• Korean Journal of Clinical Pharmacy
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• v.31 no.4
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• pp.257-267
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• 2021

Background: The need for regulatory science development to evaluate advanced regulatory products is gradually increasing without hindering the technological development. Creating a research environment and fostering experts through the establishment of regulatory agency-led policies are essential for the development of regulatory science. Method: This is a comparative study of the United States, Japan, Singapore, and Korea. The literature and websites of each regulatory agency were reviewed, and the focus was on advantages and comparing advantages based on definition, development trends, and expert training projects. Results: The United States is striving to develop regulatory science in response to changes in the new pharmaceutical industry through the regulatory science report, and to foster expert both inside and outside the Food and Drug Administration (FDA). Japan is promoting regulatory science centered on regulatory science centers, and is focusing on researching work-related regulatory science within the Pharmaceuticals and Medical Devices Agency (PMDA) and improving employees' ability to make regulatory decisions. Singapore was aiming to improve Southeast Asia's regulatory capabilities under the leadership of Centre of Regulatory Excellence (CoRE) within Duke-NUS University. In 2021, Korea is in its early stages, starting to run a university's degree program related to regulatory science this year. Conclusion: Regulatory science should be developed with the aim of improving the regulatory ability of the Ministry of Food and Drug Safety with Korea's independent concept of regulatory science.

• Journal of Distribution Science
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• v.5 no.2
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• pp.17-34
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• 2007

The Korean pharmaceutical industry has many pharmaceutical companies and business acquaintances, small quantity batch production and a lot of competition products having same ingredient. Under such a situation, an integrated distribution is said to be proper to lower distribution costs and deliver effectively: However, each business has different delivery conditions, timely delivery of small quantity batch order and other particular services, etc to have problems of competition of turnover increase. The study suggests measures below to lower distribution costs and to elevate sales business efficiency. First, Joint marketing of pharmaceuticals between pharmaceutical companies. Second, Joint delivery of three or less companies having similar business scales. Third, An agreement with wholesale distributors of unified distribution of pharmaceuticals being sold much. Fourthly, Wholesale distributors' pharmaceuticals distribution services. Fifthly, Cooperation of business acquaintance. In summary, the Korean pharmaceutical industry needs an integrated distribution system. Considering characteristics of the industry, however, the small pharmaceutical companies are thought to be difficult to accept the integrated distribution because complete integrated distribution may reduce sales.

• Korean Journal of Clinical Pharmacy
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• v.31 no.3
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• pp.171-179
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• 2021

Background: Need for regulatory science is emerging with the development of pharmaceutical industry. It is essential to train regulatory science experts to meet the needs of technology and regulations to evaluate advanced products. Major regulatory science countries are conducting the regulatory science activities and fostering the experts. Methods: Published literature and the relevant website of European Union (EU) were reviewed and criteria were developed. In particular, we focused on in depth descriptions of the Innovative Medicines Initiative program, which was conducted twice. Results: EU is striving to provide funding and training experts for the development of the regulatory science by horizon 2020 and regulatory science to 2025. Innovative medicines initiative (IMI) is a public-private partnership aimed at the development of the pharmaceutical industry, including the regulatory science. IMI education and training projects have provided various education and training course including short-term curriculum and master and doctoral course. The difference between South Korea's regulatory science expert training project in 2021 and the EU's IMI education and training projects is participation of pharmaceutical companies. While the pharmaceutical companies participate in the IMI project to select project topics and form a community, South Korea's project is focused on the Ministry of Food and Drug Safety and universities. Conclusion: Through successful active networks with regulatory party, pharmaceutical companies, and universities, a great innovative advance of regulatory science in South Korea is expected.

• Journal of Korea Fair Competition Federation
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• no.138
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• pp.10-27
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• 2008

• Journal of Korea Fair Competition Federation
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• no.139
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• pp.42-55
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• 2008

• Journal of Korea Fair Competition Federation
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• no.140
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• pp.70-83
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• 2008

• Journal of Korean Society of Industrial and Systems Engineering
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• v.22 no.52
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• pp.87-96
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• 1999

본 연구는 공통의 납기로부터 완성 시간의 편차의 평균제곱을 최소화하는 문제를 비제약적인 경우와 제약적인 경우에 다루고 있다. 모의 뜨임 기법을 이용하여 Eilon과 Chowdhury의 [4] 논문에 있는 예제를 테스트하였다. 제안된 자기 발견적 기법은 대부분의 경우에 좋은 해를 제공하였으며, 작업의 수가 200인 경우에도 해를 1초안에 찾았다. 비제약적인 경우와 제약적인 경우의 계산 결과가 제시되었으며, 다른 자기 발견적 기법에 의한 계산 결과와 비교하였다.

