The How to Prepare for an FDA Meeting: Making the Most of Pre-IND/IDE, pre-NDA and Other Critical Meetings 2015 is a seminar that covers topics such as:
- Creating rationale for FDA meetings
- Different stages of FDA meetings: pre-IND, Pre-IDE, Pre-NDA, pre-PMA, End-of-Phase 2
- Creating a meeting information package and its regulatory requirements
- Requesting process for FDA meetings
- FDA meeting follow ups
- Logistics of an FDA Meeting
The How to Prepare for an FDA Meeting: Making the Most of Pre-IND/IDE, pre-NDA and Other Critical Meetings 2015 brings together:
- Senior management executives (CEO, COO, CFO, etc.)
- Regulatory affairs professionals
- Clinical trial specialists
- Project managers
- People investing in FDA-regulated product development projects
- Regulatory compliance associates and managers