WWW.UAB.EDU/BIOTECH

Learn It Here. Use It Everywhere.

In only five courses – offered totally online – you can earn a Graduate Certificate in Biotechnology Regulatory Affairs.All you need is five courses – at your own pace – to be prepared and eligible for a career in Regulatory Affairs certifications. There is an all-time high demand for professionals with regulatory training thanks to ongoing clinical trials of new drugs, many of them soon to be approved and ready for production.

Will you be ready? Apply today.

Apply through the UAB Graduate School online at www.uab.edu/graduate

DEADLINE:February 28 (Early Acceptance)August 1 (Final Acceptance)

REQUIREMENTS: • BA or BS degree• Meet all graduate school requirements• Min. cumulative GPA of 3.0• TOEFL, IELTS & TWE scores (Int’l students)

ALL STUDENTS MUST: • Must have personal insurance coverage uab.edu/studenthealth

UAB DEPARTMENT OF CLINICAL AND DIAGNOSTIC SCIENCES Admissions Office437 School of Health Professions Building1716 9th Ave S • Birmingham, AL 35294205.934.3209 • AskCDS@uab.edu

Biotechnology Regulatory Affairs

Graduate Certificate

Application Process

Contact Information

UAB is accredited by the Southern Association of Colleges and Schools Commission on Colleges to award degrees at the baccalaureate, master’s, specialist, and doctoral levels.

The University of Alabama at Birmingham prohibits discrimination in admission, educational programs, and other student matters on the basis of race, color, religion, sex, sexual orientation, gender identity, gender expression, age, national origin, disability unrelated to program performance, veteran status or genetic or family medical history.

UAB is committed to providing an accessible learning experience for all students. If you are a student with a disability that qualifies under Americans with Disabilities Act (ADA) and Section 504 of the Rehabilitation Act, and you require accommodations, please contact Disability Support Services for information on accommodations, registration and procedures. Call 205 934-4205 or visit uab.edu/dss.

Prerequisite Requirements

Professional Phase Curriculum(15 Credit hours*)

COURSES SEM HRS

COURSES SEM HRS

Students must fulfill all Graduate School requirements for admission to a certificate program and must have completed required coursework in biology, genetics, and chemistry with a minimum grade point average of 3.0 prior to admissions.

BY 123 Introductory Biology 4BY 210 Genetics 3CH 115/116 General Chemistry I 4CH 117/118 General Chemistry II 4

BTR 605 Biotechnology Regulatory & 3 Quality Systems BTR 615 Applications of Biological Processes in 3 Drug Development BTR 620 Regulation of Food and Drugs 3BTR 640 Clinical Development of Drugs, Biologies, 3 Diagnostics and Medical DevicesBTR 690 Clinical Trial Implementation 3

*All courses are offered each semester and can be taken in any order.

The Biotechnology Regulatory Affairs certificate program provides students with targeted training and education in:• The philosophies and roles of the domestic and international regulatory agencies that oversee drug, biologic, medical device, and diagnostics development• The laws that govern the development, manufacturing and commercial distribution of drugs, biologics and medical devices.• The analysis of how emerging developments and trends are reshaping drug development and medical device regulation.

• The biological processes and laboratory techniques utilized for the discovery, development and evaluation of therapeutic drugs.• Major concepts under which clinical trials are designed and run.• The roles of the U.S. Food and Drug Administration (FDA).• Institutional Review Boards, the Code of Federal Regulations and ethical principles.• The complexities of clinical trial initiation and the issues of site and data management.

Biotechnology Regulatory Affairs

Paying for College

For detailed tuition and fees information go to: www.uab.edu/students/paying-for-college/detailed-tuition-and-fees

FINANCIAL AID

Students should apply for financial aid if they need assistance paying for college. Financial aid is awarded on an annual basis. Complete the Free Application for Federal Student Aid (FAFSA) annually. The application can be found at www.fafsa.gov.

Instructions and UAB forms are available at www.uab.edu/students/paying-for-college.

UAB SCHOOL OF HEALTH PROFESSIONS

SCHOLARSHIPS

To view opportunities, find out deadlines, and access applications, log in to UAB’s Blazer Scholarship Management and Resource Tool, BSMART, at uab.edu/bsmart.

Students majoring in programs within the School of Health Professions will be notified of award opportunities via email, each semester.

For more information, contact:

School of Health Professions, Office of Student Recruitment, Engagement and Success shp@uab.edu or 205-934-4195 School of Health Professions Building (SHPB) 230