의 DNR에 대한 윤리적 태도)

  • Yu, Eun-Yeong;Yang, Yu-Jeong
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.16 no.4
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    • pp.2691-2703
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    • 2015
  • This research aims to provide basic materials for assisting DNR patient cares by understanding ICU nurses' awareness and ethical attitude regarding DNR. A total of 154 results were analyzed which were collected from Aug. 1st to Sep. 5th in 2014 by surveying nurses working in ICU (from 1 advanced general hospital in G metropolitan city and other general hospitals of more than 700 beds in Cheolla provinces). (1) For the decision attitudes of DNR, there were both consent and objection. Consent for the patient's opinion of rejecting further treatment and life extension despite of bad prognosis. And objection for no conducting DNR in the case of the patient's wish, treatment requested by the guardian, and CPR for the patient who has no chance. (2) Objection for artificial respirator and other treatment requested by the patient's family and the entrance of guardians into ICU. Consent for the passive use of artificial respirator by the doctor and the decrease of basic care to stabilize patients physically and mentally. No specific opinion for treatment not following aseptic techniques. Objection for frequent reports to primary care physician requested by the family. (3) Acknowledging less interest by the doctor, while supporting the health care team in the case of the guardian's complaint, objection for the DNR decision mede by the primary care physician. Objection for the DNR decision by the guideline. Objection or neutrality for straightforward explanation to the patient of bad prognosis. Objection for straightforward explanation of the patient's status (even near to death) to the patient him/herself or the guardian. In conclusion, the subject of DNR is the patient and the patient's opinion should be fully reflected. The conflict arising from the scope of medical practice and decision processes should be minimized. The standard and guideline for DNR decision is required for the ethical decision making for the patient along with agreements based on full explanations.

Effect of Medium, Soil, and Irrigation Water Contaminated with Escherichia coli and Bacillus cereus on the Microbiological Safety of Lettuce (Escherichia coli 와 Bacillus cereus에 오염된 상토, 토양 및 관개용수가 상추의 미생물 안전에 미치는 영향)

  • Kim, Se-Ri;Lee, Seo-Hyun;Kim, Won-Il;Kim, Byung-Seok;Kim, Jun-Hwan;Chung, Duck-Hwa;Yun, Jong-Chul;Ryu, Kyoung-Yul
    • Horticultural Science & Technology
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    • v.30 no.4
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    • pp.442-448
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    • 2012
  • Many outbreaks of food-borne illnesses have been associated with the consumption of fresh vegetables and fruits contaminated with food-borne pathogens. Contaminated medium, manure and irrigation water are probable vehicles for the pathogen in many outbreaks. The aim of this study was to determine the potential transfer of Escherichia coli and Bacillus cereus from medium and soil fertilized with contaminated compost or irrigation with contaminated water to the edible parts of lettuce. Moreover, survivals of the two pathogens on lettuce contaminated medium, soil and irrigation water were estimated. Lettuce seeds were planted in medium contaminated with 7.5 log colony forming unit (CFU)/g of E. coli and B. cereus. Seedlings grown in the contaminated medium were transplanted in soil fertilized with contaminated pig manure compost or uncontaminated soil. Contaminated irrigation water with E. coli and B. cereus at 8.0 log CFU/mL was applied only once on the plant by sprinkle irrigation and surface irrigation. Although E. coli and B. cereus in medium and sprouted lettuce after planting seeds were reduced as time passed, these pathogens survived in seedling raising stage for extended periods. The numbers of E. coli and B. cereus in lettuce grown on contaminated soil were detected over 4.0 log CFU/g for 21 days. The numbers of E. coli and B. cereus in lettuce applied by sprinkle irrigation were higher than those of surface irrigation by 5.0 log CFU/g. Our results indicated that contaminated medium, soil and irrigation water can play an important role in the presence of food-borne pathogens on vegetables.

Investigation of Microbial Contamination Levels of Leafy Greens and Its Distributing Conditions at Different Time - Focused on Perilla leaf and Lettuce - (시기별 엽채류의 미생물 오염도와 유통 조건 조사 - 들깻잎과 상추를 중심으로 -)

  • Kim, Won-Il;Jung, Hyang-Mi;Kim, Se-Ri;Park, Kyeong-Hun;Kim, Byung-Seok;Yun, Jong-Chul;Ryu, Kyoung-Yul
    • Journal of Food Hygiene and Safety
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    • v.27 no.3
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    • pp.277-284
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    • 2012
  • The objective of this study was to investigate and evaluate microbial contamination levels of leafy greens (perilla leaf and lettuce) and its distributing conditions at different seasons (Feb, May, Aug, and Nov of the year 2011) in order to provide insight into any potential health hazards associated with consumption of these commodities. Leafy greens were collected from a farm located in Geumsan, Chungnam and wholesale markets (WM) and traditional markets (TM) located in Suwon. At the same time, temperature and relative humidity fluctuations experienced by the leafy greens during distribution from the farm to the distribution center were measured by a data logger. The contamination levels of perilla leaf and lettuce were determined by analyzing total plate count. Coliform groups, Bacillus cereus, Escherichia coli, Escherichia coli O157:H7, Salmonella spp., Listeria monocytogenes and Staphylococcus aureus were determined. The contamination levels of total aerobic bacteria, coliform groups and B. cereus in both vegetables sampled during May and August found to be higher than those sampled during February and November. E. coli O157:H7, Salmonella spp., L. monocytogenes were not detected in the vegetables analyzed in this study. There were no significant trends between samples at WM and TM in the contamination levels. Relative humidity of vegetables distributed from the farm to the distribution center showed over 90% during distribution regardless of measured seasons. In the case of background microflora on leafy greens, the density was significantly increased at 20, 30 and $37^{\circ}C$ during storage of 24h. E. coli O157:H7 and B. cereus inoculated on the leaves also showed similar increases in the storage tests. The microbial contamination levels determined in this study may be used as the fundamental data for microbial risk assessment.

