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Sponsored by
The Pharmaceutical
Compliance Forum
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NINTH ANNUAL PHARMACEUTICAL REGULATORY AND COMPLIANCE CONGRESS AND BEST PRACTICES FORUM
Transformational Learning - Effective Knowledge Exchange
October 27 - 29, 2008
Hyatt Regency On Capitol Hill
Washington, DC
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2008 PHARMA CONGRESS MULTIMEDIA
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Watch video of the 2008 Pharma Congress on the go. The Pharma Congress offers Podcasting of all general sessions on a 30gb Video iPOD™, a DVD-ROM, or a Flash Drive. Concurrent breakout session audio and all related presentation materials are also included on each multimedia format.
Click here to order! |
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MARK YOUR CALENDARS
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THIRD INTERNATIONAL PHARMACEUTICAL REGULATORY AND COMPLIANCE CONGRESS
Sponsored by Pharmaceutical Compliance Forum
May 28 - 29, 2009
Rome, Italy
www.InternationalPharmaCongress.com
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FEATURED FACULTY
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Suzanne Barone
Team Leader, Food and Drug Administration, CDER, Office of Compliance, Rockville, MD
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Diane E. Bieri, Esq.
Senior Vice President, General Counsel, Pharmaceutical Research and Manufacturers of America, Washington, DC
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John K. Iglehart
Founding Editor, Health Affairs, National Correspondent, New England Journal of Medicine, Washington, DC
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Michael K. Loucks, Esq.
First Assistant U.S. Attorney, U.S. Attorney's Office for the District of Massachusetts, Boston, MA
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Gerald F. Masoudi, Esq.
Chief Counsel, Food and Drug Administration, Former Deputy Assistant Attorney General, International, Policy and Appellate Matters, Antitrust Division, US Department of Justice, Rockville, MD
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Mark McClellan, MD, PhD
Director, Engelberg Center for Health Care Reform, Brookings Institution, Former CMS Administrator and FDA Commissioner, Washington, DC
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Mary E. Riordan, Esq.
Senior Counsel, Office of Counsel to the Inspector General, Office of Inspector General, Department of Health and Human Services, Washington, DC
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James G. Sheehan, Esq.
New York State Medicaid Inspector General, Former Associate United States Attorney, US Attorney's Office, Eastern District of Pennsylvania, Albany, NY
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Ed Silverman
Editor, Pharmalot, Newark, NJ
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Theresa A. Toigo, MBA, R.Ph.
Director, Office of Special Health Issues, Director, Office of Women's Health, Food and Drug Administration, Rockville, MD
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AND ON THE REFORM PROPOSALS OF THE PRESIDENTIAL CAMPAIGNS
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Henry J. Aaron, PhD
Senior Fellow, Economic Studies and The Bruce and Virginia MacLaury Chair, Brookings Institution, Washington, DC
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Gail Wilensky, PhD
Health Policy Advisor to the McCain Campaign, Senior Fellow, Project HOPE, Former Administrator, Health Care Financing Administration, Washington, DC
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CONGRESS CO CHAIRS
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Lori Queisser
Senior Vice President, Global Compliance and Business Practices, Schering-Plough Corporation
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Arjun Rajaratnam, Esq.
Compliance Officer, Global Pharmaceuticals, GlaxoSmithKline, Research Triangle Park, NC
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Bert Weinstein, Esq.
Vice President, Corporate Compliance, Purdue Pharma LP, Stamford, CT
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FEATURING PRECONFERENCE SESSIONS
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- Preconference I: Pharmaceutical Regulatory and Compliance Basics
- Preconference II: State Marketing, Ethics and Disclosure Laws and Federal Preemption
- Preconference III: Auditing, Monitoring and Effective Internal Investigations
- Preconference IV: Dangerous Documents: Finding Land Mines In Your FDA Records and Emails
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KEY TOPICS ADDRESSED
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- Pharmaceutical Compliance: How Far We've Come and Where we Need to Go
- OIG Update
- DOJ Update
- Blog Roundtable
- PCF CIA Survey
- How to Become a Compliance Leader
- PCF Pharmaceutical Compliance Professional and Legal Counsel Roundtable: Preparing for Change
- Health Reform Visions of the Presidential Candidates
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THE FOLLOWING TRACKS
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- Morning Track I: Sales and Marketing Compliance Update
