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 FDA Regulatory and Compliance Symposium Managing Risks — From Pipeline to Patient August 23 - 25, 2005 Classes Held in Harvard University's Annenberg Hall and Sanders Theatre, Cambridge, MA  Annenberg Hall  Sanders Theatre Symposium Hotels: The Charles Hotel Cambridge, MA 
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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 | ||||||||||||||||||||
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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.
Arthur Miller, Esq.