The 2005 FDA Regulatory and Compliance Symposium on CD-ROM
The FDA Regulatory and Compliance Symposium CD-ROM set will include video of all faculty presentations, synchronized with the PowerPoint presentations, which can easily be viewed using your computer. You can instantly navigate to the presenter and the exact content you wish to view.
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Arthur Miller, Esq.
Bruce Bromley Professor of Law
Harvard Law School
Cambridge, MA
“It is my pleasure to welcome attendees of the FDA Symposium to the campus of Harvard University. I hope that you will take advantage of this unique experience to study key Food and Drug Administration regulatory and compliance issues in this extraordinary academic environment.”
Co-Chairs
Robert Barton
Editorial Director, FDAnews, Falls Church, VA
John K. Iglehart
Founding Editor, Health Affairs, National Correspondent, New England Journal of Medicine, Washington, DC
Om Lekhraj Lala
Co-President, Harvard College Health Policy Society, Harvard University Cambridge, MA
Aabed Meer
Co-President, Harvard College Health Policy Society, Managing Editor, Harvard Health Policy Review, Harvard University, Cambridge, MA
Wayne L. Pines
President, Regulatory Services and Healthcare, APCO Worldwide, Former Deputy Commissioner for Communications, Food and Drug Administration, Washington, DC
Nancy Singer, Esq.
President, Compliance-Alliance, Former Special Counsel, AdvaMed, Founder, AdvaMed Medical Technology Learning Institute, Arlington, VA
Daniel E. Troy, Esq.
Partner, Sidley Austin Brown & Wood, Former Chief Counsel, Office of the General Counsel, Food and Drug Administration, Washington, DC
Featured Faculty
Saundra Beacham
Director, Drug Safety Operations, Actelion Pharmaceuticals US, South San Francisco, CA
John T. Bentivoglio, Esq.
Partner, King & Spalding, Former Special Counsel for Healthcare Fraud, Chief Privacy Officer, United States Department of Justice, Washington, DC
Mark S. Brown, Esq.
Partner, King & Spalding, Former Associate Chief Counsel for Enforcement, Office of the General Counsel, Food and Drug Administration, Washington, DC
Martin Browning
President, EduQuest, Former FDA Investigator and Special Assistant to the Associate Commissioner for Regulatory Affairs, Food and Drug Administration, Hyattstown, MD
Steven R. Cagle
Vice President of Marketing and Product Development, Sparta Systems, Inc., Holmdell, NJ
Anthony Celeste
Senior Vice President, Kendle/AAC Consulting Group, Former Director, Office of Regional Operations, Food and Drug Administration, Rockville, MD
Maureen Doyle-Scharff
Director of Professional Services, Ross Products Division, Abbott Laboratories, Columbus, OH
Willis Ennis
Director, Quality Assurance/Regulatory Affairs, Cambrex BioScience Walkersville, Walkersville, MD
Kelly B. Freeman, Ph.D.
Director, Compliance and Ethics for Sales, US Affiliate, Eli Lilly and Company, Indianapolis, IN
Larry Gibbons
Corporate Vice President, Global Quality, Baxter Healthcare, Round Lake, IL
J. David Haddox, DDS, MD
Vice President, Risk Management and Health Policy, Purdue Pharma LP, Stamford, CT
Kenneth Hintze
Director, Global Safety and Pharmacovigilance, Kendle, Cincinnati, OH
Linda R. Horton, Esq.
Partner, Hogan & Hartson, Former Director, International Policy, Food and Drug Administration, Brussels, Belgium
Peter Barton Hutt, Esq.
Senior Counsel, Covington & Burling, Former Chief Counsel, Office of the General Counsel, Food and Drug Administration, Washington, DC
Steven A. Johnson, Esq.
Vice President and Assistant General Counsel, Allergan, Irvine, CA
John F. Kamp, J.D., Ph.D.
Of Counsel, Wiley Rein & Fielding, Executive Director, Coalition for Healthcare Communication, Washington, DC
Michael Kowolenko, Ph.D.
Senior Vice President, Pharmaceutical Operations and Technology, Biogen Idec, Cambridge, MA
Keith M. Korenchuk, J.D., M.P.H.
Partner, McGuireWoods, Washington, DC
David L. Leo
President, Biomedical Resource Consultants, Chair, American Society for Quality, Biomedical Division, Wilbraham, MA
Arthur N. Levine
Partner, Arnold & Porter, Former Deputy General Counsel for Litigation, Food and Drug Administration, Washington, DC
Geoffrey Levitt, Esq.
Vice President and General Counsel, Regulatory and Research, Wyeth Pharmaceuticals, Collegeville, PA
Roger W. Louis, Esq.
Chief Compliance Officer, Genzyme, Cambridge, MA
Michael Marcarelli
Director, Division of Bioresearch Monitoring, Office of Compliance, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, Rockville, MD
Nan Matthews
President, The Matthews Group, Littleton, CO
Arthur Miller, Esq.
Bruce Bromley Professor of Law, Harvard Law School, Cambridge, MA
Louis A. Morris, Ph.D.
President, Louis A. Morris & Associates, Member, Drug Safety and Risk Management Advisory Committee, Former Director, Division of Drug Marketing, Advertising and Communications, Food and Drug Administration, Dix Hills, NY
Steve Ojala, Ph.D.
Global Director, Eli Lilly, Indianapolis, IN
Lisa Olson
Principal Consultant, SEC Associates, Research Triangle Park, NC
Una Ortell
Director, Regulatory Affairs, TAP Pharmaceutical Products, Inc., Lake Forest, IL
Claudio Pincus
President, The Quantic Group, Livingston, NJ
John R. Pinion, II
Vice President Quality, Contract Manufacturing and Collaborations, Genentech, Libertyville, IL
Robert Rhoades
Vice President, Compliance and Quality Management, THE WEINBERG GROUP, Washington, DC
R. Owen Richards
President and Managing Director, Quantic Regulatory Services, Livingston, NJ
Gordon B. Richman
Vice President, Strategic Compliance Consulting and General Counsel, EduQuest, Hyattstown, MD
William K. Sietsema, Ph.D.
Vice President, Clinical Affairs, Kendle, Cincinnati, OH
Annette Stemhagen, Dr.P.H., F.I.S.P.E.
Vice President, Epidemiology & Risk Management, United BioSource Corporation, Member, Drug Safety and Risk Management Advisory Committee, Food and Drug Administration, Ambler, PA
John M. Taylor, III
Former Associate Commissioner for Regulatory Affairs, Food and Drug Administration, Potomac, MD
Cynthia L. Verst-Brasch, Pharm.D., M.S.
Global Vice President, Late Phase Operating Unit, Kendle, Cincinnati, OH
L. Stephan Vincze, Esq.
Vice President, Ethics & Compliance Officer, TAP Pharmaceutical Products, Lake Forest, IL
Pam Weagraff
Founder and Principal, Acelera Consulting, Former Vice President of Regulatory, Clinical and Quality, MediSpectra, North Reading, MA
Matthew R. Weinberg
Chief Executive Officer, THE WEINBERG GROUP, Washington, DC