Graduate Certificate in Biopharmaceutical International Regulatory Affairs
The need to understand international regulations affecting the business of biotechnology and pharmaceutical companies becomes imperative in the global marketplace.
The Graduate Certificate in Biopharmaceutical International Regulatory Affairs curriculum focuses on reforms that facilitate the safety of global commerce. Students will be trained to assess international regulations and to provide an interpretation of their likely impact on the company. As a result of the program, students will gain an understanding of international regulatory requirements for countries where new products will be marketed.
Coursework will cover product approval processes, regulatory analysis, and liability laws. With the rapid expansion of local companies joining the global market, attorneys, paralegals, and biotechnology, pharmaceutical, and medical device researchers will benefit from understanding compliance and international regulations, as well as how to streamline the regulatory process. Courses from this certificate may be applied toward the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices.
NOTE: Due to website maintenance, course links are temporarily redirecting to the Northeastern University Registrar website. Please use that tool to locate class schedules.
Please note: Students who started this program prior to Fall 2016 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 q.h.)
|RGA 6220||Global Biotechnology Product Registration: EU, U.S., and Japan||4 q.h.|
|RGA 6221||European Union Compliance Process and Regulatory Affairs||4 q.h.|
Choose two of the following courses:
|RGA 6228||Managing International Clinical Trials||4 q.h.|
|RGA 6222||Global Awareness: European Medical Device Regulations||4 q.h.|
|RGA 6223||Global Awareness: Canada, Asian, and Latin American Regulatory Affairs||4 q.h.|
|RGA 6224||Regulation of Biomedical Product Commercialization by Health Canada||4 q.h.|
|RGA 6225||Japanese Medical Device Regulations and Registrations||4 q.h.|
|RGA 6226||Canadian and Australian Medical Device Regulation||4 q.h.|
|RGA 6227||Global Awareness: Emerging Medical Device Markets||4 q.h.|
|RGA 6210||Strategic Planning and Project Management for Regulatory Affairs Professionals in Domestic and International Markets||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.|
Required minimum credit hours: 16 q.h.
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 $10,624.00.
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 2016-17 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.
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