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Sponsored by
The Pharmaceutical
Compliance Forum

TWELFTH ANNUAL PHARMACEUTICAL REGULATORY AND COMPLIANCE CONGRESS AND BEST PRACTICES FORUM

Transformational Learning - Effective Knowledge Exchange

November 2 - 4, 2011
Mandarin Oriental
Washington, DC

KEYNOTE SPEAKERS

Ariel Kaminer The Ethicist, New York Times Magazine, Former Editor, Arts & Leisure Section, New York Times, New York, NY	John C. Lechleiter, PhD Chairman, President and Chief Executive Officer, Eli Lilly and Company, Chairman-elect, PhRMA Board of Directors, Indianapolis, IN	Michael K. Loucks, Esq. Partner, Skadden Arps LLP, Former First Assistant US Attorney, US Attorney's Office for the District of Massachusetts, Washington, DC
Kendra A. Martello, Esq. Assistant General Counsel, Pharmaceutical Research and Manufacturers of America (PhRMA), Washington, DC	Richard M. Mullane (Colonel, USAF, Ret.) Former NASA Astronaut, Recipient, Air Force Distinguished Flying Cross, Legion of Merit and the NASA Space Flight Medal, Albuquerque, NM	Mary E. Riordan, Esq. Senior Counsel, Office of Counsel to the Inspector General, Office of Inspector General, US Department of Health and Human Services, Washington, DC

Vivian Robinson, Esq. Partner, McGuireWoods, Former General Counsel of the UK Serious Fraud Office, Former Head, QEB Hollis Whiteman Chambers, Recorder of the Crown Court and Treasurer of Inner Temple, London, UK	Shelley R. Slade, Esq. Whistleblower Attorney, Partner, Vogel, Slade & Goldstein, Former Senior Counsel, Health Care Fraud, Civil Division, US Department of Justice, Washington, DC
Tony West, Esq. Head, Civil Division, US Department of Justice, Former California Special Assistant Attorney General, Former Assistant US Attorney, Northern California, Washington, DC	Christopher D. Zalesky, JD, CCEP, RAC Vice President Global Policy and Guidance, Johnson & Johnson Health Care Compliance and Privacy, New Brunswick, NJ

FEATURING PRECONFERENCE SESSIONS

Compliance Basics

Practical Approaches to Implementing an Aggregate Spend Program

PLENARY SESSIONS

OIG Update
DoJ Civil Division Update
Coordinating Pharma Prosecutions
FDA-DDMAC Update
Pharma 2020
Sunshine Act Regulations
FCPA and UK Bribery Act Enforcement and Compliance Update
Lessons of the Stevens Case
Lessons of the Forrest and Purdue
Best Practices to Avoid Individual Liability and Exclusion
Compliance Professional Responsibilities in the Pharma, Biotech & Device Industries
Board and Executive Responsibilities and Certifications

AND THE FOLLOWING TRACKS

PwC Annual Compliance Organization and Administration Survey
Internal and External Investigations Update
Fair Market Value Update
FCPA and UK Bribery Act Compliance Update
Compliance Lessons Learned from Medical Devices
The Hottest Emerging Issues in Industry/HCP Relationships
Government Payment and Price Reporting Update
Research & Development and Clinical Trials
Global Pharma and Device Compliance Issues

GOVERNMENT FEATURED FACULTY

Thomas W. Abrams, RPh, MBA Director, Division of Drug Marketing, Advertising, and Communications, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, Silver Spring, MD	Michael Blume, Esq. Director, Office of Consumer Litigation, US Department of Justice, Washington, DC	Joyce R. Branda, Esq. Director, Commercial Litigation Branch, US Department of Justice, Recipient, Presidential Meritorious Executive Award and Attorney General's Award for Exceptional Service, Washington, DC
Charles E. Cain, Esq. Assistant Director, FCPA Unit, Director of the Division of Enforcement, Securities and Exchange Commission, Washington, DC	Nathaniel Edmonds, Esq. Assistant Chief, Foreign Corrupt Practices Act Unit, Fraud Section, Criminal Division, US Department of Justice, Washington, DC	Bradford Lang Public Health Analyst, Health Resources and Services Administration (HRSA), Office of Pharmacy Affairs, Rockville, MD

Ann Meeker-O'Connell, MS
Acting Associate Director of Risk Science, Intelligence and Prioritization, Office of Scientific Investigation (OSI), Center for Drug Evaluation and Research (CDER), Food and Drug Administration, Rockville, MD

Jerry A. Menikoff, MD, JD
Director, Office for Human Research Protections, Office of Public Health and Science, US Department of Health and Human Services, Former Director, Office of Human Subjects Research, National Institutes of Health, Rockville, MD

COMPLIANCE PROFESSIONALS AND IN HOUSE COUNSEL

Timothy Ayers, Esq. Associate General Counsel, Executive Director of Compliance, Seattle Genetics, Bothell, WA	Peg Bollella, PharmD, CCMEP Director of Strategic Grant Operations and Metrics, sanofi-aventis US, a Sanofi Company, Bridgewater, NJ	Victoria Browning Senior Director, Corporate Compliance, Allergan, Irvine, CA
Hui Chen, Esq. Senior Corporate Counsel, Asia-Pacific Regional Lead, International Compliance Investigations, Pfizer Inc., New York, NY	Nancy M. Coddington, PhD Senior Director, US Business Compliance, AstraZeneca Pharmaceuticals LP, Wilmington, DE	Sujata T. Dayal, Esq. Corporate Vice President & Chief Compliance Officer, Biomet, Former Counsel, Domestic Legal Operations, Abbott Laboratories, Former Member, PCF Executive Committee, Warsaw, IN
Maureen Doyle-Scharff, MBA, FACME Senior Director, Team Lead, Medical Education Group, Pfizer, Columbus, OH	Michael Dusseau Executive Director, Global Compliance, Merck & Co., Inc., New York, NY	Gary F. Giampetruzzi, Esq. Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc., New York, NY
Edmund Greenidge, JD Director, Grants and Charitable Contributions, Janssen Biotech, Inc., Horsham, PA	Jeanine Jiganti, Esq. Vice President and Chief Compliance Officer, Takeda Pharmaceuticals North America, Deerfield, IL	Elizabeth V. Jobes, Esq. Vice President and Chief Compliance Officer, Adolor, Philadelphia, PA
Mark Jones, Esq. Director, Compliance, Onyx Pharmaceuticals, Inc., South San Francisco, CA	Sandra Cohen Kalter Vice President and Chief Regulatory Counsel, Medronic, Inc., Washington, DC	Jeffrey S. Kasher, PhD Vice President Global Clinical Development, Eli Lilly and Company, Indianapolis, IN
Jeffrey Klimaski, CPA Corporate Ethics & Compliance Officer, BTG International Inc., West Conshohocken, PA	Julie Kudyba Global Privacy Officer, Novartis Pharmaceuticals, Basel, Switzerland	Andy Lee Senior Vice President, Head Global Clinical Operations, Genzyme, Cambridge, MA
Daniel Moynihan, Esq. Chief Compliance Officer, EMD Serono, Rockland, MA	Melanie G. Nutt, JD, MPH Corporate Counsel, Genentech, Inc., South San Francisco, CA	Dieter Peise Associate Director Ethics & Compliance, Novartis, New York, NY
Heather Reilly Powell, Esq. Director, Compliance Training and Reporting, Daiichi Sankyo, Inc., Former Associate Director, Global Compliance, Cephalon, Inc., Parsippany, NJ	Arjun Rajaratnam, Esq. Chief Compliance Officer, Smith & Nephew, Former Compliance Officer, US Pharmaceuticals, GlaxoSmithKline, Former Member, PCF Executive Committee, Durham, NC	Jeff Rosenbaum Global Head, Ethics & Compliance, Novartis Oncology, Florham Park, NJ
Lloyd A. Rowland, Esq. Vice President and Chief Compliance Officer, Amylin Pharmaceuticals, San Diego, CA	Robert Scala Senior Director, Ethics & Compliance, Eisai Inc., Woodcliff Lake, NJ	Laura Sciarrino, Esq. Chief Legal Officer, Tercica, Inc., A Subsidiary of the Ipsen Group, Brisbane, CA
Sue Seferian, Esq. Health Care Compliance Officer, Johnson & Johnson Office of Health Care Compliance & Privacy, Titusville, NJ	Eric Siegel, JD, MBA Chief Compliance Officer, Incyte Corporation, Philadelphia, PA	Michelle Vella, Esq. Assistant General Counsel, Compliance Division, Pfizer Inc., Rockford, IL

Caroline West, Esq.
Senior Vice President, Chief Compliance and Risk Officer, Shire, Philadelphia, PA

Marc B. Wilenzick, Esq.
Compliance Officer/Chief Compliance Counsel, R&D & Medical, Pfizer Inc, New York, NY

ADVISORS AND LEGAL COUNSEL

Ted Acosta, Esq. Principal, Ernst & Young LLP, Former Senior Counsel, Office of Inspector General, US Department of Health and Human Services, New York, NY and Paris, France	Dennis K. Barnes, JD, CPA Director, Healthcare Dispute, Compliance and Investigation Practice, Navigant Consulting, Inc., Philadelphia, PA	Scott Bass, Esq. Partner and Head, Global Life Sciences Team, Sidley Austin LLP, Washington, DC
John T. Bentivoglio, Esq. Partner, Skadden Arps LLP, Former Special Counsel for Healthcare Fraud, and Chief Privacy Officer, US Department of Justice, Washington, DC	Barry H. Boise, Esq. Partner, Pepper Hamilton LLP, Philadelphia, PA	Emma Boyev Director Regulatory Compliance, Commercial Enterprise Office, Quintiles, Parsippany, NJ
Eve M. Brunts, Esq. Partner, Ropes & Gray, Boston, MA	Sam Chud Senior Director, Shire Specialty Pharmaceuticals, Wayne, PA	Colleen A. Conry, Esq. Partner and Co-Chair, Government Enforcement Practice Group, Ropes & Gray, Washington, DC
Mahnu V. Davar, Esq. Associate, Arnold & Porter LLP, Washington, DC	John DeMarrais Managing Director, KPMG LLP, Short Hills, NJ	Mark A. DeWyngaert, PhD Managing Director, Huron Consulting Group, LLC, New York, NY
Jonathan L. Diesenhaus, Esq. Partner, Hogan Lovells US LLP, Former Senior Trial Counsel, Civil Division of the US Department of Justice, Washington, DC	Jayson Dukes, CPA Senior Managing Director, FTI Consulting, New York, NY	Susan Dunne Director, Life Sciences Practice, Huron Consulting Group, Washington, DC
Fred Eaton, MBA Partner and Chair, Market Value Practice, Polaris Management Partners, New York, NY	Sue Egan Director and Principal Consultant, Sue Egan Associates, Former Vice President Compliance, AstraZeneca, Great Missenden, Buckinghamshire, UK	Eileen Erdos Principal, Fraud Investigation and Dispute Services, Ernst & Young LLP, Chicago, IL
Sean P. Fahey, Esq. Partner, Pepper Hamilton LLP, Philadelphia, PA	Thomas M. Gallagher, Esq. Partner and Chair, White Collar and Corporate Investigations Practice Group, Pepper Hamilton LLP, Philadelphia, PA	Virginia "Ginny" A. Gibson, Esq. Partner, Hogan Lovells US LLP, Philadelphia, PA
Thomas A. Gregory, CPA, CFA Partner, Fraud Investigation and Dispute Services, Ernst & Young LLP, Atlanta, GA	Jeffrey L. Handwerker, Esq. Partner, Arnold & Porter, Washington, DC	Erinn Hutchinson Director, PricewaterhouseCoopers LLP, Philadelphia, PA
Stephen J. Immelt, Esq. Partner, Hogan Lovells, Former Assistant U.S. Attorney, District of Maryland, US Department of Justice, Baltimore, MD	Mark A. Jensen, Esq. Partner, King & Spalding LLP, Washington, DC	Paul E. Kalb, JD, MD Partner and Head, Healthcare Practice, Sidley Austin LLP, Washington, DC
Jonathon L. Kellerman Principal, Pharmaceutical and Life Sciences Advisory Services, PricewaterhouseCoopers LLP, Florham Park, NJ	Michael L. Koon, Esq. Partner, Shook Hardy & Bacon, L.L.P., Kansas City, MO	Keith M. Korenchuk, JD, MPH Partner, Arnold & Porter, Washington, DC
Daniel A. Kracov, Esq. Partner and Chair, FDA and Healthcare Practice, Arnold & Porter LLC, Washington, DC	Gregory H. Levine, Esq. Partner and Co chair, Life Sciences Practice Group, Ropes & Gray, Washington, DC	Mark Linver Managing Director, Life Sciences Practice, Huron Consulting Group, New York, NY
Seth H. Lundy, Esq. Partner, King & Spalding LLP, Washington, DC	Tracy Mastro, MBA Director, Huron Consulting Group, LLC, Washington, DC	David E. Matyas, Esq. Partner, Epstein Becker & Green, Washington, DC
Michael McNeal Manager, Pharmaceutical & Life Sciences Advisory Practice, PricewaterhouseCoopers LLP, Denver, CO	Scott A. Memmott, Esq. Partner, Morgan Lewis, Washington, DC	Kathleen Meriwether, Esq. Principal, Fraud Investigation & Dispute Services, Ernst & Young LLP, Philadelphia, PA
Marc Miller, CPA, CFF Partner, Forensic Practice, KPMG, New York, NY	Scott Miller Director Commercial Compliance, inVentiv Health, Somerset, NJ	Andrew M. Parks Director, Risk Consulting, KPMG LLP, Washington, DC
Suj Patel Director, Life Sciences Practice, Huron Consulting Group, New York, NY	John Poulin Chief Solutions Architect, Life Sciences Advisory Services Practice, Huron Consulting Group, LLC, New York, NY	Kelly N. "Nikki" Reeves, MPA, JD Partner, King & Spalding LLP, Washington, DC
Brian Riewerts Partner & Global Life Sciences Compliance Practice Leader, PricewaterhouseCoopers LLP, Baltimore, MD	William A. Sarraille, Esq. Partner, Sidley Austin LLP, Washington, DC	Paul J. Silver Practice Leader, Life Sciences Advisory Services, Huron Consulting Group, LLC, Atlanta, GA
Don Soong Senior Director, Compliance Solutions Development, Cegedim Relationship Management, Bedminster, NJ	Peter S. Spivack, Esq. Partner, and Co-Leader, Investigations, White Collar and Fraud Practice Area, Hogan Lovells US LLP, Washington, DC	Alexis Stroud, MBA, CQA Director, Quality and Compliance, QPharma, Inc., New York, NY
Michael Swiatocha, MS Managing Director, Rx4HCC, Former Vice President and Compliance Officer, Schering-Plough Research Institute, Pennington, NJ	Jack T. Tanselle Director, Healthcare Dispute, Compliance and Investigation Practice, Navigant Consulting, Inc., Chicago, IL	Matt Tanzer Associate Director - Promotion Response Insights, Shire Pharmaceuticals, Wayne, PA
Manny Tzavlakis Managing Director, Life Sciences Practice, Huron Consulting Group, New York, NY	William H. von Oehsen III, Esq. Principal, Powers Pyles Sutter & Verville PC, Washington, DC	Constance A. Wilkinson, Esq. Member, Epstein Becker & Green, PC, Washington, DC