- Morning Track II: Research, Development and Clinical Trials Compliance Update
- Morning Track III: FCPA Compliance Update
- Morning Track IV: Relationships with Healthcare Professionals Compliance Update
- Morning Track V: Practical Case Studies
- Afternoon Track I: Pharmacovigilance and Drug Safety Compliance Update
- Afternoon Track II: Working with Third Parties, Vendors and Strategic Partners
- Afternoon Track III: Managing Post-Settlement Interactions with Government: CIAs, Monitors and IG Audits
- Afternoon Track IV: Emerging Compliance Challenges
- Afternoon Track V: Practical Case Studies
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AND THE FOLLOWING SPECIAL EVENTS
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- Monday, October 27, 2008 Meet the Regulator Networking Reception
- Tuesday, October 28, 2008 Company Best Practice Policy and Procedure Poster Board and Exchange Reception
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SAVE THE DATE
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FIRST ANNUAL SUMMIT ON DISCLOSURE FOR DRUG, DEVICE AND BIOTECH COMPANIES
A Hybrid Conference, Internet Event and Training Tool
March 5 - 6, 2009
Renaissance Washington DC Hotel
Washington, DC
www.DisclosureSummit.com
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THIRD INTERNATIONAL PHARMACEUTICAL REGULATORY AND COMPLIANCE CONGRESS
Sponsored by Pharmaceutical Compliance Forum
May 28 - 29, 2009
Rome, Italy
www.InternationalPharmaCongress.com
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FOURTH ANNUAL MEDICAL DEVICE REGULATORY, REIMBURSEMENT AND COMPLIANCE CONGRESS
November 9 - 11, 2009
JW Marriott Hotel
Washington, DC
www.DeviceCongress.com
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TENTH ANNUAL PHARMACEUTICAL REGULATORY AND COMPLIANCE CONGRESS
Sponsored by Pharmaceutical Compliance Forum
November 11 - 13, 2009
JW Marriott Hotel
Washington, DC
www.PharmaCongress.com
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PCF PHARMA CONGRESS PLANNING COMMITTEE
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Lori Queisser
Senior Vice President, Global Compliance and Business Practices, Schering-Plough Corporation (Co chair)
Arjun Rajaratnam
Vice President & Compliance Officer - US Pharmaceuticals, GlaxoSmithKline (Co chair)
Bert Weinstein, Esq.
Vice President, Corporate Compliance, Purdue Pharma LP (Co chair)
Ted Acosta, Esq.
Principal, Ernst & Young LLP
Scott Bass, Esq.
Partner, Sidley Austin LLP
John T. Bentivoglio, Esq.
Partner, King & Spalding LLP
Kathleen M. Boozang, Esq.
Associate Dean and Professor of Law, Cofounder, Health Law & Policy Program, and Health Law, Science and Technology Graduate Programs, Seton Hall University School of Law
David B. Chandler, Ph.D., DABT
Director of Outcomes and Analysis Corporate Compliance, Amgen
Timothy Cleary, Esq.
Vice president, Legal Affairs and Chief Compliance Officer, Sanofi Pasteur Inc.
Janice G. Cunningham, Esq.
Healthcare Compliance Officer and Corporate Counsel, Barrier Therapeutics Inc.
David Davidovic
Senior Director, Business Practices, Genentech
Kelly B. Freeman, Ph.D.
Director, US Affiliate, Compliance and Ethics, Eli Lilly and Company
Abhiroop Gandhi
Commercial Compliance, Actelion Pharmaceuticals US, Inc.
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Wendy C. Goldstein, Esq.
Partner, Epstein Becker & Green
Peter N. Grant, JD, Ph.D.
Partner, Davis Wright Tremaine, President, Health Care Conference Administrators, LLC
Keith M. Korenchuk, JD, MPH
Partner, Covington & Burling LLP
Daniel A. Kracov, Esq.
Partner, Arnold & Porter
Gregory H. Levine, Esq.
Partner, Ropes & Gray, Washington, DC
Meredith Manning, Esq.
Partner, Hogan & Hartson
Edward Miller, Esq.
Vice President, Associate General Counsel and Chief Compliance Officer,
Boehringer Ingelheim Pharmaceuticals, Inc.
Steve Mohr, Esq.
Global Compliance Officer, AstraZeneca
Lawrence P. Platkin, Esq.
Vice President and Compliance Officer, Bayer HealthCare LLC
Brian Riewerts
Partner, Global Pharmaceutical Advisory Services Group, PricewaterhouseCoopers LLP
Sue Seferian, Esq.
Senior Counsel, Johnson & Johnson
Doreen F. Shulman
Vice President, Chief Compliance and Ethics Officer Bristol-Myers Squibb
Paul J. Silver
Managing Director, Huron Consulting Group
Scot Steinheiser
Assistant Director, Corporate Compliance Astellas US LLC
Jack T. Tanselle
Director, Navigant Consulting, Inc.
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SPONSORED BY:
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PHARMA CONGRESS INTERACTIVE AUDIENCE RESPONSE SYSTEM PROVIDED BY MERIDIA
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GRANTORS:
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DIAMOND
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GOLD
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SILVER
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BRONZE
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OTHER SPONSORS:
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ASSOCIATIONS
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PUBLICATIONS
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