You are here

PMA Submissions Workshop - Spring 2019

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

Click here to view the agenda

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

Hotel Information
Courtyard Irvine Spectrum | 7955 Irvine Center Drive | Irvine, CA  92618
 

Speakers will include:

  • Gerard Prud’homme, Hogan Lovells
  • Joshua Nipper, FDA
  • Bleta Vuniq, FDA
  • Jennifer Bolton, Boston Scientific
  • Christopher Giofre, FDA
  • Quynh Hoang, King & Spalding
  • Laura Byrd, FDA
  • Abiy Desta, FDA

Registration Fees

AdvaMed Member Registration: $1,595.00

Accel Member Registration: $695.00

Government and Non-Profit Registration: $695.00

Non-Member Registration: $2,095.00

Please review our cancellation policy here