For more details on the courses, please refer to the Course Catalog
| Code | Course Title | Credit | Learning Time | Division | Degree | Grade | Note | Language | Availability |
|---|---|---|---|---|---|---|---|---|---|
| BHR5028 | Special topics in Pharmacokinetics/Pharmacodynamics efficacy assessment | 3 | 6 | Major | Master/Doctor | Biohealth Regulatory Science | - | No | |
| In this class, students will learn how to evaluate efficacy based on mathematical modeling and simulation to predict drug response and action according to drug dose and administration. | |||||||||
| BHR5029 | Special topics in ICH guidelines | 3 | 6 | Major | Master/Doctor | Biohealth Regulatory Science | Korean | Yes | |
| This course introduces the core ICH guidelines on the principles of drug development and the approval of their marketing. The purpose of ICH guidelines as a global standard for regulation and the process for their implementation will be reviewed. They will aid drug developers to acquire the quality, safety and efficacy of pharmaceuticals. | |||||||||
| BHR5033 | Understanding medical product regulation | 3 | 6 | Major | Master/Doctor | Biohealth Regulatory Science | - | No | |
| This course introduces the system of drug approval, which is critical in safety management of the drugs. Students will learn how the data obtained in the process of drug development, pre-clinical and clinical study, and CMC (Chemistry, Manufacturing and Control) are incorporated in the dossier of drug approvals. | |||||||||
| BHR5035 | Introduction to Clinical Medicine | 3 | 6 | Major | Master/Doctor | Biohealth Regulatory Science | - | No | |
| The ultimate purpose of new drug development is to promote human health and treat new disease. As the social environment, such as aging, changes and diagnostic technologies develop, rare diseases that have not been predicted so far are being discovered. Since the development of new drug due to unmet medical need is increasingly important, understanding of human diseases and functions is essential for fostering and training regulatory science professionals. This subject aims to lay the foundation on new drug development by learning the treatment mechanism, understanding disease and introducing clinical trial cases. In addition, this subject plans to understand and apply the latest treatments for anticancer drugs, circulators, brain and blood vessels, rare diseases, and CAR-T, which are major treatment areas for recent new drug development, to clinical trials. Through this class, we plan to acquire a regulatory scientific perspective on the considerations when developing new drug, clinical trial design as well as clinical trial conduct. | |||||||||
| BHR5036 | Seminar in Regulatory Science of Biohealth | 3 | 6 | Major | Master/Doctor | Biohealth Regulatory Science | Korean | Yes | |
| This course will cover from the history of regulatory science and its development, decision-making methods used by regulatory bodies, perspective of regulatory science from the pharmaceutical industry, and recently developed methodological tools to help regulatory science from academia. The course will involve presentations from relevant field experts and interactive discussions with the students for a problem-based learning. | |||||||||
| BHR5037 | Methods on data-mining in clinical study | 3 | 6 | Major | Master/Doctor | Biohealth Regulatory Science | Korean | Yes | |
| This course will provide the methodological approaches and databases for detecting potential adverse events induced by the use of medications and understand the recent trends in this field. In addition, to enhance the ability of conducting clinical study, the students will develop the study protocol and participate the practical analyses based on real-world examples. | |||||||||
| BHR5038 | Methods to Generate RWE for Assessing Effectiveness | 3 | 6 | Major | Master/Doctor | Biohealth Regulatory Science | - | No | |
| This course will cover methodological approaches (epidemiological, statistical, clinical) and considerations when conducting clinical research to investigate the effectiveness of a drug by using real-world data (RWD), that includes health insurance claims and electronic medical records. This course will nurture basic knowledge in conducting an effectiveness study that uses RWD, along with details in study design, analysis, and interpretation of results, to potentially aid in regulatory or clinical decision-making. | |||||||||
| BHR5039 | Introduction of Regulatory Science in Pharmaceuticals | 3 | 6 | Major | Master/Doctor | Biohealth Regulatory Science | Korean | Yes | |
| This course introduces the meaning of regulatory science, its purpose and research trends. Students learn the research areas of regulatory science in data science, advanced biotherapeutics, and innovative clinical trials, which will help them to propose research topics that will be relevant in Korea. | |||||||||
| BTH5005 | Regulatory Strategy and Commercialization of Biomedicine | 3 | 6 | Major | Master/Doctor | Biopharmaceutical Convergence | Korean | Yes | |
| This lecture is about 1) the main elements of biopharmaceutical development process and safety management, 2) regulations and guidelines for domestic drug approval review, 3) ICH CTD, IND, ANDA, NDA, IMD, 4) understanding of the fair and drug store And 5) commercialization strategy. | |||||||||
| BTH5018 | Advanced Microbial Chemical Biology | 3 | 6 | Major | Master/Doctor | Biopharmaceutical Convergence | - | No | |
| Lectures from a chemical-biological perspective on how secondary metabolites produced by microorganisms affect other organisms. | |||||||||
| BTH5027 | Advanced Gene Therapy | 3 | 6 | Major | Master/Doctor | Biopharmaceutical Convergence | - | No | |
| Explain the principles of gene therapy and the advantages and disadvantages of various gene delivery systems. In particular, by reviewing the gene therapies reported to date by disease, the principles of various gene therapies are understood. | |||||||||
| BTH5041 | Advanced Stem Cell Engineering | 3 | 6 | Major | Master/Doctor | Biopharmaceutical Convergence | - | No | |
| In this course, based on the understanding of the basic concept of stem cells, this course introduces more in-depth and recent research trends in stem cell application technology applied to the treatment of incurable diseases and acquires detailed research contents. | |||||||||
| BTH5050 | Research for Innovative New Drug Development | 3 | 6 | Major | Master/Doctor | Biopharmaceutical Convergence | Korean | Yes | |
| By grasping each stage of the development of new biologic drugs in detail, we acquire the knowledge necessary to develop a new paradigm of innovative biopharmaceuticals. | |||||||||
| BTH5056 | Methodologies in Interdisciplinary Science | 3 | 6 | Major | Master/Doctor | Biopharmaceutical Convergence | English | Yes | |
| A joint supervisor participates in teaching the progress of research, research methodology, and result analysis methodology. The format is research purpose, research background, research hypothesis or research motivation, interpretation of results, results, and experiments to supplement results. | |||||||||
| BTH5057 | Research Intensive Class on Biomedical Science 1 | 3 | 6 | Major | Master/Doctor | Biopharmaceutical Convergence | - | No | |
| This course focuses on the analysis of research trends in the field of biomedical science and the progress of research results conducted by graduate students. | |||||||||