ALS 435: Medical Device and Biologics Regulatory Affairs
Course Number: ALS 435
Course Name: Medical Device and Biologics Regulatory Affairs
Year: Second-year
Semester: Fall
No. Units: 0.5
Faculty/Instructor(s): Gail D. Baura, Larry Grill
Description
This course examines the operational, strategic and commercial aspects of the regulatory approval process for new medical devices, biologics, and combination products in the United States. The topics are designed to provide a chronological overview of the requirements needed to seek marketing approval. The goal of this course is to introduce and familiarize students with the terminology, timelines and actual steps followed by Regulatory Affairs professionals employed in the medical device, pharmaceutical, or biotechnology industry. Case studies from industry will be examined to supplement certain topics and to illustrate interpretation of regulations.
Prerequisites
Completion of the first year of graduate study at KGI.
Topics Covered
- Medical Device Errors, Human Factors and Electronic Health Records.
- Medical Device Legislation History, Classification and Reclassification.
- Combination Product Regulation.
- Investigational Device Exemptions, HDEs, Medical Device 510(k), Pre-Market Approval (PMA) submissions, de novo review and Product Development Protocol.
- Medical Device Good Manufacturing Practices.
- FDA Enforcement, FDA Postmarket Transformation and Medicare Reimbursement.
- FDA and the Food and Drug laws.
- Investigational New Drug Application (IND), the IND review process and FDA warning letters.
- Clinical development of new biologics and Good Clinical Practices (GCP).
- Center for Biologics Evaluation and Research (CBER), Biological License Application (BLA), Common Technical Document (CTD), BLA review process: Pre-Approval Inspections (PAI), Advisory Committees, Interacting with FDA and FDA Meetings.
Learning Objectives
After completing this course, students should have:
1. A fundamental knowledge of acronyms and terminology that are used in the FDA regulatory approval process from the design input stage through submission and review of the 510(k) or Pre-Market Approval documentation and post-market approval requirements for a new medical device.
2. Comprehension of the documentation and regulatory requirements necessary at each stage of the U.S. regulatory submission and review process for medical devices and biologics.
Grading
Medical Devices Group Project 55%
Medical Devices Reading Discussion 20%
Biologics Short Exam 20%
Biologics Reading Discussion5%
Required Texts