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.

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