M.S. in Drug Regulatory Affairs

M.S. in Drug Regulatory Affairs


With pressure to contain the cost and time it takes to create new products and bring them to market, professionals with expertise in regulatory affairs are highly sought after by pharmaceutical companies and medical device manufacturers, as well as by hospitals, health maintenance organizations (HMOs) and a range of other health care oriented organizations as well. The expertise of a DRA professional may be used in areas such as clinical trials, manufacturing, compliance, patenting, sales and marketing, IT, finance and scientific writing.

Employment opportunities include:

  • Collecting data and preparing submissions to regulatory agencies
  • Assisting in the development of procedures to ensure regulatory compliance
  • Interfacing with regulatory agencies
  • Facilitating identification and resolution of scientific and regulatory issues with regulatory agencies
  • Remaining current with federal and international regulations and communicating that information within the organization, including the creation of training materials
  • Participating in the development of new products and services
  • Participating in quality audits

In addition to a strong background in pharmaceutical science and regulatory affairs, a successful DRA professional should have excellent interpersonal and communication skills, high ethical standards, attention to detail and strong organizational skills.


Program Mission

The mission of the Master of Science program in Drug Regulatory Affairs is to prepare students to become lifelong learners and leaders in a variety of settings including biotechnology, medical devices, pharmaceuticals, consulting arena, and liaise with government and regulatory agencies worldwide. Students will: 

a) Demonstrate a mastery of a broad didactic foundation in regulatory affairs gained in advanced coursework; 

b) Develop strong skills through exposure to significant regulatory projects and case studies during which they translate their knowledge into practice; and 

c) Utilize professional skills such as statistical analysis, knowledge of regulatory guidance documents, as well as written and verbal communication skills.

These abilities will be acquired through specific coursework and seminars and other professional and personal development offered during the course of study.

Program Goals And Objectives

Goal 1: Demonstrate an understanding of the role of a medical products regulatory affairs specialist and the dynamic nature of the regulatory field.

1.1 Evaluate real and/or simulated regulatory submissions for appropriateness of the submission to the regulatory requirements of product design, manufacturing, testing, and post-market surveillance strategies.

1.2 Examine real or simulated regulatory submissions to judge adherence to prescribed guidance documents and principles of responsible clinical research.

1.3 Identify the differences between patents, trademarks, and trade secrets as they relate to regulatory and marketing strategy.


Goal 2: Identify and utilize the laws and regulations that apply to the development, testing, and production of new medical products, including medical devices, In-Vitro Diagnostics (IVDs, pharmaceuticals, biotechnology-derived therapeutics, and biologics.

2.1 Assess current U.S. –Food and Drug Administration (FDA) regulations that focus on drugs and medical devices and their impact on regulatory submissions such as New Drug Applications (NDA), Abbreviated NDAs, Investigational New Drug (IND) Applications, 510k, and Pre-Market Authorizations PMAs.

2.2 Delineate specific regulations in the Code of Federal Regulations (CFR) that address patient safety and their impact on product development.


Goal 3: Identify a specific regulatory issue for either a drug or device and be able to justify an appropriate position or strategy through presentation and written skills that permits students to acquire analytic and reasoning skills along with effective communication skills.

3.1 Strategically build various sections of a 510k submission for a Class II medical device given baseline data.

3.2 Demonstrate the ability to investigate case studies related to various regulatory topics (e.g. regulatory submissions, product defect, clinical trials and quality assurance strategies). This should include; identification of the issue, research of the topic, and development of a report summarizing the findings.

3.3 Demonstrate the ability to construct a Power Point presentation on a topic related to a current regulatory issue. This presentation should have relevant content and appropriate information that addresses the selected topic adequately.

3.4 Demonstrate the ability to construct a Power Point presentation on a topic related to a current regulatory issue and communicate the findings effectively to an audience.


Goal 4: Demonstrate the ability to develop personal and professional skills in the field of regulatory affairs.

4.1 Identify current issues within the field of regulatory affairs and develop written responses or papers suitable for peer review.

4.2 Identify a regulatory professional in the industry and discuss with them about their roles and responsibilities as a regulatory professional. Based on such discussions develop a hypothetical career pathway for yourself in outline format.

Degree Requirements

M.S. in Drug Regulatory Affairs


Students taking the Non-Thesis Option must complete 33 credits:
  • 24 Core credits
  • 9 Elective credits
  • pass the written comprehensive examination

Students taking the Thesis Option must complete 33 credits:

  • 24 Core credits
  • 6 Research and Thesis (PHA 060) credits (taken in 2 consecutive semesters)
  • 3 Research Methodology (PHA 050) credits

  Core courses  

PHA 010

Biostatistics    

3

PHA 603

Drug Regulatory Affairs

3

PHA 651

Pharmaceutical Labeling, Advertising and Promotion

3

PHA 653

Seminar in Social and Administrative Sciences

3

PHA 654

FDA Regulation of Over-the-Counter Drugs, Medical Devices and Dietary Supplements

3

PHA 657

Principles and Practices of Regulatory Compliance and Enforcement

3

PHA 660

Mechanics of Preparing INDs and NDAs

3

PHA 661 The American Pharmaceutical Industry
3


  Research and Thesis courses  

PHA 060

Research and Thesis (taken in 2 consecutive semesters)

6

PHA 050

Research Methodology

3


  Elective courses  

PHA 070

Special Problems

3
PHA 604
Pharmacoeconomics
3
PHA 607
Behavioral Pharmacy
3
PHA 615
Consumer Behavior and Contemporary Healthcare Issues
3
PHA 661
The American Pharmaceutical Industry
3

*you may also choose an elective from the list of PHA courses offered in the current semester.



CONTACT

LIU Pharmacy
John M. Pezzuto, A.B., Ph.D.
Dean