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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.

CO2 Exchange in Kwangneung Broadleaf Deciduous Forest in a Hilly Terrain in the Summer of 2002 (2002년 여름철 경사진 광릉 낙엽 활엽수림에서의 이산화탄소 교환)

  • Choi, Tae-jin;Kim, Joon;Lim, Jong-Hwan
    • Korean Journal of Agricultural and Forest Meteorology
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    • v.5 no.2
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    • pp.70-80
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    • 2003
  • We report the first direct measurement of $CO_2$ flux over Kwangneung broadleaf deciduous forest, one of the tower flux sites in KoFlux network. Eddy covariance system was installed on a 30 m tower along with other meteorological instruments from June to August in 2002. Although the study site was non-ideal (with valley-like terrain), turbulence characteristics from limited wind directions (i.e., 90$\pm$45$^{\circ}$) was not significantly different from those obtained at simple, homogeneous terrains with an ideal fetch. Despite very low rate of data retrieval, preliminary results from our analysis are encouraging and worthy of further investigation. Ignoring the role of advection terms, the averaged net ecosystem exchange (NEE) of $CO_2$ ranged from -1.2 to 0.7 mg m$^{-2}$ s$^{-1}$ from June to August in 2002. The effect of weak turbulence on nocturnal NEE was examined in terms of friction velocity (u*) along with the estimation of storage term. The effect of low uf u* NEE was obvious with a threshold value of about 0.2 m s$^{-1}$ . The contribution of storage term to nocturnal NEE was insignificant; suggesting that the $CO_2$ stored within the forest canopy at night was probably removed by the drainage flow along the hilly terrain. This could be also an artifact of uncertainty in calculations of storage term based on a single-level concentration. The hyperbolic light response curves explained >80% of variation in the observed NEE, indicating that $CO_2$ exchange at the site was notably light-dependent. Such a relationship can be used effectively in filling up the missing gaps in NEE data through the season. Finally, a simple scaling analysis based on a linear flow model suggested that advection might play a significant role in NEE evaluation at this site.

The Effects of Brand Experience and Personality on Consumer-Brand Relationships, Attachment, and Loyalty - A Comparison of Domestic and Global Brand Coffee Shops - (브랜드 체험 및 개성이 소비자-브랜드 관계, 브랜드 애착, 브랜드 충성도에 미치는 영향 - 국내외 브랜드 커피전문점 비교 -)

  • Hong, Ju-Young;Kim, Seong-Soo;Han, Ji-Soo
    • Culinary science and hospitality research
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    • v.22 no.5
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    • pp.231-251
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    • 2016
  • This study examined the effect of brand experience and personality on customer-brand relationships, brand attachment, and brand loyalty in domestic and global coffee shop brands. By comparing inter-structural relationships among factors between domestic brands and global brands, this study also provided strategic implications and directions for the effective marketing strategy of coffee shop brands. Data were collected through a self-administered survey of the consumers aged 20's to early 40's who used domestic and global brand coffee shops in Seoul and Kyunggi between August 1, 2014 and August 30, 2014. 500 surveys were distributed and 495 surveys were returned. Among them, data from 493 surveys were used for the analysis. The results from this study are as follows. First, it was found that the Think of experiences in coffee shop had a greater effect on consumer-brand relationship than the Sense-Feel. Second, the Sophistication of brand personality in coffee shop had a greater effect on consumer-brand relationship than the Excitement. Third, only Think of experience in coffee shop significantly impacted brand attachment, but Sense-Feel did not impact brand attachment. Fourth, only Excitement of brand personality in coffee shop significantly impacted brand attachment, but Sophistication did notact on brand attachment. Fifth, the consumer-brand relationship had a greater effect on brand loyalty than did brand attachment. Finally, the differences from a comparison analysis of domestic brands and global brands of coffee shop are as follows. In domestic brands, only the Sophistication of brand personality in coffee shop significantly impacted consumer-brand relationship. In global brands, the brand personality in coffee shop did not impact on consumer-brand relationship.

Correlation between Meteorological Factors and Water Discharge from the Nakdong River Barrage, Korea (낙동강 하구역 해양물리환경에 미치는 영향인자 비교분석(I) - 하구둑 방류량과 기상인자 -)