Jerry Wolf
Director, Healthcare Dispute, Compliance and Investigation Practice, Navigant Consulting, Inc., Philadelphia, PA

David Young
Senior Director, Commercial Compliance, Enterprise Compliance Office, Quintiles, Durham, NC

SAVE THE DATE

FOURTH ANNUAL SUMMIT ON DISCLOSURE, TRANSPARENCY AND AGGREGATE SPEND FOR DRUG, DEVICE AND BIOTECH COMPANIES
A Hybrid Conference and Internet Event
March 26 - 28, 2012
Renaissance Hotel
Washington, DC
www.DisclosureSummit.com

SIXTH INTERNATIONAL PHARMACEUTICAL REGULATORY AND COMPLIANCE CONGRESS
Sponsored by the Pharmaceutical Compliance Forum
May 14 - 16, 2012
Budapest, Hungary
www.InternationalPharmaCongress.com

SECOND ASIA PACIFIC PHARMACEUTICAL COMPLIANCE CONGRESS
A Hybrid Conference and Internet Event
Sponsored by Pharmaceutical Compliance Forum and Asia Pacific Healthcare Industry Compliance Team
September 11 - 13, 2012
Intercontinental Shanghai Pudong Hotel
Shanghai, China
www.AsianPharmaCongress.com

FIRST LATIN AMERICAN PHARMACEUTICAL AND MEDICAL DEVICE COMPLIANCE CONGRESS
A Hybrid Conference and Internet Event
Sponsored by Pharmaceutical Compliance Forum and Latin American Ethics and Compliance Network
October 2 - 4, 2012
Hilton Sao Paolo Morumba
Sao Paulo, Brazil
www.LatinAmericanPharmaCongress.com

THIRTEENTH PHARMACEUTICAL REGULATORY AND COMPLIANCE CONGRESS
Sponsored by Pharmaceutical Compliance Forum
November 5 - 7, 2012
Grand Hyatt
Washington, DC
www.www.PharmaCongress.com.com

BROCHURE NOW AVAILABLE

Click here to download the brochure.

