• Title/Summary/Keyword: Event Management

Search Result 1,529, Processing Time 0.024 seconds

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
    • /
    • v.21 no.1
    • /
    • pp.223-259
    • /
    • 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.

Dynamics of Inorganic Nutrients and Phytoplankton in Shihwa Reservoir (시화호에서 무기영양염과 식물플랑크톤의 동태)

  • Kim, Dong-Sup;Cho, Kyung-Je;Shin, Jae-Ki
    • Korean Journal of Ecology and Environment
    • /
    • v.33 no.2 s.90
    • /
    • pp.109-118
    • /
    • 2000
  • The dynamics of inorganic nutrients and phytoplankton population were examined at eight stations of Shihwa Reservoir, which situated near the cities newly constructed and the industrial complex of West-sea in Korea, from January to December 1999. Among environmental factors, average concentration of $NH_4$, SRP and SRSi were $522.7\;{\mu}g\;N/l$, $9.8\;{\mu}g\;N/l$ and $0.26\;{\mu}g\;Si/l$, respectively. Water quality was extremely deteriorated by a great amount of pollutants load into inner reservoir after the event of rainfall. Nutrients concentration was suddenly decreased toward the lower part. While $NO_3$ concentration did not much varied among stations, but it was relatively high in winter season. Chlorophyll-a concentration was high at the upper part of the reservoir, with average of $37.2\;{\mu}/l$, and closely related to the fluctuation of $NH_4$, SRP and SRSi concentrations. The phytoplankton development in the water column was dominated by diatom (autumn), prasinoid (winter) and dinoflagellate (summer). Dominant phytoplankton were composed to Skeletonema costatum of diatom, Prorocentrum minimum of dinoflagellate, Chroomonas spp. of cryptomonad, Eutreptiella gymnastica of euglenoid and Pyramimonas spp. of prasinoid. The large bloom of phytoplankton at the upper zone of the Shihwa Reservoir after inflow of a seawater were consistently observed. In consequence, water quality management of the inlet stream was assessed to be very important and urgent.

  • PDF

Temporal and Spatial Distributions of Basic Water Quality in the Upper Regions of Brackish Lake Sihwa with a Limited Water Exchange (물 교환이 제한적인 시화호 상류 기수역에서 기초수질의 시공간적 분포특성)

  • Choi, Kwnag-Soon;Kim, Sea-Won;Kim, Dong-Sup;Oh, Young-Taek;Heo, Woo-Myoung;Lee, Yun-Kyoung;Park, Yong-Soon
    • Korean Journal of Ecology and Environment
    • /
    • v.41 no.2
    • /
    • pp.206-215
    • /
    • 2008
  • Temporal and spatial distributions of salinity, temperature, dissolved oxygen (DO), and turbidity were investigated at seven sites in the upper regions of brackish Lake Sihwa with a limited water exchange, from March to October 2005. During the study period, salinity and temperature varied $0.1{\sim}29.9\;psu$ and $4.7{\sim}28.1^{\circ}C$, respectively, depending on seasons and sites sampled. A distinct halocline profile showing the maximum density gradient (difference over $20\;psu\;m^{-1}$ between surface and bottom layers) was observed during the rainy season, due to the decrease of salinity in surface layers by freshwater inflow. This result implies that rainfall event is the important factor forming the halocline. On the other hand, the depth and location of haloeline varied with the amount of seawater through the sluice gates and the operation systems (inflow or outflow). High DO (over 300% saturation) was observed at surface layer above the halocline in April when red tide occurred, whereas low DO (below 20% saturation) was at the bottom layer below the halocline in the rainy season. Turbidity ranged $1.5{\sim}80.3\;NTU$ showing the maximum turbidity at the layers above or upper the halocline. As a result, the distributions of DO and turbidity in the upper regions of brackish Lake Sihwa were largely affected by the variation of salinity. Also, when the halocline was formed, the water quality between upper and lower water layers may be expected completely different. This study suggests that the physicochemical characteristics of water in the brackish regions are closely associated with the causes of eutrophication such as red tide and DO deficit.

Standardization of Korean Version of Daily Stress Inventory(K-DSI) (한국어판 일상 생활 스트레스 척도(K-DSI)의 표준화 연구)

