• Journal of Biomedical Engineering Research
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• v.43 no.3
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• pp.153-160
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• 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.

• The Journal of Society for e-Business Studies
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• v.4 no.3
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• pp.43-62
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• 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
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• v.38 no.3
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• pp.207-215
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• 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.

• Journal of the Korean Society of Systems Engineering
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• v.9 no.2
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• pp.69-82
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• 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.

• Journal of the Korean Society for Aviation and Aeronautics
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• v.28 no.4
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• pp.141-146
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• 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.

• Proceedings of the Korea Contents Association Conference
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• 2007.11a
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• pp.799-803
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• 2007

In this paper, we research into an effective operation environment of digital textbook according to the adaption of an electronic textbook and analyze the approval program and the authorization program of the paper textbook for the efficient utility of a digital textbook. We propose various criterions and methods of the approval and authorization program. Finally, we show the whole process of the proposed approval and authorization program. We hope that our study apply to the standard approval and authorization program of the Ministry of Education.

• Journal of the Korea Convergence Society
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• v.11 no.1
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• pp.237-246
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• 2020

The background of the research is the following: As a result of ultra-light flying device industry development, the utilization of drones and their efficiency have been increasing. However, problems regarding flight permission·approval procedure have not been improved, resulting in increased number of civil complaints. Thus, the purpose of this research is to minimize such civil petition according to the required standards of the two government organizations through enhancing the procedure for managing and employing the system. The research methods entail pinpointing the problems by analysing ultra-light flying device related literature review and by holding focus-interviews with field experts, thereby verifying and providing improved solutions. Under (MLIT) Ministry of Land, Infrastructure and Transport supervision and in accordance with aviation security law, the research provides various updated functions such as improved civil petition processing system's employment and management system, flight approval, integration of names, process, format regarding aviation photographing approval, tool buttons such as the 'Main' button in the system's homepage. This research has the following expected effects : Firstly in the law and regulations section, the clear distinction in the missions and roles of each organization enhances cooperations in tackling civil petition. Secondly the integration of civil petition process reduces time and improves efficiency. And lastly, the improvement of supplementary tools for the public is expected to minimize civil petitions. Future research needs to be conducted under the supervision of the Ministry of National Defense(MND). Factors such as systematic infrastructure for flight photography approval, related unit's reorganization following the defense reform 2.0, and guaranteed conditions for field security action units need to be ameliorated.

• Proceedings of the Korean Society of Applied Pharmacology
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• 2007.11a
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• pp.117-126
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• 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.

• Korean Journal of Occupational Health Nursing
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• v.28 no.4
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• pp.271-284
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• 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.

• Proceedings of the Korean Institute of Information and Commucation Sciences Conference
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• 2001.05a
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• pp.524-527
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• 2001

According to the very rapid technological change and market mega-trends, the ITU(International Telecommunication Union) is now under Reform. In line with whole ITU reform, ITU-T (ITU- Telecommunications Standardization Sector) as global standards development organization has setup the two major environment such as ITU-T resolutions and new standards approval process for new study period 2001-2904 in the WTSA-2900. In this paper, we analyze on detailed EDH(Electronic Document Handling) activities, EDH related resolution and Methods as strategic tools within the ITU-T and its application to the New approval process which is described in ITU-T Recommendation A.8(AAP). Finally, we discuss future ITU-T EDH policy and suggest direction of Korean EDH policy.