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PMA Submissions Workshop – Fall 2019

October 10, 2019 to October 11, 2019
Washington, DC
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

The PMA Submissions Workshop will take place October 10-11 at the AdvaMed Office in Washington, DC.

View hotel list

Address:
701 Pennsylvania Ave. N.W.
Suite 800
Washington, D.C.

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

Note: Early-bird pricing is available for AdvaMed Members and Non-Members. Register by September 6, 2019 for $200 off your registration! Also, check your confirmation email for opportunities to save even more on your next workshop!

Please review our cancellation policy here