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Wednesday, November 11, 2009
Preconference Symposia (Optional, choose one)






    7:00 a.m.



Congress Registration



    8:00 a.m.



Preconferences Commence; Choose one




PRECONFERENCE I



PRECONFERENCE I: COMPLIANCE 101









This interactive pre-conference session, designed for new compliance professionals, or those new to the pharmaceutical industry. Compliance resources will be provided.

Margaret K. Feltz
Associate Director, Corporate Compliance, Purdue Pharma LP, Stamford, CT (Co chair)

Wendy C. Goldstein, Esq.
Partner, Epstein Becker & Green P.C., New York, NY (Co chair)
Presentation Material (Acrobat)
Presentation Material (Acrobat)
Presentation Material (Acrobat)



8:00 a.m.




Introduction and Overview to the Seven Elements of an Effective Corporate Compliance Program
  • Compliance Personnel and Infrastructure
  • Written Standards
  • Hotlines
  • Training
  • Auditing and Monitoring
  • Investigations
  • Screening and Discipline



10:15 a.m.



Break



10:30 a.m.



Interactive Practice Session to Discuss Elements of an Effective Compliance Program



12:00 p.m.




Preconference Adjournment; Lunch on your Own



PRECONFERENCE II



RECENT GOVERNMENT SETTLEMENTS AND LESSONS LEARNED









During this pre-conference session, the panels will present and discuss recent settlements in the pharmaceutical industry and the lessons that can be drawn for meeting the government's expectations for state of the art compliance programs.

John T. Bentivoglio, Esq.
Partner, Skadden Arps LLP; Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, US Department of Justice, Washington, DC (Co chair)

Peter S. Spivack, Esq.
Partner, Hogan & Hartson, Washington, DC (Co chair)



8:00 a.m.



Introduction and Overview



8:15 a.m.



State and Federal Enforcement of Off-label Promotion: What Compliance Lessons can be Drawn from Recent Cases

Meredith Manning, Esq.
Partner, Hogan & Hartson, LLC; Former Assistant US Attorney, Civil Division, US Attorney's Office; Former Associate Chief Counsel, Food and Drug Administration, Washington, DC
Presentation Material (Acrobat)

Jeffrey Steger, Esq.
Trial Attorney, Office of Consumer Litigation, US Department of Justice, Washington, DC
Presentation not provided



9:15 a.m.



Anti-kickback Settlements

John T. Bentivoglio, Esq.
Partner, Skadden Arps LLP; Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, US Department of Justice, Washington, DC
Presentation Material (Acrobat)

Jay Darden, Esq.
Assistant Chief, Fraud Section, US Department of Justice, Washington, DC



10:00 a.m.



Break



10:30 a.m.



FCPA

Sandy Merber, Esq.
Counsel, International Trade Regulation and Sourcing, General Electric Co., Washington, DC
Presentation Material (Acrobat)

Hank Bond Walther, Esq.
Assistant Chief, Fraud Section, US Department of Justice, Criminal Division, Washington, DC
Presentation not provided

Peter S. Spivack, Esq.
Partner, Hogan & Hartson, Washington, DC
Presentation not provided



11:30 a.m.



Faculty Q&A



12:00 p.m.




Preconference Adjournment; Lunch on Your Own



PRECONFERENCE III



INTERNET AND SOCIAL NETWORKING COMMUNICATION




8:00 a.m.



Introduction and Overview: Challenges for the Pharmaceutical Industry in Internet and Social Networking Marketing Activities

Daniel A. Kracov, Esq.
Partner and Chair, Arnold & Porter LLC, FDA and Healthcare Practice, Washington, DC (Co chair)

Matthew M. Malloy, Esq.
Director and Associate General Counsel, The Procter & Gamble Company, Cincinnati, OH (Co chair)
Presentation Material (Acrobat)



8:45 a.m.



The Industry Perspective on the Regulation of the Internet and Social Networking Communications Marketing

Jeffrey K. Francer, Esq.
Assistant General Counsel, Pharmaceutical Research and Manufacturers Association, Washington, DC
Presentation Material (Acrobat)

Robert Pineda, Esq.
Assistant Counsel, Regulatory, Merck & Co., Inc., North Wales, PA
Presentation Material (Acrobat)



10:00 a.m.



