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Pharmaceuticals and Clinical Trials Management 725
Certificate Program
Requirements
Pharmacology, Cellular and Molecular 718
Pharmacy
Philosophy 730
Physics and Astronomy 750
Physiology and Integrative Biology 761
Planning and Public Policy 762
Plant Biology 765
Political Science 790
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  Graduate School-New Brunswick 2017 Programs, Faculty, and Courses Pharmaceuticals and Clinical Trials Management 725 Requirements  

Requirements


The certificate requires completion of 15 credits, including three required courses (9 credits) and two elective courses for 6 credits.

The required courses are:

16:137:510 (F) Drug Development from Concept to Market (3)

Provides an overview of the process of drug development in the pharmaceutical industry. The drug development pipeline from target selection through clinical trials and marketing will be discussed, employing expert guest lecturers from different stages of the developmental process. An interactive case study format will be used to study the developmental history of specific drug candidates throughout the course, starting with the target identification and method of drug discovery, through the development of lead compounds, patent filings, drug refinement, clinical trials, regulatory approvals, and marketing processes. Students will develop industry-specific teamwork skills as well as continuing their development of oral and written communication skills.

16:137:580 (S) Practical Aspects of Clinical Trial Design/Conduct (3)
Provides extensive training in clinical research and clinical data management. It incorporates end-to-end training for all clinical research areas with a special focus on clinical data management processes, documentation, and clinical data management systems. The course includes extensive practical sessions to provide rigorous hands-on experience on a clinical data management system (CDMS), which is widely used in the pharmaceutical industry today. It also provides hands-on experience in protocol development, case report form development, clinical database planning, database design, clinical data entry, clinical data definition, discrepancy management, and writing validation procedures.

16:137:582 (S) Fundamentals of Regulatory Affairs (3)
Provides an overview of the laws, regulations, and regulatory agencies governing pharmaceuticals, devices, biologics, and combination products marketed in the United States and in the world. The course also discusses the historical context in which the FDA evolved; its structure and its relationship with other U.S. regulatory agencies. Provides an overview of market clearance pathways for drugs, biologics, medical devices, and combination products so that the development and delivery of safe and effective health care products can be expedited. Emphasizes teamwork, oral communication skills, and written communication skills.


Two elective courses must be taken for the certificate. The full list of elective courses is available at http://mbs.rutgers.edu/certificate-pharmaceuticals-and-clinical-trials-management. See also the entry in this catalog for Business and Science 137.

Students must attend at least six colloquia in the professional science master's program for the certificate.
 
For additional information, contact RU-info at 732-932-info (4636) or colonelhenry.rutgers.edu.
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