• 한국치위생학회지
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• 제14권2호
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• pp.241-250
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• 2014

Objectives : The purpose of the study was to examine the ethical requirements for the protection of human subjects in the publication guidelines of dental health journals. Methods : The guidelines of 27 dental health journals were reviewed to determine ethical standards alone, with Helsinki Declaration, by an institutional review board (IRB), informed consent, protection of subject privacy and confidentiality, and no conflicts of interest. Results : 1. Dentistry journals listed on National Research Foundation of Korea had a conflict of interest disclosure provisions of the contribution(76.9%) and the IRB approval(61.5%). 2. Half of the dental health journals were not listed on National Research Foundation of Korea Society but they agreed the advance posting provisions. 3. Dental hygiene journals provide 100% of ethics alone and receive 75% of IRB in the papers. 4. Dental health and dental hygiene journals have conflicts of interest disclosure regulations(59.2%) and IRB approval(51.8%). 5. There existed statistically significant differences between the dental health journals whether they were listed on the human subjects and ethical standards for protection in National Research Foundation of Korea or not. Conclusions : While the publication guidelines of dental health journals have followed to a greater extent in recent years, there is still a need for further instructions to ensure that the authors satisfy all ethical requirements in conducting research on human subjects. IRB approval for dental journals must be standardized and reinforced reflecting the characteristics of each journals. The researchers should obey the code of ethics suitable for education and the editors must review the paper continuously.

• 한국주거학회:학술대회논문집
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• 한국주거학회 2004년도 추계학술대회 논문집
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• pp.375-380
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• 2004

Restricting reconstruction, demand of remodeling has increased in deteriorated apartment. But remodeling process and steps are not taken, it is difficult to advance smoothly. Therefore, this study indicates improvement plans and understands the problems In advancing remodeling. In the result of the investigation the problems are the resident of agreements and legal approval. The goverment must complete laws about remodeling. Also, residents and an association need plans for conversation.

• 해양환경안전학회지
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• 제29권1호
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• pp.15-23
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• 2023

정부는 행정규제기본법 개정('19.07.17)을 통하여 경제활력 제고를 위하여 규제를 최소화하고 포괄적 네거티브 규제원칙을 적용하였다. 사전규제에서 우선허용-사후규제로의 정책환경이 변화하였다. 하지만 해양오염방제 자재·약제는 법적의무인증제도가 적용되어 제품을 판매할 때마다 검정을 실시하여 제조업체의 자율성을 억제하여 왔다. 또한 방제자재·약제 생산업체는 대부분 영세하여 구입자가 주문 의뢰 시마다 제품을 소량 생산하는 방식을 취하고 있다. 이에 해양오염방제 자재·약제 형식승인, 성능시험, 검정제도도 시대의 흐름에 맞춰 시장 및 업계의 자율성을 보장하고 효율성 향상을 위해 규제완화의 필요성이 제기되었다. 본 연구에서는 현 제도의 문제점을 파악하고 국내·외 제도를 비교·분석을 통한 개선방안을 제안하였다

• 약학회지
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• 제56권1호
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• pp.60-65
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• 2012

This study examines factors associated with drug approvals and patent issues of the Korean pharmaceutical firms. The 22 firms were selected based on 2006 year's publicly noticed sales amount. Number of approved drugs was identified through Korea Food and Drug Administration and the information regarding the patents that each firm has issued during the year 2000~2006 was collected from the Korea Patent Office. The number of approved drugs has increased annually, especially after the introduction of substance patent system in 1987 and in 2000 again with the policy change into the separation of drug prescribing and dispensing practice. The number of initial approval of NCEs as well as the number of patents per firm decreased during the year 2000~2006. The 12 firms with larger revenue occupied more than 80% of the patents being issued. There was a positive relationship between share of prescription drugs out of approved drugs and the average number of patents issued. However, number of approved drugs did not show positive association with the number of patents issued per firm. Therefore, the study results imply that firms need to invest more in increasing number of approvals for their specific prescription drugs in order to achieve a good performance in the future.

