Foley Hoag Emerging Enterprise Center Bay Colony Corporate Center


Medical Development Group’s November 3 Forum: Clinical Trial Design & Management in an Evolving Regulatory Environment

Waltham, Massachusetts, October 12, 2010 – This event will focus on important expectations and recent changes from the FDA on clinical trial requirements towards regulatory approval. Presentations will cover the fundamentals, benefits and challenges of Bayesian statistics, the clinical/regulatory landscape and challenges that face CAD device manufacturers, potential changes in the FDA 510(k) clearance process, and the impact of Comparative Effectiveness Research and Health Technology Assessments on reimbursement.

Moderator
Nandini Murthy, Principal, Regulatory Consultant
ENEM Consulting LLC Lexington, MA

Panelists
Nitin Patel, Ph.D. Chairman and CTO
Cytel, Inc. Lexington MA
Presentation: Bayesian statistics in clinical trials

John DeLucia, Vice President of RA/QA
iCAD, Inc. Nashua, NH
Presentation: Update on clinical requirements for imaging and CAD devices

Michael Ferguson, Ph.D. Global Director, Clinical Outcomes and Translational Research, Office of Medical and Health Affairs
Philips Healthcare Andover, MA
Presentation: Clinical Evidence Planning through the Product Life Cycle: A Regulatory and Reimbursement Perspective

Meeting Fee (includes buffet dinner)
At the door:
$40 nonmembers, $30 members, payable by cash or check to “MedDev Group, Inc.”


Prepaid online:
$30 nonmembers, $20 members
We strongly encourage everyone to register and prepay online.
Become a member NOW (good for 12 months). 
You may also become a member at the meeting.

When
Wednesday November 3, 2010
5:30 – 8:00 PM

Location
Foley Hoag Emerging Enterprise Center
Bay Colony Corporate Center
1000 Winter St. 
Suite 4000 North Entrance

Waltham MA. 
Map to the Emerging Enterprise Center: (Click here for directions)

For more information, contact Judy Isaacson:
Phone: 401.461.8059
Email: judy@vitalnow.net

About MDG
The Medical Development Group, (www.meddevgroup.org), headquartered in Massachusetts and serving the entire New England region, is a community of individuals professionally committed to the Medical Device and other Medical Technology industry segments united by the belief that innovation and advances in technology lead to substantial improvements in health care.