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Sponsored by
The Pharmaceutical
Compliance Forum
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THIRTEENTH ANNUAL PHARMACEUTICAL REGULATORY AND COMPLIANCE CONGRESS AND BEST PRACTICES FORUM
Transformational Learning - Effective Knowledge Exchange
November 5 - 7, 2012
Grand Hyatt
Washington, DC
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KEYNOTE SPEAKERS
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Thomas W. Abrams, RPh, MBA
Director, Office of Prescription Drug Promotion (OPDP), US Food and Drug Administration, Silver Spring, MD |
Lanny A. Breuer, Esq.
Head, Criminal Division, US Department of Justice, Former Special White House Counsel, Former Assistant District Attorney, New York City, Washington, DC |
Deirdre Connelly
President - North America Pharmaceuticals, GlaxoSmithKline, Former President of US Operations, Eli Lilly and Company, Philadelphia, PA
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Gregory E. Demske, Esq.
Chief Counsel to the Inspector General, Office of Inspector General, Department of Health and Human Services, Washington, DC |
Susan Dentzer
Editor-in-Chief, Health Affairs, Health Policy Analyst, The News Hour with Jim Lehrer, Washington, DC |
Louis Joseph Freeh, JD, LLM
Partner, Pepper Hamilton LLP; Founder and Chairman, Freeh Group International Solutions; Former Director, Federal Bureau of Investigation; Former Judge, United States District Court, Southern District of New York, Wilmington, DE
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Paul E. Kalb, JD, MD
Partner and Global Coordinator, Life Sciences Practice, Sidley Austin LLP, Washington, DC |
Carmen M. Ortiz, Esq.
United States Attorney, District of Massachusetts, Boston, MA |
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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FEATURING PRECONFERENCE SESSIONS
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- Compliance 101
- Auditing and Monitoring Boot Camp
- A Comprehensive Overview of Pharma and Medical Device Corporate Integrity Agreements (CIAs)
- The New Era of Scrutiny: FCPA Compliance in Pharma Operations
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PLENARY SESSIONS
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- OIG Update
- DOJ Criminal Division Update
- Prosecuting Pharma and Device Fraud
- FDA-DDMAC Update
- AUSA Panel
- Qui Tam Panel
- State Enforcement Panel
- Best Practices in Negotiating and Implementing CIAs
- State Disclosure, Federal Sunshine Act and Global Transparency
- Life Sciences in America the Morning after the Election
- Managing Internal and External Investigations
- PhRMA's New Compliance Work Group Update
- Global Pharma and Device Compliance Issues and Strategies
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PHARMA CONGRESS IS
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AND MINI SUMMITS
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- Mini Summit I: Co-pay Coupon Litigation Update
- Mini Summit II: What Enhanced Obligations in CIAs and DPAs say about Agency Expectations for Compliance Programs
- Mini Summit III: Compliance Issues in Global R&D and Medical Affairs
- Mini Summit IV: US Disclosure Implementation Update
- Mini Summit V: Medical Device Compliance Issues Update
- Mini Summit VI: Global Pharma and Device Compliance Issues
- Mini Summit VII: Anticorruption, Including FCPA and UK Bribery Act Update
- Mini Summit VIII: Fair Market Value Update
- Mini Summit IX: Enforcement Threat Against Individuals
- Mini Summit X: Global Transparency Update
- Mini Summit XI: Special Compliance Issues and of Small Pharma and Medical Device Companies
- Mini Summit XII: Integrating a Culture of Ethics into Your Compliance Program
- Mini Summit XIII: Government Price Reporting Update
- Mini Summit XIV: Clinical Trial Disclosure and Results Reporting Liability under FDAAA, Section 801
- Mini Summit XV: Board and Management Certifications and Working with an IRO
- Mini Summit XVI: Drug Samples Disclosure: The Next Horizon?
- Mini Summit XVII: Professional Responsibilities for Compliance Officers and In-house Counsel in the
- Pharmaceutical, Biotech and Medical Device Industries
- Mini Summit XVIII: Compliance Program Innovation
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LEADING ASSISTANT US ATTORNEYS
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Marilyn May, Esq.
Senior Litigation Counsel, US Attorney's Office, Eastern District of Pennsylvania, United States Department of Justice, Philadelphia, PA |
Maureen Ruane, Esq.
Assistant US Attorney and Chief, Health Care and Government Fraud Unit, Criminal Division, United States, Attorney's Office, District of New Jersey, Newark, NJ
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Susan Winkler, Esq.
Assistant US Attorney, United States Attorney's Office, District of Massachusetts, Boston, MA |
John T. Bentivoglio, Esq.
Partner, Skadden Arps LLP; Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, US Department of Justice, Washington, DC (Moderator)
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LEADING STATE PROSECUTORS
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Jacob Bergman, Esq.
Special Assistant Attorney General, Medicaid Fraud Control Unit, NY Office of the Attorney General, New York, NY |
Cynthia O'Keeffe
Deputy Chief, Civil Medicaid Fraud Division, Texas Office of the Attorney General, Austin, TX |
Robert Patten
Managing Attorney, Medicaid Fraud Division, Office of the Attorney General, Boston, MA
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Nicholas N. Paul, Esq.
Supervising Deputy Attorney, General, Bureau of Medi-Cal Fraud and Elder Abuse, Office of the Attorney General, California Department of Justice San Diego, CA |
Virginia "Ginny" A. Gibson, Esq.
Partner, Hogan Lovells, US LLP; Former Executive Assistant US Attorney, United States, Attorney's Office, Eastern District of Pennsylvania, Philadelphia, PA (Moderator)
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LEADING QUI TAM COUNSEL
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Michael A. Morse, Esq.
Partner, Pietragallo Gordon Alfano Bosick & Raspanti, LLP, Former Assistant District Attorney, Philadelphia District Attorney's Office, Philadelphia, PA |
Joseph E. B. "Jeb" White, Esq.
Partner, Nolan & Auerbach, PA, Philadelphia, PA |
Kirk Ogrosky, Esq.
Partner, Arnold & Porter, Former Deputy Chief, Fraud Section, US Department of Justice, Washington, DC (Moderator)
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REPORT FROM THE NEW PhRMA COMPLIANCE WORK GROUP
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Diane Bieri, Esq.
Partner, Arnold & Porter LLP, Former Executive Vice President and. General Counsel, PhRMA, Washington, DC |
Kendra Martello, Esq.
Assistant General Counsel, PhRMA, Washington, DC |
Anne Nobles, MA, JD
Chief Ethics and Compliance Officer and Senior Vice President Enterprise Risk Management, Eli Lilly and Company, Indianapolis, IN
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COMPLIANCE 101
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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 |
Michael Kendall, Esq.
Partner and Head, White-Collar Defense Group, McDermott Will & Emery LLP, Former Deputy Associate Attorney General and Counselor, United States Department of Justice, Boston, MA
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Janet L. "Lucy" Rose
Founder, Lucy Rose and Associates, Former Director, Division of Drug Marketing, Advertising, and Communications (DDMAC), FDA, Washington, DC |
Kelly B. Freeman, PhD
Senior Director, Ethics and Compliance, Eli Lilly and Company, Indianapolis, IN (Moderator)
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DRUG SAMPLES DISCLOSURE: THE NEXT HORIZON?
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Kendra Martello, Esq.
Assistant General Counsel, PhRMA, Washington, DC |
Marilyn May, Esq.
Senior Litigation Counsel, US Attorney's Office, Eastern District of Pennsylvania, United States Department of Justice, Philadelphia, PA |
Karen Rothschild, Esq.
Regulatory Counsel, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Drug Security, Integrity and Recalls, Silver Spring, MD |
John Patrick Oroho, Esq.
