Analysis of Recent FDA Guidance Documents Workshop – New date April 26

Please join the Indiana Medical Device Manufacturers Council (IMDMC) for our rescheduled

Part 2 – Analysis of Recent FDA Guidance Documents Workshop

Now on April 26, 2012

 

CLE Credits Have Been Requested

Agenda

10:00 am EST Welcome
10:05 Section 522 Post Market Surveillance Guidance document
(FINAL issued in July 2010)
Natlie S. Heck, MS, RAC, Zimmer Inc.
10:45 Risk Based Clinical Trials Monitoring (DRAFT issued in August 2011)Kara Mezger, Zimmer Inc. (invited)
11:30 Use of Exculpatory Language and Informed Consent Guidance
Leah Kendall, Epstein Becker & Green
12:15 Lunch provided
1:15 Proposed Changes to the Common Rule
Indiana University Representative TBA (invited)
1:45 Draft Guidance on Unsolicited Requests for Off-Label Use
David Chadwick, Cook Medical
2:30 Moderated Q&A Panel
Ralph Hall, Faegre Baker Daniels
3:00 Adjourn

Registration Fees: $125 IMDMC Member / $175 Non-Member
Discounts available for IMDMC members registering more than 5 registrants on the same form.

Location: Montage, 8580 Allison Pointe Blvd, Indianapolis, IN 46250

Please register to attend the event now!

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