ALS 463: Current Issues for FDA Regulated Products
Course Number: ALS 463
Course Name: Current Issues for FDA Regulated Products
No. Units: 3.0
Faculty/Instructor(s): Susan Bain
400-level Technical/Business Designations: Technical
Clinical and Regulatory Affairs: Elective
Medical Devices and Diagnostics: Elective
The business environment and regulatory framework pertaining to the medical products industry continue to change rapidly, as they are constantly challenged by competition, politics and new technological possibilities. The highly lucrative and competitive nature of this industry requires professionals have a good working knowledge, background and understanding of FDA's most recent developments, trends and legislation affecting product development, licensing and manufacturing of current and future pharmaceutical products and devices.
ALS 463 is a one-creditcourse that will provide students with a broad background and understanding of the most current regulatory developments, strengthening their capacity to discuss and address contemporary issues effecting the pharmaceutical and medical device industry. The student will become familiar with the challenges posed by recent legislation and enforcement and be better able to analyze, plan and navigate in the dynamic and complex medical products industry.
ALS 462, Introduction to Food and Drug Law recommended but not required for successful completion of this course. Students who have not taken ALS 462 should purchase and review the textbook required for ALS 462: Fundamentals of US Regulatory Affairs, Seventh Edition.
By the end of this course the students will have been exposed to and understand the background, requirements and challenges involved with new regulations, enforcement activities and product requirements facing the ever-changing landscape of the regulated medical products industry.
Students will be better prepared for entry into a variety of professional roles in the medical products industry including Regulatory, Quality, Research and Development and Marketing and be equipped to knowledgeably research and discuss these contemporary issues shaping the pharmaceutical, biotechnology and medical device industries.
The students will be able to analyze current practices and procedures used at pharmaceutical and medical device firms and make recommendations to management regarding emerging "best practices" in regulatory, quality and marketing, effecting product development, manufacturing and sale of finished drugs and devices.