Investigational Device Exemption (IDE) Submission Workshop

Wednesday, February 24, 2010

Las Vegas, NV | The Westin Casuarina Hotel


MTLI offers this one-day interactive workshop to lead attendees through the regulatory and practical guidelines governing when an IDE is required, how to compile an effective IDE applications, the rules governing clinical studies and human subject protection, Institutional Review Boards, types of pre-IDE meetings and communications, early/expanded access, foreign studies and export, and reimbursement for investigational devices.

Click here for the Full Agenda


Who Should Attend
Regulatory experts involved with premarket submissions
Clinical experts
Registration
AdvaMed Member $1095 Register Now
Non-Member $1295
AdvaMed EGCC Member $895
Government $395

Agenda Overview
View Full Agenda
What is an IDE
Mechanics of an IDE Application
Regulatory Requirements During Trial Conduct
BIMO Audits
Reporting Results
Best Practices

Click here for the Full Agenda


Speakers
Lynn Henley, Public Health Analyst, FDA/CDRH
Anthony Blank, VP Cardiovascular Regulatory Affairs, Boston Scientific
Michael Morton, Senior Director, Regulatory Affairs, Medtronic
Linda Godfrey, Chief, Program Enforcement Branch A, Division of Bioresearch Monitoring, FDA/CDRH

Click here for the Full Agenda

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General Information

It is the responsibility of the registrant to verify their company’s active membership status prior to registering.  You may check if your company is an active member by clicking here.  There will be no adjustments or refunds made for registrations made as non-members, when registrant’s company is a member company.  Higher non-member rate will be charged for registrations received under member registration when companies are found to be non-members.


For Sponsorship Opportunities, Hotel Information and Seminar Logistics, please contact Veronica Allen.  For information regarding Registration issues, please contact Katia Kunze.

Please be advised that any registrations received after 5 pm on Wednesday December 2nd will not appear on the participants roster.  It is MTLI policy not to release revised participants rosters after the seminar.

CANCELLATION & REFUND POLICY

All cancellations must be received in writing by Katia Kunze. All cancellations received 11 business days or more prior to the start of the program are subject to a 10 percent cancellation fee. There will be NO REFUNDS for cancellations received within the 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 Katia Kunze with the substitute's information. All cancellation refunds will be processed within 30 business days from date cancellation request is received.  Topics and speakers are subject ot change without notice.  Advamed reserves the right to cancel or reschedule any program, whereupon full registration feew 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.

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Location Information

The Westin Casurina Hotel
160 East Flamingo Drive
Las Vegas, NV 89109
1-866-837-4215 (reservations)

A limited number of rooms have been reserved at this hotel for seminar participants, at the reduced rate of $129.  Please make your reservations by contacting the hotel and identifying yourself as a member of the Advanced Medical Technology Association room block or by clicking here.  This rate will be available until February 5, 2010.  Room and rates are subject to availability after this date.  Please make your reservations early as the block will fill up quickly.

 

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Frequently Asked Questions

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