• 식품과학과 산업
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• 제52권2호
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• pp.153-170
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• 2019

바이오기술의 비약적인 발전에 따라 식품산업에서도 유전자변형미생물을 이용한 효소제 연구가 활발히 이루어지고 있으나, 국내에서는 이를 실제 산업에 이용하기 위한 식품 및 식품첨가물에 대한 적합한 법적 규제수준과 심사관리 현황에 대한 사례가 매우 부족한 실정이다. 현재까지 국내에서 식품 생산을 목적으로 한 유전자변형미생물의 심사 승인사례는 총 6건으로 그 용도가 기능성 감미료 제조에 국한되어 있다. 생산공정이용 또는 밀폐환경이용을 목적으로 개발한 유전자변형미생물이더라도 식품에 적용하는 경우 안전성 심사 시 환경위해성 심사를 포함해야 하며, 이를 이용하여 제조된 식품 및 식품첨가물은 식품원료 등의 한시적기준 심사를 별도로 진행해야 한다. 반면, 해외에서 유전자변형미생물을 이용하여 제조된 제품을 단순 수입 판매하고자 하는 경우 최종 제품에 대한 심사만 요구되고 있어, 국내에서 직접 제조를 하고자 하는 경우에 비하여 인허가 심사에 소요되는 비용 기간에서 유리한 구조이다. 기술 선진국인 미국 유럽은 직접 섭취가 아닌 식품가공을 목적으로 하고 최종 제품에 유전자변형 미생물 및 유래물질이 잔존하지 않을 경우, 다양한 법규 제도를 통하여 합리적인 수준에 안전성 심사의 기준을 세분화하고 단계별로 완화하고 있다. 이러한 제도적 장치들은 '제조'의 관점에서 자국의 개발자가 보다 합리적이고 효율적으로 기술 상업화를 할 수 있는 환경을 조성하는데 크게 기여한다. 국내에서도 2013년부터 안전등급 1등급에 해당하는 유전자변형미생물을 생산공정에만 이용하는 경우는 안전성 평가 자체보다는 밀폐시설의 설치 및 운영을 체계화하는데 중점을 두고자 하였다. 그러나 이러한 보완 제도는 아직까지 산업용 LMO에 국한하여 시행되고 있어, 앞으로 그 범위를 식품용 LMO까지 확대하기 위한 산 학 연의 관심과 논의가 필요하다. 본 기고문에서는 식품용 유전자변형미생물의 국내와 선진국의 심사사례, 법규체계 및 심사기준에 대한 비교 분석을 통하여 국내 관련 법규제도개선의 기회를 마련하고자 한다.

• 에너지공학
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• 제21권3호
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• pp.265-270
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• 2012

에너지절약에 대한 규제가 심하고 국민 다수가 에너지절감에 대한 관심이 높은 상태에서 사업계획승인을 받은 건축물이 건축허가가 지연되어 주변 신규 사업건과 함께 입주된 지역에서 관리비가 20~30% 차이가 발생한다면 심각한 민원이 될 것이다. 따라서 사업계획승인 시점에 에너지절약계획서를 작성하되 주택법 시행령 제18조로 인한 공사착수가 연장이 되어 2년이 경과 되거나 지연 될 때에는 건축허가 시점에서 현 기준에 의한 에너지절약계획서를 적용하는 것이 국가 에너지계획이나 민원에 대한 미연에 방지책이 될 것이라 생각한다. 에너지절약계획서의 목적과 요소의 기술들이 그 기능을 다하지 못하고 단순히 인, 허가 수순에 지나지 않는다면 많은 인력을 투입하여 검토하고 자문하는 것이 무의미한 시간 손실일 것이다. 정부나 건축주가 에너지 save측면을 공감하고 건물에너지효율을 개선하여야 할 것이다.

