유럽의 규제과학 및 규제과학 인재양성 프로젝트
European Regulatory Science and Regulatory Science Expert Training Project
1
조회
0
다운로드
1
인용
0
참고문헌
키워드
초록
Background: Need for regulatory science is emerging with the development of pharmaceutical industry. It is essential to trainregulatory science experts to meet the needs of technology and regulations to evaluate advanced products. Major regulatory sciencecountries are conducting the regulatory science activities and fostering the experts. Methods: Published literature and the relevantwebsite of European Union (EU) were reviewed and criteria were developed. In particular, we focused on in depth descriptions of theInnovative Medicines Initiative program, which was conducted twice. Results: EU is striving to provide funding and training expertsfor 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. IMIeducation and training projects have provided various education and training course including short-term curriculum and master anddoctoral course. The difference between South Korea’s regulatory science expert training project in 2021 and the EU’s IMI educationand training projects is participation of pharmaceutical companies. While the pharmaceutical companies participate in the IMIproject to select project topics and form a community, South Korea’s project is focused on the Ministry of Food and Drug Safety anduniversities. Conclusion: Through successful active networks with regulatory party, pharmaceutical companies, and universities, agreat innovative advance of regulatory science in South Korea is expected.
Abstract
Background: Need for regulatory science is emerging with the development of pharmaceutical industry. It is essential to trainregulatory science experts to meet the needs of technology and regulations to evaluate advanced products. Major regulatory sciencecountries are conducting the regulatory science activities and fostering the experts. Methods: Published literature and the relevantwebsite of European Union (EU) were reviewed and criteria were developed. In particular, we focused on in depth descriptions of theInnovative Medicines Initiative program, which was conducted twice. Results: EU is striving to provide funding and training expertsfor 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. IMIeducation and training projects have provided various education and training course including short-term curriculum and master anddoctoral course. The difference between South Korea’s regulatory science expert training project in 2021 and the EU’s IMI educationand training projects is participation of pharmaceutical companies. While the pharmaceutical companies participate in the IMIproject to select project topics and form a community, South Korea’s project is focused on the Ministry of Food and Drug Safety anduniversities. Conclusion: Through successful active networks with regulatory party, pharmaceutical companies, and universities, agreat innovative advance of regulatory science in South Korea is expected.
참고문헌 (37)
- Hines PA, "The European Medicines Agency’s goals for regulatory science to 2025", Nat Rev Drug Discov, 18(6), pp.403~404 (2019)
- Sakuma I, "Education and training in regulatory science for medical device development", Annu Int Conf IEEE Eng Med Biol Soc, pp.3155~3158 (2013)
- Hines PA, "Regulatory science and innovation programme for Europe(ReScIPE) : A proposed model", Br J Clin Pharmacol, 86(12), pp.2530~2534 (2020)
- Honig P, "Regulation and innovation : Role of regulatory science in facilitating pharmaceutical innovation", Clin Pharmacol Ther, 105(4), pp.778~781 (2019)
- Donnelly F, "Regulatory science as a means to respond to EU healthcare challenges and global market meeds", Journal of Regulatory Science, 4, pp.21~28 (2016)
- Institute of Medicine, "Strengthening a workforce for innovative regulatory science in therapeutics development: workshop summary", pp.31~41 (2012), National Academies Press
- Meyer RJ, "The role of academic medical centers in advancing regulatory science", Clin Pharmacol Ther, 95(5), pp.471~473 (2014)
- "Center of regulatory excellence"[URL]
- "Road map to 2015"[URL]
- Gaspar R, "Towards a European strategy for medicines research(2014-2020) : The EUFEPS position paper on Horizon 2020", Eur J Pharm Sci, 47(5), pp.979~987 (2012)
- "Horizon 2020", Nat Mater, 11(6), pp.477~ (2020)
- Laverty H, "The innovative medicines initiative-10 years of public-private collaboration", Front Med(Lausanne), 6, pp.275~ (2019)
- "EMA regualtory science to 2025strategic reflection"[URL]
- Goldman M, "The innovative medicines initiative moves translational immunology forward", Eur J Immunol, 43(2), pp.298~302 (2013)
- Goldman M, "The innovative medicines initiative : a European response to the innovation challenge", Clin Pharmacol Ther, 91(3), pp.418~425 (2012)
- Goldman M, "The innovative medicines initiative : an engine for regulatory science", Nat Rev Drug Discov, 14(1), pp.1~2 (2015)
- Spindler P, "Innovation of medical products: The evolution of regulatory science, research, and education", Ther Innov Regul Sci, 50(1), pp.44~48 (2016)
- "Innovative Medicines Initiative website"[URL]
- Dance A, "Regulatory science : Researchers in the pipeline", Nature, 496(7445), pp.387~389 (2013)
- "Report from the IMI-EMA-FDA regulatory science summit-collaborative research through publicprivate partnership in support to advancing regulatory science"[URL]
- Payton A, "On-course(®)portal : a tool for in-service training and career development for biomedical scientists", Drug Discov Today, 18(17-18), pp.803~806 (2013)
- "IMI EMTRAIN website"[URL]
- Payton A, "Course fees and academic ranking : insights from the IMI EMTRAIN on-course® database", Drug Discov Today, 19(7), pp.830~833 (2014)
- Hardman M, "LifeTrain : towards a European framework for continuing professional development in biomedical sciences", Nat Rev Drug Discov, 12(6), pp.407~408 (2013)
- "LifeTrain website"[URL]
- Klech H, "European initiative towards quality standards in education and training for discovery, development and use of medicines", Eur J Pharm Sci, 45(5), pp.515~520 (2012)
- "SafeSciMET website"[URL]
- "Eu2P website"[URL]
- Boeynaems JM, "A European approach to clinical investigator training", Front Pharmacol, 4, pp.112~ (2013)
- "PharmaTrain website"[URL]
- Silva H, "Core competencies for pharmaceutical physicians and drug development scientists", Front Pharmacol, 4, pp.105~ (2013)
- Kerpel-Fronius S, "Education and training for medicines development, regulation, and clinical research in emerging countries", Front Pharmacol, 6, pp.80~ (2015)
- Silva H, "Continuing medical education and professional development in the European Union", Pharm Med, 26(4), pp.223~233 (2012)
- Bongiovanni S, "Good research practice in non-clinical pharmacology and biomedicine. Handbook of Experimental Pharmacology, vol 257", pp.1~17 (2020), Springer Open
- "EQIPD website"[URL]
- Bespalov A, "Introduction to the EQIPD quality system", Elife, 10, pp.e63294~ (2021)
- "Regulatory science talent training project (R&D) announcement" (2021)[URL]