Executive Vice President and Chief Strategy Officer, Porzio Pharmaceutical Services, LLC, Principal, Porzio, Bromberg & Newman PC, Morristown, NJ (Moderator)
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INTEGRATING A CULTURE OF ETHICS INTO YOUR COMPLIANCE PROGRAM
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Matthew Pachman, Esq.
Vice President and Chief Ethics Officers, FTI Consulting, VP, Chief Compliance Officer, Altegrity, VP, Compliance, Ethics and Business Practices, Freddie Mac, Director, Legal (and Ethics), MCI, Washington, DC |
Jeffrey S. Paden
Deputy Compliance Officer, GlaxoSmithKline, Research Triangle Park, NC |
Caroline West, Esq.
Senior Vice President, Chief Compliance and Risk Officer, Shire Pharmaceuticals, Inc., Philadelphia, PA (Moderator)
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ANTICORRUPTION UPDATE
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Michael Kendall, Esq.
Partner and Head, White-Collar Defense Group, McDermott Will & Emery LLP, Former Deputy Associate Attorney General and Counselor, United States Department of Justice, Boston, MA |
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
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THE NEW ERA OF SCRUTINY: FCPA COMPLIANCE IN PHARMA OPERATIONS
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Gregory A. Paw, Esq.
Partner, Pepper Hamilton LLP, Former Director, Division of Criminal Justice, Office of the New Jersey Attorney General, Former Deputy US Attorney, US Attorney's Office for the Eastern District of Pennsylvania, Philadelphia, PA |
Jonathan Marks, CPA, CFF, CITP, CFE
National Fraud, Ethics & Anti-Corruption Services Leader, Crowe Horwath, New York, NY
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John Roberts
Senior Manager, Deloitte Forensics, Philadelphia, PA |
R.J. Saturno
Harsco Corporation, Harrisburg, PA
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ENFORCEMENT THREAT AGAINST INDIVIDUALS
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Thomas M. Gallagher, Esq.
Chair, White Collar Litigation and Investigations Practice Group, Pepper Hamilton LLP, Philadelphia, PA |
Lori Queisser
Principal, Advisory Services, KPMG LLP, Former Senior Vice President, Global Compliance, and Business Practices, Schering-Plough Corporation, Former Member, PCF Executive Committee, Indianapolis, IN
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BEST PRACTICES IN NEGOTIATING AND IMPLEMENTING A CIA
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Kris Curry
Vice President, Health Care Compliance, Johnson & Johnson Pharmaceuticals, Titusville, NJ |
Mary DiMauro
Executive Director, Compliance, Merck & Co., Whitehouse Station, NJ |
Jeff Fleming
Americas and US Compliance Officer, AstraZeneca Pharmaceuticals LP, Wilmington, DE
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Michael L. Shaw
Vice President & Compliance Officer, GlaxoSmithKline-North America Pharmaceuticals, Former Senior Counsel, Office of Inspector General, Philadelphia, PA |
Thomas A. Gregory, CFA, MBA
Partner, Fraud Investigation & Dispute Services, Ernst & Young LLP, Atlanta, GA (Moderator)
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A COMPREHENSIVE OVERVIEW OF PHARMA AND MEDICAL DEVICE
CORPORATE INTEGRITY AGREEMENTS (CIAS)
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Tracy Mastro, MBA
Senior Director, Life Sciences Advisory Services, Huron Consulting Group, Washington, DC |
Paige Slater, PA-C
Global CIA Program Director, Corporate Ethics and Compliance, Synthes, Inc., West Chester, PA |
Bert Weinstein, Esq.
Vice President, Corporate Compliance, Purdue Pharma LLP; Former Member, PCF Executive Committee, Stamford, CT
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Wendy C. Goldstein, Esq.
