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MS RegAffairs FY13

This program provides a Master's degree in regulatory affairs for medical products. The curriculum covers regulations for drugs, biologics, and medical devices and prepares students to help companies navigate the regulatory environment and bring products to market. The degree aims to give students the knowledge and skills needed to work in fields like medical product development and clinical investigations.

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Gyanendra Singh
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284 views2 pages

MS RegAffairs FY13

This program provides a Master's degree in regulatory affairs for medical products. The curriculum covers regulations for drugs, biologics, and medical devices and prepares students to help companies navigate the regulatory environment and bring products to market. The degree aims to give students the knowledge and skills needed to work in fields like medical product development and clinical investigations.

Uploaded by

Gyanendra Singh
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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This program is appropriate for international applicants

who want to study in the U.S. on a student visa.

o c
ONLINE

MASTER OF SCIENCE
I N R E G U L AT O R Y A F FA I R S F O R D R U G S ,
BIOLOGICS, AND MEDICAL DEVICES

CURRICULUM

Ever-changing laws and regulations are driving demand for

RGA 6100 Introduction to Drug and Medical



Device Regulation
BTC 6210 Human Experimentation: Methodological

Issues Fundamental to Clinical Trials
RGA 6201 New Drug Development:

A QA/Regulatory Overview
RGA 6200 Biologics Development:

A QA/Regulatory Overview
RGA 6202 Medical Device Development:

A QA/Regulatory Overview
RGA 6203 Food, Drug, and Medical Device Law:

Topics and Cases (should be taken as the

final required course)

regulatory affairs professionals who can help companies


effectively bring medical products to market. To prepare
you to effectively manage regulatory activities, Northeastern
Universitys College of Professional Studies offers the
Master of Science in Regulatory Affairs for Drugs, Biologics,
and Medical Devices.
This unique graduate degree is designed to deepen your
understanding of current regulations and their practical

graduate degree programs

CAMPUS

application in the development and commercialization of


drugs, biologics, and medical device products. Regulatory
affairs courses within this program will provide you with the
integrated knowledge and broad perspectives you need to
effectively manage the regulatory process.
Program Objectives:
n

Gain the essential knowledge and skills required

to help companies navigate an increasingly complex

regulatory environment

Acquire the foundation necessary to work within a

variety of fields, including medical product

development, pharmaceutical sales, strategic

Required Core Courses (Essential Topics)

Completion of RGA 6280: Advanced Writing on International


Biomedical Topics may be required of students as a
condition for their continued enrollment in this program.

Safety and Surveillance

25 q.h.

4 q.h.
4 q.h.
4 q.h.
4 q.h.
4 q.h.
5 q.h.

4 q.h.

Choose one of the following courses:

BTC 6211 Validation and Auditing of Clinical



Trial Informatics
RGA 6212 Safety Sciences 1: Introduction to Safety

and Surveillance for Drugs, Biologics, and

Medical Devices in the U.S. and Abroad
RGA 6213 Safety Sciences 2: Safety Surveillance,

Pharmacoepidemiology, and Risk
RGA 6230 Clinical Laboratory Management in

Clinical Trials
RGA 6280 Advanced Writing on International

Biomedical Topics


4 q.h.
4 q.h.
4 q.h.
4 q.h.
4 q.h.

Please note: completion of this course may be


required of students as a condition for their
continued enrollment in this program.

Sharpen your understanding of the laws that govern

TCC 6310 Regulatory Documentation Processes


4 q.h.
TCC 6370 Regulatory Writing: Medical Device Submissions 4 q.h.
TCC 6380 Regulatory Writing: New Drug Applications 4 q.h.
RGA 6233 Application of Quality System Regulation in 4 q.h.

Medical Device Design and Manufacturing
RGA 6234 Drug and Device Supplier Risk Management 4 q.h.