PCF REGISTRATION DISCOUNT

Click here for PCF registration discount.

SPONSORED BY:

The Pharmaceutical Compliance Forum (PCF) is 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 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 two-day international compliance congress in the Spring and a three-day US compliance congress each Fall.

CO CHAIRS

Gary DelVecchio
Executive Director, US Pharmaceutical Compliance and Ethics, Bristol-Myers Squibb Company, Plainsboro, NJ

Margaret K. Feltz, Esq.
Director, Corporate Compliance, Purdue Pharma LP, Stamford, CT

Kelly B. Freeman, PhD
Ethics and Compliance Officer, Eli Lilly and Company, Indianapolis, IN

Michael L. Shaw
Vice President & Compliance Officer, GlaxoSmithKline-NA Pharmaceuticals, Former Senior Counsel, Office of Inspector General, Philadelphia, PA

POSTER BOARD RECEPTION CHAIR

Kathryn A. Fillenwarth
Advisor, LRL Ethics and Compliance, Lilly Research Laboratories, Eli Lilly & Company, Indianapolis, IN

GRANTORS:

PLATINUM

SILVER

BRONZE

ADDITIONAL

PCF PHARMA CONGRESS PLANNING COMMITTEE

Gary DelVecchio
Executive Director US Pharmaceutical Compliance and Ethics, Bristol-Myers Squibb Company (Co chair)

Margaret K. Feltz, Esq.
Director, Corporate Compliance, Purdue Pharma LP (Co chair)

Kelly B. Freeman, PhD
Ethics and Compliance Officer, Eli Lilly and Company (Co chair)

Michael L. Shaw
Vice President & Compliance Officer, GlaxoSmithKline-NA Pharmaceuticals (Co chair)

Ted Acosta, Esq.
Principal, Ernst & Young LLP

Timothy Ayers, Esq.
Associate General Counsel, Executive Director of Compliance, Seattle Genetics

Scott Bass, Esq.
Partner, Sidley Austin LLP

John T. Bentivoglio, Esq.
Partner, Skadden Arps LLP

Colleen Conry, Esq.
Partner, Ropes & Gray

Sujata T. Dayal
Corporate Vice President and Chief Compliance Officer, Global Operations, Biomet, Inc.

Thomas M. Gallagher, Esq.
Partner and Chair, White Collar and Corporate Investigations Practice Group, Pepper Hamilton LLP

Gary F. Giampetruzzi, Esq.
Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc.

Wendy C. Goldstein, Esq.
Partner, Epstein Becker & Green

Alessandra N. Hawthorne
Vice President, Chief Ethics and Compliance Officer, Boehringer Ingelheim USA, Inc.

Elizabeth V. Jobes, Esq.
Vice President and Chief Compliance Officer, Adolor

Jonathan Kellerman
Partner, Global Pharmaceutical Advisory Services Group, PricewaterhouseCoopers LLP

Daniel A. Kracov, Esq.
Partner and Chair, Arnold & Porter LLC, FDA and Healthcare Practice

Marie L. Martino
US Compliance Officer, AstraZeneca Pharmaceuticals LP

Maxine Nogard
Senior Director, Global Corporate Compliance, Biogen Idec, Inc.

Lawrence P. Platkin
Vice President and Compliance Officer, Bayer Healthcare LLC

Arjun Rajaratnam
Chief Compliance Officer, Smith & Nephew

Kelly N. "Nikki" Reeves, MPA, JD
Partner, King & Spalding LLP

Susan Romanus
Vice President, Chief Ethics & Compliance Officer at Daiichi Sankyo

Jeffrey Rosenbaum
Global Head, Ethics & Compliance, Novartis Oncology

Karen Patruno Sheehy, Esq.
Vice President, US Corporate Compliance Officer, sanofi-aventis

Eric Siegel, Esq.
Chief Compliance Officer, Incyte Corporation

Paul J. Silver
Managing Director, Huron Consulting Group

Jack T. Tanselle
Director, Navigant Consulting, Inc.

Caroline West, Esq.
Senior Vice President, Chief Compliance and Risk Officer, Shire Pharmaceuticals, Inc.

Ronald L. Wisor, Jr., Esq.
Partner, Hogan Lovells US LLP

Christopher D. Zalesky
Executive Director World Wide Office of Health Care Compliance & Privacy, Johnson & Johnson

Richard L. Zimmerer
Partner, Forensic Advisory Services, KPMG LLP

PAST GLOBAL PHARMA CONGRESS CITIES