  • Joe, Sook-Haeng;Lee, Hyeon-Soo;Song, Hyun-Cheol;Kim, Seung-Hyun;Sub, Kwang-Yun;Sin, Dong-Kyun;Ko, Seung-Duk
    • Korean Journal of Psychosomatic Medicine
    • /
    • v.8 no.1
    • /
    • pp.72-87
    • /
    • 2000
  • Objectives : This study was to provide normative data of Korean version of DSI(K-DSI), a sensitive measure of relatively minor stressors that could be administered daily. Methods : K-DSI was administered in 524 adults, age of 19 or over, daily for 1 week. On the seventh day, Becks Depression Inventory(BDI), State-Trait Anxiety Inventory(STAI), and Social Readjustment Rating Scale(SRRS) were also given to test the convergent validity. Analyses(ANOVA or t-test) were conducted to examine the potential effects of demographic variables on K-DSI score. Internal consistency for reliability and Pearson's corelation coefficient with BDI, STAI, SRRS for convergent validity were computed. Percentile scores were calculated for daily and weekly K-DSI Event, Impact and I/E Ratio scores. Results : K-DSI scores in women were higher than those in men. According to age and educational level, the younger and the higher educational level the normative groups were, the higher were K-DSI scores. Among the 5 categories of the inventory, the category of cognitive stressors was highest. Internal consistency of K-DSI(Cronbach's $\alpha$) was .99. Daily and Weekly events and impacts scores were significantly correlated with the scores of State-Trait Anxiety Inventory, Social Readjustment Rating Scale, and Beck Depression Inventory. 75 percentile scores of the daily/weekly Events, Impacts, and I/E ratio were 17/118 - 124, 57/368 - 389 and 3.48 - 3.49/3.47 - 3.48 respectively. And 95 percentile scores of daily/weekly Events, Impacts, and I/E ratio were 57/151- 161, 405/1038 - 1122, and 4.72 - 4.86/4.46 - 4.56 respectively. Conclusion : Reliability and validity of K-DSI were tested satisfactorily. Authors presented the normative data of K-DSI for Koreans. K-DSI could be a useful measure in clinical settings or researches to assess the minor stressors frequently experienced in everyday life.

  • PDF

A Study on Preschool Teachers' Dental Health Recognition and Behaviors about Preschoolchildren Dental Health Care (어린이집 교사의 구강보건실태와 유아구강보건관리에 대한 인식)

  • Lee, Hyang-Nim;Shim, Hyung-Sun
    • Journal of dental hygiene science
    • /
    • v.8 no.4
    • /
    • pp.283-289
    • /
    • 2008
  • This study was performed to obtain data about dental health to develop childrens' dental health education program. This research surved from from 22 July 2008 to 11 August 2008 and questionaire given to 140 teacher from Gwangsan-gu and Buk-gu and Dong-gu in Gwangju city. Collected data were analyzed with SPSS 12.0 program. The results of this study were as follows: 1. The dental health condition which teacher is recognizing is most with the facility 52.9% which is healthy, one day toothbrush qualitative number of times 3 times 67.1% and the dental floss qualitative number of times is 49.3%. Uses most the oral hygiene device which plentifully is 51.4% with the dental gargle solution, the dental problem which is knowing dental caries with 45.7% to be highest, perception dental sensitivity was 30.7%. 2. Periodical dental prosecuting says that 93.6% is executing, also the case which a dental inspection result in the parents notifies was 78.6%, after notifying treat, the case which confirms was 60.7%. The case which is the toothbrush qualitative time which is systematic was 95.0%, about dental healthily and food the case which executes an education was 93.6%. 3. About educational background by infantile dental health care of teacher with recognition currently the effectiveness of dental health care is higher from below junior college graduating (p < 0.05). dental hygienic relation experience event participation intention (p < 0.01) comes from the above of university graduation from infantile dental health care from important degree of teacher role was higher the junior college graduation group (p < 0.05). 4. Recognition there was not a difference which is beneficial with an educational background by about career by infantile dental health care of teacher. For the buccal cavity hygiene management of the infants thinks with the fact that also the development of the curricular material and the educational program and teacher buccal cavity hygiene education will be necessary.

  • PDF

A Characteristics of 16 Scenes of Chilitan and Management of Chiltanjung, Milyang (밀양 칠탄정 경영과 칠리탄 16경의 경관특성)

