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An Update on Regulatory Compliance

February 25, 2011
View Presentations
Location
Barnes & Thornburg LLP
11 South Meridian Street, Indianapolis, IN (Map)
*Parking is available at the Denison Parking Garage located on Meridian Street, just south of Barnes & Thornburg. The cost is around $14 to park and you pay in the lobby before leaving with debit, credit or cash. Parking is also available at the Circle Centre Mall just a couple of blocks from Barnes & Thornburg at a lower rate.
Primary Sponsors: 

Supporting Sponsors
Beckman Coulter, Inc.

Conference Marketing Partner
BioCentury
Overview

The new administration, leadership and legislation all contribute to the recent changes in how the FDA performs its role.  At the same time, manufacturers of pharmaceutical products, nutritionals, medical devices and diagnostic equipment, and other medical technologies are constantly looking for new ways to distribute, market and sell their products. Many would say that the effects of this combination are putting businesses under more  regulatory scrutiny, subjecting companies to more liability and delaying the availability of new products and therapies to healthcare providers and ultimately, the public. This program will bring experts from industry and the regulatory environment together to discuss whether this is indeed the case and review strategies for the future.

Agenda
8:00am-9:00amRegistration and Breakfast
  
9:00am-9:15amWelcome and Introduction
 Kep Carmichael, Partner and Co-Chair, Life Science Practice Group, Barnes & Thornburg LLP
  
9:15am-10:15amKeynote Presentation- The FDA in the 21st Century: Reflections of a Veteran FDA Observer
 Steve Usdin, Senior Editor, BioCentury
  
10:15am-10:30amBreak
  
10:30am-12:00pmMorning Panel- New Product Reviews and Approvals
 

Moderator: Todd Vare, Partner and Co-Chair, Nanotechnology Practice Group, Barnes & Thornburg LLP

Panel Members:

Tom Bolton, Manager of Regulatory Affairs, Eurand (Presentation)

Chris Kilander, Regulatory Affairs Manager & Corporate Compliance Administrator, Cook Urological, Inc.

Hugh Tucker, PhD, Distinguished Research Fellow, Global Research & Development, Mead Johnson Nutrition

Donna Zimmerman, PhD, Vice President, Elona Biotechnologies, Inc. (Presentation)

12:00pm-1:30pmLuncheon Keynote- The FDA Perspective
 

Introduction of Keynote Speaker

Craig Hadley, PhD, Associate Director, North America Regulatory Science, Mead Johnson Nutrition

Keynote 

Peter Pitts, President & Co-Founder, Center for Medicine in the Public Interest, Former Associate Commissioner for External Relations, U.S. Food and Drug Administration

Networking

1:30pm-3:00pmAfternoon Panel- Current Business Operations
 

Moderator: Colleen Hittle, RAC, Managing Partner, Anson Group

Panel Members:

David Ceryak, Senior Director & Assistant General Counsel, Regulatory Legal Team, Eli Lilly and Company (Presentation)

Lynn Gagel, Assistant General Counsel, Roche Diagnostics Corporation

Richard E. Kruger, PhD, Principal, Kruger Consulting, Inc.

Joe Levitt, Former Director, Center for Food Safety & Applied Nutrition, U.S. Food and Drug Administration

3:00pm-3:15pmClosing Remarks
 George M. Telthorst, Director, IU Kelley, Center for the Business of Life Sciences