You are here

PMA Submissions Workshop - Spring 2019

May 16, 2019 to May 17, 2019
Irvine, CA
Regulatory
Workshop

Register now and save $200 with early bird pricing!

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.

Click here to view the agenda

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

Hotel Information
Courtyard Irvine Spectrum | 7955 Irvine Center Drive | Irvine, CA  92618
Room rate:  $189.00
Cut-off Date for reservations:  Monday, April 22, 2019.
Reservations Link: Book your group rate for Advamed Submissions Workshop