  • Park, San;Yaan, Han-Sam;Lee, In-Cheal;Kim, Hean-Tae
    • Journal of the Korean Society of Marine Environment & Safety
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    • v.14 no.2
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    • pp.111-117
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    • 2008
  • We estirmted the yearly and monthly variation in discharge from the Nakdong River Barrage. We studied the total monthly discharge, the mean daily discharge, and the maximum daily discharge based on the observational discharge data for the 11-year period 1996-2006. We also examined the correlation between the discharge and the meteorologiml factors that influence the river inflow. The results from this study are as follows. (1) The total monthly discharge for 11 years at the Nakdong River Barrage was $224,576.8{\times}10^6\;m^3$: The daily maximum was in 2003, with $56,292.3{\times}10^6\;m^3$. The largest daily mean release discharges occurred in August with $52,634.2{\times}10^6\;m^3$ (23.4% of the year), followed by July and September in that order with 23.1 and 17%, respectively. (2) The monthly pattern of discharge could be divided into the flood season for the period July-September (discharge =$1000{\times}10^6\;m^3$/day), the normal season from April to June and October (discharge=$300{\times}10^6\;m^3$/day), and the drought season from December to March (discharge < $300{\times}10^6\;m^3$/day). (3) Periods of high temperature, low evaporation loss, and short sunshine duration produced a much higher discharge in general. Conditions of low rainfall and high evaporation loss, as was the rose in 2003, tended to reduce the discharge, but high rainfall and low evaporation loss tended to increase the discharge as it did in 200l. (4) The dominant wind directions during periods of high discharge were NNE (15.5%), SW and SSW (13.1%), S(12.1%), and NE (10.8%) This results show that it run bring on accumulation of fresh water when northern winds are dominant, and it run flow out fresh water toward offslwre when southern winds are dominant.

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Change in the Korean Fertility Control Policy and its Effect (출산력 억제정책의 영향과 변천에 관한 고찰)

  • Hong, Moon-Sik
    • Korea journal of population studies
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    • v.21 no.2
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    • pp.182-227
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    • 1998
  • Korean government decided to adopt an explicit population control policy in 1961 and from the following year the establishment and operation of the national family planning programme was included in each of the Five-Year Economic Development Plans that began in 1962. This policy was pursued in the understanding that without proper population control measures korea could not be able to achieve economic development. Korean national family planning programme is characterized by contraceptive target system through public health network with distribution of free contraceptives by family planning field workers and clinical contraceptive services such as IUD, vasectomy and tubaligation at designated clinics by the government. In addition, IE&C activities by the Planned Parenthood Federation of Korea and programme evaluation and research by the Korea Institute for Health and Social Affairs contributed to the development of the government programme. Between 1960 and mid 1980s the nation's total fertility rate was reduced from 6.0 to population replacement level of 2.1 and thereafter it has been maintained at 1.6 to 1.7 of below replacement level. With a short period of less than three decades fertility transition was completed in Korea. It is estimated that if the current level of below replacement fertility continues, the population in Korea stabilize at around 52.78 million people by the year 2028, and it will begin to decrease thereafter. Under this circumstances, the government adopted new directions and strategies of the population policy in June 1996, focused primarily on population quality and social welfare than on demographic arenas. In spite of over 80 percent of high contraceptive prevalence among married women, high incidence of induced abortions is maintained. Moreover, the prevalence of sex selective induced abortions using procedures to determine the sex of the fetus has resulted in an imbalance in the sex ratio at birth. In order to overcome those problems associated with reproductive health new policy for population quality control and health promotion programme should be highly strengthened in the future.

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A Study of the Department of Dental Hygiene and Dental Laboratory Technology Student's Demand for the Credit Bank System (학점은행제(치위생과, 치기공과)를 이용한 학사학위 취득에 관한 요구도 조사)

  • Yu, Ji-Su
    • Journal of dental hygiene science
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    • v.7 no.3
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    • pp.153-159
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    • 2007
  • To investigate requirements for the process of credit bank system in life-long education institutions attached to colleges, this research was conducted with seniors at the departments of dental hygiene and dental laboratory technology, in the health line of the specific College from March 26 to April 15, 2007, followed by analysis using an SPSS/WIN 12.0 program, obtaining the following results. 1. 89.7% of the respondents had a plan to take a bachelor's degree and 56.1% of whom had such a plan for the purpose of personal development (p<0.05). 2. 73.5% of the respondents preferred the credit bank system in a lifelong education institution attached to a college to take a bachelor's degree. 3. 34.8% presented the greatest advantage of taking a bachelor's degree through the credit bank system that they could take a degree in a short period of time while 33.8% presented the most serious disadvantage that they might low social recognition. 4. As for requirements for the process of operating the credit bank system, 80.3% regarded required subjects for the major as appropriate basic ones. 79.9% regarded it as proper that filling more than 20 credits made it possible to take a degree. 5. As directions for improving the system, it was found that the students was thinking that strict academic record management is needed, and the degrees from the system must be recognized equally to those in regular colleges, social awareness in those degrees should be enhanced, and also credits assigned to cultural subjects should be reduced, and the limitation in the number of credits being able to be obtained in one center should be removed.

