Completing the set of interactive submissions workshops, industry and FDA experts will lead you through the strategic considerations and practical steps of filing a Premarket Approval.
Agenda topics include:
- Steps to develop a PMA submission strategy
- Best practices of quality system information for PMA applications
- What to expect during a submission review
- Preparation needed for an advisory panel meeting
- Tips to prepare for an inspection
- Ins and outs of BIMO inspections
- How to deal with unexpected clinical outcomes, animal test results, and adverse panel recommendations
- Needed supplemental submissions for approved PMAs
- Real world case studies
- And more!