Partner, Epstein Becker & Green, New York, NY (Moderator) |
Paul J. Silver
Practice Leader, Life Sciences Advisory Services, Huron Consulting Group, Atlanta, GA (Moderator)
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WHAT ENHANCED OBLIGATIONS IN CIAs AND DPAs SAY ABOUT
AGENCY EXPECTATIONS FOR COMPLIANCE PROGRAMS
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Christopher Fletchall
Senior Advisor, Ethics and Compliance, Eli Lilly and Company, Indianapolis, IN |
Steven J. Tave, Esq.
Counsel, Gibson, Dunn & Crutcher LLP; Former Associate Chief Counsel for Enforcement, Office of Chief Counsel, US Food and Drug Administration, Washington, DC |
Thomas W. Beimers, Esq.
Special Counsel, Faegre Baker Daniels; Former Senior Counsel for Administrative and Civil Remedies, Office of the Inspector General, US Department of Health and Human Services, Minneapolis, MN (Moderator)
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BOARD AND MANAGEMENT CERTIFICATIONS AND WORKING WITH AN IRO
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Victoria Browning
Senior Director Corporate Compliance Operations, Allergan Inc., Irvine, CA |
Meredith Manning, Esq.
Co-director, Pharmaceutical and Biotechnology, Practice Group, Hogan Lovells LLP, Former Assistant US Attorney, Civil Division, US Attorney's Office in Washington, DC, Former Associate Chief Counsel, Office of General Counsel, FDA, Washington, DC |
Jean McKiernan
Director, Advisory Pharmaceutical and Life Sciences, PwC Chicago, IL
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STATE DISCLOSURE LAWS, SUNSHINE ACT AND
GLOBAL TRANSPARENCY INITIATIVES
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William E. Buzzeo, MS
Vice President and General Manager, Compliance Solutions Division, Cegedim Relationship Management, Richmond, VA |
Katrina S. Cahill
Senior Manager, Global Transparency Lead, Biogen Idec, Weston, MA |
Trudy J. Seeley
Senior Manager, Transparency Operations, Sanofi US, Bridgewater, NJ |
David A. Vento
Director, Pharmaceutical & Life Sciences Advisory, PwC, Irvine, CA (Moderator)
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US DISCLOSURE IMPLEMENTATION UPDATE
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Daniel Char, Esq.
Associate General Counsel - Commercial, Smith & Nephew, Boston, MA |
Diane Cruz-Burke, Esq.
Assistant General Counsel, Eli Lilly and Company, Indianapolis, IN |
Gus Papandrikos, MBA
Director Transparency Operations, Sanofi, New York, NY
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Eve M. Brunts, JD, LLM
Partner, Ropes & Gray, Boston, MA (Moderator) |
Jack T. Tanselle
Director, Healthcare Dispute, Compliance and Investigation Practice, Navigant Consulting, Inc., Indianapolis, IN (Moderator)
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GLOBAL TRANSPARENCY UPDATE
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Peter Burberry
Senior Director, Global Practices, Business Practice Management, Allergan Inc., Irvine, CA |
Katrina S. Cahill
Senior Manager, Corporate Compliance - Global Transparency Lead, Biogen Idec, Weston, MA
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William E. Buzzeo, MS
Vice President and General Manager, Compliance Solutions Division, Cegedim Relationship Management, Richmond, VA (Moderator) |
Kelly N. "Nikki" Reeves, MPA, JD
Partner, King & Spalding LLP, Washington, DC (Moderator)
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PROFESSIONAL RESPONSIBILITY FOR PHARMA, DEVICE AND BIOTECH
IN-HOUSE COUNSEL AND COMPLIANCE PROFESSIONALS
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Edward (Ed) Berg, Esq.
Vice President, Associate General Counsel, Sanofi, New York, NY |
Thomas Glavin, Esq.
Vice President and Deputy Compliance Officer, Shire Pharmaceuticals, Wayne, PA |
Robert Hoehn, Esq.
