The certificate requires
completion of 15 credits, including four required courses (12 credits) and one elective
course for 3 credits.
The required courses are:
16:137:510 (F) Drug
Development from Concept to Market (3)
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. The drug development pipeline from target selection through clinical
trials and marketing, employing expert guest lecturers from different stages of
the developmental process. The developmental pipeline for small-molecule and
biological drugs; economic aspects of small molecular and biological drug
development; and intellectual property and regulatory issues at transitional
phases in the development process.
16:137:580 (S) 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.
16:137:582
(S)
Fundamentals of Regulatory Affairs (3)
Laws, regulations, and regulatory agencies governing pharmaceuticals, devices, biologics, and combination products marketed in the United States and in the world. The historical context in which the FDA evolved; its structure
and its relationship with other U.S. regulatory agencies. Market clearance pathways
for drugs, biologics, medical devices, and combination products. Emphasis on
teamwork, oral communication skills, and written communication skills.
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/certificate-pharmaceuticals-and-clinical-trials-management. See also the entry in this catalog
for Business and Science 137.