• Defense and Technology
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• no.11 s.141
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• pp.44-55
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• 1990

말레이지아의 방위산업 육성은 수많은 장애요소로 인하여 제약을 받게 될 것이다. 협소한 국내시장이 하나의 핵심적인 제약요소이다. 전략적인 원자재의 부족이 또 다른 요소이며, 숙련된 전문성의 부족이 장래발전을 방해하고 있다. 이러한 문제들 외에 원자재, 혹은 전문성, 혹은 면허문제이건간에 항상 국제의존의 문제가 남게 된다. 말레이지아가 자신의 독립적인 연구개발을 통해 국내생산을 수행할수 없는한 말레이지아는 이러한 국제의존의 함정으로부터 벗어날수 없을 것이다

• Proceedings of the Korean DIstribution Association Conference
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• 2007.11a
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• pp.43-66
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• 2007

의약품 산업은 소득 수준의 향상에 따라 건강에 대한 관심이 고조되고, 과학 기술의 발달에 따라 난치병 치료제가 개발되면서 세계 의약품 시장이 지속적으로 성장하고 있어, 21세기의 가장 주목 받는 차세대 성장 동력 산업 중 하나로 분류 된다. 이러한 의약품 산업은 정밀 화학이나 생명 공학 기술의 첨단 산업 분야로서 고도의 두뇌 인력을 필요로 하는 고부가가치 산업이기 때문에, 부존자원이 빈약하고 인적자원이 풍부한 우리나라의 경우 차세대 성장 동력 산업으로 육성하여야 하는 산업이다. 본 논문은 2007년 4월 2일 한${\bullet}$미 FTA 의약품 분야 체결이 한국 의약품 유통에 미치는 영향올 분석 및 검토한 후, 국내 제약사의 위기 상황을 극복하기 위한 대응 방안으로서 새로운 사업 모델인 셀프 메디케이션의 활용 방안에 대해 연구하였으며, 전략적 관점에서 선택과 집중의 이슈를 유형별로 나눈 후 국내 제약사의 강점인 일반 의약품, 대체 의약품 시장의 효율성과 기능을 강화할 수 있는 방안에 대해 연구하였다. 이를 위해 의약품의 특정과 경로 별 유통구조의 특정 그리고 우리나라와 선진국의 사례를 비교 분석한 결과 유럽 제약회사의 경우처럼 R&D 등 기술 혁신에 필요한 투자가 부족하면 세계의약품 시장의 경쟁에서 뒤떨어지고, 반대로 쥴릭 파마 코리아의 경우처럼 선진 다국적 물류회사의 국내 의약품 도매시장 석권이라는 현상도 알 수 있었다. 또한 미국과 FTA를 체결한 국가들의 많은 부작용 사례와 한${\bullet}$미 FTA 의약품 분야의 이슈를 비교 검토한 결과 많은 부정적 영향이 미치는 것으로 확인되었다. 따라서 국내 제약사의 위기 상황을 극복하기 위해 셀프 메디케이션을 전략적 관점에서 선택과 집중의 이슈에 대해 국내 제약사의 유형별로 대웅 방안을 제시하였다.

• Journal of Distribution Science
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• v.6 no.2
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• pp.41-60
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• 2008

This study examined state of local pharmaceuticals industry and investigated distribution system. The study found out associated problems as well as improvements of distribution system of local pharmaceuticals. Finally, to improve distribution system of local pharmaceuticals, the study investigated distribution system of 10 kinds of pharmaceuticals of 'J' Company being a leading local manufacturer of local pharmaceuticals, and found out improvements of the distribution system. The study collected and compiled 'J' Company's internal slips and reporting material from April 1, 2008 to July 31, 2008, and interviewed persons in charge continuously to find out state and problems of the distribution system.