Biopharmaceutical Domestic Regulatory Affairs

Degree:
Location: Anywhere

Why U.S. Biopharmaceutical Regulatory Affairs?

The Graduate Certificate in Biopharmaceutical Domestic Regulatory Affairs prepares students to enter the field as regulatory affairs professionals.

As biotechnology and pharmaceutical companies rapidly seek federal approval for products, demand is growing for qualified regulatory affairs professionals. The Graduate Certificate in Biopharmaceutical Domestic Regulatory Affairs is designed to provide students with a greater understanding of biopharmaceutical product regulation and the industry's evolving compliance requirements in the US.

Scientists developing new products and legal experts guiding them through the FDA approval process will benefit from regulatory affairs training. The program will also prepare students to assure compliance, reduce costs, and improve techniques governing acquisition and measurement. Students will also develop a vocabulary of over 750 acronyms and technical/regulatory words to which the FDA has applied its own distinctive meaning.


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Unique Features

  • Courses from this certificate may be applied toward the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices
  • Online format designed for working professionals

What you'll study

General Requirements

Graduate Certificate in Biopharmaceutical Domestic Regulatory Affairs Core Requirements
RGA 6000 - Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation
2.00
RGA 6001 - Introduction to Food and Drug Administration Medical Device Regulation
2.00
RGA 6101 - Therapeutic Product Development: A Regulatory Overview
4.00

Biopharmaceutical Domestic Regulatory Affairs Electives

Complete two of the following:

RGA 6203 - Food, Drug, and Medical Device Law: Topics and Cases
5.00
RGA 6210 - Strategic Planning and Project Management for Regulatory Affairs
4.00
RGA 6211 - Combination Products and Convergence
4.00
RGA 6212 - Introduction to Safety Sciences
4.00
RGA 6214 - The Food and Drug Administration: Creation, Behavior, Regulatory Culture
4.00
RGA 6216 - The Medical, Social, and Financial Dimensions of Orphan Drugs
4.00
RGA 6217 - Biomedical Product Development: From Biotech to Boardroom to Market
4.00
RGA 6380 - Regulatory Writing: New Drug Applications
4.00

Did You Know?

Nearly all RASI professionals (99%) have university degrees, and 69% have pursued postgraduate studies (RAPS, 2014).

 

Stackable Certificate

Credits earned completing this certificate can be applied towards the MS in Regulatory Affairs.

 

Average Time to Completion

1 Year

Commitment

Part-Time

Entry Terms

Fall
Spring
Summer
Winter

Visa Eligible

No