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 that professionals have a good working knowledge, background and understanding of the role regulatory strategy plays in effective product development.
ALS 463 will provide students with a broad background and understanding of several of the components that comprise a regulatory strategy for a drug product in development. The focus of the class will be on small molecule drug development, but many of the concepts will be applicable to biologic, and to a lesser extent device, regulatory strategy as well. The course will expose students to some of the most current regulatory developments in the context of strategic product development, strengthening their capacity to discuss and address contemporary issues affecting the industry. The student will become familiar with the elements that comprise a regulatory strategy 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.
After completing the course, students should be able to: