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PMA Submissions Workshop - Fall 2018

October 18, 2018 to October 19, 2018
Washington, DC
Regulatory
Workshop

Save $200 with early bird pricing!

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.

Click here to learn more about the 510(k) Submissions Workshop

Click here to learn more about the IDE Submissions Workshop

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

Hotel Reservations:
Room rate:  $325
Room cut-off date:  Sept. 21, 2018
Reservation link: https://book.passkey.com/event/49486011/owner/544/home

Save $200 with early bird pricing - register now!

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.