| Course ID: | PHAR 6010E. 4 hours. |
| Course Title: | Pharmaceutical, Biotechnology, and Device Industries |
Course
Description: | Foundational knowledge of the pharmaceutical, biotechnology, and
medical device industries. Emphasis on organization, product
development, new product applications and commercialization-
associated activities, including drug discovery, chemical
synthesis, laboratory practices, quality assurance, regulatory
affairs, manufacturing, design control, marketing, and
post-marketing surveillance. |
| Oasis Title: | PHR BIOTEC DEV IND |
| Duplicate Credit: | Not open to students with credit in PHAR 6010 |
| Nontraditional Format: | Four hours per week for fifteen weeks online study, including
teaching, assignments, discussion, problem-based learning, and
case-based learning. Weekend seminar(s) totaling eight contact
hours (onsite or video conference) utilizing case-based and
problem-based learning methods. |
| Prerequisite: | Permission of department |
| Grading System: | A-F (Traditional) |
|
| Course Objectives: | Outline the product development process of the Food and Drug
Administration (FDA); recognize good laboratory practices in
healthcare products industry; outline the process for new
product applications; describe the pre-approval and approval
process for new and existing products, including the planning
and implementation of clinical studies; discuss the workings
of the pharmaceutical, biotechnology and biodevice industries;
locate information necessary in their role as regulatory
affairs professionals; distinguish between the subjective and
interpretive aspects of the regulations; categorize the complex
interaction between regulatory and development processes. |
| Topical Outline: | Industry organization; process for product development; product
commercialization; drug discovery and chemical synthesis;
quality assurance processes; regulatory affairs procedures
including, manufacturing, design control, planning and
implementing clinical studies, product application, marketing,
and post-marketing surveillance. |
| Honor Code Reference: | All academic work must meet the standards contained in A
Culture of Honesty. Each student is responsible to inform
themselves about those standards before performing any academic
work. A Culture of Honesty is the University of Georgia's
policy and procedures for handling cases of suspected
dishonesty and can be found online at www.uga.edu/ovpi. UGA
Student Honor Code states "I will be academically honest in all
of my academic work and will not tolerate academic dishonesty
of others." |