PMA Submissions Workshop
February 25 – 26, 2016 — Irvine Marriott, Irvine, CA
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.
- 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
18000 Von Karman Avenue
Irvine, CA 92612
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
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