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medical technology

VIEWS: 88 PAGES: 3

									 The Medical Technology Leadership Forum



     FDA in the 21st Century:
  Issues and Their Impact on
         Medical Technology

December 8-9, 2008
Indianapolis, IN

Hosted by: Indiana University School of
Medicine

                                                                               Photograph by Harold Miller




                                                  Event Registration
The Food and Drug Administration is facing
enormous challenges, including an expanded        To register for this event, please visit the
                                                  “Events and Activities” page of the MTLF
role in a globalized marketplace; questions       website – www.mtlf.org .
about its scientific capacity, problems due to
limited financial resources, changing relations
                                                  Hotel Information
with industry and physicians including ethics
and conflict of interest challenges, and          The MTLF has reserved a block of rooms at
                                                  Sheraton Indianapolis City Centre
political pressures to expand its role in the
healthcare marketplace.                           31 West Ohio Street
                                                  Indianapolis, IN 46204
                                                  (317) 635-2000
What should the future of FDA be? What are
                                                  Single room rates are $119 per night.
the major policy issues and how should those
issues be addressed?                              To make reservations, (317) 635-2000 and
                                                  mention the Medical Technology Leadership
                                                  Forum for the discounted rate.
For more information, contact Sue Riesgraf
at: sriesgraf@comcast.net                              Deadline for hotel reservations is
                                                             November 24, 2008.




                                                                                     Draft 11/14/08
Monday, December 8, 2008                                           Panorama Ballroom

5:00 p.m.   WELCOME RECEPTION
6:30 p.m.   DINNER

            WELCOME
            Stephen Ferguson, Chairman, Cook Group Incorporated (confirmed)

            The Honorable David F. Durenberger, former U.S. Senator, Board of
            Directors, MTLF (confirmed)

7:15-8:30   KEYNOTE ADDRESS
            FDA’s Scientific Capacity

            Gail H. Cassell, Ph.D., Vice President Scientific Affairs and Distinguished
            Lilly Research Scholar, Eli Lilly and Company; Member, FDA Science
            Advisory Board, “FDA Science and Mission at Risk” (confirmed)


Tuesday, December 9, 2008                                          Panorama Ballroom

7:30 am     REGISTRATION AND CONTINENTAL BREAKFAST

8:00 am     WELCOME
            Dr. Ora Pescovitz, President and CEO, Riley Hospital for Children, Executive
            Associate Dean for Research, Indiana University School of Medicine, Interim
            V.P. for Research Affairs, Indiana University (confirmed)

            David Johnson, President and CEO BioCrossroads; Board Member, MTLF
            (confirmed).

8:30-9:30   SESSION 1: FDA’S RESOURCES AND REGULATORY TOOLS: CAN FDA
            DO ITS JOB?

            Philip J. Phillips, Medical Device Practice Director, Becker & Associates;
            former CDRH Deputy Director, Office of Device Evaluation (confirmed)

            Discussants
            Suzanne M. O’Shea, JD, LLM, Counsel, Baker & Daniels; formerly 21 years
            at FDA with broad range of responsibilities including regulatory counsel
            (confirmed).

            David S. Wilkes, MD, Director, Center for Immunobiology, IU School of
            Medicine; entrepreneur, ImmuneWorks, LLC (confirmed).



                                                                            Draft 11/14/08
9:30-9:45    Break

9:45-11:00   SESSION II: ETHICS, CONFLICTS OF INTEREST

             Eric M. Meslin, Ph.D., Director, Indiana University Center for Bioethics,
             Associate Dean for Bioethics and Professor of Medicine and of Medical and
             Molecular Genetics, Indiana University School of Medicine (confirmed).

             Discussants:
             Ora H. Pescovitz, MD President and CEO, Riley Hospital for Children,
             Executive Associate Dean for Research, Indiana University School of Medicine,
             Interim V.P. for Research Affairs, Indiana University (confirmed)

             Neal Fearnot, Ph.D., President, Cook/MED Institute (confirmed)

11:00        INTRODUCTION OF MTLF TO INDIANA
             Dan Peterson, The Cook Group

11:30        LUNCH

12:00        KEYNOTE ADDRESS
             Challenges of Leadership at FDA

             Jane Henney, M.D., Professor of Internal Medicine and Public Health Sciences,
             University of Cincinnati; former Commissioner, Food and Drug Administration
             (confirmed).

1:00-1:45    KEYNOTE ADDRESS
             FDA and the Political Process

             The Honorable Evan Bayh, U.S. Senator (D/IN) (confirmed)

1:45- 3:00   FDA I N A GLOBALIZED ECONOMY; EXPANDING THE SCOPE OF THE
             AGENCY

             Susan Alpert, Ph.D., M.D., Senior Vice President, Chief Regulatory Officer,
             Medtronic; former FDA official (confirmed)

             John L. Stigi, Food and Drug Administration, Office of Communication,
             Education and Radiation (OCER), Director, Division of Small Manufacturers,
             International, and Consumer Assistance. (invited).

             Ralph Hall, JD, Distinguished Visiting Practitioner and Professor, University of
             Minnesota Law School. (confirmed).

3:00 p.m. Next Steps and Concluding Remarks



                                                                             Draft 11/14/08

								
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