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510(k) Submissions Workshop - Spring 2017

February 27, 2017 to February 28, 2017
Irvine, CA
Regulatory
Workshop

Overview

FDA and industry experts are coming together to teach you the basics of 510(k) submissions.

Agenda topics include:

  • FDA’s updates to the 510(k) process
  • Different types of 510(k)s
  • Considerations for determining a product's regulatory route to market
  • Factors to consider when planning and assembling a 510(k) submission
  • Tips and hints on interacting with FDA during the 510(k) review process
  • Deciding when to submit a new 510(k) for a device modification
  • 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.



IDE Submissions Workshop March 1 | Irvine, CA - Learn more here
PMA Submissions Workshop March 2-3 | Irvine, CA - Learn more here

 

Speakers

Speakers include:

  • Marjorie Shulman, Director, Premarket Notification Program, ODE/CDRH/FDA
  • Frank Pokrop, Director, Regulatory Affairs, BD
  • Pamela Weagraff, Director, Medical Device & Diagnostics Regulatory, QuintilesIMS
  • Andy Van Haute, Sidley Austin
  • Sonali Gunawardhana, Wiley Rein

Event Logistics

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 
 

Additional Info

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 ssmith@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 Sophearay Smith at ssmith@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.