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.
Athena Title
Pharm Biotech Device Indust
Equivalent Courses
Not open to students with credit in PHAR 6010E
Non-Traditional 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.