Graduate Certificate in Biopharmaceutical Domestic Regulatory Affairs
As biotechnology, pharmaceutical, and medical device companies rapidly seek federal approval for products, demand is growing for qualified regulatory affairs professionals. Scientists developing new products and legal experts guiding them through the FDA approval process will benefit from regulatory affairs training.
The Graduate Certificate in Biopharmaceutical Domestic Regulatory Affairs is designed to provide students with a greater understanding of medical device regulation and the industry's unique software development and validation issues. 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 in 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.
Please note: Students who started this program prior to Fall 2015 should follow the curriculum reflected on their DegreeWorks audits via the self-service tab of their myNEU portal. Please consult your advisor with any questions.
Required Courses (16-17 q.h.)
|RGA 6200||Biologics Development: A QA/Regulatory Overview||4 q.h.|
|RGA 6201||New Drug Development: A QA/Regulatory Overview||4 q.h.|
|RGA 6202||Medical Device Development: A QA/Regulatory Overview||4 q.h.|
Choose one of the following courses:
|RGA 6203||Food, Drug, and Medical Device Law: Topics and Cases||5 q.h.|
|RGA 6210||Strategic Planning and Project Management for Regulatory Affairs Professionals in Domestic and International Markets||4 q.h.|
|RGA 6211||Combination Products and Convergence||4 q.h.|
|RGA 6212||Safety Sciences 1: Introduction to Safety and Surveillance for Drugs, Biologics, and Medical Devices in the U.S. and Abroad||4 q.h.|
|RGA 6214||Food and Drug Administration: Creation, Behavior, and Regulatory Culture||4 q.h.|
|RGA 6216||Medical, Social, and Financial Dimensions of Orphan Drugs||4 q.h.|
|RGA 6217||Biomedical Product Development: From Biotech to Boardroom to Market||4 q.h.|
|TCC 6370||Regulatory Writing: Medical Device Submissions||4 q.h.|
|TCC 6380||Regulatory Writing: New Drug Applications||4 q.h.|
Total Quarter Hours: 16-17
Below are the official Admissions Requirements for this program.
- Online application
- Statement of purpose (500-1000 words): identifying your educational goals and expectations from the program; please be aware that the University's academic policy on plagiarism applies to applicant's statement of purpose
- Professional resume: Current resume that displays job responsibilities, relevant experience, and education history
- Official undergraduate degree documentation
- Proof of English language proficiency: ONLY for students for whom English is not their primary language: English language proficiency guidelines
For general admissions information and recommended admissions deadlines, Graduate Admissions.
All requirements must be received prior to review.
Estimated total tuition for this program is $10,112.00.
Tuition for individual courses is based on the number of quarter hours. Most courses are 3-6 quarter hours. See Graduate Tuition Rates for details.
Use our Tuition Calculator below to see if transfer credit or tuition reimbursement from your employer could reduce your total tuition.
Please note: The estimated total tuition is based on tuition rates for Academic Year 2015-16 and does not include any fees or other expenses. Some courses and labs have tuition rates that may increase or decrease total tuition. Tuition and fees are subject to revision by the president and Board of Trustees at any time.
*A maximum of 9 quarter hours of graduate- or doctoral-level credit obtained at another institution may be awarded as Advanced Graduate Credit to the Doctor of Education program.
Considering a graduate certificate?
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- Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices
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