한국임상약학회지 (Korean Journal of Clinical Pharmacy)

  • 제31권3호
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  • Pages.171-179
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  • 2021
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  • 1226-6051(pISSN)
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  • 2508-786X(eISSN)
한국임상약학회 (Korean College Of Clinical Pharmacy)
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유럽의 규제과학 및 규제과학 인재양성 프로젝트

European Regulatory Science and Regulatory Science Expert Training Project

  • 신호철 (중앙대학교 제약산업학과) ;
  • 박재홍 (중앙대학교 제약산업학과) ;
  • 김지원 (중앙대학교 제약산업학과) ;
  • 백다정 (중앙대학교 제약산업학과) ;
  • 이윤지 (중앙대학교 약학대학) ;
  • 정선영 (중앙대학교 제약산업학과) ;
  • 강원구 (중앙대학교 약학대학) ;
  • 김하형 (중앙대학교 약학대학) ;
  • 최영욱 (중앙대학교 제약산업학과) ;
  • 김은영 (중앙대학교 제약산업학과)
  • Shin, Hocheol (Department of Pharmaceutical Industry, Chung-Ang University) ;
  • Park, Jaehong (Department of Pharmaceutical Industry, Chung-Ang University) ;
  • Kim, Jiwon (Department of Pharmaceutical Industry, Chung-Ang University) ;
  • Baek, Dajung (Department of Pharmaceutical Industry, Chung-Ang University) ;
  • Lee, Yun-ji (College of Pharmacy, Chung-Ang University) ;
  • Jung, Sun-Young (Department of Pharmaceutical Industry, Chung-Ang University) ;
  • Kang, Wonku (College of Pharmacy, Chung-Ang University) ;
  • Kim, Hahyung (College of Pharmacy, Chung-Ang University) ;
  • Choi, Young Wook (Department of Pharmaceutical Industry, Chung-Ang University) ;
  • Kim, Eunyoung (Department of Pharmaceutical Industry, Chung-Ang University)
  • 투고 : 2021.09.13
  • 심사 : 2021.09.23
  • 발행 : 2021.09.30
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초록

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.

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참고문헌

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