FDA Regulatory and Compliance Symposium at Harvard Features 61 Speakers From FDA, CMS, DOJ and Industry

Aug 03, 2006, 01:00 ET from FDAnews

    FALLS CHURCH, Va., Aug. 3 /PRNewswire/ -- FDAnews announces the final
 agenda for the Second Annual FDA Regulatory and Compliance Symposium
 (http://www.fdasymposium.com), the industry's leading regulatory and
 compliance event for the drug and medical device industries, to be held
 August 22-25 on the campus of Harvard University, Cambridge, MA.
     "Regulatory, compliance, quality assurance, manufacturing, clinical
 trial, reimbursement and marketing professionals need to stay abreast of
 the critical issues facing the industry, said Matt Salt, publisher of
 FDAnews, cosponsor of the event. "This Symposium is the best way to meet
 key FDA officials and industry's top regulatory and compliance
 professionals and attend interactive sessions that explore the latest
 developments in the drug and medical device industries."
     The Second Annual FDA Regulatory and Compliance Symposium will help
 drug and device makers prepare for the full impact of changes flowing from
 the FDA and Congress, while clarifying many of the uncertainties. The
 Symposium will also provide practical, state-of-the-art solutions to the
 challenges of eliminating or reducing risks throughout the product life
 cycle -- from the drug pipeline to manufacturing to patient delivery.
     Government keynote speakers for this year's Symposium include:
     *  Thomas Abrams, RPh, MBA, Director, Division of Drug Marketing,
        Advertising, and Communications, CDER, FDA
     *  Peter Bach, MD, MAPP, Senior Advisor, Office of the Administrator, CMS
     *  Sheldon Bradshaw, Esq., Chief Counsel, FDA
     *  Igor Cerny, Pharm.D., Director, CDER Advisors and Consultants Staff,
        Office of Executive Programs, FDA
     *  Jon Clark, Associate Director for Policy Development and GMP, Office of
        Pharmaceutical Science, CDER, FDA
     *  Kim Colangelo, Associate Director for Regulatory Affairs, Office of New
        Drugs, CDER, FDA
     *  Scott Gottlieb, MD; Deputy Commissioner for Medical and Scientific
        Affairs, Office of the Commissioner, FDA
     *  David Horowitz, Esq., Deputy Associate Commissioner for Compliance
        Policy, Office of Regulatory Affairs, FDA
     *  Steve Phurrough, MD, MPA, Director, Coverage and Analysis Group, Office
        of Clinical Standards & Quality, CMS
     *  CAPT Paul Seligman, MD, MPH, Associate Director for Safety Policy and
        Communication, CDER, FDA
     *  James Sheehan, Esq., Associate United States Attorney, U.S. Attorney's
        Office for the Eastern District of Pennsylvania
     *  David Waterbury, Esq., Senior Counsel and Director, Washington State
        Medicaid Fraud Control Unit
     The Symposium also includes more than 49 expert speakers from business
 and academia who will discuss regulatory and compliance topics in five
 separate tracks. In addition, there will be a pre-conference workshop and
 networking sessions.
     The Symposium is on the Harvard University campus. Classes are in
 Annenberg Hall of the Sanders Theatre Complex.
     The FDA Regulatory and Compliance Symposium is sponsored by FDAnews,
 Harvard Health Policy Review, Health Affairs and Medical Education