Health Care Compliance Officer, Acclarent (a Johnson & Johnson company), San Francisco, CA
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Freddy Jimenez, Esq.
Assistant General Counsel, Johnson & Johnson, New Brunswick, NJ |
Thomas E. Costa
Vice President, US Pharmaceuticals Compliance, Bristol-Myers Squibb Co., Princeton, NJ |
Christopher D. Zalesky, JD, CCEP, RAC
Vice President Global Policy and Guidance, Johnson & Johnson Health Care Compliance and Privacy, New Brunswick, NJ (Moderator)
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AUDITING AND MONITORING BOOT CAMP
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Lori Alarimo, Esq.
Vice President and Deputy Compliance Officer, Allergan, Former Assistant General Counsel, Pfizer, Irvine, CA |
Thomas C. Frongillo, Esq.
Partner, Head of Litigation (Boston Office) and Co-Chair, White Collar Criminal Practice, Weil Gotshal & Manges, Boston, MA |
Michael Hercz, Esq.
Director, Audit and Enterprise Risk Services, Deloitte & Touche LLP; Former Vice President and Chief Compliance Officer, Victory Pharmaceuticals, Inc., Costa Mesa, CA
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Vickie L. McCormick
Vice President, Health Care Compliance, DePuy, Inc.; Chief Compliance Officer, DePuy Orthopaedics, Inc.; Former Chief Compliance Officer, St. Jude Medical, Warsaw, IN |
Jeff Rosenbaum
Vice President, Chief Compliance Officer, Vertex Pharmaceuticals; Former Global Head, Ethics & Compliance, Novartis Oncology, Boston, MA |
Lawrence P. Platkin
Vice President and Compliance Officer, Bayer Healthcare LLP, Wayne, NJ (Moderator) |
L. Stephan Vincze, JD, LL M, MBA
Director, Audit and Enterprise, Risk Services, Deloitte & Touche LLP; Former Vice President, Ethics and Compliance Officer/Privacy Officer, TAP Pharmaceutical Products Inc., Boston, MA (Moderator)
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GOVERNMENT PRICE REPORTING UPDATE
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Cynthia B. Bass
Associate General Counsel, U.S. Legal Department, sanofi, Bridgewater, NJ |
George Kenny, Esq.
Senior Account Manager, Managed Care and Customer Operations, 340B, Genentech USA, Inc., San Francisco, CA |
Frank Prybeck
Director, Government Pricing and Contract Administration, Celgene Corporation, Berkeley Heights, NJ
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Marcy Imada
Principal, Deloitte & Touche LLP, Los Angeles, CA (Moderator) |
John D. Shakow, Esq.
Partner, FDA & Life Sciences Practice, King & Spalding, Washington, DC (Moderator)
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CO-PAY COUPON LITIGATION UPDATE
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Perry Goldman, Esq.
Vice President and Deputy General Counsel, Onyx Pharmaceuticals, San Francisco, CA |
William A. Sarraille, Esq.
Partner, Sidley Austin LLP, Washington, DC
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Daryl Todd
Johnson & Johnson, New Brunswick, NJ |
Richard L. Zimmerer
Partner, Forensic Advisory Services, KPMG LLP, Los Angeles, CA
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COMPLIANCE EFFECTIVNESS REVIEWS: BENEFITS TO THE BOARD OF DIRECTORS AND BEYOND
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Richard Eschle
Director, Policy & Risk Management, Novartis Pharmaceuticals Corporation, East Hanover, NJ |
Saul B. Helman, MD, MBA
Managing Director, Disputes and Investigations Practice, Navigant, Chicago, IL
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FAIR MARKET VALUE UPDATE
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Yogesh Bahl, MBA
Partner, National Practice Leader - Life Sciences, Deloitte Financial Advisory Services LLP, New York, NY |
Mark A. DeWyngaert, PhD
Managing Director, Huron Consulting Group, LLC, New York, NY |
Fred Eaton, MBA
Partner, Polaris Management Partners, New York, NY
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Prateep Menon, CFA
Principal, Deloitte Financial Advisory Services LLP, New York, NY
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John Moose, MBA, CPA, ABV
Manager, Huron LifeSciences, Chicago, IL
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COMPLIANCE ISSUES IN GLOBAL R&D AND MEDICAL AFFAIRS
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Gerald "Jerry" Kuncio, PhD
Deputy Compliance Officer for North America Medical Affairs, GlaxoSmithKline; Former Medical/Scientific Compliance and Ethics Director, AstraZeneca, Philadelphia, PA |
Mark Barnes
Director of Sponsored Research and Clinical Research Compliance Officer, Harvard University, Cambridge, MA (Moderator) |
Kathleen Meriwether, Esq.