  • Kim, Soo-jin;Jung, Hae-Joon
    • Journal of the Korean Institute of Traditional Landscape Architecture
    • /
    • v.37 no.3
    • /
    • pp.22-36
    • /
    • 2019
  • This research identified landscape characteristics of Chilitan(칠리탄) area, which had been managed by Son Giyang(1559~1617, p. Ohhan), in order to understand the political viewpoint and ideal landscapes, sought after by Confucian scholars in the 16~17th century. As the research method for the interpretation of each scene's spatial strucutres and meanings, paintings and poems in Chiltanjungsipyukgyeongdo(the Paintings of the 16 Scenes of Chiltanjung Area) were analyzed, which were followed by the on-site survey. Son lived hermit life with the nature after he decided to retire into the country for the chaotic political environment in the 4th year of Gwanghaegun's reign. Admiring Eum Jareung(B.C. 39-41, p. Eumgwang)'s hermit life, he named a headstream to Chilitan, erected pavilion and made place for angling by the stream, as Eum did in the hermitage. However he worried the king and royal politics in spite of his hermit life, which showed his political viewpoint of Confucianism. In addition, every column of buildings in the garden was named in order to imply both thoughts of Neo-Confucianism and Idleness Naturalism, which highlight a moral training and being comfortable amid poverty and taking pleasure in and honest life style. The present landscape of wonlim could be back to 1936, where Unganru, Byeokripjae and Chiltanjung are surrounding Eupcheondang. Chines character, such as Jimamsuseok, Giam, Ohhansonsunseongjanggujiso and Jogi, are inscribed on the rocks in the landscape garden, from which placeness could be inferred. According to the record of the construction, pine, fir, paulownia, ginkgo, peach trees, bamboo and lotus were planted, and ginkgo, bamboo, crape myrtle, pine and chestnut tress are still living in the garden, which mean plants had been planted in the light of their practical values as well as symbolic meanings. The method for describing 16 scenes of Chiltanjung could be characterized to the structure of 「Place+Scene(a particural activity, event, or action), and these placeness could be analyzed by categorizing the scene to near, middle and far views. Each scene symbolically presents a hermit, noble man, Taoist ideology, homeland, or peacetime, which were adpoted to depict landscapes of Chiltanjung area as the Confucian utopia.

Clinical Features Affecting the Efficacy of Systemic Clonazepam for Management of Burning Mouth Syndrome (구강작열감증후군의 치료를 위한 전신적 클로나제팜의 투여 시 환자의 임상적 특징에 따른 효능의 차이에 관한 연구)

  • Min, Bo-Kyong;Jung, Jae-Kwang;Choi, Jae-Kap
    • Journal of Oral Medicine and Pain
    • /
    • v.37 no.3
    • /
    • pp.161-167
    • /
    • 2012
  • Burning mouth syndrome(BMS) is defined as chronic, painful burning sensation in the oral mucosa. Treatments for BMS include medication and psychiatric interventions. Capsaicin, alpha-lipoic acid, and topical and systemic clonazepam showed more effective in reducing the symptoms of BMS in the previous studies. The purpose of this study is to evaluate of the therapeutic efficacy of systemic clonazepam in BMS and to elucidate the relationships between such a efficacy and various clinical features, including age, pain intensity, pain duration, previous dental history and condition of oral mucosa. A retrospective clinical records audit was performed of patients diagnosed with BMS between January 2011 and August 2012. Patients were prescribed 0.5 mg clonazepam two times daily. Pain was assessed by patients on an 11-point numeric rating scale (NRS; 0 to 10) before and 1-2 weeks after systemic administration of clonazepam. The efficacy of clonazepam was evaluated in terms of patient's age, initial pain intensity, pain duration, presence or absence of precipitating event, condition of the tongue, presence or absence of denture. A total of 50 patients (46 women, 4 men) were included in this study. The patients were divided into two or three groups according to above clinical features. The amount of mean NRS reduction in patients with severe initial pain was $3.33{\pm}2.74$, whereas that in patients with mild initial pain was $1.64{\pm}1.54$. The amount of mean NRS reduction in oldest patients was $3.53{\pm}1.94$ (${\geq}$70yrs), and those in another younger patients were $2.88{\pm}1.80$(< 60yrs) and $1.54{\pm}2.86$(60yrs ${\leq}$ age < 70yrs), respectively. It was concluded that the older patients and the patients with higher intensity of initial pain tend to show better efficacy of clonazepam. However, There were no statistically significant differences according to pain duration, presence or absence of precipitating events, tongue fissuring, and wearing dentures.

A Study on the General Characteristics, Correlation of COVID-19 and Prevention Behavior of Radiologists at K University Hospital (K 대학병원 방사선사의 COVID-19(코로나19)에 대한 일반적 특성, 지식 및 행위와 상관성, 감염 예방 행위에 관한 연구)

  • Choi, Hyeun-Woo;Park, Sung-Hwa;Cho, Eun-Kyung;Ryeom, Hunkyu;Lee, Jong-Min
    • Journal of the Korean Society of Radiology
    • /
    • v.15 no.2
    • /
    • pp.211-217
    • /
    • 2021
  • The purpose of this study is based on the convergence establishment of a coronavirus infection management system that can occur during clinical trials by grasping the knowledge of corona, infection possibility, infection prevention possibility, and implementation level of infection prevention behavior of radiologists working at K University Hospital. It is in providing data. This study was a descriptive research study, and data were collected from 50 radiologists working at K University Hospital from March 25 to June 30, 2020. The characteristics of the subjects and their knowledge of the COVID-19, the possibility of infection, the possibility of infection prevention, and the level of implementation of infection prevention actions were surveyed, and the collected data were analyzed with SPSS 25.0. The frequency and percentage were calculated for the general characteristics and infection-related characteristics of the subjects. The correlation between variables was analyzed by Pearson's correlation coefficient, and the factors influencing the progression of infection prevention behavior were analyzed by multiple regression analysis. Factors influencing COVID-19 infection prevention behavior shown in this study were 1.7 points for infection prevention behavior when corona knowledge increased by 1 point, and infection prevention activity increased by 11.3 points when the level of transmission pathway recognition rose 1 point. When the figure rose by 1 point, the infection prevention behavior increased by 4.2 points. When looking at the standard regression coefficient, preventive behavior is performed. Among knowledge, transmission path perception, and anxiety, the factor that has the greatest influence was the perception of the transmission path of COVID-19. As factors influencing the implementation of infection prevention actions, knowledge of COVID-19, awareness of transmission paths, and anxiety appear to be the potential of infection prevention, so in the event of a corona outbreak, information on infectious diseases and education on the possibility of infection prevention should be provided to promote the implementation of preventive action.

