• 제목/요약/키워드: data exclusivity

검색결과 18건 처리시간 0.017초

의약품 자료독점제도의 국가별 현황과 국내 제도의 발전방향 (Pharmaceutical Data Exclusivity - Comparative Study and Future Direction in Korea)

  • 박실비아
    • Journal of Pharmaceutical Investigation
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    • 제39권4호
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    • pp.299-307
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    • 2009
  • Data exclusivity is one of the most important intellectual property rights of pharmaceuticals. During data exclusivity period, third parties are prohibited from relying on the data which the original company has submitted to regulatory authority for drug application. I investigated data exclusivity systems for pharmaceuticals in the US, EU, Canada and Korea. New chemical entities were usually given the longest periods of data exclusivity compared to drugs with new indication or new formulation, although the protection periods varied by country. For new drugs to be entitled to a data exclusivity, strict conditions should be met. Data exclusivity has also been provided as an incentive to promote clinical investigation and drug development for pediatric population or orphan diseases. In Korea, data exclusivity was adopted in 1995 as an additive provision to "drug re-examination" which is to investigate post-marketing safety information of new drugs. It was introduced with few discussion on the purposes or effects of data exclusivity on pharmaceutical industry and pharmaceutical market in this country. I found that Korea's data exclusivity system falls short of considerations on valuing innovation of pharmaceutical research. It is necessary to improve data exclusivity system in order to promote innovative pharmaceutical development and to balance intellectual property rights protection and access to drugs in this country.

Netflix in Indonesia: Influential Factors on Customer Engagement among Millennials' Subscribers

  • AUDITYA, Annisa;HIDAYAT, Z.
    • 유통과학연구
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    • 제19권1호
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    • pp.89-103
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    • 2021
  • Purpose: This study is to explore how Netflix Customers' Engagement was influenced by Instagram Content, Perceived Price, Exclusivity, and Motivation in the context of Media Streaming and the role of Willingness to Subscribe as the mediating variable. This study underlines millennial's willingness to engage and the form of engagement. Research design, data, and methodology: The data for this research were collected from 100 Netflix's Millennials subscribers who follow @netflixid Instagram. All the results were analyzed and verified using SEM-PLS. Results: Research findings indicated that Willingness to Subscribe, Exclusivity, Motivation, and Instagram Content positively influenced Customer Engagement among Netflix millennials' subscribers. In contrast, Perceived Price had a negative effect on Customer Engagement. Conclusions: As a consequence, the exclusivity that Netflix offers to its audience by a recommendation algorithm has been proven to increase the engagement. This study also disclosed that the most definite form of positive engagement shown by Netflix millennials' subscribers is a behavioral aspect, where they positively recommend Netflix (word of mouth). The study findings can be a reference for the media streaming industry in their efforts to strengthen the engagement with their customers, especially the millennials, and provide knowledge about consumer behavior in digital technology.

럭셔리 패션 플랫폼 속성이 온라인 구전의도에 미치는 영향 (The Effects of Luxury Fashion Platforms' Attributes on Consumer eWOM)

  • 김수지;허희진;추호정
    • 한국의류학회지
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    • 제45권4호
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    • pp.685-702
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    • 2021
  • This study aims to discover how the perceived attributes of luxury fashion platforms affect consumer trust and satisfaction as well as online word-of-mouth intention. Based on a literature review, this study derived four dimensions of perceived attributes: brand assortment size, exclusivity, convenience, and personalization. The paper presents findings from an online survey targeting 359 consumers in their 20s to 30s who had recent experience with luxury fashion platforms. Based on the collected data, a structural model equation analysis was performed using AMOS 22.0 and SPSS 26.0. The findings illustrated that brand assortment size, exclusivity, and personalization had positive effects on consumers' platform trust. In addition, brand assortment size and convenience had a positive impact on satisfaction. Overall, the findings of the study illustrate that perceived attributes of luxury fashion platforms have a significant impact on consumers' platform trust and satisfaction and online word-of-mouth intentions. This study reveals that consumers' trend orientation moderates the effects of consumer attitude and behavioral intention. The academic practice of this study has laid the foundation for understanding mechanisms of marketing strategies by providing the characteristics of platforms in the luxury fashion industry.