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Study on the viewpoint of the balance(平衡觀) on the 'Sanghan prescription(傷寒方) throughout the academic sources of 'Sang Han Lon' (상한론(傷寒論)의 학술연원(學術淵源)을 통(通)한 상한방(傷寒方)의 평형관 고찰)

  • Kim, Ji-hyung;Park, Sun-Dong
    • The Journal of Dong Guk Oriental Medicine
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    • v.4
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    • pp.25-52
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    • 1995
  • 'Sang Han Lon' became the sources for treatment and prescription in the Oriental medicine. After that, for some 1800 years the various writings for studying in many ways more than 1000 books which many old sages really intended to inquire into and study the value of books. It is considered that it is the result which the old sages tried to grope for many-sided directions in order to understand 'Sang Han Lon'. In this study, I tried to inquire into prescription and its relevant medicinal substances, that is to say, the crystalization of the physiology, pathology and treating method on the basis of the academic sources of his thoughts. The method to approach is "from what basis of thought system was 'Sang Han Lon' derived first of all?" Secondly, how was the thought system, which became the basis of 'Sang Han Lon', applied to concretely? I studied on the basis of the above important two problems. It is well known to everybody that 'Sang Han Lon' succeeded to the tradition of Naekyung(內經) as well as Cwuyek(周易, Chinese classic on divination). Besides, I inquired into and arrived at conclusion as follows that how the viewpoint on the balance(平衡觀), which was one of the common point between. Cwuyek(周易) and medical science in case of the 'Sanghan prescription'(傷寒方), was applied to concretely. 1. In naming, it is considered that from the same interconnection which the common point with Cwuyek(周易) was the same as obtaining the imigination(取象), the imagination was obtained and was named. 2. In case of being concerned in the gastro-intestinal track, namely, the core of the balance and harmony with the balance and harmony being emphasized, '理中'(It implies 'taking care of gasstro-intestinal track')" and '建中'(It implies 'establishing of gastro-intestinal track'), that is to say, '中'(It implies 'taking care of' & 'establishing of gastro-intestinal track') was emphasized much more. 3. In case of treatment taking advantage of three kinds of medicine in draught, powder and pills in the prescription, while treating during adjusting the slowness and fastness, I maintained the harmony not to damage the righteousness(正氣). 4. In case of the prescription, when exhaling(發散), astringing(收斂), loosing bowels, protecting the gastro-intestinal track and vomitting, he used the medicinal sustances in order to protect the gastro-intestinal track and treated not to damage the righteousness. 5. Especially, in case of the prescription in order to adjust the negative and positive principle of inside-outside(素囊陰陽), he composed of medicinal substances relevant to hot, cold, spicy and sour(寒熱辛酸) in conformity with the prescription and I paid much more attention to the one-sided treatment. Considering the various prescriptions, it is regarded that the adjusting prescription is kept its balance. 6. In the way of processing the medicinal substances in order to change effect of medicine in conformity with the reenactment, he tried to plan the balance of '一升一降' with the decrease of RHEI RADIX ET RHIZOMA(大黃) and increase of wine. 7. In boiling the medicine, he boiled the composed medicine in the time sequence for the purpose of adjusting the slowness and fastness and adapted to harmony of the negative and positive principle(陰陽調和) on the essence function(體峻用純). 8. In taking medicine, he tried to reduce the time of taking the medicine in case of being boiled slowly and tried to increase the dosage and eventually he planned the balance of one time slowness and one time fastness. As I inquired into the above result, a few steps for protecting method to boil the relevant medicinal substances, how to take the medicine and how to process the composed medicinal substances in order to change the effect of medicine can make the human body, which the disease penetrate into, go forward to the righteousness(正氣) and what is much beter, it is considered that this protecting method can be a carefully considerable one in order to protect the righteousness and can subdue the disease, not to damage the gastro-intestinal track and there can exist the viewpoint of balance(平衡觀) on its core.

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A Method for Establishing Chronology of Cloud Patterns Based on the Cover Patterns of Oegyujanggak Uigwe Books in the Late Joseon Period (외규장각 의궤 책의 문양을 통한 운보문 편년 설정 방법)