Emergy Evaluation Overview of the Natural Environment and Economy of the Han River basin in Korea (한강유역의 자연환경과 사회경제활동에 대한 에머지 평가 - 한강유역 및 한강하구 관리를 위한 정책제언 -)

  • Kang, Dae-Seok
    • Journal of the Korean Society for Marine Environment & Energy
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    • v.10 no.3
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    • pp.138-147
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    • 2007
  • An emergy concept was used to evaluate the environment and economy of the Han River basin in Korea and to suggest policy perspectives far the sustainable utilization of its environment and associated estuarine ecosystem. The economy of the basin used $5.19{\times}10^{23}\;sej/yr$ of emergy in 2005. The economy of the Han River basin was heavily dependent on outside energy sources from foreign countries and other parts of Korea, with internal sources, renewable and nonrenewable, contributing only 15.6% to the total emergy use. The basin's trade balance in terms of emergy showed trade surplus, whereas there was a deficit in monetary terms. The population of the Han River basin was far greater than the carrying capacity calculated using the emergy flow, with renewable carrying capacity only at 1.8% of the basin's population and developed carrying capacity at 14.3%. The economy of the basin imposed a substantial stress on its environment, with an environmental loading ratio of 54.8. Overall, the economy of the Han River basin was not sustainable with an emergy sustainability of 0.02. These are reflected in lower quality of living expressed in the emergy term than the national average. Deconcentration of population and economic activities is needed to reduce environmental stress on the environment of the basin and its valuable estuarine ecosystem. Policies to restore ecosystem productivity of the basin are also needed to ensure the sustainability of the basin's economic activities and the sustainable utilization of the Han River estuary. In this regard, it is urgently needed for the Korean government to implement sustainable management measures for the Han River estuary, a well-preserved, productive natural estuarine ecosystem in Korea.

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The physical geography in general:yesterday and tomorrow (자연지리학 일반: 회고와 전망)

  • Son, Ill
    • Journal of the Korean Geographical Society
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    • v.31 no.2
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    • pp.138-159
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    • 1996
  • There has been a tendency for Geomorphology and Climatology to be dominant in Physical Geography for 50 years in Korea. Physical Geography is concerned with the study of the totality of natural environment through the integrated approaches. But, an overall direction or a certain paradigm could not be found, because major sub-divisions of Physical Geography have been studied individually and the subjects and the approaches in studying Physical Geography are enormously diverse. A consensus of opinion could not also exist in deciding what kind of the sub-divisions should be included in the physical geography in general and how those should be summarized. Furthermore it would be considered imprudent to survey the studies of Physical Geography besides those of Geomorphology and Climatology due to the small number of researchers. Assuming that the rest of Physical Geographical studies with the exception of Geomorphological and Climatological studies are the Physical Geography in general, the studies of Physical Geogrpahy in general are summarized and several aspects are drown out as follows. First the descliption of all possible factors of natural environments was the pattern of early studies of Physical Geography and the tendency is maintained in the various kinds of research and project reports. Recently Physical Geographers have published several introductory textbooks or research monographs. In those books, however, the integrated approaches to Physical Geography were not suggested and the relationship between man and nature are dealt with in the elementary level. Second, the authentic soil studies of Physical Geographers are insignificant, because the studies of soil in Physical Geography have been mostly considered as the subsidiary means of Geomorphology Summarizing the studies of Soil Gegraphy by physical geographers and other Pedologists, the subjects are classified as soil-forming processes, soil erosions, soil in the tidal flat and reclaimed land, and soil pollution. Physical Geographers have focused upon the soil-forming processes in order to elucidate the geomorphic processes and the past climatic environment. The results of other subjects are trifling. Thirdy Byogeygrayhers and the results of studies are extremely of small number and the studies of Biogeography in Korea lines in the starting point. But, Biogeography could be a more unifying theme for the Physical-human Geography interface, and it would be expected to play an active part in the field of environmental conservation and resource management. Forth, the studies of Hydrogeography (Geographical Hydrology) in Korea have run through the studies of water balance and the morphometric studies such as the drainage network analysis and the relations of various kinds of morphometric elements in river. Recently, the hydrological model have introduced and developed to predict the flow of sediment, discharge, and ground water. The growth of groundwater studies is worthy of close attention. Finally, the studies on environmental problems was no mole than the general description about environmental destruction, resource development, environmental conservation, etc. until 1970s. The ecological perspectives on the relationship between man and nature were suggested in some studies of natural hazard. The new environmentalism having been introduced since 1980s. Human geographers have lead the studies of Environmental Perception. Environmental Ethics, Environmental Sociology, environmental policy. The Physical geographers have stay out of phase with the climate of the time and concentrate upon the publication of introductory textbooks. Recently, several studies on the human interference and modification of natural environments have been made an attempt in the fields of Geomorphology and climatology. Summarizing the studies of Physical Geography for 50 years in Korea, the integrated approaches inherent in Physical Geography disappeared little by little and the majol sub-divisions of Physical Ceography have develop in connection with the nearby earth sciences such as Geology, Meteorology, Pedology, Biology, Hydrology, etc been rediscovered by non-geographers under the guise of environmental science. It is expected that Physical Geography would revive as the dominant subject to cope with environmental problems, rearming with the innate integrated approaches.

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