IMDMC’s 2011 Annual Conference – 20 Years Serving the Device Community

Thursday October 6, 2011

Featuring:

Christy Foreman,
Director, Office of Device Evaluation, CDRH, FDA
&
Tim Ulatowski
Former Director of Compliance CDRH,
currently Principal, NDA Partners LLC

Location: Montage Meeting Facility
8580 Allison Pointe Blvd.
Indianapolis, IN 46250
Directions / Nearby Hotels

CLE Credits have been requested

 

Exclusively sponsored by:

Baker & Daniels, LLP

Agenda

9:15 am
Welcome
Danelle Miller, IMDMC President, Roche Diagnostics Corporation

9:30
Christy Foreman, Director, Office of Device Evaluation, CDRH, FDA

10:30
Break

10:45
Device clinical research: Evolution of government expectations & potential impact on your business
1. Recent enforcement trends
Leah Kendall, Attorney, Epstein Becker Green
2. FDA/OHRP efforts to modernize and revise regulations and guidance,
Gretchen Bowker, COO, Pearl Pathways
3. Case study: How increasing pressures in the clinical space may impact device development
Zimmer Clinical, TBD

11:15
Top Regulatory Issues
1. User Fees
Colleen Hittle, President & CEO, Anson Group
2. Post Market Surveillance
Sandra Williams, Consultant, Anson Group
3. EU Standards
Russ Gray, Principal Consultant/ Director of Device Operations & Combination Product, Anson Group
4. New Guidance / IOM Report / Update on FDA’s Innovation Initiatives/ UDI
Ralph Hall, Counsel, Baker & Daniels

12:15
Annual Business Meeting / Recognition of Past Presidents

12:30
Exhibit Break & Lunch

1:30
Tim Ulatowski, Principal, NDA Partners LLC
Former Compliance Director, CDRH

2:30
Break

2:45
Regulatory Affairs & Marketing:
Partnering for efficiency, compliance and clear communication?
Paul Leininger, Group Product Director, Hip Marketing, DePuy Orthopaedics, Inc

3:15
Top Compliance & Enforcement Issues
1. Anti-Corruption: Foreign Corrupt Practices Act and the UK Bribery Act
Carol Seaman, Vice President and Chief Compliance Officer, Cook Group Incorporated
2. Social Media and the Medical Device Sector Issues in Advertising and Promotion
Cynthia Kretz General Counsel, Cook Group Incorporated
3. Physician Payment Sunshine Provisions of the Patient Protection and Affordable Care Act
Dan Peterson, VP, Industry & Government Relations, Cook Group Inc.

4:00
Wrap Up & Adjourn

Register Online Now

Members: $125
Non-Members: $175

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