PharmaceuticalRegulatory and ComplianceCongress and Best PracticesForum PREPARING FOR THE NEXT WAVE OF CHANGE

THE ELEVENTH ANNUAL

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Silver Grantors:

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Sponsor:

October 20 – 22, 2010JW Marriott Hotel • Washington, DCwww.PharmaCongress.com • 800-503-7419

Co chairs:Colleen M. Craven,Vice President,Corporate Compliance & BusinessPractices, Endo Pharmaceuticals

Margaret K. Feltz, Director,Corporate Compliance,Purdue Pharma LP

Kelly B. Freeman, PhD, Director,US Affiliate, Compliance and Ethics,Eli Lilly and Company

Michael L. Shaw, Vice President andCompliance Officer, GlaxoSmithKline -NA Pharmaceuticals, Former SeniorCounsel, Office of Inspector General

Keynote Speakers:Thomas W. Abrams, RPh, MBA,Director, Division of Drug Marketing,Advertising, and Communications,Center for Drug Evaluation andResearch (CDER), FDA

Richard A. Feinstein, Esq., Director,Bureau of Competition, Federal TradeCommission, Former Supervisor,Antitrust Division, US DoJ

Stephen F. Mohr, Esq., Global Compliance Officer, AstraZeneca

Mary E. Riordan, Esq., Senior Counsel,Office of Counsel to the InspectorGeneral, Office of Inspector General

Brent L. Saunders, JD, MBA, ChiefExecutive Officer, Bausch & Lomb

Preconference Sessions:• Compliance Basics

• Internet and Social NetworkingCommunication Update

Featured Plenary Sessions:• OIG Update • DoJ Update • FTC Update • FDA Update • PCF Pharmaceutical Compliance Professional

and Legal Counsel Roundtable • Roundtable on Federal Sunshine Act and State

Disclosure Laws • Global Compliance: Reports from the Field • Individual Liability Panel • Conflicts of Interest Panel • Former Regulator Panel: What I can

Say Now that I am out of Government

Featured Tracks:• Advanced Issues in Auditing and Monitoring

• Internal and External Investigations Update

• Research & Development and Clinical Trials

• Federal Sunshine Act and State DisclosureLaws Update

• Compliance Program Trends and Best Practices

• Healthcare Professionals Compliance Update

• Government Price Reporting Update

• FCPA Compliance Update

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THE ELEVENTH ANNUAL PHARMACEUTICAL REGULATORY AND COMPLIANCE CONG RESS AND BEST PRAC TICES FORUM: PREPARING FOR THE NEXT WAVE OF CHANGE

Pharmaceutical and Health CareExecutives and Board Members

Compliance Executives

Health Plan, Health System and Physician Organizations

Medical Directors

Physicians

Pharmacists and Pharmacy Technicians

Purchasers, including PrivateEmployers and Public Purchasers

Pharmaceutical Manufacturers

Generic PharmaceuticalManufacturers

Site Management Organizations

Clinical Research Organizations

Pharmacy Benefit Management Companies

Nurses

About the Pharmaceutical Compliance Forum:

T he Pharmaceutical Compliance Forum (PCF) is a coalition of senior compliance professionals and legal counsel frommore than 50 of the largest research-based pharmaceutical

manufacturers. The PCF was founded in early-1999 by complianceprofessionals from the pharmaceutical industry to promote effectivecorporate compliance programs. The members meet twice a year, fortwo days, focusing on open and informal sharing of compliance infor-mation, best practices, and current developments in the field, andsponsors a three-day compliance congress each Fall. For membershipinformation, contact Tim Bower at 215-599-6617or via email atinfo@PharmaComplianceForum.org. Please visit their website atwww.PharmaComplianceForum.org.

