| |
May 04, 2024
|
|
|
|
|
2022-2023 Catalog [ARCHIVED CATALOG]
|
BIOT 218 - Medicinal Product Lifecycle and Capstone Project
PREREQUISITES: BIOT 214 - Food and Drug Law , BIOT 215 - Clinical Trials ; or Program Advisor Approval.
PROGRAM: Biotechnology
CREDIT HOURS MIN: 3
LECTURE HOURS MIN: 3
DATE OF LAST REVISION: Fall, 2019
Medicinal Product Life Cycle and Capstone Project is the last of a suite of four Regulatory Affairs Online courses that have been designed to teach the skills and knowledge required by medicinal product and biotechnology industries. The first four weeks of this course will provide a basic introduction to medicinal product lifecycle, and the last 12 weeks will be focused on completing one of three possible capstone projects (student’s choice with instructor guidance) that will incorporate skills and knowledge acquired from the three previous RA courses and the first 4 weeks of this course.
MAJOR COURSE LEARNING OBJECTIVES: Upon successful completion of this course, the student will be expected to:
- Search, locate, and apply regulatory information and guidance as it pertains to Investigative New Drug (IND), Biologic Licensing Application (BLA), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), FDA databases, and standards.
- Distinguish and compare how product life cycles differ amongst drugs, biologics, medical devices, and combination products to include surveillance monitoring post commercialization.
- Comprehend, demonstrate, and analyze information from authoritative websites each week in Share the Knowledge discussion postings and replies.
- Search, locate, and apply regulatory information and guidance as it pertains to Investigative Device Exemption (IDE), Pre-Market Approval (PMA), and FDA CDRH databases: e.g., FOIA reading room, MAUDE, 510k, recalls, standards, classification, and PMA.
- Identify and implement medical device design guidance from the FDA.
- Apply ISO 14971 and ICH Q9 and FDA cGMP regulations in medicinal product formation.
- Research and interpret information located in MAUDE, FAERS, Recalls, CDRH FOIA, Device Classification, REMS, title 21 CFRs, Warning letters, TPLC, PMA, 510(k), and many more databases found within FDA.gov website
- Create a regulatory packet directly linked to a capstone project.
- Demonstrate ability to write in a concise, persuasive, and logical manner in order to convey a compelling narrative to the FDA.
COURSE CONTENT: Topical areas of study include -
- Product Life Cycle Management
- Product Life Cycle Drugs and Biologics
- Product Life Cycle Medical Devices
- Risk Management 1 - ISO 14971
- Choose Capstone Project from three possible projects:
- 1.) 510k Submission, 2.) IVC Filter, 3.) Pre-Submission meeting with FDA.
GRADING POLICY
| A |
90-100 |
| B |
80-89 |
| C |
70-79 |
| D |
60-69 |
| F |
0-59 |
Course Addendum - Syllabus (Click to expand)
|
|
