Courses in pharmaceutical regulatory affairs

Written by jared lewis
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Courses in pharmaceutical regulatory affairs
Pharmaceutical distribution is heavily regulated by the government. (pills image by Dariusz Urbanczyk from

The pharmaceutical industry is heavily regulated. Pharmacy students must sometimes take advanced courses in pharmaceutical regulatory affairs in order to gain some type of understanding of the various rules and regulations. Some students choose to enter the regulatory side of the industry, however, and instead pursue entire degrees or certificates devoted to pharmaceutical regulation. Various colleges and universities offer courses in both an online and on-campus format.

Master's Degree Courses--Drug Regulatory Affairs

The University of Florida offers an online Master of Science degree in pharmacy with a concentration in drug regulatory affairs. The program is designed to last approximately 22 months and requires 30 credit hours for completion. Students must have either a bachelor's degree in pharmaceutical science or the doctor of pharmacy degree (Pharm.D.). Courses offered in the program cover a wide variety of areas in the regulatory environment, including pharmaceutical outcomes and policy, regulating pharmaceutical access and cost, federal regulation of controlled substances, federal regulation of pharmacy and drugs, ethics in drug production, use and distribution, pharmaceutical products and public policy, practices and procedures of administrative agencies, and health care risk management.

College of Pharmacy

Pharmacy Regulation & Policy

2209 NW 13th St., Suite D

University of Florida

Gainesville, FL 32609


Graduate Certificate Courses in Pharmaceutical Manufacturing Regulation

The Stevens Institute of Technology in New Jersey offers a 12-credit-hour graduate certificate in the area of pharmaceutical validation and regulatory affairs. The primary focus of this certificate is to provide students with a more specialised understanding of the drug manufacturing process. Part of its focus is on the validation of quality in light of various manufacturing methods that rely upon electronics and the way that regulation affects the manufacturing process. Only four courses are required as part of the certificate. These include studies in the areas of pharmaceutical industry regulation and compliance, contemporary concepts in pharmaceutical validation, validation and regulatory affairs in pharmaceutical manufacturing and quality in pharmaceutical manufacturing.

Stevens Institute of Technology

Howe Center, 12th Floor

Castle Point on the Hudson

Hoboken, NJ 07030


Regulatory Affairs Certificate Courses

California State University offers an advanced certificate in pharmaceutical regulatory affairs. The program is designed for anyone seeking a career in one of three areas: pharmaceutical regulation, the medical device industry and biopharmaceuticals. The program is designed to last 12 months and requires four courses in this field. Admission to the program is open to anyone interested in learning the material, although a bachelor's degree is recommended. Coursework is offered entirely online. Courses include studies in areas such as introduction to food and drug law, practical ethics for health care professionals, the manufacturing process for drugs and biologics and the pharmaceutical, biotechnology and biodevice industries.

California State University, East Bay

Continuing Education

25800 Carlos Bee Blvd, WA 804

Hayward, CA 94542


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