How to Prepare for an FDA Meeting: Making the Most of Pre-IND/IDE, pre-NDA and Other Critical Meetings 2015

Topics

• 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

Who should Attend

• 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