Health Plans and Health Insurers

Wholesale, Retail, Mail Orderand Internet Pharmacies

Health Care Attorneys and In-house Counsel

Compliance Officers

Privacy Officers

Ethics Officers

Food and Drug Law Attorneys

Pharmaceutical Consultants

Investment Bankers

Venture Capitalists

Health Care Regulators and Policy Makers

Health Services Researchersand Academics

Auditors

Who Should Attend:

Wednesday, October 20, 2010Preconference Symposia

7:00 am Congress Registration

8:00 am Preconferences Commence (Choose one)

PRECONFERENCE I: COMPLIANCE BASICS

8:00 am Compliance Overview: Laws and Regulations, the OIGCompliance Program Guidance for Pharmaceutical Manufacturers, the Federal Sentencing Guidelines, and Important Settlements with the GovernmentWendy C. Goldstein, Esq., Member of the Firm, Epstein Becker & GreenPC, New York, NY (Co chair)

9:00 am FDA Regulatory Overview: Trends Affecting theRegulation of Advertising and Promotion, the FDA Review Process andRequirements for Claim Support, Fair Balance, and DTC PromotionLucy Rose, MBA, President, Lucy Rose and Associates, Former Director,Office of Training and Communications, Center for Drug Evaluation andResearch (CDER), Food and Drug Administration, Roseland, VA (Co chair)

10:00 am Break

10:15 am Implementing the Seven Elements of a ComplianceProgram: Practical Advice and Best Practices for Policy Development,Training, Communications, Monitoring, Auditing, and Corrective ActionsKelly B. Freeman, PhD, Ethics and Compliance Officer, Eli Lilly andCompany, Indianapolis, IN (Co chair)

11:15 am Interactive Group Discussion of Hypothetical Scenarios

11:45 am Questions and Comments

Noon ADJOURNMENT AND LUNCH ON YOUR OWN

PRECONFERENCE II: INTERNET AND SOCIAL NETWORKING COMMUNICATION UPDATE

8:00 am Welcome and Introductions Timothy Ayers, Esq., Senior Director, Associate General Counsel, AllosTherapeutics, Inc., Princeton, NJ (Co chair)

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

8:15 am Overview: The Current State of FDA Regulation andEnforcement Relating to the Internet and Social MediaDaniel A. Kracov, Esq., Partner and Chair, FDA and Healthcare Practice,Arnold & Porter LLC, Washington, DC

9:00 am Addressing Internet and Social NetworkingCommunications in Your Compliance ProgramTimothy Ayers, Esq., Senior Director, Associate General Counsel, Allos Therapeutics, Inc., Princeton, NJ

9:45 am Dos and Don’ts in Addressing Online Communications—Good and Bad—About Your Products and CompanyMeredith Manning, Esq., Partner, Hogan Lovells US LLP, FormerAssistant US Attorney, Civil Division, US Attorney’s OfficeFormer AssociateChief Counsel, Food and Drug Administration, Washington, DC

10:30 am Break

11:00 am Establishing a Social Media Monitoring ProgramMaxim Duprat, Director, Pharmaceutical & Life Sciences Practice,PricewaterhouseCoopers LLP, Florham Park, NJ

11:30 am Faculty Q&A

Noon ADJOURNMENT AND LUNCH ON YOUR OWN

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Wednesday, October 20, 2010Pharma Congress Day I Government Enforcement

1:00 pm Welcome and IntroductionColleen M. Craven, Vice President, Corporate Compliance & BusinessPractices, Endo Pharmaceuticals, Chadds Ford, PA (Co chair)

1:15 pm Keynote: OIG UpdateMary E. Riordan, Esq., Senior Counsel, Office of Counsel to theInspector General, Office of Inspector General, US Department ofHealth and Human Services, Washington, DC

1:45 pm Keynote: DoJTony West, Esq. (Invited), Head, Civil Division, US Department ofJustice, Former California Special Assistant Attorney General, FormerAssistant US Attorney, Northern California, Washington, DC

2:45 pm Keynote: FDA-DDMAC UpdateThomas W. Abrams, RPh, MBA, Director, Division of Drug Marketing,Advertising, and Communications, Center for Drug Evaluation andResearch (CDER), Food and Drug Administration, Silver Spring, MD

3:15 pm Break

3:45 pm Keynote: FTC Enforcement UpdateRichard A. Feinstein, Esq., Director, Bureau of Competition, Federal Trade Commission, Former Supervisor, Antitrust Division, US Department of Justice, Washington, DC

4:15 pm Setting the Stage: PCF Pharmaceutical ComplianceProfessional and Legal Counsel Roundtable

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

5:30 pm ADJOURNMENT AND NETWORKING RECEPTION

Thursday, October 21, 2010Pharma Congress Day II7:00 am Registration Opens

Continental Breakfast in Exhibit Hall

MORNING PLENARY SESSION8:00 am Welcome and Introduction to Day II Morning

Plenary Session: Overview of the Sunshine ActMargaret K. Feltz, Director, Corporate Compliance, Purdue Pharma LP,Stamford, CT (Co chair)

