The certificate requires
completion of 15 credits, including four required courses (12 credits) and one elective
course for 3 credits.
The required courses are:
16:137:580 Practical Aspects of Clinical Trial Design/Conduct
(3)
The fundamental concepts pertaining to the design,
analysis, and interpretation of clinical research studies. Students will learn to design randomized
controlled trials.
16:137:510 Drug
Development from Concept to Market (3)
An introduction to the drug development process in the
context of its scientific, economic, legal, and regulatory aspects. Student
teams will develop industry-specific teamwork skills and oral and written
communication skills through a progressive competitive marketing analysis of an
assigned therapeutic area. Analysis of the methods of the drug development
pipeline from target selection through clinical trials and marketing, employing
expert guest lecturers from different stages of the developmental process.
Students will develop a basic understanding of: 1) the developmental pipeline
for small molecule and biological drugs; 2) economic aspects of small molecular
and biological drug development; and 3) intellectual property and regulatory
issues at transitional phases in the development process.
16:137:582
Regulatory Writing for Submissions and Approvals (3) (in development)
An acceptable
substitute is 16:137:502 Principles of Communication and Leadership for Science and Technology Management (3).
16:137:583 Ethics and Regulations in Clinical Research (3)
Basic concepts and policies
relating to the conduct of clinical research. Formal mechanisms that guide
researchers and protect the rights and well-being of research subjects. The
importance of randomization when planning clinical trials, protecting
confidentiality, selection of participants, risk management, monitoring and
observation, record-keeping, and informed consent. GLP, GCP, DHHS, FDA, HIPAA, IRB
regulations.
One elective course must be taken
for the certificate. The full list
of elective courses is available at http://psm.rutgers.edu/content/certificate-pharmaceuticals-and-clinical-trials-management. See also the entry in this catalog
for Business and Science 137.
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