In the early stages of the pharmaceutical drug approval process, it is essential to maximize outcomes of the Pre-Investigational New Drug (IND) meeting with FDA. Understanding how to navigate initial steps and communications with FDA is a critical first step. This course will provide an outline for how to establish personnel roles working toward the effort, and will provide strategies to enhance study outcomes, meet goals, and work within specific timeframes. We will discuss general expectations for a Pre-IND meeting and requirements for the Pre-IND meeting packet. The course will review other aspects of the Pre-IND phase, such as the Request for Designation (RFD), types of FDA accelerated approval programs, as well as the basics of documentation and laboratory notebook management.
• Understand regulatory requirements for a Pre-IND meeting, the request for a Pre-IND meeting, and the meeting packet
• Know the expectations of FDA and of the company before, during, and after a Pre-IND meeting
• Identify where to find valuable resources and guidances related to the Pre-IND phase
• Recognize differences between the FDA Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and the Office of Combination Products
• Understand the purposes of and differences between a Pre-RFD and an RFD
This course will be offered live online on Wednesday, May 26th, 2021,1:30-4:00pm ET