한미FTA와 TPP협정의 비교분석을 통한 의약품 분야 국제통상규범에 대한 연구 (The Pharmaceuticals Regime in the KORUS FTA and the TPP Agreement: A Comparative Analysis)

  • 윤미경
    • 통상정보연구
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    • 제18권4호
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    • pp.165-193
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    • 2016
  • 본 논문은 한미FTA와 TPP협정을 비교분석하여 의약품 분야 국제통상규범이 어떻게 진화해가고 있는지 살펴본다. TRIPS협정 이후 양자 또는 지역 자유무역협정을 통해 자료독점 보장과 같은 의약품 분야의 지재권 보호 강화는 물론이고 의약품 판매 허가 및 약가 결정 방식 등 보건의료 제도 측면에서도 신약 개발자의 이익을 강화하는 방향으로 규제조화가 이루어져 왔으며, 그 전형적인 예가 한미 FTA와 TPP협정이다. 특히, 가장 처음으로 바이오의약품 자료보호 규정을 도입한 TPP협정은 향후 모든 협정의 기준으로 자리매김할 것이다. 그럼에도 불구하고 TPP협정은 한미FTA와 비교하여 의약품 분야 지재권 보호 정도가 전반적으로 더 강화되었다고 보기 어렵고, 부분적으로는 오히려 더 높은 정책적 유연성을 내포하고 있는 것으로 평가된다. 향후 한국이 TPP협정 가입 협상을 하게 되거나 한미FTA를 재협상해야 한다면, 두 협정 간 이러한 차이를 잘 활용한 적극적이고 선제적인 협상 전략을 도입할 필요가 있다.

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A Study on Energy Platform Using Data in the US: Based on Opening Platform Model

  • Song, Minzheong
    • International journal of advanced smart convergence
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    • 제10권3호
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    • pp.41-50
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    • 2021
  • The purpose of this study is to analyze various energy platforms using data in the US and to suggest directions and implications. Some of the leading energy platforms are selected and analyzed based on the opening platform model. We focus on the case analysis of the US utility companies. In case of the horizontal open platform, Green Button sponsor's 'Connect My Data (CMD)' driven by the government invites the utility companies to jointly develop the sponsor's data solution. In case of the vertical open platform, the certification program 'Share My Data (SMD)' allows backward compatibility, because the technical improvement is minimal. The utility companies benchmark Amazon's three-sided market mediation and prefer platform and category exclusivity. For the former, they have data analytics companies like Enervee, Opower and for the latter, they have electronics manufactures and energy service providers (ESPs) like Distributed Energy Resources (DERs). Based on this US case study, we suggest the energy platforms to open their platform for renewable energy supply, energy conservation, high-efficiency products, and residential DER dissemination. To successfully implement the government's energy transition policy, the US platforms should be benchmarked as a business model. Especially, it is needed for them to coordinate a platform ecosystem. To ensure trust in the products and services offered on the marketplace platform, platform's certification program is helpful.

A Model for Machine Fault Diagnosis based on Mutual Exclusion Theory and Out-of-Distribution Detection

  • Cui, Peng;Luo, Xuan;Liu, Jing
    • KSII Transactions on Internet and Information Systems (TIIS)
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    • 제16권9호
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    • pp.2927-2941
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    • 2022
  • The primary task of machine fault diagnosis is to judge whether the current state is normal or damaged, so it is a typical binary classification problem with mutual exclusion. Mutually exclusive events and out-of-domain detection have one thing in common: there are two types of data and no intersection. We proposed a fusion model method to improve the accuracy of machine fault diagnosis, which is based on the mutual exclusivity of events and the commonality of out-of-distribution detection, and finally generalized to all binary classification problems. It is reported that the performance of a convolutional neural network (CNN) will decrease as the recognition type increases, so the variational auto-encoder (VAE) is used as the primary model. Two VAE models are used to train the machine's normal and fault sound data. Two reconstruction probabilities will be obtained during the test. The smaller value is transformed into a correction value of another value according to the mutually exclusive characteristics. Finally, the classification result is obtained according to the fusion algorithm. Filtering normal data features from fault data features is proposed, which shields the interference and makes the fault features more prominent. We confirm that good performance improvements have been achieved in the machine fault detection data set, and the results are better than most mainstream models.

