PMA Submissions Workshop

February 28 – March 01, 2013 — Sheraton Crystal City, Arlington, VA

Overview |  Agenda |  Speakers |  Logistics |  Fees

Overview

Completing the MTLI set of interactive submissions workshops, senior industry experts and members of the CDRH device evaluation and bioresearch monitoring staffs lead professionals through the strategic considerations and practical steps of filing a Premarket Approval, illustrated with real world case studies. Topics include:

New Acceptance and Filing Review guidance document
eCopy Program for Medical Device Submissions
Strategy development and evidence requirements
Productive meetings with FDA
The mechanics of premarket approval submission development
Advisory panels, inspectional activity
Conditions of approval studies

Please contact skinchen@advamed.org for Group Discounts
(discount does not apply to EGCC, Government, or Non-Profit Organizations)

TESTIMONIALS

"I found this conference to be well organized, respectful of the attendees time and other obligations, and EXTREMELY informative and educational."

"Very well orchestrated and professionally done. Topics were relevant and meaningful. Liked the breakout groups.."

"excellent balance, coverage and access to speakers...food was great too"

"All of the speakers were excellent, knowledgeable, and approachable. The Q&A was very helpful."

“The PMA Submissions and PMA Supplements course was excellent. Great content and useful information.”

“The PMA Submissions and PMA Supplements was very well organized and the selection of topics and flow of content was well planned.”

"I thought the workshop was excellent. The speakers knew the material and were willing to give real world experiences to back up their slides..."

This workshop is pre-approved by RAPS as eligible for up to 10 credits towards a participants RAC re-certification upon full completion.

Agenda

Click here to Download.

Speakers

Laura Byrd, PMA Staff, ODE, FDA/CDRH
Long Chen, PhD, Scientific Reviewer, FDA/CDRH/ODE/DSD
Irfan Khan, BIMO Reviewer, OMPT/CDRH/OC
Michelle Noonan-Smith, Quality System Specialist, FDA/CDRH, Office of Compliance
Hina M. Pinto, MSE, Regulatory Advisor, FDA/CDRH/ODE
Lawrence “Jake” Romanell, Deputy Ombudsman, FDA/CDRH, Office of the Director
Tony Blank, Cofounder and Senior Advisor, Barton & Blank, LLC
Christine L. Brauer, Ph.D., Regulatory Affairs Consultant, Brauer Device Consultants, LLC
Michael Morton, Senior Director, Regulatory Affairs, Medtronic

Hotel & Meeting Logistics

Sheraton Crystal City
1800 Jefferson Davis Highway
Arlington, VA  22202
Reservations:  1-888-627-8209 (Reference AdvaMed when making reservations)
or online by Clicking Here
Room rate:  $195.00
Rate available 3 days prior/post meeting date based on hotel availability
Hotel cut-off date for reservations:  2/3/13

Registration Fees

AdvaMed Member Registration: $1,595.00
AdvaMed Member Registration (< $30 Million gross sales): $695.00
Government and Non-Profit Registration: $695.00
Non-Member Registration: $2,095.00


Please contact skinchen@advamed.org for Group Discounts (Discount does not apply to AdvaMed Accel, Government, or Non-Profit Organizations)