PMA Submissions Workshop

Thursday, February 25 – Friday, February 26, 2010

Las Vegas, NV | The Westin Casuarina Hotel


Completing the MTLI set of interactive submissions workshops, senior industry experts and members of the CDRH device evaluation and bioresearch monitoring staffs lead participants through the strategic considerations and practical steps of filing a PMA, illustrated with real world case studies. Topics include strategy development and evidence requirements, productive meetings with FDA, the mechanics of submission development, advisory panels, inspectional activity, conditions of approval studies, and the care and feeding of approved PMAs.

Click here for the Full Agenda


Who Should Attend

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




Agenda Overview
View Full Agenda
  • Beginning at the Beginning
  • Development of a PMA Submission Strategy
  • Meetings with the FDA
  • Mechanics of PMA Submission Development and Submission
  • During Submission Review
  • Inspectional Activity
  • Advisory Panels
  • Conditions of Approval Studies
  • Dealing with the Unexpected
  • The Care and Feeding of Approved PMAs
  • Real World Case Studies

Click here for the Full Agenda


Speakers
Anthony Blank, Vice President Cardiovascular Regulatory Affairs, Boston Scientific
Laura Byrd, PMA Staff, ODE, FDA/CDRH
Michael Morton, Senior Director, Regulatory Affairs, Medtronic
Les Weinstein, Ombudsman, FDA/CDRH
Anastacia M. Bilek, Branch Chief, FDA/OPMD Division of Enforcement
Helen Lavin, Regulatory Affairs Manager, Boston Scientific

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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