FDA Update 2012

When: « Back to Calendar December 7, 2012 @ 7:30 am - 3:00 pm
Where: Mass. Medical Society
860 Winter St
Waltham,MA 02451
Cost: $ 150
Categories: MassMEDIC Events

Collaboratively hosted by the ASQ Biomedical Division/New England Discussion Group, MassMEDIC and  RAPS, FDA Update brings area medtech regulatory and quality executives the latest and best information on current trends. This year’s program will examine how the elections will impact Congressional action and FDA policies; updates on the UDI & IMDRF initiatives; and reports from the CDRH Ombudsman; and the local FDA offices.  The program will also include a networking lunch and ample opportunities to meet with regulatory professionals from around the region.




8:30 a.m. Welcome & Introduction
Tom Sommer, President, MassMEDIC

The Impact of the 2012 Elections on MedTech Policy
JC Scott, Sr. Executive Vice President, Government Affairs, AdvaMed
Areta L. Kupchyk, Partner, Nixon Peabody, LLP

Regulating MedTech’s Use of Social Media – A MassMEDIC Project
Jim Weinrebe, Executive Vice President, Schwartz MSL

10:00 a.m. Networking Break

10:30 a.m. Introduction
David Leo, Founder, Past Chairman, Board Member
ASQ Biomedical Division – New England Discussion Group

Update on FDA’s Unique Device Identification (UDI) Rule
Jay Crowley, Sr. Advisor, Patient Safety, FDA/CDRH 

Update on the New International Medical Device Regulators Forum (IMDRF)
Kimberly A. Trautman, Associate Director for International Affairs, FDA’s Medical Device International Quality Systems Expert. Office of the Center Director

12:00 p.m. Luncheon

1:00 p.m. Introduction
Susan K. Haman, Group Manager, Regulatory Affairs, Beckman Coulter Genomics
Chair, RAPS, Boston Chapter

FDA New England District Update: Activities and Accomplishments of the District in FY 2012
Capt. Mutahar S. Shamsi, USPHS, District Director, New England District, FDA

CDRH Appeals and FDA Safety and Innovation Act of 2012
David S. Buckles, Ph.D., FACC, FAD/CDRH Ombudsman

FDA’s Global Challenge in the Regulatory Science Testing Arena
Brian L. Baker, P.E., FDA Director, Winchester Engineering and Analytical Center

3:00 p.m. Program Adjourns