Korean J Clin Pharm.
2021 Sep;31(3):171-179. 10.24304/kjcp.2021.31.3.171.
European Regulatory Science and Regulatory Science Expert Training Project
- Affiliations
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- 1Department of Pharmaceutical Industry, Chung-Ang University, Seoul 06974, Republic of Korea
- 2Clinical Data Analysis, Evidence-Based Clinical Research Laboratory, Departments of Health Science & Clinical Pharmacy, College of Pharmacy, Chung-Ang University, Seoul 06974, Republic of Korea
- 3College of Pharmacy, Chung-Ang University, Seoul 06974, Republic of Korea
- KMID: 2520991
- DOI: http://doi.org/10.24304/kjcp.2021.31.3.171
Abstract
- 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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