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.
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