The Clinical Development Process: Investigational Product, Plan, and Data Management
This course will discuss the clinical development process, including the regulatory obligations of the sponsor of a new drug or product. Topics in this course include: Clinical Research Plan, Protocol Plan, Subject Selection Process, Data Collection, and NDA Submission. After completing this course, learners will be able to identify the steps leading to the final FDA review and approval for marketing of a new product.
Identify the steps leading to the final FDA review and approval for marketing of a new product.