PRESS RELEASE: 2008 PCF Pharmaceutical Regulatory Compliance Congress and Best Practices Forum Features Keynote Address by Former CMS Administrator and FDA Commissioner Mark McClellan, MD, PhD
  • Sponsored by the Pharmaceutical Compliance Forum
  • October 27 - 29, 2008
  • Hyatt Regency on Capitol Hill, Washington, DC
  • www.PharmaCongress.com
PRESS RELEASE
Phone: 800-684-4549
Email: registration@hcconferences.com
Website: www.PharmaCongress.com


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WASHINGTON DC USA -- HEALTHCARE UPDATE NEWS SERVICE™ -- AUGUST 29, 2008: The Ninth Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum (the Pharma Congress), www.PharmaCongress.com, October 27 - 29, 2008, at the Hyatt Regency On Capitol Hill in Washington, DC features Sales and Marketing Compliance Track.

ON THE FUTURE OF THE PHARMACEUTICAL SECTOR
IN AMERICAN HEALTHCARE
On Wednesday, October 29, 2008 the keynote address on The Future of the Pharmaceutical Sector in American Healthcare will be delivered by:

Mark McClellan, MD, PhD
Director, Engelberg Center for Health Care Reform, Brookings Institution, Former CMS Administrator and FDA Commissioner, Washington, DC

FEATURED FACULTY
Suzanne Barone
Consumer Safety Officer, Food and Drug Administration, Rockville, MD
Diane E. Bieri, Esq.
Vice President, General Counsel, Pharmaceutical Research and Manufacturers of America, Washington, DC
John K. Iglehart
Founding Editor, Health Affairs, National Correspondent, New England Journal of Medicine, Washington, DC
Michael K. Loucks, Esq.
First Assistant U.S. Attorney, U.S. Attorney's Office for the District of Massachusetts, Boston, MA
Mark McClellan, MD, PhD
Director, Engelberg Center for Health Care Reform, Brookings Institution, Former CMS Administrator and FDA Commissioner, Washington, DC

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
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
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
Theresa A. Toigo, MBA, R.Ph.
Director, Office of Special Health Issues, Director, Office of Women's Health, Food and Drug Administration, Rockville, MD


AND REPRESENTATIVES OF THE PRESIDENTIAL CAMPAIGNS
Judith M. Feder, PhD (Invited)
Advisor to the Barack Obama Campaign, Former Staff Director, US Bipartisan Commission on Comprehensive Health Care, Former Principal Deputy Assistant Secretary, Department of Health and Human Services, Washington, DC

Jay Khosla, JD, MHA
Health Policy Advisor, John McCain 2008, Former Health Counsel, Budget Committee, United States Senate, Washington, DC

CONGRESS CO CHAIRS
Lori Queisser
Senior Vice President, Global Compliance and Business Practices, Schering-Plough Corporation

Arjun Rajaratnam, Esq.
Compliance Officer, Global Pharmaceuticals, GlaxoSmithKline, Research Triangle Park, NC
Bert Weinstein, Esq.
Vice President, Corporate Compliance, Purdue Pharma LP, Stamford, CT

FEATURING PRECONFERENCE SESSIONS
  • 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

KEY TOPICS ADDRESSED
  • 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

THE FOLLOWING TRACKS
  • 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

AND THE FOLLOWING SPECIAL EVENTS
  • Monday, October 27, 2008 Meet the Regulator Networking Reception
  • Tuesday, October 28, 2008 Company Best Practice Policy and Procedure Poster Board and Exchange Reception

PCF PHARMA CONGRESS PLANNING COMMITTEE
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.


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

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.


PHARMA CONGRESS SPONSOR: PHARMACEUTICAL COMPLIANCE FORUM

The Pharma Congress is sponsored by the Pharmaceutical Compliance Forum (PCF), www.PharmaComplinceForum.org, a coalition of senior compliance professionals and legal counsel from more than 50 of the largest research-based pharmaceutical manufacturers. The 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 in membership since its founding. The members meet twice a year, for two days, focusing on open and informal sharing of compliance information, best practices, and current developments in the field, and sponsors a three-day compliance congress each Fall.


CONGRESS EXHIBIT & SPONSORSHIP INFORMATION

For sponsorship and exhibit information go to www.pharmacongress.com/promotional/index.html or contact Joni Lipson, Exhibit Manager, 215-599-6626 phone, 215-545-8107 fax, joni.lipson@rmpinc.com.


CONGRESS REGISTRATION INFORMATION

Register online at www.pharmacongress.com/registration.html, call 800-684-4549, email registration@hcconferences.com or write:

    Pharma Congress Office
    3291 West Wilson Road
    Pahrump, NV 89048




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