FDA Commissioner McClellan, MD, PhD and Senior Staff Address Pharmaceutical Regulatory Issues at Pharmaceutical Regulatory and Compliance Congress
- Sponsored by Pharmaceutical Compliance Forum
- Nov. 12-14, 2003
- Renaissance Marriott Hotel, Washington DC
Contact: Paul Tunnecliff
WASHINGTON DC USA -- HEALTHCARE UPDATE NEWS SERVICETM - OCTOBER 21, 2003: The Pharmaceutical Compliance Forum, the leading association of pharmaceutical industry compliance professionals, announced today the participation of FDA Commissioner Mark B. McClellan, MD, Ph.D. and other FDA senior staff in the Fourth Annual Pharmaceutical Regulatory Compliance Congress and Best Practices Forum, which will be held Nov. 12-14, 2003, in Washington DC.
FDA SENIOR STAFF ADDRESS PHARMACEUTICAL REGULATORY ISSUES:
OTHER FDA REGULATORY AND COMPLIANCE PRESENTATIONS:
- Keynote Presentation: Regulating the Pharmaceutical Development Enterprise by Mark B. McClellan, MD, Ph.D., Commissioner of Food and Drugs, Food and Drug Administration, Rockville, MD
- Plenary Session Presentation: Progress in FDA's Drug Product Quality Initiative by Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD
- Plenary Session Presentation: The FDA Regulation of Drug Promotion by Thomas L. Abrams, Director, Division of Drug Marketing, Advertising & Communications, U.S. Food and Drug Administration, Rockville, MD
OTHER KEYNOTE SPEAKERS:
- Special FDA Regulatory and Enforcement Update by Peter Barton Hutt, Esq., Partner, Covington & Burling and Former Chief Counsel, Food and Drug Administration, Washington, DC
- Pharmaceutical Compliance Issue Update: Pricing, Off Label Marketing, and Kickbacks by John Bentivoglio, Esq., Partner, Arnold and Porter and Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, United States Department of Justice, Washington, DC
- Advertising, Sales, Marketing, and Promotion: Integrating Compliance Into the Commercial Practices by Kathleen A. Knight, Esq., Vice President, Deputy General Counsel and Assistant Secretary, Alcon Laboratories, Inc., Fort Worth, TX and Catherine A. Sazdanoff, Divisional Vice President, Ethics and Compliance, Abbott Laboratories, Abbott Park, IL
- GMPs Explained - A Primer on Developing a GMP Compliance Program by Raymond A. Bonner, Esq., Partner, Sidley Austin Brown & Wood, Washington, DC
- Preparing for an FDA Inspection by Arthur N. Levine, Esq., Partner, Arnold & Porter and Former Deputy Chief Counsel for Litigation, Food and Drug Administration, Washington, DC
- Managing a Part 11 Compliance Initiative by Pat Roche, Partner, PricewaterhouseCoopers, Florham Park, NJ
Arthur L. Caplan, Ph.D.
Director, Center for Bioethics, University of Pennsylvania, Fellow, American Association for the Advancement of Science, the Hastings Center, the College of Physicians of Philadelphia, and the New York Academy of Medicine, Philadelphia, PA
Acting Principal Deputy Inspector General, Office of Inspector General, Department of health and Human Services, Washington, DC
Chairman, President and CEO, Merck & Co., Inc., Whitehouse Station, NJ
John Guthrie, Esq.
Director, Medicaid Fraud Control Unit, Office of Attorney General, Columbus, OH
Thomas B. Leary, Esq.
Commissioner, Federal Trade Commission, Washington, DC
Michael Loucks, Esq.
Chief of the Health Care Fraud Unit, Assistant U.S. Attorney, U.S. Attorney's Office for the District of Massachusetts, Boston, MA
Dennis M. Nally
Chairman and Senior Partner, PricewaterhouseCoopers LLP, New York, NY
Administrator, Center for Medicare and Medicaid Services, Department of Health and Human Services,Washington, DC
James Sheehan, Esq.
Chief of the Civil Division, Assistant U.S. Attorney, U.S. Attorney's Office for the Eastern District of Pennsylvania, Philadelphia, PA
Douglas M. Lankler, Esq.
Senior Corporate Counsel, Deputy Compliance Officer, Pfizer Inc., New York, NY
Arjun Rajaratnam, Esq.
Compliance Officer, Global Pharmaceuticals, GlaxoSmithKline, Research Triangle Park, NC
Bert Weinstein, Esq.
Vice President and Assistant General Counsel, Merck & Co., Whitehouse Station, NJ
CO SPONSORED BY:
SPONSOR: THE PHARMACEUTICAL COMPLIANCE FORUM:
- Association of Clinical Research Professionals
- Food and Drug Law Institute
- International Federation of Pharmaceutical Manufacturers Associations
- International Pharmaceutical Privacy Consortium
- IRB Forum
- Pharmacy & Therapeutics (P&T) Society
- Society of Research Administrators International (SRA)
- The Acumen Journal of Life Sciences
- American Pharmaceutical Review
- BNA's Pharmaceutical Law & Industry Report
- BNA's Medical Research Law & Policy Report
- CenterWatch Monthly Newsletter
- Clinical Trials Advisor
- Drug and Market Development Publications
- FDA News
- Genaissance Health Care Partners
- Harvard Health Policy Review
- Health Affairs
- Human Research Report
- JobWatch Clinical Research Careers Monitor
- Journal of Pharmaceutical Development and Regulation
- Med Ad News
- Pharma Marketing Network
- Pharma Marketing News
- Pharma Privacy Watch
- Pharmaceutical Executive Magazine
The Congress is sponsored by the Pharmaceutical Compliance Forum (PCF). PCF was founded in early-1999 by compliance professionals from the pharmaceutical industry, to promote effective corporate compliance programs. The organization is open to others in the industry, and has more than doubled its membership since it was founded. The members meet twice a year, for 1-2 days, focusing on open and informal sharing of compliance information, best practices and current developments in the field.
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