PMA Submissions Workshop

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

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.