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규제과학 및 규제과학 전문가 양성 프로젝트의 국내외 동향분석: 미국, 일본, 싱가포르, 한국을 중심으로
Analysis of Trends in Regulatory Science and Regulatory Science Experts Training Projects: US, Japan, Singapore, and Korea 원문보기

한국임상약학회지 = Korean journal of clinical pharmacy, v.31 no.4, 2021년, pp.257 - 267  

박재홍 (중앙대학교 제약산업학과) ,  신호철 (중앙대학교 제약산업학과) ,  김지원 (중앙대학교 제약산업학과) ,  김민수 (중앙대학교 제약산업학과) ,  도인구 (중앙대학교 제약산업학과) ,  임희연 (중앙대학교 제약산업학과) ,  이지원 (중앙대학교 제약산업학과) ,  이윤지 (중앙대학교 약학대학) ,  정선영 (중앙대학교 제약산업학과) ,  강원구 (중앙대학교 약학대학) ,  김하형 (중앙대학교 약학대학) ,  최영욱 (중앙대학교 제약산업학과) ,  김은영 (중앙대학교 제약산업학과)

Abstract AI-Helper 아이콘AI-Helper

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 fo...

주제어

참고문헌 (51)

  1. Callreus T, Schneider CK. The Emergence of Regulatory Science in Pharmaceutical Medicine. Pharm Med 2013;27:345-51. 

  2. Hyun JH. The concept of regulatory science and policy trends. BioIN. Vol. 27. 2015. Available from https://www.bioin.or.kr/board.do?num264406&cmdview&bidreport. Accessed September 30, 2021. 

  3. Sakuma I. Education and training in regulatory science for medical device development. Annu Int Conf IEEE Eng Med Biol Soc 2013;2013:3155-8. 

  4. Uchiyama, M. Regulatory science. PDA J Pharm Sci Technol 1995;49(4):185-7. 

  5. Uyama Y. The importance of a regulatory science approach for better pharmaceutical regulation. Translat Regulat Sci 2019;1(1):8-11. 

  6. Kondo T, Hayashi Y, Sato J, Sekine S, Hoshino T, Sato D. Evolving vision of regulatory science in the global medical community. Clinical Pharmacology & Therapeutics 2019;107(1):136-9. 

  7. Honig P, Zhang L. Regulation and innovation: Role of regulatory science in facilitating pharmaceutical innovation. Clin Pharmacol Ther 2019;105(4):778-81. 

  8. Tominaga T, Asahina Y, Uyama Y, Kondo T. Regulatory science as a bridge between science and society. Clin Pharmacol Ther 2011;90(1):29-31. 

  9. Asahina Y, Tanaka A, Utama Y, Kuramochi K, Maruyama H. The Roles of regulatory science research in drug development at the pharmaceuticals and medical devices agency of Japan. Ther Innov Regul Sci 2013;47(1):19-22. 

  10. National Institute of Food and Drug Safety Evaluation. Food and Drug R&D story. Vol. 01. 2018. Available from https://www.nifds.go.kr/brd/m_20/view.do?seq12591&srchFr&srchTo&srchWord%EC%8B%9D%EC%9D%98%EC%95%BD&srchTp0&itm_seq_10&itm_seq_20&multi_itm_seq0&company_cd&company_nm&page2. Accessed September 30, 2021. 

  11. Food and Drug Administration. 2021 Advancing Regulatory Science at FDA: FOCUS AREAS OF REGULATORY SCIENCE (FARS). Available from https://www.fda.gov/news-events/fda-brief/fda-brief-fda-publishes-report-focus-areas-regulatory-science. Accessed September 30, 2021. 

  12. Korea Biomedicine Industry Association. Biopharmaceutical Industry Trend Report. 2020. Available from http://www.kobia.kr/bbs/board.php?tblnotice&modeVIEW&num327&category&findEx&findType&findWord&sort1&sort2&it_id&shop_flag&mobile_flag&page1. Accessed September 30, 2021. 