8:30 am Roundtable on Federal Sunshine Act and StateDisclosure Laws: Top Challenges and Compliance BestPractices

Karen Lowney, Senior Director, Global Compliance, Cephalon, Frazer, PA

Rore Middleton, Esq., Senior Manager, Corporate Compliance, PurduePharma LP, Stamford, CT

Trudy J. Seeley, Esq., Compliance Manager, State Law Compliance and US Corporate Compliance, sanofi-aventis, Bridgewater, NJ

Heidi Straub, Senior Director, Physician Aggregate Spend Team (PhAST), Eli Lilly and Company, Indianapolis, IN

Jack T. Tanselle, MBA, Director, Healthcare Dispute, Compliance andInvestigation Practice, Navigant Consulting, Inc., Chicago, IL (Co moderator)

David J. Wysocky, Director, Pharmaceutical & Life Sciences Practice,PricewaterhouseCoopers LLP, Florham Park, NJ (Co moderator)

9:45 am Transition Break

MORNING TRACK SESSIONS

MORNING TRACK I: ADVANCED ISSUES IN AUDITING AND MONITORING Debjit A. Ghosh, MS, MPH, Managing Director, Life Sciences AdvisoryServices, Huron Consulting Group, New York, NY (Co chair)

A. Monica Jonhart, Senior Director, Ethics, Quality & Compliance, OtsukaAmerica, Princeton, NJ (Co chair)

10:15 am Overview of Monitoring and AuditingDebjit A. Ghosh, MS, MPH, Managing Director, Life Sciences AdvisoryServices, Huron Consulting Group, New York, NY

A. Monica Jonhart, Senior Director, Ethics, Quality & Compliance, Otsuka America, Princeton, NJ

10:45 am Mature Compliance Monitoring and AuditingEileen Erdos, Partner, Ernst & Young LLP, Cleveland, OH

Kathleen Meriwether, Esq., Principal, Fraud Investigation & Dispute Services,Ernst & Young, Former Assistant United States Attorney, Eastern District ofPennsylvania, Department of Justice, Philadelphia, PA

Debra Neumann, Director, Corporate Compliance and Business Practices,Endo Pharmaceuticals, Chadds Ford, PA

11:15 am Advanced Issues in Monitoring and Auditing BestPractices Roundtable: Lessons Learned from RecentCIA’s and DPA’s

A. Monica Jonhart, Senior Director, Ethics, Quality & Compliance, OtsukaAmerica Pharmaceutical, Inc., Princeton, NJ

Gary Mendelsohn, Assistant Field Director, Corporate Compliance, Astellas US LLC, Evanston, IL

Amy Pawloski, Director, US Pharmaceuticals Compliance and EthicsMonitoring, Bristol-Myers Squibb, Princeton, NJ

Angela Rodin, MBA, Vice President, Group Internal Audit,GlaxoSmithKline, Philadelphia, PA

Chris Santarcangelo, Assistant Director, Corporate Compliance, PurduePharma LP, Stamford, CT

Diane Tolzman, Senior Director, Sales, Marketing and Global Compliance,Astellas US LLC, Vancouver, WA

Tracy Mastro, Director, Life Sciences Advisory Services, Huron ConsultingGroup, Washington, DC (Moderator)

Lynn Shapiro Snyder, Esq., Member of the Firm, Epstein Becker & GreenPC, Washington, DC (Moderator)

12:15 pm Proceed to Networking Luncheon

MORNING TRACK II: INTERNAL AND EXTERNAL INVESTIGATIONS UPDATE John T. Bentivoglio, Esq., Partner, Skadden Arps LLP, Former SpecialCounsel for Healthcare Fraud and Chief Privacy Officer, US Department ofJustice, Washington, DC (Co chair)

Gary F. Giampetruzzi, Esq., Assistant General Counsel and Chief ofGovernment Investigations, Pfizer, Inc., New York, NY (Co chair)

10:15 am The Basics of Governmental InvestigationsElizabeth V. Jobes, Esq., Vice President and Compliance Officer, AdolorCorporation, Former Assistant District Attorney, Philadelphia, PA, Exton, PA

