Graduate Certificate in Regulatory Affairs

The regulation of clinical research is, in and of itself, a dynamic and emergent field. It brings together the science in which products—drugs, devices, biologics, and vaccines—and treatment protocols are developed for improved global healthcare. Both the graduate certificate and master of science in health sciences in the field of regulatory affairs programs prepare scientists and regulatory professionals to manage the key elements of the clinical research regulatory process.

The certificate program is ideal for the scientist with an advanced degree who may be at the starting point of entering the regulatory affairs profession within the industry or the government sector. The certificate requires the completion of 18 credits in regulatory affairs coursework, all of which may be counted toward the degree.

Visit the program website for additional information.

Adminssion Requirements

Article	Requirement
To be accepted to this program, you must have:	A bachelor's degree
	3.0 GPA or above on a 4.0 scale
	Previous work experience. Healthcare Experience Preferred
Statement of purpose	Please include a 250-500 word essay describing your reasons for undertaking study at the George Washington University, and your academic objectives, career goals, and related qualifications, including collegiate, professional, and community activities, relevant to your program of interest. Include any substantial accomplishments not already mentioned on the application form.
Recommendations required:	Two (2) letters of recommendation
Prior academic records:	Official transcripts from every college and university attended. All non-U.S. transcripts (including those in English) must be evaluated by an accredited foreign credential agency. Please find the list of member organizations here: https://www.naces.org/members
International Students:	Applicants who are not U.S. citizens are also required to submit official test scores for Test of English as a Foreign Language (TOEFL) or Pearson’s Test of English (PTE) Academics or the academic International English Language Test System (IELTS). The following are the minimum scores for admission consideration: TOEFL: 250 computer-based or 100 Internet-based GW's school code for the TOEFL is 5246. PTE: overall score of 86 IELTS: overall band score of 7.0, with no individual band score below 6.0 International applicants may be considered for admission without submitting the above scores if: You are a citizen of a country where English is the official language, You hold a bachelor’s degree from a country where English is the official language and language of instruction, You hold a bachelor’s degree from an institution accredited by a U.S. regional accrediting agency.

Supporting documents not submitted online should be mailed to:

George Washington University 
ATTN: Transcript Processing Center 
8300 Norman Center Dr 
Suite 400 
Bloomington, MN 55437 

Alternatively, official electronic transcripts can be sent to transcripts@hsprograms.gwu.edu.

Contact for questions:

hsphora@gwu.edu
202-994-0384 (phone)
202-994-0870 (fax)
Hours: 9 am to 5 pm, Monday through Friday

The following requirements must be fulfilled: 12 credits in required courses.

All credits earned in this program are transferable to the master of science in health sciences in the field of regulatory affairs degree program.

Course List

Code	Title	Credits
Required
RCR 6201	Introduction to Global Regulatory Affairs and Clinical Research
RCR 6202	Regulatory Strategy in the Development of Therapeutics
or RAFF 6203	Regulatory Strategy in the Development of Devices and Diagnostics
RAFF 6205	Regulatory Affairs Compliance
One course selected from the following:
RCR 6206	International Regulatory Affairs and Clinical Research
RAFF 6204	Clinical Research for Regulatory Affairs
RAFF 6207	Advertising and Promotion of Regulated Medical Products