의약품 자료독점권(Data Exclusivity)에 대한 비교법적 고찰 - COVID-19 치료제 및 백신 개발을 대비하여 - (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 -)

  • 박지혜
    • 의료법학
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    • 제21권1호
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    • pp.223-259
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    • 2020
  • COVID-19가 순식간에 세계적으로 퍼져나가면서 이 바이러스에 대한 치료제 및 백신에 대한 연구 개발 이슈가 뜨겁다. 그 중에서도 렘데시비르(Remdesivir)가 가장 먼저 눈에 띄는 치료효과를 나타내며 본격적인 임상시험에 돌입하였고, 각 국가들은 긴급 승인을 통해 해당 의약품의 사용을 허가하고 있다. 그런데 렘데시비르의 개발사인 주식회사 길리어드는 렘데시비르를 희귀의약품으로 품목허가 신청하여 시민단체들로부터 많은 질타를 받았다. 그 이유는 희귀의약품으로 신약이 품목허가를 취득하는 경우 7년의 독점적 지위를 부여받을 수 있기 때문이다. 희귀의약품에게 장기간 동안 독점적 지위를 부여하는 것은 희귀질환으로 고생하는 환자들에게 치료기회를 부여하기 위해 제약회사에게 개발 동기를 부여하는 정책적 취지로부터 나온 것으로, 감염병 치료제에 적용하기에는 적절하지 않았기 때문이다. 본 논문은 이러한 정책적 의도를 바탕으로 의약품에 독점적 지위를 부여하고 있는 법령에 대하여 미국, 유럽, 일본을 상대로 비교법적 고찰을 통해 국내 제도의 문제점 및 개선 방향에 대해 살펴보는 내용을 담고 있다. 국내 제도는 독점적 지위 부여 방식에 있어 법령에 명시적인 조항을 두고 있지 않고, 재심사제도를 활용하여 우회적으로 독점적 지위를 부여하고 있다는 근본적인 문제를 갖고 있다. 이와 더불어 희귀의약품의 경우 「희귀질환관리법」과 「의약품의 품목허가·신고 심사 규정」에서 중복적으로 재심사기간을 규정하고 있다는 점, 상대적으로 독점기간을 길게 부여하고 있음에도 불구하고 사정변경 발생 시 독점적 지위를 회수할 수 있는 견제 조항이 존재하지 않는다는 점 등이 보완되어야 할 부분으로 보인다. 생물의약품의 경우에는 국내에는 우회적으로라도 의약품의 독점적 지위를 부여할 수 있는 규정이 존재하지 않는다. 생물의약품의 경우 특허를 받기 어렵다는 점에서, 독점권을 부여하는 것이 의약품 개발을 유도하는 큰 동기가 될 수 있음에도 이러한 조항이 없다는 점은 국내 법제의 아쉬운 점이라 볼 수 있다. 미국의 경우 최초의 동등생물의약품에도 1년의 독점기간을 부여한다는 점에 비추어 볼 때, 국내 법제는 생물의약품에 독점적 지위를 부여하는 것에 대하여 상당히 엄격하게 제한하고 있다고 해석된다. 이는 추후 국내 제약사의 생물의약품 개발 의지를 저하시킬 수 있다는 점에서, 또한 국제 규제의 조화를 맞출 필요가 있다는 점에서 국내 제도의 개선의 필요성이 인정된다 할 것이다. COVID-19의 발현을 기회로 삼아, 의약품에 독점권을 부여하고 있는 국내 제도가 가지고 있는 문제점에 대하여 다시 한 번 살펴보고, 통일된 법적 근거를 마련할 수 있도록 관련 법제에 대한 전반적인 개정이 이루어 질 것을 기대해보는 바이다.