Joshua S. Levy, Esq., Partner, Ropes and Gray, Former Assistant USAttorney, District of Massachusetts, US Department of Justice, Boston, MA

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10:45 am Handling Internal InvestigationsJoshua Drew, Esq., Director, Corporate Compliance & Business Practices,Endo Pharmaceuticals, Former Assistant US Attorney, US Attorney’s Office,District of New Jersey, Former Trial Attorney at Fraud Section, CriminalDivision, US Department of Justice, Chadds Ford, PA

11:15 am State InvestigationsJohn T. Bentivoglio, Esq., Partner, Skadden Arps LLP, Former SpecialCounsel for Healthcare Fraud and Chief Privacy Officer, US Department ofJustice, Washington, DC

Gary F. Giampetruzzi, Esq., Assistant General Counsel and Chief ofGovernment Investigations, Pfizer, Inc., New York, NY

11:45 am International InvestigationsPeter S. Spivack, Esq., Partner, Hogan Lovells, Former Assistant United StatesAttorney, Central District of California, Washington, DC

12:15 pm Proceed to Networking Luncheon

MORNING TRACK III: RESEARCH & DEVELOPMENT AND CLINICAL TRIALSAnup Kharode, Director, Pharmaceutical & Life Sciences Practice,PricewaterhouseCoopers LLP, Philadelphia, PA (Co chair)

Laura A. Wittenauer, Ethics and Compliance Officer, Lilly ResearchLaboratories, Eli Lilly & Company, Indianapolis, IN (Co chair)

10:15 am Patient RecruitmentSusan Barsky, R&D Compliance and Process Manager, Shire Pharmaceuticals,Philadelphia, PA

10:45 am Fair Market Value in Research and DevelopmentLaura A. Wittenauer, Ethics and Compliance Officer, Lilly ResearchLaboratories, Eli Lilly & Company, Indianapolis, IN

11:15 am Clinical Trial Results Disclosure: A Case StudyAnup Kharode, Director, Pharmaceutical & Life Sciences Practice,PricewaterhouseCoopers LLP, Philadelphia, PA

11:45 am Good Clinical Practice Compliance: Avoiding theMistakes that can Derail your Business

Gregory H. Levine, Esq., Partner, Ropes and Gray, Washington DC

12:15 pm Proceed to Networking Luncheon

MORNING TRACK IV: ADVANCED COMPLIANCE STRATEGIES RE FEDERAL SUNSHINE ACT AND STATE DISCLOSURE LAWS Jennifer Colapietro, Partner, Pharmaceutical and Life Sciences Practice,PricewaterhouseCoopers, LLP, Florham Park, NJ (Co chair)

Heidi Straub, Senior Director, Physician Aggregate Spend Team (PhAST),Eli Lilly and Company, Indianapolis, IN (Co chair)

10:15 am Strategic and Operational Challenges Resulting fromthe New PPACA and Recent Supreme Court Rulings

Jennifer Colapietro, Partner, Pharmaceutical and Life Sciences Practice,PricewaterhouseCoopers LLP, Florham Park, NJ

Jonathan Diesenhaus, Esq., Partner, Hogan Lovells, Former Senior TrialCounsel, Civil Division, US Department of Justice, Washington, DC

11:00 am Are you Ready to Audit your Aggregate SpendProcesses and Systems: Key Steps you Need toConsider Now

Eve Costopoulos, Esq., Vice President, Chief Ethics and Compliance Officer,Eisai, Inc., Woodcliff Lake, NJ

Marci Juneau, Manager, Life Sciences Advisory Services, Huron ConsultingGroup, Atlanta, GA

Manny Tzavlakis, Director, Life Sciences Advisory Services, Huron ConsultingGroup, New York, NY

11:30 am Sunshine Provisions within PPACA/HCEARA and theOpportunity to Improve your HCP “System” Right Now

Jack T. Tanselle, MBA, Director, Healthcare Dispute, Compliance andInvestigation Practice, Navigant Consulting, Inc., Chicago, IL

Noon Aggregate Spend and Disclosure Requirements —How Automated Reporting and Master DataManagement Can Improve Compliance

Don Soong, Senior Director, Compliance Solutions Development, Cegedim Dendrite, Bedminster, NJ

