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 | - | 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 | 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 | - | 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 | - | 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 | 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 | 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 | - | 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 | 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. | |||||||||
| BTH5006 | Advanced Biotechnology | 3 | 6 | Major | Master/Doctor | Biopharmaceutical Convergence | - | No | |
| Advanced Biotechnology provides the basis for the application of biological science at the molecular level such as synthesis of DNA, RNA and protein, genome sequencing and analysis, regulation of gene expression, mutagenesis and recombination of DNA, and Omics data analysis. This course also provides advanced knowledge and technologies for human and animal health including molecular diagnostics, protein and gene therapy and vaccines, and for the development of useful products and it's mass production using microorganisms, plants and animals for applications in industry, agriculture, environment and biomedicine. | |||||||||
| BTH5007 | Protein Engineering | 3 | 6 | Major | Master/Doctor | Biopharmaceutical Convergence | - | No | |
| This lecture introduces basic biochemistry and structural knowledges for protein engineering together with case studies for industrial and medical applications | |||||||||
| BTH5008 | Advanced Medical Biotechnology | 3 | 6 | Major | Master/Doctor | Biopharmaceutical Convergence | - | No | |
| Lectures on understanding of drug delivery and diagnostic technologies and applied technologies through convergence between academic fields such as medicine, biotechnology, and nanotechnology. | |||||||||
| BTH5009 | Microbial Culture Engineering | 3 | 6 | Major | Master/Doctor | Biopharmaceutical Convergence | - | No | |
| The goal is to establish a theoretical concept for optimizing the fermentation process and separation and purification process for the production of microbial metabolites, and it helps to train human resources required for the enzyme and fermentation industry by directly delivering experimental experiences such as fermentation, enzymatic mechanism, purification, and immobilization of microorganisms. | |||||||||
| BTH5010 | Peptide Drug Development | 3 | 6 | Major | Master/Doctor | Biopharmaceutical Convergence | - | No | |
| This class focuses on peptide therapeutics which are emerging drugs. The conventional peptide chemistry and cutting edge chemistry related to peptide preparation are covered by the lectures and seminar. Preparation and application for therapeutics of peptide libraries are discussed in-depth. | |||||||||
| BTH5013 | Advanced Biochemistry | 3 | 6 | Major | Master/Doctor | Biopharmaceutical Convergence | - | No | |
| This course aims at students who have completed basic biochemistry to understand what diseases are associated with the modification of biochemical reactions, and how to apply or apply biochemistry in the process of diagnosis and treatment of disease in the future. | |||||||||