Break



10:15 a.m.



The Federal Trade Commission's Approach to Internet and Social Networking Marketing

Richard L. Cleland
Assistant Director, Division of Advertising Practices, Bureau of Consumer Protection, Federal Trade Commission, Washington, DC
Presentation Material (Acrobat)



11:00 a.m.



Faculty Round Table Discussion Based on Hypotheticals: Marketing on the Internet and Social Networking Communications



12:00 p.m.




Preconference Adjournment; Lunch on Your Own




    DAY I: Recent Government Enforcement
    Wednesday, November 11, 2009






1:00 p.m.



Welcome and Introduction

Colleen M. Craven
Vice President, Corporate Compliance & Business Practices, Endo Pharmaceuticals, Chadds Ford, PA (Co chair)



1:15 p.m.




Regulator Panel on Transparency and Disclosure

Melissa J. Lopes, Esq.
Deputy General Counsel, Massachusetts Department of Public Health, Boston, MA

George Till, MD
State Legislator, Vermont, Jericho, VT

Cody Wiberg, PharmD, RPh
Executive Director, Minnesota Board of Pharmacy, Minneapolis, MN

John Patrick Oroho, Esq.
Executive Vice President, Porzio Pharmaceutical Services; Principal, Porzio, Bromberg & Newman PC, Morristown, NJ (Moderator)
Discussion Only



2:15 p.m.




Overview: Pfizer CIA Promotional Monitoring Requirements

Lori Alarimo, Esq.
Senior Corporate Counsel, Promotional Quality Assurance, Pfizer Inc., New York, NY

Edward Nowicki, Esq.
Deputy Compliance Officer-Global Programs, Senior Corporate Counsel, Corporate Compliance, Pfizer Inc., New York, NY
Presentation Material (Acrobat)

John S. Rah
Partner, Morgan, Lewis & Bockius LLP, Washington, DC
Presentation not provided



2:45 p.m.



Transition Break





    AFTERNOON TRACK SESSIONS





AFTERNOON TRACK I



Compliance Program Elements: How to Implement and Enhance a Pharmaceutical Compliance Program to Meet Evolving Regulatory Standards









  • This track will teach attendees the "how" of compliance program operations, not just focus on the "what".
  • This track will be particularly useful for attendees who are new to compliance and/or new to the pharmaceutical industry



3:00 p.m.




How to Structure your Compliance Department

Doreen F. Shulman
Vice President, Chief Compliance and Ethics Officer, Bristol-Myers Squibb, Princeton, NJ (Co chair)

Peter S. Spivack, Esq.
Partner, Hogan & Hartson, Washington, DC (Co chair)

Jack T. Tanselle
Director, Navigant Consulting, Inc., Chicago, IL (Co chair)
Presentation Material (Acrobat)



3:30 p.m.




How to Create and Maintain Procedural Documents

Frances T. Germann
Director, Procedural Document Governance, Bristol-Myers Squibb, Princeton, NJ
Presentation Material (Acrobat)



4:00 p.m.




How to Deliver Innovative and Effective Compliance Training

Jack T. Tanselle
Director, Navigant Consulting, Inc., Chicago, IL

Mark Williamson
Director, Compliance and Ethics Education and Communication, Bristol-Myers Squibb, Princeton, NJ
Presentation not provided



4:30 p.m.




How Program Management Can Keep you on Track

Leila A. Daiuto
Director, Life Sciences & Healthcare, Axentis, Inc., Cleveland, OH

Edward H. Leskauskas
Director, Compliance and Ethics Operations and Program Management, Bristol-Myers Squibb, Princeton, NJ
Presentation Material (Acrobat)



5:30 p.m.




