The FDA has published guidance regarding the types of meetings that will generally be granted and the information needed to conduct the meeting. However, the guidance tend to be general and interpreted in multiple ways. This topic will provide practical examples and suggestions for standard meetings as well as requesting and conducting non-typical meetings (such as during fast track, clinical hold, or for breakthrough therapy topics).
Rehearsal, post-meeting follow-up, and documenting nonformal FDA interactions will also be discussed in detail.
Why You Should Attend:
Obtaining feedback from the FDA at various times during the development process is crucial to the company to ensure that resources are not wasted and alignment is achieved. This session will provide you with the information you need to request, prepare for and conduct meetings with the FDA to maximize successful outcomes and receive actionable direction and information.
- Standard FDA Meeting Types and Timing
- General Qualifying Requirements
- Preparing the Meeting Request
- Preparing the Briefing Document
- Rehearsing for the Meeting
- Conduct of the Meeting
- Post-Meeting follow up
- Non-typical FDA meetings
- Preparation for non-typical meetings
- Documenting Informal meetings and correspondence
- Reference to meetings during future submissions
- Regulatory Affairs Departments
- Quality Departments
- Compliance Departments
- Program Management Teams
- Project Management Teams
- Manufacturing Departments
- Everyone who may contribute to or participate in an FDA meeting