  13. Ministry of Food and Drug Safety. The 1st Regulatory Science Innovation Forum. Announcement. 2021. Available from http://www.nifds.go.kr/brd/m_20/view.do?seq12774&srchFr&srchTo&srchWord%EA%B7%9C%EC%A0%9C%EA%B3%BC%ED%95%99&srchTp0&itm_seq_10&itm_seq_20&multi_itm_seq0&company_cd&company_nm&page1. Accessed September 30, 2021. 

  14. Shin HC, Park JH, Kim JW, et al. European regulatory science and regulatory science expert training project. Korean J Clin Pharm 2021;31(3):171-179. 

  15. Jasanoff S. What is the regulatory science? Concept and history in United States and in Japan - Interview with Professor Sheila Jasanoff -. Clin Eval 2011;39(1) 

  16. Moghissi AA, Calderone RA, McBridea DK, Jaegera L. Innovation in Regulatory Science: Metrics for Evaluation of Regulatory Science Claims Based on Best Available Regulatory Science. Journal of Regulatory Science 2017;5(1):50-59 

  17. Ministry of Food and Drug Safety. Singapore's pharmaceutical industry characteristics and policies, related organizations and regulations. 2016. Available from https://www.mfds.go.kr/brd/m_617/view.do?seq32233&srchFr&srchTo&srchWord&srchTp&itm_seq_10&itm_seq_20&multi_itm_seq0&company_cd&company_nm&page4. Accessed September 30, 2021. 

  18. C. Wohlin, Guidelines for snowballing in systematic literature studies and a replication in software engineering. In: Proceedings of the 18th International Conference on Evaluation and Assessment in Software Engineering, London, United Kingdom, May 13-14, 2014. 

  19. Pharmaceuticals and Medical Devices Agency website. Available from https://www.pmda.go.jp/english/rs-sb-std/rs/0003.html. Accessed September 30, 2021 

  20. European Medicines Agency. Road map to 2015. Available from https://www.ema.europa.eu/en/documents/report/road-map-2015-european-medicines-agencys-contribution-science-medicineshealth_en.pdf2010. Accessed September 30, 2021 

  21. Food and Drug Administration. Impact stories website. Available from https://www.fda.gov/drugs/regulatory-science-action/impact-stories. Accessed September 30, 2021. 

  22. Sheffield KM, Dreyer NA, Murray JF, Faries DE, Klopchin MN. Replication of randomized clinical trial results using real-world data: paving the way for effectiveness decisions. J Comp Eff Res 2020;9(15):1043-50. 

  23. FDA CERSI web site. Available from https://www.fda.gov/science-research/advancing-regulatory-science/centers-excellence-regulatory-science-and-innovation-cersis. Accessed September 30, 2021. 

  24. Moghissi AA, Calderone RA, Auffret JP, et al. Regulatory Science Education: The Need for Generalization. Journal of Regulatory Science 2020;8:1-7. 

  25. Hines PA, Guy RH, Brand A, Humphreys AJ, Papaluca-Amati M. Regulatory science and innovation programme for Europe (ReScIPE): A proposed model. Br J Clin Pharmacol 2020;86(12): 2530-4. 

  26. ORISE web site. Available from https://orise.orau.gov/fda/. Accessed September 30, 2021. 

  27. National Cancer Institude. Interagency Oncology Task Force Fellowship. Available from https://www.cancer.gov/grants-training/training/at-nci/iotf. Accessed September 30, 2021. 

  28. U.S. Food & Drug Administration. Training and Continuing Education. Available from https://www.fda.gov/training-and-continuing-education. Accessed September 30, 2021. 

  29. University of Maryland. Master of Science (MS) and Graduate Certificate in Regulatory Science. Available from http://www.pharmacy.umaryland.edu/academics/regulatoryscience. Accessed September 30, 2021. 

