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Updated in [July 27th, 2023]

This course provides learners with an understanding of the importance of US Food & Drug Administration (FDA) regulations for public health, and how to navigate through the FDA regulations to market a biologic or pharmaceutical. Participants will gain knowledge of the drug development process and the key regulatory steps toward FDA approval, as well as develop their ability to conduct regulatory intelligence and develop a regulatory strategic plan. This course is beneficial for scientists, physicians, entrepreneurs, public health professionals, industry analysts, consultants, and biomedical students interested in the biotechnology and pharmaceutical industry.

Course Syllabus

Section 1: Welcome & Introduction

Section 2: Pre-Investigational New Drug (Pre-IND) - Preclinical Development

Section 3: Investigational New Drug (IND) - Clinical Development

Section 4: New Drug Application - Getting A Drug Approved

Section 5: Post-Approval - Marketed Drug

Section 6: Course Wrap-Up