Drug Regulatory Affairs and Policy

课程简介

Drug Regulatory Affairs and Policy 课程名称：Master of Science Program in Drug Regulatory Affairs and Policy 学位类型：理学硕士（Drug Regulatory Affairs and Policy） 修读模式：全日制或兼读制 学制：全日制: 1 年 兼读制: 2 年s 学费：港币330,000 开设学院/学系：Division of Life Science 官方网站：https://drap.hkust.edu.hk 课程简介：The Master of Science (MSc) Program in Drug Regulatory Affairs and Policy is designed to train professionals in drug regulatory affairs and policy, which are critical areas for Hong Kong and Greater Bay Area development. A not

关键信息

入学要求

To qualify for admission, applicants must meet all of the following requirements. Admission is selective and meeting these minimum requirements does not guarantee admission. 1. General Admission Requirements of the University Applicants seeking admission to a master's degree program should have obtained a bachelor’s degree from a recognized institution, or an approved equivalent qualification. 2. English Language Admission Requirements Applicants have to fulfill English Language requirements with one of the following proficiency attainments: TOEFL iBT: 80 (for tests taken prior to 21 January 2026) * 4.5 (for tests taken from 21 January 2026 onwards) * TOEFL pBT: 550 TOEFL Revised paper-delivered test: 60 (total scores for Reading, Listening and Writing sections) IELTS (Academic Module): Overall score: 6.5 and All sub-score: 5.5 * * Refers to scores in one single attempt only. Test at home option is not accepted. Applicants are not required to present TOEFL or IELTS score if their first language is English, or they obtained the bachelor's degree (or equivalent) from an institution where the medium of instruction was English. 3. Program-Specific Admission Requirements A bachelor's degree or above in life sciences, business management, engineering, health science, law, computer sciences, mathematics, and other relevant disciplines. 4. Additional Information Relevant work experience in areas such as pharmaceuticals, medical devices, or health-related industry will be highly favorable. 原文链接：https://prog-crs.ust.hk/pgprog/2027-28/msc-drap/ 二、课程简介（英文原文） The Master of Science (MSc) Program in Drug Regulatory Affairs and Policy is designed to train professionals in drug regulatory affairs and policy, which are critical areas for Hong Kong and Greater Bay Area development. A notable highlight in the HKSAR Policy Address 2023 is the establishment of Hong Kong Centre for Medical Products Regulation (CMPR). The HKCMPR will be dedicated to potential restructuring and strengthening of current regulatory and approval regimes for medicine, medical devices and medical technology, in order to accelerate the approving applications and launching for registration of pharmaceutical products to the market. Our program is unique for preparing students to become proficient managers and main practitioners of guidance documents, laws, and regulations for pharmaceutical companies and government agencies. Upon completion of this program, graduates will be well-equipped to assume regulator y affairs positions in pharmaceutical, biotechnology, medical device, diagnostic and healthcare products companies, as well as government agencies. 三、学习目标（英文原文） On successful completion of the program, graduates will be able to: Understand the rationale behind, and basic management practices of, quality control and quality assurance of pharmaceutical product development. Develop a thorough understanding on the relevant laws/regulations and/or regulatory environment of drug registration in China or US market. Gain professional training in keeping up with the increasing scope and complexity of the governmental regulations. Enhance good personality and communication skills in pharmaceutical regulations and policy. Serve as the top management and become main practitioners of the laws and regulations for pharmaceutical companies and/or government agencies; advising them on the regulatory aspects and climate that would affect their proposed activities. Ensure that the pharmaceutical companies comply with the regulations of NMPA or FDA drug registration and laws pertaining to their business, and work with central, provincial and local regulatory agencies and personnel on specific issues affecting their business. 四、课程设置（英文原文） Minimum Credit Requirement 30 credits Required Courses 12 credits DRAP 5001 DRAP 5002 DRAP 5003 DRAP 5004 Elective Courses 18 credits Students are required to take at least three DRAP courses from the following list: BTEC 5220 BTEC 5340 BTEC 5380 BTEC 5550 DRAP 5101 DRAP 5102 DRAP 5103 DRAP 5104 DRAP 5105 DRAP 5106 DRAP 5107 DRAP 6201 DRAP 6202 ELBT 5101 ELBT 5102 ELBT 5103 ELBT 5104 ELBT 5105 Remarks Part-time students may take a maximum of 9 credits in each term.

课程结构

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