  30. Johns Hopkins University. MS in Regulatory Science/Drug Compliance. Available from https://advanced.jhu.edu/academics/graduate/ms-regulatory-science. Accessed September 30, 2021. 

  31. Stanford University in collaboration with the University of California at San Francisco. UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI). Available from https://www.ucsf.edu/education. Accessed September 30, 2021 

  32. University of Southern California. Regulatory science. Available from https://regulatory.usc.edu. Accessed September 30, 2021. 

  33. PMDA. Mid-term Targets/Mid-term Plan. Available from https://www.pmda.go.jp/english/about-pmda/midterm-targets-plans/0001.html. Accessed September 30, 2021 

  34. PMDA Center for Regulatory Science. Available from https://www.pmda.go.jp/files/000235786.pdf. Accessed September 30, 2021 

  35. PMDA. Direction of the Fourth Mid-term Plan. 2018. Available from https://www.pmda.go.jp/files/000226342.pdf. Accessed September 30, 2021. 

  36. Yamaguchi T, Uchida E, Okada T, et al. Aspects of gene therapy products using current genome-editing technology in Japan. Hum Gene Ther 2020;31(19-20):1043-53. 

  37. ICMRA web site. Available from http://www.icmra.info/drupal/en. Accessed September 30, 2021. 

  38. Osawa M, Ueno T, Ishikawa H, Imai Y, Garimella T. Population pharmacokinetic analysis for daclatasvir and asunaprevir in Japanese subjects with chronic hepatitis C virus infection. J Clin Pharmacol 2018;58(11):1468-78. 

  39. Matsushita S, Tachibana K, Kondoh M. The clinical innovation network: a policy for promoting development of drugs and medical devices in Japan. Drug Discov Today 2019 Jan;24(1):4-8. 

  40. Yamada K, Itoh M, Fujimura Y, et al. The utilization and challenges of Japan's MID-NET ® medical information database network in postmarketing drug safety assessments: A summary of pilot pharmacoepidemiological studies. Pharmacoepidemiol Drug Saf 2019;28(5):601-8. 

  41. JAMED wet site. Available from https://www.amed.go.jp/en/index.html. Accessed September 30, 2021. 

  42. Regulatory Science and Emerging Technology in Japan. Available from https://www.nihs.go.jp/kanren/iyaku/20200928-dga.pdf. Accessed September 30, 2021 

  43. NIHs wet site. Available from http://www.nihs.go.jp/english/index.html. Accessed September 30, 2021. 

  44. PMDA. Comprehensive cooperation agreement. Available from https://www.pmda.go.jp/rs-std-jp/joint-grad-school/0001.html. Accessed September 30, 2021. 

  45. PMDA. Asian Pharmaceutical and Medical Device Training Center. Available from https://www.pmda.go.jp/int-activities/training-center/0001.html. Accessed September 30, 2021. 

  46. CoRE web site. Available from https://www.duke-nus.edu.sg/core/education-journey. Accessed September 30, 2021. 

  47. Lim JCW. Strengthening health products regulatory systems to enhance access to quality health products in the Asia-Pacific. Ther Innov Regul Sci 2018;52(6):751-754. 

  48. Sungkyunkwan University Pharmaceutical Regulatory Science Center Web site. Available from https://kraps.co.kr/. Accessed September 30, 2021. 

  49. Ministry of Food and Drug Safety. Regulatory science expert training project (R&D) announcement 2021. Available from https://www.mfds.go.kr/brd/m_99/view.do?seq44172. Accessed September 30, 2021. 

  50. Tohkin M. Current status of regulatory science education in faculties of pharmaceutical science in Japan. Yakugaku Zasshi 2017;137(4):453-7. 

  51. Kang D, Bae EM, Kim S, Kim S, Choi SE. Regulatory science: Definition and development strategy. Yakhak Hoeji 2021;65(5):335-3. 

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