The IND/IDE Development Process

Presenter:

Lynn Rose, PhD, Director
Research Associate Professor, Pediatrics, UW
Director, Clinical Operations, Cystic Fibrosis TDN
Coordinating Center, Seattle Children’s
Pre-clinical Research and Development Core, ITHS

Objectives:

• Understand the basis of FDA emphasis on safety
• Understand how to build regulatory science into your research program
• Understand when an IND is required
• Learn about the regulatory resources available to you