IDE Submissions Workshop

February 24, 2016 — Irvine Marriott, Irvine, CA

Overview |  Agenda |  Speakers |  Logistics |  Fees

Overview

During this interactive workshop, FDA staff 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

Presentation slides will be sent after the conclusion of the workshop.

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

Click here to Download.

Speakers

  • Anna Schroeder, Biomedical Engineer, IDE Program, CDRH, FDA
  • Catherine M. Vitols, Senior Principal Regulatory Affairs Specialist, Corporate Regulatory Affairs, Medtronic
  • Vinny Podichetty, Senior Director Clinical Research, MicroVention, Inc. A TERUMO Group Company
  • Albert Rodriguez, CDRH, FDA
  • Chad Coberly, VP of Clinical, Regulatory, and Legal Affairs, Cohera Medical, Inc.
  • Tony Blank, Cofounder and Senior Advisor, Barton & Blank, LLC
  • Todd Gross, PhD, 3D Communications

 

Hotel & Meeting Logistics

Irvine Marriott
18000 Von Karman Avenue
Irvine, CA 92612
949-553-0100

Reserve your room here or contact Marriott Reservations Desk directly at 1-800-228-9290. Specify the Advanced Medical Technology Association

Cut-off date for reservations is Friday, February, 12 2016.
Room rate is: $189.00 single/double 

Can't make this date? We are offering the same workshop this fall.  Click here to learn more.

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


Please contact skinchen@advamed.org for Group Discounts.