Adjournment and Networking Reception




AFTERNOON TRACK II



An Integrated Approach to Compliance: Addressing Healthcare Fraud and Abuse Compliance Risks Throughout a Product's Lifecycle









  • This track will focus on healthcare fraud and abuse compliance risks in the areas of clinical research and development and sales and marketing, including government price reporting, pharmacovigilance and medical information.
  • This track will be particularly useful for seasoned pharmaceutical compliance professionals



3:00 p.m.




Introduction and Overview

John T. Bentivoglio, Esq.
Partner, Skadden Arps LLP; Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, Department of Justice, Washington, DC (Co chair)

Elizabeth V. Jobes, Esq.
Vice President and Chief Compliance Officer, Adolor Corporation; Former Senior Director, Global Compliance Officer, Cephalon; Former Assistant District Attorney, Philadelphia District Attorney's Office, Exton, PA (Co chair)

Brian Riewerts
Partner, Global Pharmaceuticals and Life Sciences, PricewaterhouseCoopers LLP, Baltimore, MD (Co chair)



3:15 p.m.




Advanced Issues in Clinical Compliance

Colleen Gorman
Senior Director, Technical Operations Lead, Pfizer, Inc., New York, NY

Anup Kharode
Senior Manager, US Pharmaceutical and Life Sciences Advisory, PricewaterhouseCoopers LLP, Formerly Principal Scientist, Clinical Development, GlaxoSmithKline, Philadelphia, PA
Presentation Material (Acrobat)

Kelly N. "Nikki" Reeves, MPA, JD
Partner, King & Spalding LLP, Washington, DC
Presentation Material (Acrobat)



4:00 p.m.




Advanced Issues in Commercial (Sales & Marketing) Compliance

Karen Lowney
Senior Director of Global Compliance, Cephalon, Former Director of International Compliance, Schering-Plough, Frazer, PA

Kathy Tench
Manager, Huron Consulting Group, New York, NY

Manny Tzavlakis
Director, Life Sciences Advisory Services, Huron Consulting Group, New York, NY
Presentation Material (Acrobat)



4:30 p.m.




Advanced Issues in Medical Affairs Compliance

Elizabeth V. Jobes, Esq.
Vice President and Chief Compliance Officer, Adolor Corporation; Former Senior Director, Global Compliance Officer, Cephalon; Former Assistant District Attorney, Philadelphia District Attorney's Office, Exton, PA

Harvey C. Kaish
Vice President and Senior Counsel, Bristol-Myers Squibb, Plainsboro, NJ

Ann E. Lewis, Esq.
Counsel, Ropes and Gray, former Vice-President and Senior Counsel, U.S. Healthcare Law Compliance, Bristol-Myers Squibb, New York, NY
Presentation Material (Acrobat)



5:30 p.m.




Adjournment and Networking Reception




AFTERNOON TRACK III



Transparency and Third Party Compliance Requirements









  • This track will focus on state and federal marketing disclosure laws, clinical trial disclosure laws and vendor access requirements



3:00 p.m.




Introduction and Overview

Eve Costopoulos
Vice President, Global Compliance, Schering-Plough Corporation, Kenilworth, NJ (Co chair)

Kris Curry
Senior Director, Health Care Compliance Operations, Johnson & Johnson Pharmaceutical Research & Development, Titusville, NJ (Co chair)

Gregory H. Levine, Esq.
Partner, Ropes & Gray, Washington, DC (Co chair)

Paul J. Silver
Managing Director, Practice Leader, Life Sciences Advisory Services, Huron Consulting Group, Atlanta, GA (Co chair)
Presentation Material (Acrobat)



3:15 p.m.




Sunshine Act: Latest Developments and Industry Impact

Albert F. Cacozza, Jr., Esq.
Partner, Ropes & Gray LLP; Former Counsel, Subcommittee on Labor, Committee on Labor and Human Resources, United States Senate, Washington, DC
Presentation Material (Acrobat)

Marina Pearlman
Senior Corporate Counsel, Pfizer, New York, NY
Presentation Material (Acrobat)

Gregory H. Levine, Esq.
Partner, Ropes & Gray, Washington, DC (Moderator)



3:45 p.m.