터치폰 인터랙션의 Flicking에 대한 감성 터치감에 대한 연구 (A Research on Emotion Assessment by Touch Sensibility Flicking on Mobile Phone)

  • 김지혜;황민철;김치중;박재언;문성철
    • 대한인간공학회지
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    • 제29권4호
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    • pp.533-540
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    • 2010
  • This study was to suggest the proper level of touch sensibility for twenties while flicking touch phones. A rapid prototype of $480{\times}800$ pixel size was developed for the experiment. Participants were 20 undergraduates, not visually and physically handicapped in using touch phones. 15 different modes, with each mode changing in velocity when flicking the prototype were randomly presented to each subject. The subjects were asked to score what they felt in each mode on a 1-to-6 Likert scale. The data was analyzed by the one-way ANOVA procedure. Each mode showed significant differences in 8 representative emotions except for exclusivity feeling and fresh feeling. Each velocity mode was scaled by the multidimensional scaling technique. Then, vector coordinates in each emotion were obtained by simple regression analysis. 15 velocity modes and each emotion were joint-plotted by the MDS, PROXSCAL. The findings in this study could be basic data for studying affective touch sensibilities in multiple ways.

스페셜 오더 상품과 모바일 SNS 홍보 전략이 브랜드 럭셔리 및 브랜드 관계에 미치는 영향 (Effect of Special Order Products and Mobile SNS Promotions on Perceived Brand Luxury and Brand Relationship)

  • 이계정;이은정
    • 한국의류산업학회지
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    • 제19권4호
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    • pp.411-420
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    • 2017
  • With the increasing popularization of low-priced luxury markets, maintaining the genuine values of luxury has become crucial for luxury fashion brands to attract customers who want exclusivity and rarity. The world-leading luxury fashion houses have employed a variety of experiential marketing strategies like special order product strategies and mobile SNS promotion strategies, yet little research exists on there the strategies actually positively impact brand luxury images and customer attitudes towards the brand. This study empirically analyzed the effects of customer experience of special order products on perceived brand luxury and brand relationship. Furthermore, the study also tested relationships among perceived brand luxury, brand relationship, and brand loyalty. A survey was conducted with Korean female consumers who had purchase experiences of special order products from the brands. We analyzed the data of MTO-experienced respondents due to the lack of respondents who had experienced custom-made product services. The result indicates the significant effect of experience of MTO on brand relationship; however, we found only a partial support for the effect of MTO on brand luxury. Likewise, we found a partial support for the effect of mobile SNS promotion strategies on perceived brand luxury versus full support for the effect on brand relationship.

현대 패션사진에 나타난 스토리텔링의 미적 특성 - 스티븐 마이젤 패션사진을 중심으로 - (The Research on Aesthetic Characteristics of Storytelling Expressed in Modern Fashion Photographs - With a Focus on Steven Meisel's Fashion Photos -)

  • 박미주;양숙희
    • 복식문화연구
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    • 제17권1호
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    • pp.132-148
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    • 2009
  • The objective of this article is to examine the possibility of 'story-telling' as united concept of causality and subjectivity through sequence combination, and the 'similarity' between object and image in fashion photographs making diversity of meanings. To analyze and investigate the research, as evidential data this paper used the photos of Steven Meisel from 2002 till 2007 Vogue published in Korea, U.S, and Italy, as well as other visual data like graphic collections, catalogs, art-related data and internet data. This research runs both theoretical and positive investigations to suggest the function of story-telling in the Process of opened-communicative roles of fashion photos. Thus this paper investigated Steven Meisel's storytelling in his fashion photos; short moment of event, continuity of time, compound of sequence, and complexity of viewpoint. This paper also studied the aesthetic characteristics of Steven Meisel's fashion photos as categories of overlapped meaning, arbitrariness of interpretation, exclusivity of message, and decoding. The research result suggests that clothing not only includes current age's value but also among social constitutions it includes multilateral characteristics. Ultimately this paper is also making meaning alive by cutting off the chain of 'firm' meanings of fashion photo. That seems like opening the opportunity for correctly understanding fashion's meaning which has the aspects of ambivalence of changing meanings and values by the motivation of context and text.

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