The Continuing Evolution of the FDA

November 16, 2012

Location

West Lafayette - MED Institute, a Cook Group Company
Purdue Research Park
1 Geddes Way, West Lafayette, IN (Directions)

Primary Sponsors

 

Overview

Between changes in the politically appointed leadership and the new reauthorization law for fees and product approvals, the FDA continues to be in a state of flux.  At the same time, the agency is attempting to make itself more relevant to a variety of new products being developed and more “user friendly”.  What will it take for the FDA to maintain its balance in the years ahead?   Veterans and observers of the agency will present their opinions as to what’s next for the agency.

 

Agenda

8:00 am – 9:00 am	Registration and Breakfast
9:00 am – 9:15 am	Welcome and Introduction
	Matt Waninger President, MED Institute, Inc. (a Cook Group Company)
9:15 am – 10:15 am	Keynote Presentation- Medical Device Regulatory Reform and the FDA Safety and Innovation Act
	Janet Trunzo Senior Executive Vice President, Technology and Regulatory Affairs, AdvaMed
10:15 am – 10:30 am	Break
10:30 am – 12:00 pm	Panel - Expected Changes From the Recent FDA Safety and Innovation Act
	Moderator: Neal Roach Partner, Taft Stettinius & Hollister LLP
	Panel Members:
	Wendy Turner Group Director, Regulatory Operations, Johnson & Johnson Global Surgery Group
	Dr. Robert Metcalf Vice President Global Regulatory Affairs -US, Eli Lilly & Company
	Kelly Davis Associate Director of Regulatory Affairs, Baxter BioPharma
	Tim Gee Connected Health Specialist, The Anson Group
12:00 pm – 1:30 pm	Luncheon Keynote- Working with the FDA from the Inside Out
	Introduction: Dan Peterson Vice President, Industry and Government Affairs, Cook Group
	Susan Alpert Principle, SFA Consulting LLC Former Vice President of Regulatory Affairs and Compliance at Medtronic; former Vice President of Regulatory  Sciences at C.R. Bard, Inc.; former Director of The Office of Device Evaluation, FDA
	Networking
1:30 pm – 3:00 pm	Afternoon Panel – New Initiatives to Make the Agency More Effective and Efficient
	Moderator: Colleen Hittle President and CEO, The Anson Group
	Panel Members:
	Neal Fearnot Vice President, Cook Group Inc.
	Randy Julian Founder & President, Indigo BioSystems, Inc.
	Joe Muldoon CEO, FAST Biomedical
	Wade Lange, President & CEO, ImmuneWorks
3:00 pm – 3:15 pm	Wrap Up George Telthorst, Director, Center for the Business of Life Sciences, IU Kelley School of Business