• 대한의용생체공학회:의공학회지
• /
• 제43권3호
• /
• pp.153-160
• /
• 2022

As new types of medical devices are emerging through convergence with advanced technology, innovative technologies are becoming hot issues in health policy because of their disruptiveness. This study analyzed the innovative medical device management systems in the US, China and Korea. Innovative medical devices have been defined differently depending on the country's management system, but in common, they are defined as products that do not exist or have dramatically improved performance compare to existing products by applying innovative technologies. Innovative medical devices have been supported by regulatory authorities during product development and approval processes. While the US and China have more than 300 products designated as innovative medical devices with diverse functions, application fields, and manufacturing countries considering the initial situation of the implementation for the system, Korea has only 16 products, mainly radiology and diagnostic devices and made in Korea only as innovative medical device. In addition, Korea shows the highest market approval rate of innovative medical devices compare to the US and China, and it is necessary to prepare the approval process in consideration of product diversity.

• 한국전자거래학회지
• /
• 제4권3호
• /
• pp.43-62
• /
• 1999

This paper is to analyze business activities of approval/permission (A/P) and to describe its problems. To conduct the A/P business activities currently, there are many problems such as complex business process and different business policies among the each organization. In order to solve the problems, this paper suggests the A/P system of highway construction CALS (Commerce at Light Speed). CALS, a top down vision of complete computing integration, promises to support electronic data exchange. The A/P system is designed to classified documents based on CALS standard and store them to database. The data register to the A/P system by the Internet, and each construction company can use the A/P system by Internet also. Benefits of the A/P system is reduction in junk documents for approval/permission actives, improvement in conduct and services life cycle support.

• Journal of Pharmaceutical Investigation
• /
• 제38권3호
• /
• pp.207-215
• /
• 2008

Drug approval-patent linkage is the practice of linking drug marketing approval to the patent status of the originator's product and not allowing the grant of marketing approval to any third party prior to the expiration of the patent term unless by consent of the patent owner. Article 18.9.5 of Korea-US Free Trade Agreement requires that Korea introduce the linkage system in drug marketing approval. However, Korea is unfamiliar with the linkage system. In addition, there have been lots of arguments over the impacts of this system on Korean pharmaceutical industry and pharmaceutical market in the future. This report investigated the linkage systems of the US and Canada. The US and Canada have implemented drug approval-patent linkage system since 1984 and 1993, respectively. Both countries have patent lists for drug approvalpatent linkage on which originators are required to list patents on substance, product, and use of their drugs. Generic or follow-on drug applicants must contain a certification regarding each patent listed that relates to the referenced drug. If the patent holder files suit for patent infringement within 45 days of notice of application, drug approval is not allowed for several months - 30 months in the US and 24 months in Canada. Both countries have amended their systems after having experienced unexpected results such as listing improper and additional patents, multiple patent litigations and delayed generic entries. After reviewing the US and Canada's experiences, we suggested three principles needed in implementing the system: protecting patent holder's right; promoting generic drug development and marketing; monitoring the process and the effect of the system.

• 시스템엔지니어링학술지
• /
• 제9권2호
• /
• pp.69-82
• /
• 2013

US DoD operated JCIDS(Joint Capability Integration and Development System) for top down requirement generation. Although the JCIDS can be a good practice for the countries which are trying to shift from bottom up to top down requirement generation, it contains many processes related with review and approval. In this study we structured a joint capability integration and development process from the JCIDS eliminating the organization dependent review or approval process so that it can be applied to any organization with some modification. Furthermore we implemented the process in the computer aided systems engineering tool, Cradle, for convenient use of the process. The result of this study can provide a basic process for top down capability development, and an efficient why of doing each element of the process using CASE tool.

• 한국항공운항학회지
• /
• 제28권4호
• /
• pp.141-146
• /
• 2020

The International Civil Aviation Organization (ICAO) developed Doc 9995 "Manual of Evidence-based Training," with the intention of providing guidance by establishing a new methodology for the development and conduct of a recurrent training and assessment program. The airline pilot training regulations were largely based on the evidence of hull losses from early generation jets, and in order to mitigate a risk, simply repeating an event in a training program was sufficient. At the time, studies concluded that it was time to change the paradigm of training and assessment program for pilots. One airline alone implemented Evidence-Based Training (EBT) program in their flight crew training and assessment program while another airline partially implemented the EBT program. In the regulatory framework of MOLIT, specific EBT regulations have not been established yet. Therefore, it is recommended to develop rules and standards that comply with ICAO SARPs as soon as possible. In this study we review the key steps in the implementation of the baseline EBT, approval process of baseline EBT program, and policy options regarding the implementation of EBT. It will provide guidance to operators, Approved Training Organizations (ATO), and stakeholders.

• 한국콘텐츠학회:학술대회논문집
• /
• 한국콘텐츠학회 2007년도 추계 종합학술대회 논문집
• /
• pp.799-803
• /
• 2007

본 논문에서는 전자교과서가 도입됨에 따라 디지털교과서를 효과적으로 운영할 수 있는 방안을 탐색하며 디지털교과서의 성공적인 활용을 위해서 서책형 교과서의 검정 및 인정 방법과 과정을 검토하고 이들 방법이 디지털교과서는 어떠한 기준과 절차에 의해 검인정이 이루어져야 하는지 검인정 방안을 제안하였다. 그리고 디지털교과서의 검인정은 전통적 서책형 교과서와는 다르게 디지털교과서 표준 사양에 적합하게 개발되었는지 심사하는 과정에 대해 제시해 보고 디지털교과서로써의 역할과 기능을 수행할 수 있는지의 형식 및 내용에 대해 검정하는 방법 등으로 구분하여 연구가 이루어졌다. 이러한 연구를 토대로 제안하고 있는 디지털교과서의 검정 방법이 새롭게 계획하고 있는 디지털교과서 검인증 과정에 적용될 수 있기를 기대한다.

