Certificate in Pharmaceuticals and Clinical Trials Management

Pharmaceuticals and Clinical Trials Management 725

Program Offered: Certificate in Pharmaceuticals and Clinical Trials Management

Director of Certificate Program: Professor Deborah Silver, Executive Director, Professional Science Master’s Program, Busch Campus, 848-445-5117.

Certificate Program

The certificate in pharmaceuticals and clinical trials management is designed to introduce students to the management of clinical trials. Pharmaceutical industries and businesses today need workers who not only possess up-to-date knowledge in their fields, but who have also acquired skills that enable them to carry out the objectives of the regulatory bodies, such as the Food and Drug Administration, in ensuring public health.

Students currently enrolled in master of science, doctor of philosophy, and postdoctoral degree programs in science, mathematics, and engineering fields are eligible to apply for the certificate and will be awarded the certificate upon completion of the 15 credits required. Students who already possess a graduate degree in science, mathematics, or engineering may also apply independently for the certificate program. Individuals who have worked in industry for at least five years are eligible to apply for the certificate program as part-time students.

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 (9 credits):

16:137:510  (F) Drug Development from Concept to Market (3)
The course will provide 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)
This course is designed to provide 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)
This course provides an overview of the laws, regulations, and regulatory agencies governing Pharmaceuticals, Devices, Biologics and Combination Products marketed in the US and in the world. The course also discusses the historical context in which the FDA evolved; its structure and its relationship with other US regulatory agencies. The course will provide an overview of market clearance pathways for drugs, biologics, medical devices and combination products so that the development and delivery of safe and effective healthcare products can be expedited. This course will emphasize teamwork, oral communication skills, and written communication skills.

Two elective courses (6 credits) 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.