Ajou News

NEW Participate in Project to Develop Human Resources in Regulatory Science and Experts in Bio-health Regulatory Science

  • 2021-05-24
  • 1605

Ajou University was chosen to participate in the R&D Project to Nurture Human Resources in Regulatory Science, sponsored by the Ministry of Food and Drug Safety (MFDS), and will receive a subsidy of KRW 2.5 billion in total over the next five years.


Regulatory science involves the development of new tools, criteria, and approaches to evaluate safety, validity, quality, and performance, among others, of food, drugs, medical devices and other regulated products. Recent growth in the bio-health industry has triggered a notable increase in demand for human resources in this field.


The R&D Project to Nurture Human Resources in Regulatory Science is a new government-funded initiative in 2021 by the MFDS and aims at developing researchers and field experts to lead new industries in regulatory science through trilateral cooperation among industry, academia, and research institutes.


The selection of universities to carry out the project occurred through a contest in which the MFDS designated projects in the three fields of pharmaceuticals, medical devices, and food. Ajou University was chosen for ‘Evaluation of Pharmaceutical Product Safety’ (managed by the College of Pharmacy; Chief of Research Lee Suk-hyang, Dean of the College of Pharmacy). As a result, the College of Pharmacy will begin a graduate program in Bio-health and Regulatory Science and invite 20 new students beginning the second semester of the 2021 academic year.


The curriculum for Bio-health and Regulatory Science majors will focus on on-site, practical education, which will include Advanced Theory on Regulatory Science, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines, Clinical Pharmacology, Evidence-based Regulatory Decision-making, Big Data (RWD/RWE) Analysis and internships at bio-pharma companies.


Graduates will be able to move on to numerous entities, including pharmaceutical research institutes and bio-health safety evaluation companies, or work as regulatory science legal experts in relation to certification of contract research organizations (CROs) or healthcare data analysts.


Throughout this project, Ajou University plans to cultivate more than 120 core persons to lead the global regulatory science industry. To achieve this goal, the major will begin in the second semester this year and the Department of Bio-health Regulatory Science in 2022.