IDE Submissions Workshop

Wednesday, October 28, 2009

Alexandria, VA | Hilton Alexandria Old Town


SPECIAL PROMOTION - Please do not submit your registration online, we will do it for you!

AdvaMed's MTLI is offering a $250 discount on all remaining 2009 courses. In order to obtain the $250 discount, please visit our website at www.advamedmtli.org and complete the registration form but do no submit it online.

After completing your registration form, PDF the form and email it to kkunze@advamed.org or print it out and fax it to 202.783.8750 Attention: Katia. Please indicate your request for the $250 discount in the body of the email or the fax cover sheet and we'll take it from there. Some restrictions may apply.

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.

 

 Sponsored by:

Medmarc Logo

 

 

Click here for the Full Agenda


Who Should Attend
Regulatory professionals and product developers involved in US device and diagnostics regulatory submissions.

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

Anthony Blank, VP Cardiovascular Regulatory Affairs, Boston Scientific
Christine Brauer, Consultant, Brauer Device Consultants
Michael Morton, Senior Director, Regulatory Affairs, Medtronic
Linda Godfrey, Chief, Program Enforcement Branch A, Division of Bioresearch Monitoring, FDA/CDRH
Sheila Brown, RN, Nurse Consultant, FDA/CDRH
Owen Faris, Pacing, Definbrillators and Leads Brach, FDA
Sonna Patel-Ramman, Circulatory Support and Prosthetics Branch, FDA

Click here for the Full Agenda

- Back to Top -


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

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 ten 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 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.

This seminar is being offered in conjunction with the IDE & PMA seminars (for 510k)/ 510k & PMA Seminars (for IDE)/ 520k & IDE Seminars (for PMA) If you would like to register for two or all three seminars at the same time, we are offering a $ 100 per seminar registration discount ($300 total discount if you register for the 3 seminars at the same time). In order to receive your discount, please contact Katia Kunze at 202.434.7237 or via email at kkunze@advamed.org. Please be aware that in order to receive the discount, you must contact Ms. Kunze, as the registration system will NOT allow you to receive the discount if you register on-line.

Please be advised that registrations received after 4 pm October 16, 2009, will not appear in the Participants Roster distributed to all attendees at the Seminar.  It is MTLI policy NOT to release updated Participant Rosters after the seminar.

- Back to Top -


Location Information

Hilton Alexandria Old Town
1767 King Street
Alexandria, VA
703.647.2014


A limited number of rooms have been set aside for attendees to the 510k-IDE-PMA seminars, at the discounted rate of $209. 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 Monday, September 25. Room and rates are subject to availability after this date. Please make your reservations early as the block will fill up quickly.

- Back to Top -


Frequently Asked Questions

- Back to Top -