12:30 pm Proceed to Networking Luncheon

12:15 pm LUNCHEON AND PRESENTATION

Luncheon Address: Liability for IndividualsPaul E. Kalb, JD, MD, Partner, Sidley Austin LLP, Washington, DC

AFTERNOON TRACK SESSIONS

AFTERNOON TRACK I: COMPLIANCE PROGRAM TRENDS AND BEST PRACTICESEric Siegel, Esq., Chief Compliance Officer, EMD Serono, Inc., Rockland, MA (Co chair)

Paul J. Silver, Practice Leader, Life Sciences Advisory Services, HuronConsulting Group, LLC, Atlanta, GA (Co chair)

1:15 pm The Continuing Evolution of CIAsThomas A. Gregory, Partner, Ernst & Young, Atlanta, GA

Retta M. Riordan, JD, President, Riordan Consulting LLC, Former Business Ethics and Compliance Officer, Organon USA Inc., Westfield, NJ

1:45 pm Compliance Effectiveness and Board CertificationThomas D. Forrester, Esq., Vice President, US Corporate ComplianceOfficer, sanofi-aventis, Bridgewater, NJ

Saul B. Helman, MD, Managing Director, Healthcare Dispute, Complianceand Investigation Practice, Navigant Consulting, Inc., Chicago, IL

2:15 pm Practical Compliance Implications of the IntegrityProvisions under PPACA to Rx

Wendy C. Goldstein, Esq., Member of the Firm, Epstein Becker & Green PC,New York, NY

2:45 pm Proactive Compliance Monitoring — Past, Present and Future

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

3:15 pm Break

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AFTERNOON TRACK II: HEALTHCARE PROFESSIONALS COMPLIANCE UPDATE—THE HOTTEST EMERGING ISSUES IN INDUSTRY/HCP RELATIONSHIPSThomas Glavin, Esq., Vice President and Deputy Compliance Officer, Shire Pharmaceuticals, Philadelphia, PA (Co chair)

Ann E. Lewis, Esq., Counsel, Ropes and Gray, Former Vice-President andSenior Counsel, US Healthcare Law Compliance, Bristol-Myers Squibb, New York, NY (Co chair)

1:15 pm Investigator Sponsored Research, Clinical TrialInvestigator Compliance and Compliance Issues inResearch-Related Relationships

Eve M. Brunts, Esq., Partner, Ropes and Gray, Boston, MA

1:45 pm Live Monitoring of Speaker Programs: Ways toAccomplish a lot during this Process

Eric Siegel, Esq., Chief Compliance Officer, EMD Serono, Inc., Rockland, MA

Paul J. Silver, Practice Leader, Life Sciences Advisory Services, Huron ConsultingGroup, Atlanta, GA

2:15 pm Industry Support for Authors and Publications: What Good Looks Like

Albert F. Cacozza, Jr., Esq., Partner, Ropes and Gray, Former Counsel to theSubcommittee on Labor Committee on Labor and Human Resources, UnitedStates Senate, Washington, DC

2:45 pm Track Faculty Q&A

3:15 pm Break

AFTERNOON TRACK III: GOVERNMENT PRICE REPORTING: WHAT EVERY COMPLIANCE PROFESSIONAL NEEDS TO KNOWJerry R. Wolf, MBA, Director, Healthcare Dispute, Compliance andInvestigation Practice, Navigant Consulting, Inc., Philadelphia, PA (Co chair)

Joseph J. Skupen, Senior Director, US Corporate Compliance, sanofi-aventis US, Bridgewater, NJ (Co chair)

1:15 pm Overview of Government Pricing Implications withinPPACA/HCEARA

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

1:45 pm Pricing Issues and Compliance Post-HealthcareReform

Jeffrey L. Handwerker, Esq., Partner, Arnold & Porter, Washington, DC

2:15 pm Auditing the Government Price Reporting ChangesMandated by Health Reform

Susan Dunne, Director, Life Sciences Advisory Services, Huron ConsultingGroup, Washington, DC

Joseph J. Skupen, CPA, Senior Director, US Corporate Compliance, sanofi-aventis US, Bridgewater, NJ

2:45 pm Monitoring Better Practices: Key Risk Areas inBuilding Your Program

Erinn Hutchinson, Director, Pharmaceutical & Life Sciences Practice,PricewaterhouseCoopers LLP, Philadelphia, PA

