PMA Submissions Workshop

February 25 – 26, 2016 — Irvine Marriott, Irvine, CA

Overview |  Agenda |  Speakers |  Logistics |  Fees

Overview

Completing the set of interactive submissions workshops, senior industry experts and FDA staff 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

Presentation slides will be sent after the conclusion of the workshop.

This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Agenda

Click here to Download.

Speakers

  • Erin Cutts, Supervisory Biomedical Engineer, FDA/CDRH, Office of Device Evaluation
  • Bleta Vuniqi, CSO, Respiratory, ENT, General Hospital, and Ophthalmic Device Branch, FDA/CDRH, Office of Compliance
  • Albert Rodriguez, Consumer Safety Officer, FDA/CDRH, Office of Compliance
  • Chad Coberly, VP of Clinical, Regulatory, and Legal Affairs, Cohera Medical, Inc.
  • Tony Blank, Cofounder and Senior Advisor, Barton & Blank, LLC
  • Laura Byrd, PMA Staff, ODE, FDA/CDRH

 

Hotel & Meeting Logistics

Irvine Marriott
18000 Von Karman Avenue
Irvine, CA 92612
949-553-0100

Reserve your room here or contact Marriott Reservations Desk directly at 1-800-228-9290. Specify the Advanced Medical Technology Association

Cut-off date for reservations is Friday, February 12, 2016.
Room rate is: $189.00 single/double 

Can't make this date? We are offering the same workshop this fall.  Click here to learn more.

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 contact ssmith@advamed.org for Group Discounts.