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The Johns Hopkins University
Krieger School of Arts and Sciences
Advanced Academic Programs
Master of Science in Biotechnology
Concentration in Bioscience Regulatory Affairs
Program Plan
Name ________________________________________________
Email __________________________________
Address________________________________________________________________________________________
Street
Apt. #
Telephone: Home ______________________
City
State
Zip
Work ___________________________
Primary Campus (Homewood, MCC, On-line) _________________________________
List below, in chronological order, the ten courses you plan to complete for your degree program and indicate the term in
which you expect to enroll in each (e.g. Summer ’04, fall ’06). Students may take more than 10 courses.
Concentration_________________________________________
Course Number
(Pre-requisite Course
Course Title
Bio-Organic Chemistry
Term & Year __________
_____________________)
Four Core Courses (Required): 410.601, 410.602, 410.603, 410.604 or replacement courses if waiver
granted.
1. ____________
__________________________________
_________________
2. ____________
__________________________________
_________________
3. ____________
__________________________________
_________________
4. ____________
__________________________________
_________________
Four Concentration Courses (Required):
5. ____________
__________________________________
6. ____________
__________________________________
7. ____________
__________________________________
8. ____________
__________________________________
_________________
_________________
_________________
_________________
Two Science Elective Courses (Required):
9. ____________
__________________________________
10.____________
__________________________________
_________________
_________________
Additional Courses (Not required for MS):
11. ____________ __________________________________
12.____________
__________________________________
_________________
_________________
Note: Some concentration courses also count as science electives.
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Concentration in Bioscience Regulatory Affairs
Developed in consultation with representatives from the Food and Drug Administration (FDA), the
Regulatory Affairs Professional Society (RAPS), and the biotechnology industry, this concentration in
the Master of Science in Biotechnology provides students with the knowledge and understanding
required for companies and organizations to comply with federal and state regulatory statutes for the
development, approval, and commercialization of drugs, biologics, foods, and medical devices.
Students in this concentration must complete four core science courses, four core regulatory
affairs courses, and two electives.
4 Core Science Courses:




410.601 Biochemistry
410.602 Molecular Biology
410.603 Advanced Cell Biology I
410.604 Advanced Cell Biology II
Core courses are prerequisites for all other 600 level biotechnology courses.
If you have not covered the content of these courses in prior coursework, they must be
taken before other courses for your master’s degree program.
Review descriptions or our core courses and of any other prior course work that may have covered
the same material. If you have covered the content of a core course, you may request a waiver.
Substitute another course for a core course that is waived; ten courses are required for the degree.
4 Concentration Courses (choose from the following):
410.627
410.649
410.651
410.673
410.676
410.683
Translational Biotechnology: From Intellectual Property to Licensing*
Introduction to Regulatory Affairs
Clinical Development of Drugs and Biologics*
Biological Processes in Regulatory Affairs*
Food and Drug Law
Introduction to GMP Compliance
*Also counts as a science elective
2 Science Elective Courses:
Students may choose any two science electives for which they have completed the
prerequisites. For a complete list of electives, visit biotechnology.jhu.edu.
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Contact Information
For specific questions regarding the Concentration in Bioscience Regulatory Affairs or MS in
Bioscience Regulatory contact:
Jamie L. Austin, RAC
301-448-9671
jausti12@jhu.edu
For specific questions regarding the Concentration in Biotechnology Enterprise, Certificate in
Biotechnology Enterprise, Masters in Biotechnology Enterprise and Entrepreneurship, or MS
Biotechnology/MBA contact:
Katherine Wellman
301-294-7112
kmwellman@jhu.edu
For specific questions regarding the Concentration in Molecular Targeting and Drug Discovery
contact:
Dr. Patrick Cummings
410-516-4724
cupat@jhu.edu
For specific questions regarding the Concentration in Biodefense, Concentration in
Bioinformatics, and MS in Bioinformatics contact:
Dr. Kristina Obom
301-294-7159
kobom@jhu.edu
For questions regarding the MS in Biotechnology Program (without a concentration) contact:
Dr. Meredith Safford
301-294-7079
msafford@jhu.edu