3:15 pm Break

AFTERNOON TRACK IV: FCPA COMPLIANCE UPDATEKeith M. Korenchuk, JD, MPH, Partner, Arnold & Porter, Washington, DC(Co chair)

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

Gonzalo M. Cornejo, Esq., Vice President and Associate General Counsel,GlaxoSmithKline, Philadelphia, PA (Co chair)

1:15 pm Global Anti-Bribery: Anti-Corruption (ABAC)Compliance: Overview and Advanced Issues

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

Gonzalo M. Cornejo, Esq., Vice President and Associate General Counsel,GlaxoSmithKline, Philadelphia, PA

2:00 pm FCPA/Anti-bribery Compliance AssessmentsGregory A. Crouse, CPA, Partner, Pharmaceutical Compliance Investigative& Dispute Services, Ernst & Young LLP, Washington, DC

2:45 pm Faculty Q&A

3:15 pm Break

AFTERNOON PLENARY SESSION

3:45 pm Introduction to Afternoon Plenary SessionMichael L. Shaw, Esq., Vice President & Compliance Officer,GlaxoSmithKline-NA Pharmaceuticals, Former Senior Counsel, Office ofInspector General, Philadelphia, PA (Co chair)

4:00 pm Practical Perspectives on Global ComplianceStephen F. Mohr, Esq., Global Compliance Officer, AstraZeneca, London, UK

4:30 pm Global Compliance: Reports from the Field

Asia:Scott Bass, Esq., Partner and Chair, Global Life Sciences Team, SidleyAustin LLP, Washington, DC

Gordon M. Chapman, Executive Director, Compliance and Ethics, AsiaPacific, Bristol-Myers Squibb, New York, NY

Europe:Roeland van Aelst, Executive Director International, WW Office Health CareCompliance & Privacy (EMEA, Canada, Lat-Am, Asia-Pac), Johnson &Johnson, Brussels, Belgium

Latin and South America:Juan Francisco Millan, MD, Executive Director, CETIFARMA (PharmaIndustry Association), Mexico City, Mexico

Middle East/Africa:Gabor Danielfy, Senior Director, Health Care Compliance and PrivacyEMEA, Johnson & Johnson, Issy-les-Moulineaux, France

Moderator: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

5:45 pm ADJOURNMENT DAY II

Friday, October 22, 2010Pharma Congress Day III • Policy and Ethics 7:00 am Registration Opens

Continental Breakfast in Exhibit Hall

8:00 am Introduction to Day ThreeKelly B. Freeman, PhD, Ethics and Compliance Officer, Eli Lilly and Company,Indianapolis, IN (Co chair)

8:15 am Keynote: Compliance Perspectives from the Perspective ofPrivate Equity and C-Suite

Brent L. Saunders, JD, MBA, Chief Executive Officer, Bausch & Lomb, Former SpecialAdvisor, General Atlantic, Former Senior Vice President and President, Consumer HealthCare, and Former Senior Vice President, Global Compliance and Business Practices,Schering-Plough Corporation, Past President, Health Care Compliance Association, Founder,International Association of Privacy Professionals, Kenilworth, NJ

8:45 am Individual Liability PanelThomas E. Costa, Vice President, US Pharmaceuticals Compliance and Ethics, Bristol-Myers Squibb, Princeton, NJ

Anne Nobles, Esq., Chief Ethics and Compliance Officer and Senior Vice President, EnterpriseRisk Management, Eli Lilly and Company, Indianapolis, IN

Thomas M. Gallagher, Esq., Partner and Chair, White Collar and Corporate InvestigationsPractice Group, Pepper Hamilton LLP, Former Prosecutor in the Criminal Division, USAttorney’s Office, Eastern District of Pennsylvania, Philadelphia, PA (Moderator)

9:30 am Conflicts of Interest PanelBernard Lo, MD (Invited), Professor of Medicine and Director, Program in Medical Ethics,Department of Medicine, University of California, San Francisco, Chair, Committee onConflict of Interest in Medical Research, Education, and Practice; Institute of Medicine, San Francisco, CA

Thomas P. Stossel, MD, American Cancer Society Professor of Medicine, Director,Translational Medicine Division, Senior Physician, Hematology Division Brigham & Women'sHospital, Boston, MA

