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Biohealth Regulatory Science

For more details on the courses, please refer to the Course Catalog

교육과정
Code Course Title Credit Learning Time Division Degree Grade Note Language Availability
CSP5036 Pharmaceutical Communication 3 6 Major Master/Doctor Clinical and Social Pharmacy - No
This course is designed to help students become effective counselors and advocates for patients healthcare professionals. This course covers presents communication concepts and skills, communication tools and practical exercises for applying the patients and other health professionals.
CSP5038 Studies on Innovative Biotherapeutics 3 6 Major Master/Doctor Clinical and Social Pharmacy - No
This course is aimed (1) to understand science of innovative biotherapeutics including gene therapy, cell therapy, recombinant antibody products, recombinant protein products, vaccines, as well as targeted therapy. (2) to study related regulations and development guidelines (3) to be able to make development strategy for the innovative biotherapeutics.
CSP5039 Methods on Generating RWE for the evaluation of Drug Effectiveness 3 6 Major Master/Doctor Clinical and Social Pharmacy - No
This course will cover generating real-world evidence (RWE) on drug effectiveness by using real-world data (RWD), which includes electronic medical records and common data models. This course will provide detailed knowledge on the considerations and the process of conducting the study, such as a single-arm trial or external comparator, which are newly developed and utilized in this field.
CSP5040 Seminars in Pharmacoepidemiology 3 6 Major Master/Doctor Clinical and Social Pharmacy - No
This course is aimed to provide the considerations when conducting a pharmacoepidemiological study. The considerations will be divided into four parts (selection of study design, minimization of bias, study design-specific considerations, statistical analyses), and students will read at least 2 articles each week. Students will re-establish the fundamental knowledge in pharmacoepidemiology and enhance their ability to adapt to their researches
CSP5042 Advanced method in Pharmacoepidemiological study 3 6 Major Master/Doctor Clinical and Social Pharmacy - No
This course will deal with the diverse study design including case-crossover, self-controlledcase-series as well as cohort and case control design. The course will cover the concept of bias and solutions to reduce bias by study design and statistical method. The student will accomplish writing a study protocol, presentation, and participate in discussion for each protocol.
CSP5044 Analysis of Healthcare Database Using R 3 6 Major Master/Doctor Clinical and Social Pharmacy - No
This lecture deals with big data management focusing on data.table/fst packages, and statistical methods commonly used with jskm/jstable/jsmodule packages, and how to organize analysis results in various forms (documents, slides, web apps) with rmarkdown/shiny. All examples use data from HIRA/KNHIS/KNHANES so students can start analyzing the big data right away. By managing the code in the Github repository, I expect them to become familiar with open source and even be able to create R packages.
DHC5038 Measuring patient-reported outcomes in Digital Health Era 3 6 Major Master/Doctor 1-8 Digital Health Korean Yes
Interest in the patient's views of his or her illness and treatment has increased dramatically. Patient-reported outcomes (PROs) have emerged as precise methodological measures of patient-centered variables and have been successfully employed using diverse platforms and technologies, enhancing the value of research in critical illness survivorship and in direct patient care. However, good quality measurement of patient-reported outcomes is a complex activity requiring considerable expertise and experience. This class intended to serve two main purposes. First, this class presents the current status of health measurement, reviewing its theoretical and methodological bases and indicating those areas in which further development is required. Second, the course will teach the leading health measurement methods, providing practical information for those who intend to use a measure for clinical and research applications in digital health era
IPS5004 Good Manufacturing Practices 3 6 Major Master/Doctor 1-4 Industrial Pharmaceutical Science Korean Yes
This course will help students to understand GMP and to establish manufacturing strategy based on GMP guidelines. Topic includes practical knowledge of GMP and its regulation, guideline as well as GMP operation.
IPS5005 CMC(Chemistry, Manufacturing & Quality Controls) 3 6 Major Master/Doctor 1-4 Industrial Pharmaceutical Science - No
This course provides knowledges about drug manufacturing facility criteria, and the related policies and practices on DMF data submission. Topic includes practical knowledge of facility standards of manufactory and its regulation, DMF system as well as DMF writing.
IPS5006 Pharmacovigilance 3 6 Major Master/Doctor 1-4 Industrial Pharmaceutical Science - No
The objective of the course is to introduce the student to the post-marketing surveillance policies and help them acquire practical knowledges. It covers the basic concept of Pharmacovigilance, PMS related regulations, and importance of collecting data, reporting with adverse drug effects.
IPS5009 Introduction to Medical Product Regulation 3 6 Major Master/Doctor 1-4 Industrial Pharmaceutical Science Korean Yes
This course provides a comprehensive and strong foundation in the fundamentals of Regulatory compliance for drug. The content is ideal for those looking for an introduction to regulatory compliance or current compliance trends within the regulated environment. Topic include: RA history, how to access regulatory information, drug submission etc.
IPS5014 Clinical Trial Analysis 3 6 Major Master/Doctor 1-4 Industrial Pharmaceutical Science - No
The objective of this course is to apply epidemiological research methods to the solution of clinical problems and to the improvement of clinical decision making using the best available evidence. The course will present the main Clinical Epidemiology issues related to study design and interpretation using a wide variety of examples for practicing clinicians.
IPS5015 Clinical Trial Management (GCP) 3 6 Major Master/Doctor 1-4 Industrial Pharmaceutical Science Korean Yes
The objective of this course is to learn the mechanism of clinical studies and clinical trials. After this course, participants can conduct various clinical studies and trials. With understanding investigator's roles in clinical research, they can design the studies, develop the protocols, and make an analysis of data. Also they will learn the basic regulatory affairs and the ethics for clinical research.
IPS5020 Convergence Seminar on Market Access 3 6 Major Master/Doctor 1-4 Industrial Pharmaceutical Science Korean Yes
This course deals with problem that occurred in the all process of drug development in order to cover convergence issues for all management of pharmaceutical field. Course content will be included discussions and presentations in problem-based learning by students and experts or CEO.
IPS5021 Principles of Pharmacoepidemiology 3 6 Major Master/Doctor 1-4 Industrial Pharmaceutical Science - No
The course will help students acquired a basic understanding of the concepts and practice of pharmacoepidemiology. This course covers inference about the effects of pharmaceuticals from case report, case series, cohort studies, case-constrol studies and odds ratio. relative risk. Then, it is shown how epidemiological techniques are applied to pharmacoepidemiological studies.