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IDE Submissions Workshop - Spring 2017

March 1, 2017
Irvine, CA
Regulatory
Workshop

During this interactive workshop, FDA and industry experts will lead you through the regulatory and practical guidelines governing when an investigational device exemption (IDE) is required.

Agenda topics include

  • The purpose of an IDE
  • Tips on making the best use of pre-submission meetings
  • Components of a successful IDE submission
  • Common errors and deficiencies in an IDE application
  • The ins and outs of BIMO inspections
  • Details about the regulatory requirements needed during trial conduct
  • And more

This course has been pre-approved by RAPS as eligible for up to 6 credits towards a participant’s RAC recertification upon full completion.
 

510(k)Submissions Workshop February 27-28 | Irvine, CA - Learn more here
PMA Submissions Workshop March 2-3 | Irvine, CA - Learn more here

Speakers include:

  • Anna Schroeder, Biomedical Engineer, IDE Program, CDRH, FDA
  • Albert Rodriguez, Consumer Safety Officer, FDA/CDRH, Office of Compliance
  • Gerard Prud’homme, Hogan Lovells
  • Yarmela Pavlovic, Hogan Lovells
  • Susan Resnick, PhD, 3D Communications

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 
 

Registration Fees

AdvaMed Member Registration: $995.00

Accel Member Registration: $695.00

Government and Non-Profit Registration: $695.00

Non-Member Registration: $1,295.00

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.