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SOCIAL AND ADMINISTRATIVE SCIENCES>
Social & Administrative Sciences

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Master of Sciences Degree with specialization in:

Pharmacy Administration

Drug Regulatory Affairs

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Professional Program:

Doctor of Pharmacy
(Pharm D.)


Other Graduate Programs:

Doctor of Philosophy with specialization in Pharmaceutics

Master of Science Degree-Pharmaceutics with specialization in:
- Industrial Pharmacy
- Cosmetic Science

Master of Science Degree with specialization in Pharmacology/Toxicology

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Social and Administrative Sciences

Master of Science Degree
with specialiation in
Drug Regulatory Affairs

Drug Regulatory Affairs is an exceedingly complex and growing field of endeavor. Almost every operational component of the pharmaceutical industry is strongly dependent on having individuals with expertise related to the legal and regulatory environment, as well as clinical research protocols. The program is intended to help students gain an understanding of and appreciation for the myriad Federal statutes and regulations that control the drug-approval process not only in the United States but worldwide. Another aim of the program is to provide the stimulating background for students to make the most of their capabilities and to prepare them for a dynamic work environment in which they will function more effectively.

Degree Requirements

Students taking the Non-Thesis Option must complete 33 credits of course work and pass the written Comprehensive Examination. Students taking the Thesis Option must complete 33 credits of course work of which 3 credits are for Research Methodology, PHA 050, and 6 credits are for Research and Thesis, PHA 060. Thesis students must register for PHA 060 in two consecutive semesters, 3 credits each semester.

Required Courses Cr.
PHA 010 Biostatistics  3
PHA 603 Drug Regulatory Affairs         3
PHA 651 Pharmaceutical Labeling, Advertising and Promotion     3
PHA 653

Seminar in Social and Administrative Sciences     

3
PHA 654 Regulation of OTC Drugs, Medical Devices, Cosmetics, and Animal Drugs 3
PHA 657

Principles and Practices of Regulatory Compliance and Enforcement       

3
PHA 660 Mechanics of Preparing INDs and NDAs    3
PHA 661 Pharmaceutical Industry        3
 24
Electives and Research  Cr.
PHA 050 Research Methodology* 3
PHA 060 Research and Thesis* 3
PHA 601 Marketing Research and Analysis   3
PHA 604 Pharmacoeconomics   3
PHA 607 Behavioral Pharmacy     3
PHA 613 Marketing Management   3
PHA 614 Health Literacy 3
PHA 645 Internship in Drug RegulatoryAffairs    3
PHA 655 Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs 3
PHA 656 Current Enactments, Regulations and Guidelines     3
9
Total Credits 33

*Required for students taking the Thesis Option.
                              

In consultation with the Division Director, students may select electives from the graduate course offerings in the Division of Social and Administrative Sciences and the School of Business, Public Administration and Information Sciences.

 

Arnold & Marie Schwartz College of Pharmacy and Health Sciences - 75 Dekalb Avenue - Brooklyn, New York. (718) 488-1004