Join us in Washington, D.C. where FDA and industry experts will come together to lead you through the strategic considerations and practical steps of filing a Premarket Approval. This unique opportunity will help you better understand the FDA perspective on PMA submissions, from processes to approval to modifications. Throughout the 2-day workshop, you’ll obtain actionable insights and strategies for assembling and streamlining an effective PMA submission.
Take advantage of our group discounts
3 or more attendees - save 15% (use code group15 at checkout)
5 or more attendees - save 20% (use code group20 at checkout)
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 topics will 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
Grand Hyatt Washington
1000 H Street NW
Washington, DC 20001
Room rate: $325
Room cut-off date: Sept. 21, 2018
Reservation link: https://book.passkey.com/event/49486011/owner/544/home
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 AdvaMedEvents@AdvaMed.org. 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 us at AdvaMedEvents@AdvaMed.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.