• 한국융합학회논문지
• /
• 제11권1호
• /
• pp.237-246
• /
• 2020

본 연구의 배경 및 문제는 초경량비행장치 산업의 발전으로 드론의 성능이 향상되고 운행 대수는 증가하는 반면에 비행 인·허가 과정은 개선되지 않아 민원이 증가하는 추세에 있다. 목적은 민원을 최소화하고 양개기관 요구조건에 맞게 시스템 운용 및 관리 전반에 대한 개선이다. 연구방법은 문헌연구 및 조사를 통하여 문제점을 도출하고 기관 및 전문가들의 포커스 그룹 인터뷰를 통해 검증하여 개선안을 제시하였다. 연구결과는 국토부 주관 하 항공안전법 내에 양개기관 임무·역할 및 시스템 운용·관리에 대한 반영, 비행 인·허가에 대한 명칭·절차·양식의 통합, 시스템 상에 홈페이지 바로가기 등 다수의 기능개선이다. 기대효과는 첫째, 관련법령에 양개기관의 임무와 역할을 명시함으로서 민원처리 협조가 원활해지며 둘째, 민원처리 프로세스를 통합함으로서 처리 기간단축으로 효율성이 향상되고 셋째, 대국민서비스 부가기능을 개선함으로서 민원 최소화가 기대된다. 향후 연구는 국방부 주관 하 항공촬영허가에 대한 제도적 기반마련, 국방개혁 2.0연계 관할부대 재편성, 현장 보안조치부대 여건보장 등 개선이 필요하다.

• 한국응용약물학회:학술대회논문집
• /
• 한국응용약물학회 2007년도 Proceedings of The Convention
• /
• pp.117-126
• /
• 2007

Cosmetics have mild activity on the human body, and intended to be used for cleaning, beautifying the human body, and also keeping healthy skin or hair, promoting attractiveness or altering the appearance. Functional cosmetics, in other words cosmeceuticals, are restricted for following functions: 1) Whiten the skin tone by preventing deposition of melanin pigmentation or lightening of the color of melanin of skin, 2) alleviate or improve wrinkles of the skin, and 3) protect the skin from the ultra violet rays from the sun. According to the functions of the functional cosmetics, skin whitening products, anti-wrinkle products, and suntan & sunscreen products are manufactured. In order to manufacture and import the functional cosmetics in Korea, the approval process in KFDA is necessary. The review process in KFDA is performed based on The Korea Food and Drug Administration Notification 2007-44, "The Regulation of Reviewing the Functional Cosmetics" (June 29, 2007). Only after the approval of KFDA, functional cosmetics are allowed to advertise to the consumers for their functionality.

• 한국직업건강간호학회지
• /
• 제28권4호
• /
• pp.271-284
• /
• 2019

Purpose: This study aimed to examine the process from occurrence of a hospital nurse's suicide to workers' compensation approval, responses of the parties involved, issues debated during approval deliberations, and significant policy changes resulting from the incident. Methods: We conducted in-depth interviews with involved parties and collected various documents, including newspaper articles, forum proceedings, and the agency report on determination of workers' compensation. Content analysis was performed on the collected data. Results: A Joint Task Force continuously reported its progress and findings through mass media such as newspaper, radio, and TV. These activities exerted pressure on a government agency to conduct an occupational disease review and significantly impacted the workers' compensation approval. The agency recognized associations between the hospital's inadequate nurse training and the suicide but did not confirm the excessive overtime and workplace harassment experienced by the nurse as causes of the suicide. This case's media coverage and impact resulted in a law prohibiting workplace harassment and a hospital system dedicating at least one nurse to training activities. Conclusions: This incident had a significant social impact as the first case of workers' compensation approval for a hospital nurse's suicide. However, the case produced no structural changes in nurses' working conditions such as heavy workloads.

• 한국정보통신학회:학술대회논문집
• /
• 한국해양정보통신학회 2001년도 춘계종합학술대회
• /
• pp.524-527
• /
• 2001

정보통신분야의 대표적인 국제 표준화기구인 ITU (International Telecommunication Union)는 급변하는 기술 및 시장 흐름에 대응하여, 최근 많은 계획을 추진하고 있다. ITU 표준화 분야에서의 개혁 조치는 크게 보아 신속한 표준 제정을 위한 표준화 절차의 개선과 이를 위한 관련 규정의 변경으로 구분되며, 이를 위해 이번 회기(2001-2004) 동안 ITU 표준화 작업의 근거가 될 ITU 표준화 규정(ITU-T Resolutions, A-Series Recommendations)을 ITU-T 총회(WTSA-2000)에서 완료하였다. 본 논문에서는 ITU 개혁 내용 중 ITU-T가 표준화 절차의 효율화를 위해 전략적 도구로 내세우고 있는 EDH(Electronic Document Handling)와 관련된 표준화 활동 현황 및 관련 규정을 상세히 분석하고, 또한 현재 EDH방법을 도입하여 새롭게 추진되고 있는 표준화 절차(AAP: Alternative Approval Process, A.8)에서의 적용방법 등을 고찰하고, 향후 국내 표준화 활동의 대응방향을 제시하고자 한다.