Event | 16-17 May 2019 | Irvine, California, United States

PMA Submissions Workshop - Spring 2019

Yarmela Pavlovic and Gerard Prud'homme will be speakers at the PMA Submissions Workshop – Spring 2019. The workshop will lead you through the strategic considerations and practical steps of filing a premarket approval.

Agenda topics include:

• Steps to develop a premarket approval (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 bioresearch monitoring program (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.