Principal, Fraud Investigation and Dispute Services, Ernst & Young LLP; Philadelphia, PA (Moderator)
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CLINICAL TRIAL DISCLOSURE AND RESULTS REPORTING LIABILITY UNDER FDAAA, SECTION 801
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Jarilyn Dupont, JD
Director of Regulatory Policy, FDA/Office of Policy, Food and Drug Administration, Silver Spring, MD |
Ann Meeker-O'Connell, MS, CCEP
Office of Policy, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD
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Marc B. Wilenzick, Esq.
Former Compliance/Chief Compliance Counsel, R&D and Medical, Pfizer, Inc., New York, NY |
Julie Finegan, Esq.
Associate Chief Counsel, US Food and Drug Administration, Silver Spring, MD (Moderator)
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SPECIAL COMPLIANCE ISSUES AND STRATEGIES OF SMALL
PHARMACEUTICAL AND MEDICAL DEVICE COMPANIES
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Justin A. Dillon
Vice President, Chief Ethics and Compliance Officer, Ipsen Biopharmaceuticals, Inc.; Former Deputy Ethics and Compliance Officer, North America Pharma and Vaccines, GlaxoSmithKline, Basking Ridge, NJ |
Daniel A. Kracov, Esq.
Partner and Head, FDA and Healthcare Practice, Arnold & Porter, Washington, DC
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Timothy Ayers, JD, MPH
Vice President and Chief Compliance Officer, Dendreon; Former Associate General Counsel and Executive Director of Compliance, Seattle Genetics, Bothell, WA (Moderator) |
Elizabeth V. Jobes, Esq.
Senior Vice President and Chief Compliance Officer, Auxilium Pharmaceuticals Inc; Former Vice President and Chief Compliance Officer, Adolor, Philadelphia, PA (Moderator)
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MEDICAL DEVICE COMPLIANCE ISSUES UPDATE
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Eileen Erdos
Principal, Fraud Investigation and Dispute Services, Ernst & Young LLP, Chicago, IL, USA |
JJ Kuhn, Esq.
Senior Director, Ethics and Compliance, Medtronic Neuromodulation, Minneapolis, MN
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Julie Brubaker
Healthcare Compliance Specialist, Biomet, Warsaw, IN (Moderator) |
Ronald L. Wisor, Jr., Esq.
Partner, Hogan Lovells US LLP, Washington, DC (Moderator)
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GLOBAL PHARMA AND DEVICE COMPLIANCE ISSUES AND STRATEGIES
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Sue Egan
Director and Principal Consultant, Sue Egan Associates, Editor, Life Science Compliance, Former Vice President Compliance, AstraZeneca, Great Missenden, Buckinghamshire, UK |
Abdul Luheshi, MBA, PhD
Vice President Health Care Compliance, Asia Pacific, Johnson & Johnson International, Inc., Co-chair, Asia Pacific American Pharma Congress, Singapore |
Clivetty Martinez, PhD
Regional Vice President Latin America, Office of Healthcare Compliance and Privacy, Johnson & Johnson International, Inc., Chair, Latin American Ethics and Compliance Network, Co-chair, Latin American Pharma Congress, Miami, FL
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Richard Rew
Senior Vice President and General Counsel, ArthroCare Corporation, Austin, TX |
Vincenzo Salvatore, Esq.