• 패션비즈니스
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• 제25권1호
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• pp.165-178
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• 2021

With rise in economic activity of fandoms, fashion brands often collaborate with K-pop stars such as BTS to enhance brand preference and sales. This study analyzes why people engage in fandom activity and its effects on collaboration fashion brand preference by focusing on 'BTS' and fandom 'Army'. This study aims to provide information to establish marketing strategies by identifying the influence of fandom culture related to the Korean Wave and the fashion industry, and empirically analyzing factors affecting active customer formation for long-term growth. The data were collected from BTS fan club 'Army' and a total data sets were analyzed using SPSS25.0 statistics program. The findings of this research were as following. Frist, BTS fandom motivation were identified as Need for Approval, Communication Need, Professionalism Need, Need to Belong, Consumption Need and the BTS fan groups were categorized into 3 groups. Third, comparing BTS goods values and collaboration brand preference an excess in each group was revealed. This study is significant because it provides essential data for the marketing strategy of fandom market by comparing marketing effects of BTS with the characteristics of fandom consumers and identifying the different desires of each group. As a result of this research, it can be seen that BTS an influential leading brand, has been adopted, and the research direction of empirical analysis has been presented. In practice companies can select specific fandom targets by using the sub-levels of fandom types that have become clear and implement marketing strategies of the fandom market.

• Molecules and Cells
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• 제46권1호
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• pp.10-20
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• 2023

Antisense oligonucleotide (ASO) technology has become an attractive therapeutic modality for various diseases, including Mendelian disorders. ASOs can modulate the expression of a target gene by promoting mRNA degradation or changing pre-mRNA splicing, nonsense-mediated mRNA decay, or translation. Advances in medicinal chemistry and a deeper understanding of post-transcriptional mechanisms have led to the approval of several ASO drugs for diseases that had long lacked therapeutic options. For instance, an ASO drug called nusinersen became the first approved drug for spinal muscular atrophy, improving survival and the overall disease course. Mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene cause cystic fibrosis (CF). Although Trikafta and other CFTR-modulation therapies benefit most CF patients, there is a significant unmet therapeutic need for a subset of CF patients. In this review, we introduce ASO therapies and their mechanisms of action, describe the opportunities and challenges for ASO therapeutics for CF, and discuss the current state and prospects of ASO therapies for CF.

• 한국항공운항학회지
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• 제23권2호
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• pp.57-62
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• 2015

As the issuance of type certificate and production certificate for KC-100 Naraon, Korea is ranked as the State of Design and the State of Manufacture for civil aircraft specified in the Convention on International Civil Aviation. It means that another responsibilities are imposed and new frameworks are required for the airworthiness management including the continuing airworthiness. So far the minimum airworthiness management system was sufficient as the State of Registry for the aircraft operations and safety management. However, we need to establish and maintain the airworthiness management system for the effective certification and oversight of our air operators and approval holders. This paper introduces the new obligations under the Convention on International Civil Aviation, reviews the current aviation regulations and procedures and presents the strategy for the establishment of the regulatory system to ensure the airworthiness of aircraft.

• 대한의용생체공학회:의공학회지
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• 제44권6호
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• pp.414-427
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• 2023

Implantable bioabsorbable combination products undergo inherent degradation and systemic absorption within the physiological environment, thereby streamlining the therapeutic regimen and obviating the imperative for invasive extraction procedures. This inherent property not only enhances patient convenience and therapeutic efficacy but also underpins a paradigm of support characterized by heightened safety parameters. Within the regulatory landscapes of Korea, the United States, and Europe, implantable bioabsorbable combination products are meticulously classified into distinct categories, either as pharmaceutical implants or as implantable medical devices, depending on their primary mode of action. This scholarly investigation systematically examines the regulatory frameworks governing implantable bioabsorbable combination products in South Korea, the United States, and Europe. Notable discrepancies across national jurisdictions emerge concerning regulatory specifics, including terminology, product classification, and product name associated with these products. The conspicuous absence of standardized approval regulations presents a formidable barrier to the commercialization of these advanced medical devices. This academic discourse passionately emphasizes the critical need for formulating and implementing a sophisticated regulatory framework capable of streamlining the product approval process, thereby paving the way for a seamless path to commercializing implantable bioabsorbable combination products.