Biopharmaceutical Domestic Regulatory Affairs

Degree:
  • Certificate
Location: Boston

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 FDA has applied its own distinctive meaning. Courses from this certificate may be applied toward the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices.


More Details

Unique Features


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 6101 - Therapeutic Product Development: A Regulatory Overview
4.00

Complete the appropriate number of electives to meet the minimum quarter-hour requirement: 

RGA 6002 - Regulatory Compliance Culture
2.00
BTC 6210 - Human Experimentation: Methodological Issues Fundamentals
4.00
RGA 6203 - Pharmaceutical and Medical Device Law: Topics and Cases
5.00
RGA 6207 - Global Impact of Electronic Common Technical Document (eCTD) Submissions
4.00
RGA 6210 - Strategic Planning and Project Management for Regulatory Affairs
4.00
RGA 6212 - Introduction to Safety Sciences
4.00
RGA 6215 - Project Management in Early Drug Discovery and Development
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 - Advanced Regulatory Writing: New Drug Applications
4.00
RGA 6410 - Fundamentals of CMC Regulations and Methods
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

Meets F-1 Visa Requirements

Yes