Senior Counsel, Sidley Austin LLP, Professor of International Law, University of Insubria, Former Head of Legal Service, European Medicines Agency, Varese, Italy |
Gonca Sonmez
Compliance Counsel International Operations/Emerging Markets, Novo Nordisk, Zurich, Switzerland
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Yuet-Ming Tham, Esq.
Partner, Sidley Austin LLP, Hong Kong |
Roeland Van Aelst
Vice President EMEA & Canada, Office of Health Care Compliance & Privacy, Johnson & Johnson International, Inc., Board Member, International Society of Healthcare, Ethics and Compliance Professionals (ethics), Co-chair, Latin American Pharma Congress, Brussels, Belgium |
Brian Riewerts
Partner, Global Pharmaceuticals and Life Sciences, PwC, Baltimore, MD (Moderator)
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SAVE THE DATES
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FIFTH ANNUAL SUMMIT ON DISCLOSURE, TRANSPARENCY AND AGGREGATE SPEND
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A Hybrid Conference and Internet Event
February 19 - 21, 2013
The Ritz-Carlton
Washington, DC
www.DisclosureSummit.com
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SEVENTH INTERNATIONAL PHARMACEUTICAL COMPLIANCE CONGRESS
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A Hybrid Conference and Internet Event
Sponsored by International Society of Healthcare Compliance Professionals
Cosponsored by Pharmaceutical Compliance Forum
May 21 - 23, 2013
Meliá Castilla Hotel
Madrid, Spain
www.InternationalPharmaCongress.com
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THIRD ASIA PACIFIC PHARMACEUTICAL
COMPLIANCE CONGRESS
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A Hybrid Conference and Internet Event
Sponsored by Asia Pacific Healthcare Industry Compliance Team
Cosponsored by Pharmaceutical Compliance Forum
September 10 - 12, 2013
Kuala Lampur, Malaysia
www.AsianPharmaCongress.com
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FOURTEENTH PHARMACEUTICAL REGULATORY AND COMPLIANCE CONGRESS
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A Hybrid Conference and Internet Event
Sponsored by Pharmaceutical Compliance Forum
October 28 - 30, 2013
Hyatt Regency on Capitol Hill
Washington, DC
www.PharmaCongress.com
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REGISTER FOR PCF INDIVIDUAL AND GROUP REGISTRATION DISCOUNTS
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Click here to register.
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BROCHURE NOW AVAILABLE
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Click here to download the brochure.
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SPONSORED BY:
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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.
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VOTE BY ABSENTEE BALLOT
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Click here for information regarding voting by absentee ballot in all 50 states.
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CO CHAIRS
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Gary DelVecchio
Executive Director, US Pharmaceutical Compliance and Ethics, Bristol-Myers Squibb Company, Plainsboro, NJ
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Margaret K. Feltz, Esq.
Director, Corporate Compliance, Purdue Pharma LP, Stamford, CT
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Kelly B. Freeman, PhD
Senior Director, Ethics and Compliance, 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
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GRANTORS:
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DIAMOND
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SILVER
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BRONZE
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ADDITIONAL
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MEDIA PARTNERS:
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FREE TRIAL OFFER FOR INSIDE HEALTH POLICY
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Inside Washington Publishers is offering friends of the Thirteenth Pharma Congress a free four-week trial subscription to their newsletter Inside Health Policy. The free trial includes all regular subscriber services, including an e-mail alert every business day as a reminder of what's been added to the site.
