Interactions with the FDA During the IND/NDA Phases
In this beginner online course, you will learn the various methods for communicating with the FDA, including telephone calls, emails, faxes, and meetings. Special attention is given to the types of formal FDA meetings available to industry, as well as specific details on how and when to request them. Finally, you will receive specific recommendations, based on the experience of leading regulatory affairs professionals, on how to conduct successful and productive meetings with FDA.
This On Demand Training will take approximately 2 hours to complete.
- FDA’s Guidance on Meetings
- Time Course of Events in Requesting a Meeting
- Objectives and Conduct of Specific Meetings With FDA
- Principles for Communicating with FDA
- Meeting Etiquette
- How to Resolve Issues or Disputes with FDA
- Summary on Interacting with FDA
- Advisory Committee Meetings
Who should attend?
- Regulatory affairs professionals new to the IND/NDA processes
- Clinical development professionals
- Basic researchers
- Quality and manufacturing professionals
- Medical writers
- Business and marketing professionals
- Clinical research academicians
At the conclusion of this activity, participants should be able to:
- Apply formal meeting principles and practices when interacting with the FDA during the IND/NDA phases
- List time course of events for sponsors in requesting a Type A, B, or C meeting with FDA