Pilihan program

Ringkasan program

This program is designed to deepen their understanding of current regulations and their practical application in the development and commercialization of drugs, biologics, and medical device products. Regulatory affairs courses within this program will provide students with the integrated knowledge and broad perspectives needs to effectively manage the regulatory process. From discovery to commercialization, this regulatory affairs master’s degree will cover the steps that are required to bring a medical product to market, both in the U.S. and around the globe.

Modul program

The modules are Required Courses (24 q.h.): RGA 6100 Introduction to Drug and Medical Device Regulation 4 q.h., BTC 6210 Human Experimentation: Methodological Issues Fundamental to Clinical Trials 4 q.h., RGA 6201 New Drug Development: A QA Regulatory Overview 4 q.h., RGA 6200 Biologics Development: A QA Regulatory Overview 4 q.h., RGA 6202 Medical Device Development: A QA Regulatory Overview 4 q.h., RGA 6203 Food, Drug, and Medical Device Law: Topics and Cases (this course should be taken as the final required course) 4 q.h., Choose one of the following Business and Law courses (4 q.h.): BTC 6260 The Business of Medicine and Biotechnology 4 q.h., HMG 6170 Health Law, Politics, and Policy (Students taking this course must also take a 1 q.h., independent study course to meet the 4 q.h., Business and Law course requirement.) 3 q.h., RGA 6110 Understanding the Health Care Landscape 4 q.h., RGA 6112 Biomedical Intellectual Property Management: Patents, Trademarks, Copyrights, Trade Secrets, and Technology Licensing 4 q.h., RGA 6214 Food and Drug Administration: Creation, Behavior, and Regulatory Culture 4 q.h., RGA 6220 Global Biotechnology Product Registration: E.U., U.S. Product Regulation 4 q.h., RGA 6221 European Union Compliance Process and Regulatory Affairs 4 q.h., RGA 6218 Regulatory Affairs in an Entrepreneurial Environment 4 q.h., RGA 6217 Biomedical Product Development: From Biotech to Boardroom to Market 4 q.h., RGA 6240 The Evolving Indian Regulatory Landscape 4 q.h., Choose one of the following Safety and Surveillance courses (4 q.h.): BTC 6211 Validation and Auditing of Clinical Trial Information 4 q.h., RGA 6206 Practical Aspects of Regulatory Compliance 4 q.h., RGA 6212 Safety Sciences 1: Introduction to Safety and Surveillance for Drugs, Biologics, and Medical Devices in the U.S. and Abroad 4 q.h., TCC 6370 Regulatory Writing: Medical Device Submissions 4 q.h., TCC 6380 Regulatory Writing: New Drug Applications 4 q.h., TCC 6310 Regulatory Documentation Processes 4 q.h., RGA 6219 Advertising and Promotion of Drugs and Medical Device Products 4 q.h., RGA 6230 Clinical Laboratory Management in Clinical Trials 4 q.h., Choose from one of the following Development and Marketing courses (4 q.h.): BTC 6213 Clinical Trial Design Optimization and Problem Solving 4 q.h., RGA 6205 Emerging Trends and Issues in the Medical Devices Industry 4 q.h., RGA 6210 Strategic Planning and Project Management for Regulatory Affairs Professionals in Domestic and International Markets 4 q.h., RGA 6211 Combination Products and Convergence 4 q.h., RGA 6215 Project Management in Early Drug Discovery and Development 4 q.h., RGA 6216 Medical, Social, and Financial Dimensions of Orphan Drugs 4 q.h., PMC 6212 Clinical Drug Development Data Analysis: Concepts and Applications 4 q.h., RGA 6228 Managing International Clinical Trials 4 q.h., RGA 6280 Advanced Writing on International Biomedical Topics 4 q.h., Elective Courses-Some Suggested Topics: RGA 6213 Safety Sciences 2: Safety Surveillance, Pharmacoepidemiology, and Risk Management in the U.S. and Abroad 4 q.h., RGA 6222 Global Awareness: European Medical Device Regulations 4 q.h., RGA 6223 Global Awareness: Introduction to Canadian, Asian, and Latin American Regulatory Affairs 4 q.h., RGA 6225 Global Awareness: Japan Medical Device Regulations and Registrations 4 q.h., RGA 6226 Canadian and Australian Medical Device Regulations 4 q.h., RGA 6227 Global Awareness: Emerging Medical Device Markets 4 q.h., COP 6940 Personal and Career Development: Leadership in Practice 3 q.h.

Persyaratan masuk bagi mahasiswa internasional

Applicants should have an official associate or bachelor's degree transcript from an accredited college or university in the U.S, stating degree conferral and date. International applicants should have a TOEFL score of 79 on the internet-based test, 550 on the paper-based test; TOEIC score of 700; IELTS score of 6.0; NU Global English Exam score of 100. They should have obtained ‘Pre-1’ in Eiken Test in Practical English Proficiency.

Kualifikasi

Magister (S2)

Institusi penerbit ijazah

NORTHEASTERN UNIVERSITY

Nama jurusan

Northeastern University