Disclosure of Clinical Trial Results: Obligations and Best Practices

Mark A. DeWyngaert, MBA, PhD
Managing Director, Huron Consulting Group, New York, NY
Presentation Material (Acrobat)

Craig A. Metz, PhD
Vice President Regulatory Affairs, GlaxoSmithKline, Research Triangle Park, NC
Presentation Material (Acrobat)



4:15 p.m.




Disclosure of Third-Party Data: Compliance and Beyond

Anthony Brennan
Director, Policy and Audit Interface, Johnson & Johnson, Titusville, NJ

Howard L. Dorfman, Esq.
Counsel, Ropes & Gray LLP; Former Chief Legal Officer, Pharmaceutical Division, Bayer Healthcare LLC; Former Counsel, US Medicines Group, Bristol-Myers Squibb, New York, NY

Patricia Molino
Vice President Public Affairs, Johnson & Johnson Corporate Communications, New Brunswick, NJ
Presentation Material (Acrobat)

Katie B. Topolewski
Senior Counsel, Commercial Business, Corporate Compliance, Endo Pharmaceuticals, Chadds Ford, PA

Dave Wysocky
Director, Pharmaceutical and Life Sciences Advisory Services, PricewaterhouseCoopers LLP, Lebanon, NJ

Kris Curry
Senior Director, Health Care Compliance Operations, Johnson & Johnson Pharmaceuticals Groups, Titusville, NJ (Moderator)
Presentation Material (Acrobat)



5:00 p.m.




Third Party Data: How to Collect and Use It Effectively

Eve Costopoulos
Vice President, Global Compliance, Schering-Plough Corporation, Kenilworth, NJ

Debjit A. Ghosh, MS, MPH
Managing Director, Huron Consulting Group, New York, NY

John Poulin
Solutions Architect, Huron Consulting Group, New York, NY
Presentation Material (Acrobat)



5:30 p.m.




Adjournment and Networking Reception




AFTERNOON TRACK IV



Instituting a Truly Global Compliance Program









  • This track will focus on a number of areas that companies operating globally need to make sure they have considered as their compliance organizations mature. This track is for legal counsel and seasoned compliance professionals in global organizations.



3:00 p.m.




Introduction and Overview Panel: What is a Global Compliance Organization in Practice?

Scott Bass, Esq.
Partner, Sidley Austin LLP, Washington, DC (Co chair)
Presentation Material (Acrobat)

Kathleen Meriwether, Esq.
Principal, Fraud Investigation & Dispute Services, Ernst & Young LLP; Former Assistant United States Attorney, Eastern District of Pennsylvania, US Department of Justice, Philadelphia, PA (Co chair)

Caroline West, Esq.
Senior Vice President, Chief Compliance and Risk Officer, Shire Pharmaceuticals, Inc., Wayne, PA (Co chair)



3:45 p.m.




Panel: Building Promotional and Event Review Processes in an International Environment

Keith M. Korenchuk, JD, MPH
Partner, Arnold & Porter, Washington, DC

Sheila Stranks
Senior Director and Deputy Compliance Officer, International, Shire Pharmaceuticals Group plc; Magistrate, Basingstoke Law Courts, Basingstoke, Hampshire, UK

Sharon J. White
Director, International Compliance Office, Wyeth Pharmaceuticals, Collegeville, PA

Kathleen Meriwether, Esq.
Principal, Fraud Investigation & Dispute Services, Ernst & Young; Former Assistant United States Attorney, Eastern District of Pennsylvania, US Department of Justice, Philadelphia, PA(Moderator)
Presentation Material (Acrobat)



4:30 p.m.




Safety and Pharmacovigilance Issues Globally

Michael Giffin
Director of Life Sciences, World Class International, New York, NY
Presentation Material (Acrobat)



5:15 p.m.




Reference Pricing: Staying Ahead of Evolving Regulatory Landscape

James C. Stansel, Esq.
Partner, Sidley Austin LLP; Former Acting General Counsel, US Department of Health & Human Services, Washington, DC
Presentation Material (Acrobat)



6:00 p.m.




Adjournment and Networking Reception




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