  • Lee, Eunjoo
    • Korean Journal of Heritage: History & Science
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    • v.52 no.4
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    • pp.18-37
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    • 2019
  • This study derived a method for establishing the chronology of cloud patterns by examining the arrangement of the treasure motifs in the cloud pattern used in the relevant pattern-decorated book covers of 89 Oegyujanggak Uigwe books, which are currently housed in the National Museum of Korea. The cloud pattern with a treasure motif was used in the covers of a total of 89 books from King Hyojong Gukjangdogam Uigwe (1659) to Sadoseja Garyedogam Uigwe (1744), spanning 86 years. First, to analyze the cloud pattern, it should be broken down into smaller parts to the extent that the different shapes of treasure motifs can be recognized. Secondly, the method of decoding the pattern is as follows: First, check whether the pattern is arranged in one or two directions from the vertex of the cloud's head, and determine the direction of the cloud tail. Then, decode the treasure motif's arrangement starting from the vertex of the cloud's head toward the direction the tail of manja is headed. Record the findings of this decoding process by categorizing them. Thirdly, as a result of the analysis, a total of 28 types of cloud patterns with treasure motifs were identified in 89 books. There were 45 types of treasure motifs used in such patterns. Finally, we have concluded that applying the method of decoding the treasure motif in the cloud pattern to portraits, excavated costumes, and various relics can be useful to establish the chronology of cloud patterns in the late Joseon period. The method suggested in this study is called 'The Reading Method of Chronology in Cloud Pattern with Treasure Motifs' (also 'Jeung-ha Cloud Pattern Reading Method').

Military Competition and Arms Control in Space (우주상 군비경쟁과 군비통제)

  • Shin, Dong-Chun;Cho, Hong-Je
    • The Korean Journal of Air & Space Law and Policy
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    • v.26 no.2
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    • pp.203-237
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    • 2011
  • Since USSR successfully launched its satellite "Sputnik"in 1957, many countries including US and USSR began military use of space, and engaged in arms race in space, which is against spirit and ideals of peaceful use of space as common heritage of mankind stipulated in many treaties such as Outer Space Treaty. With worsening Cold War between East and Western Bloc, this military use of space and arms race in space has been intensifying. Regarding the ideals of peaceful use of space, it is interpreted that military use of space is possible unless it does not have the purpose of aggression. The military use of space may have diverse forms such as attacking satellites in space, or attacking from satellites, making use of present and future technologies available which should include the use of nuclear and kinetic/hyper-speed weapons, laser, particle beams, near explosion, disturbance weapons in different directions (i.e., surface to space, space to space, and space to surface). Arms control is being implemented by the efforts of many countries in different formalities including legislature of international treaties under the auspices of UNCOPUOS and prohibition of weapons of mass destruction. Taking outstanding examples aiming at arms control by international community, there are confidence building measures (CBM), strengthening implementation of existing treaties, partial ban of nuclear tests, countryand regional approach, comprehensive approach and measures having legally binding force. While U.S. has surpassed other countries concerned in the area of military useof space, it withdrew from OST in early 2000s, thereby raising concern of international community. It requires concerted efforts of cooperationand implementation by international society to make sure peace of mankind and environmental conservation through arms control in space. Observing de facto possession of nuclear weapons by North Korea following series of nuclear tests and launching satellites, and efforts of launching rockets by South Korea, it is strongly needed for both countries to take part in arms control efforts by international community.

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Development of Health Promotion Program through IUHPE - Possibilities of collaboration in East Asia - (IUHPE를 통한 건강 증진 프로그램의 발달-동아시아권의 공동연구의 가능성-)

  • Moriyama, Masaki
    • Proceedings of The Korean Society of Health Promotion Conference
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    • 2004.10a
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    • pp.1-16
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    • 2004
  • This paper considers the possibilities of health promotion from the following perspectives; (1) IUHPE, (2) socio-cultural similarities, (3) action research, and (4) learning from our past. 1. The IUHPE values decentralized activities through regions, and countries such as Japan, Korea, Hong Kong, Taiwan and China belong to NPWP region. Since IUHPE World Conference was held in Japan in 1995, Japan used to occupy more than 60% of NPWP membership. After 2001, membership is increasing rapidly in Chinese speaking sub-region. The transnational collaboration is still in its beginning phase. 2. Confucianism is one of key points. Confucian tradition should not be seen only as obstacles but as advantages to seek a form of health promotion more acceptable in East Asia. 3. Within the new public health framework, people are expected to create and live their health. However, especially in Japan, the tendency of 'lacking of face-to-face explicit interactions' is still common at health-promotion settings as well as academic settings. Therefore, the author tried participatory approaches such as asking WlFY (interactive questions designed for subjects to review their daily life and environment) and as introducing round table interactions. So far, majority of participants welcome new trials. 4. The following social phenomena are comparatively discussed after Japanese invasion and occupation of Korea ended in 1945; ·status of oriental medicine, ·separation of dispensary services, and ·health promotion specialist as a national license. In contrast to Japanese' tendency of maintaining the status quo and postponing of substantial social change, trend toward rapid and dynamic social changes are more commonly observed in Korea. Although all of above possibilities are still in their beginning stages, they are going to offer interesting directions waiting for further challenges and accompanying researches.

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