Compliance and Processes

the development, manufacturing, and commercial

Business and Law

distribution of drugs, biologics, and medical devices

Choose one of the following courses:

marketing, and clinical investigations

Examine every step of the drug development and

regulation process

Analyze how emerging developments and trends are

reshaping medical device regulations

BTC 6260 The Business of Medicine and Biotechnology 4 q.h.


RGA 6110 Understanding the Health-Care Landscape 4 q.h.
RGA 6214 Food and Drug Administration: Creation,
4 q.h.

Behavior, and Regulatory Culture
RGA 6216 Medical, Social, and Financial Dimensions
4 q.h.

of Orphan Drugs
RGA 6217 Biomedical Product Development: From Biotech 4 q.h.

to Boardroom to Market
RGA 6218 Regulatory Affairs in an Entrepreneurial
4 q.h.
Environment
RGA 6219 Advertising and Promotion of Drugs and
4 q.h.

Medical Device Products
RGA 6235 Emerging Product Categories in the
4 q.h.

Regulation of Drugs and Biologics
continued on back

www.nor thea s te r n. e du/ c ps

1. 877. 668. 772 7

4 q.h.

g.56
Jan14_rev14

MASTER OF SCIENCE
I N R E G U L AT O R Y A F FA I R S F O R D R U G S ,
BIOLOGICS, AND MEDICAL DEVICES
Development and Strategy

4 q.h.

Choose one of the following courses:

BTC 6213 Clinical Trial Design Optimization and


4 q.h.

Problem Solving
PMC 6212 Clinical Drug Development Data Analysis:
4 q.h.

Concepts and Applications
RGA 6112 Biomedical Intellectual Property Management: 4 q.h.

Patents, Trademarks, Copyrights, Trade Secrets,

and Technology Licensing
RGA 6205 Emerging Trends and Issues in the
4 q.h.

Medical Devices Industry
RGA 6210 Strategic Planning and Project Management 4 q.h.

for Regulatory Affairs Professionals in Domestic

and International Markets
RGA 6211 Combination Products and Convergence
4 q.h.
RGA 6215 Project Management in Early Drug Discovery 4 q.h.

and Development
RGA 6245 Regulation of Generic Pharmaceutical
4 q.h.

and Biosimilar Products
RGA 6250 Financing and Reimbursement in
4 q.h.

Biomedical Product Development
International

4 q.h.

Choose one of the following courses:

RGA 6220 Global Biotechnology Product Registration:



E.U., U.S. Product Regulation
RGA 6221 European Union Compliance Process and

Regulatory Affairs
RGA 6222 Global Awareness: European Medical Device

Regulations
RGA 6223 Global Awareness: Introduction to Canadian,

Asian, and Latin American Regulatory Affairs
RGA 6225 Global Awareness: Japan Medical Device

Regulations and Registrations
RGA 6226 Canadian and Australian Medical

Device Regulations
RGA 6227 Global Awareness: Emerging Medical

Device Markets
RGA 6228 Managing International Clinical Trials
RGA 6240 The Evolving Indian Regulatory Landscape

www.nor thea s te r n. e du/ c ps

1. 877. 668. 772 7

Open Elective

4 q.h.

Choose one of the following courses or one course from


any other category.

COP 6940 Personal and Career Development:



Leadership in Practice






3 q.h.

Enrollment into this course requires participation in


the cooperative education program (subject to
availability). Students must also take RGA 6920 (1 q.h.)
to meet the 4 q.h. elective course requirement.
Effective spring 2012, all students in this program
are required to complete both RGA 6100 and
BTC 6210 before enrolling in COP 6940.

RGA 6206 Practical Aspects of Regulatory Compliance 4 q.h.


Total Quarter Hours:

45 q.h.

Information about tuition rates for the 20132014 academic year is available on
northeastern.edu/cps/tuition-financial-aid.
Tuition and fees are subject to revision by the
President and the Board of Trustees at any time.

4 q.h.
4 q.h.
4 q.h.
4 q.h.
4 q.h.
4 q.h.
4 q.h.
4 q.h.
3 q.h.

g.56
Jan14_rev14

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