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KMID : 0941820210310030171
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Korean Journal of Clinical Pharmacy
2021 Volume.31 No. 3 p.171 ~ p.179
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European Regulatory Science and Regulatory Science Expert Training Project
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Shin Ho-Cheol
Park Jae-Hong
Kim Ji-Won
Baek Da-Jung
Lee Yun-Ji
Jung Sun-Young
Kang Won-Ku
Kim Ha-Hyung
Choi Young-Wook
Kim Eun-Young
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Abstract
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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.
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KEYWORD
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Regulatory science, innovative medicines initiative, IMI, education and training, training project
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