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2012 PCF PHARMA CONGRESS PLANNING COMMITTEE
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Gary DelVecchio
Executive Director, US Pharmaceutical Compliance and Ethics, Bristol-Myers Squibb Company (Co chair)
Margaret K. Feltz
Associate Director, Corporate Compliance, Purdue Pharma LP (Co chair)
Kelly B. Freeman, PhD
Senior Director, Ethics and Compliance, Eli Lilly and Company (Co chair)
Michael L. Shaw, Esq.
Vice President & Compliance Officer, GlaxoSmithKline-NA Pharmaceuticals (Co chair)
Ted Acosta, Esq.
Principal, Ernst & Young LLP
Timothy Ayers, MPH, JD
Vice President and Chief Compliance Officer, Dendreon
Wayne Baker
Senior Vice President and Chief Sales Officer, Advanced Health Media LLC
Scott Bass, Esq.
Partner, Sidley Austin LLP
John T. Bentivoglio, Esq.
Partner, Skadden Arps LLP
Eve M. Brunts, Esq.
Partner, Ropes & Gray
William E. Buzzeo, MS
Vice President and General Manager Compliance Solutions Division, Cegedim Relationship Management
Sujata T. Dayal
Corporate Vice President and Chief Compliance Officer, Global Operations, Biomet, Inc.
Fred Eaton, MBA
Partner, Polaris Management Partners
Jeffrey E. Fleming, Esq.
Americas & US Compliance Officer, AstraZeneca Pharmaceuticals LP
Thomas Forrester, Esq.
Vice President, US Legal Affairs and General Counsel, Lundbeck Inc.
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.
Michael Hercz, Esq.
Director, Audit and Enterprise Risk Services, Deloitte & Touche LLP
Elizabeth V. Jobes, Esq.
Senior Vice President, Chief Compliance Officer, Auxilium Pharmaceuticals Inc.
Jonathan Kellerman
Partner, Global Pharmaceutical Advisory Services Group, PwC LLP
Daniel Kracov, Esq.
Partner, Arnold & Porter
Maxine Nogard
Senior Director, Global Corporate Compliance, Biogen Idec, Inc.
John Patrick Oroho, Esq.
Executive Vice President and Chief Strategy Officer, Porzio Pharmaceutical Services, LLC; Principal, Porzio, Bromberg & Newman
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, Daiichi Sankyo
Jeff Rosenbaum
Vice President, Chief Compliance Officer, Vertex Pharmaceuticals
Karen Patruno Sheehy, Esq.
Vice President, US Corporate Compliance Officer, Sanofi
Eric Siegel, Esq.
Executive Vice President & General Counsel, 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
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2011 PHARMA CONGRESS CONTENT NOW AVAILABLE
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The 2011 Pharma Congress conference content is now available in a variety of formats.
Click here for more info.
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FEATURING VIDEO PRESENTATIONS BY PHARMA LEADERS:
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2012 Second Asia Pacific Pharma Congress Keynote Address by
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Mark Mallon, MBA
Regional Vice President Asia Pacific and President China, AstraZeneca, Former Executive Vice-President and Chief Operating Officer, AstraZeneca KK (Japan), Shanghai, China
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2012 Sixth International Pharma Congress Keynote Address by
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Christopher A. Viehbacher
Chief Executive Officer, Sanofi, Chairman, Genzyme, Paris, France
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2011 Twelfth Pharmaceutical Regulatory Compliance Congress and Best Practices Forum by
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John C. Lechleiter, PhD
Chairman, President and Chief Executive Officer, Eli Lilly and Company, Chairman-elect, PhRMA, Indianapolis, IN
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2011 Fifth International Pharma Congress Keynote Address by
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David Brennan
Former Chief Executive Officer, AstraZeneca, President, IFPMA, Past Chairman, PhRMA, London, UK
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PAST GLOBAL PHARMA CONGRESS CITIES
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Washington, DC
Brussels
Paris
Rome
Berlin
Istanbul
Singapore
2012 - Budapest, Hungary
2012 - Shanghai, China
2012 - São Paulo, Brazil
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