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
This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
- Bleta Vuniqi, FDA/CDRH, Office of Compliance
- Abiy Desta, Ombudsman, CDRH
- Melissa Sage, Ombudsman's Office, CDRH
- Albert Rodriguez, Consumer Safety Officer, FDA/CDRH, Office of Compliance
- Anne Rossi, Senior Manager, Regulatory Affairs, Boston Scientific Corporation
- Gerard Prud’homme, Partner, Hogan Lovells US
- Chris Mullin, 3D Communications
- Additional FDA speakers to be announced
Courtyard Irvine Spectrum
7955 Irvine Center Drive
Irvine, CA 92618
Room rate: $200
Room block cut-off date: Monday, February 13, 2017
Room booking link: Book your group rate for AdvaMed Submissions Workshop
AdvaMed Member Registration: $1,595.00
Accel Member Registration: $695.00
Government and Non-Profit Registration: $695.00
Non-Member Registration: $2,095.00
Cancellation and Refund Policy
All cancellations must be received via email to Sophearay Smith at email@example.com. Cancellations received 10 business days or more prior to the start of the program are eligible for a full refund. There will be no refunds for cancellations received less than 10 business days prior to the start of the program, including "no shows".
We welcome substitutions in lieu of cancellations at any time. Please contact Sophearay Smith at firstname.lastname@example.org with the substitute's registration information. All cancellation refunds will be processed within 30 business days from date cancellation request is received.
Topics and speakers are subject to change without notice. AdvaMed reserves the right to cancel or reschedule any program, and the full registration fee will be refunded or applied to the rescheduled program in accordance with the registrant's preference. In the event of cancelled programs, AdvaMed assumes no responsibility for transportation, hotel, or other expenses incurred by registrants.