Register » FDA Update – In Conjunction with ASQ – New England Biomedical Discussion Group & RAPS

When: « Back to Calendar December 12, 2017 @ 8:00 am - 3:30 pm
Where: Mass. Medical Society
860 Winter St
Waltham,MA 02451
USA
Cost: $ 175
Contact: MassMEDIC
617 414-1340
info@massmedic.com
Categories: MassMEDIC Events

Collaboratively hosted by the ASQ Biomedical Division/New England Discussion GroupMassMEDIC and RAPS, this daylong program is designed to give RA, QA and C-level executives a one-day crash course on the pending regulatory issues facing the industry. The agenda will include comprehensive presentations by FDA officials, industry representatives and regulatory experts.

 

AGENDA

7:00 am

Registration / Coffee / Networking

8:30 am

FDA – Update on Current Policies and Priorities
Vernessa T. Pollard, Partner, McDermott Will & Emery

CDRH Report
William H. Maisel, MD, MPH
Director, Office of Device Evaluation (Acting); Deputy Director for Science and Chief Scientist, Center for Devices and Radiological Health, U.S. Food and Drug Administration

10:00 am

Networking Break

10:30 am

FDA New England District Office Update
Joseph Matrisciano, District Office Director, U.S. Food and Drug Administration

Digital Health Initiatives at FDA
Heather Agler, Sr. Science Health Advisor, Center for Devices and Radiological Health, U.S. Food and Drug Administration

12:00 pm

Luncheon 

1:00 pm

EU MDR: Review of Significant Changes and Timeline for Manufacturers
Glen Emelock, Senior Partner, The CRO Group, Inc.; Lead Auditor/Product Reviewer, National Standards Authority of Ireland

Dissecting Newly Released ODE Guidance Documents: What’s New, What’s Not, and How Will They Impact Your Submission Strategy
Sheila Hemeon-Heyer, MS, JD, FRAPS, Founder and President, Heyer Regulatory Solutions LLC

2:30 pm

Program Concludes

 

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