A Study of the Golden Royal Seals Made by the Directorate for the Restoration of the Golden Royal Seals(金寶改造都監) in 1705 (1705년 금보개조도감(金寶改造都監) 제작 금보 연구)

  • Je, Ji-Hyeon
    • Korean Journal of Heritage: History & Science
    • /
    • v.50 no.1
    • /
    • pp.42-57
    • /
    • 2017
  • The Joseon Dynasty (1392~1910) had a long tradition of making official seals to commemorate the granting of official royal titles, including posthumous honorary titles, to its kings, queens, crown princes and queen dowagers. These royal seals were typically gold-plated or made of jade. After the death of its holder, each seal would be stored in the royal seal depository in the Royal Ancestral Shrine. Extensive efforts were made to restore the traditions and culture of the royal family of Joseon during the reign of King Sukjong (r. 1674~1720). In 1705, discussions were held about the royal ceremonial objects, including the royal seals, stored in the Royal Ancestral Shrine, resulting in the reproduction of a set of accessories related with the storage of royal seals and ten golden royal seals which had been lost during wars or had yet to be made. With these reproductions, each shrine chamber of the Royal Ancestral Shrine would have had at least one seal. The details of the reproduction project were meticulously recorded in The Royal Protocol by the Directorate for the Restoration of Golden Royal Seals("金寶改造都監儀軌"). Given that the restoration project was the single event that led to the reproduction of all the golden royal seals, it is reasonable to conclude that the directorate had fulfilled a historically significant function. In this study, the main discussion is focused on the establishment of the directorate and the storage and management of the damaged royal seals. The discussion includes the manufacturing process of the golden seals, for which The Royal Protocol is compared with other similar documents in order to gain more detailed knowledge of the measurements of the turtle knob, the lost-wax casting technique, the gold plating with mercury amalgamation technique, and other ornamentation techniques. The discussion also covers the activities of the artisans who made the royal seals, based on a study of the royal protocols; the styles of the artifacts, based on an examination of the remaining examples; and the techniques used by the Directorate for the Restoration of Golden Royal Seals to produce the royal seals in 1705.

Demonstration of Disaster Information and Evacuation Support Model for the Safety Vulnerable Groups (안전취약계층을 위한 재난정보 및 대피지원 모델 실증)

  • Son, Min Ho;Kweon, Il Ryong;Jung, Tae Ho;Lee, Han Jun
    • Journal of the Society of Disaster Information
    • /
    • v.17 no.3
    • /
    • pp.465-486
    • /
    • 2021
  • Purpose: Since most disaster information systems are centered on non-disabled people, the reality is that there is a lack of disaster information delivery systems for the vulnerable, such as the disabled, the elderly, and children, who are relatively vulnerable to disasters. The purpose of the service is to improve the safety of the disabled and the elderly by eliminating blind spots of informatization and establishing customized disaster information services to respond to disasters through IoT-based integrated control technology. Method: The model at the core of this study is the disaster alert propagation model and evacuation support model, and it shall be developed by reflecting the behavioral characteristics of the disabled and the elderly in the event of a disaster. The disaster alert propagation model spreads disaster situations collected using IoT technology, and the evacuation support model uses geomagnetic field-based measuring technology to identify the user's indoor location and help the disabled and the elderly evacuate safely. Results: Demonstration model demonstration resulted in an efficient qualitative evaluation of indoor location accuracy, such as the suitability of evacuation route guidance and satisfaction of services from the user's perspective. Conclusion: Disaster information and evacuation support services were established for the safety vulnerable groups of mobile app for model verification. The disaster situation was demonstrated through experts in the related fields and the disabled by limiting it to the fire situation. It was evaluated as "satisfaction" in the adequacy of disaster information delivery and evacuation support, and its functional satisfaction and user UI were evaluated as "normal" due to the nature of the pilot model. Through this, the disaster information and evacuation support services presented in this study were evaluated to support the safety vulnerable groups to a faster disaster evacuation without missing the golden time of disaster evacuation.