Jack T. Tanselle, MBA, Director, Healthcare Dispute, Compliance and Investigation Practice,Navigant Consulting, Inc., Chicago, IL (Moderator)

10:15 am Break

10:30 am Former Regulator Panel: What I can Say Now that I am out of Government

Laurence J. Freedman, Esq., Partner, Patton & Boggs, Former Assistant Director, FraudSection, Commercial, Litigation Branch, Civil Division, US Department of Justice,Washington, DC

Michael K. Loucks, Esq., Partner, Skadden Arps LLP, First Assistant US Attorney, US Attorney’s Office for the District of Massachusetts, Washington, DC

Meredith Manning, Esq., Partner, Hogan & Hartson, LLC, Former Assistant US Attorney,Civil Division, US Attorney’s Office, Former Associate Chief Counsel, Food and DrugAdministration, Washington, DC

Kathleen Meriwether, Esq., Principal, Fraud Investigation & Dispute Services, Ernst &Young, Former Assistant United States Attorney, Eastern District of Pennsylvania, Departmentof Justice, Philadelphia, PA

Kirk Ogrosky, Esq., Partner, Arnold & Porter, Former Deputy Chief for Health Care Fraud,Criminal Division and Director, Medicare Fraud Strike Force (MFSF), Former Assistant USAttorney, Southern District of Florida, Former Assistant Attorney General, Kentucky, USDepartment of Justice, Washington, DC

John T. Bentivoglio, Esq., Partner, Skadden Arps LLP, Former Special Counsel for HealthcareFraud and Chief Privacy Officer, US Department of Justice, Washington, DC (Moderator)

NOON CONGRESS ADJOURNMENT

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2010 PCF Pharma Congress Planning Committee:Colleen M. Craven,Vice President, CorporateCompliance & Business Practices, Endo Pharmaceuticals(Co chair)

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

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

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

Timothy Ayers, Esq., Senior Director,Associate General Counsel,Allos Therapeutics, Inc.

Scott Bass, Esq., Partner, Sidley Austin LLP

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

Kevin L. Espinoza, US Deputy Compliance Officer,North America Pharmaceuticals, GlaxoSmithKline

Thomas Forrester,Vice President, US CorporateCompliance Officer, sanofi-aventis

Wendy C. Goldstein, Esq., Member of the Firm,Epstein Becker & Green

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

Daniel Kracov, Esq., Partner,Arnold & Porter

Ann Lewis, Esq., Counsel, Ropes & Gray

Kathleen Meriwether, Esq., Principal, Fraud Investigation& Dispute Services, Ernst & Young

Jonathon Kellerman, Partner, Global PharmaceuticalAdvisory Services Group, PricewaterhouseCoopers LLP

Doreen F. Shulman,Vice President, Chief Complianceand Ethics Officer, Bristol-Myers Squibb

Paul J. Silver, Practice Leader, Life Sciences AdvisoryServices, Huron Consulting Group

Peter S. Spivack, Esq., Partner, Hogan Lovells

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

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

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REGISTRATION BINDING AGREEMENTRegistration (whether online or by this form) constitutes a contract and all of these termsand conditions are binding on the parties. In particular, these terms and conditions shallapply in the case of any credit/debit card dispute.

TOTAL FOR ALL OPTIONS: $

THE ELEVENTH ANNUAL PHARMACEUTICAL CONGRESS

HOTEL INFORMATION/RESERVATIONSA special group rate of $299.00 single/double per night (plus tax) has beenarranged for the Pharmaceutical Congress 2010 attendees. To receive the group rate,call the dedicated reservations phone line: 506-474-2009 or 800-266-9432 andmention the group code “Pharma Congress 2010.” For information on how to bookyour hotel room online, please go to the travel tab at www.PharmaCongress.com.

Reservations will be accepted until the cut-off date Tuesday, October 5, 2010. Afterthis, reservations will be accepted on a space-available basis at the prevailing rate.

JW Marriott Hotel1331 Pennsylvania Avenue, NW • Washington, DC 20004Reservations: 506-474-2009 or 800-266-9432

Pharmaceutical Regulatoryand Compliance Congress and Best Practices Forum

Pharmaceutical Regulatoryand Compliance Congress and Best Practices ForumPublications Printing Dept.41651 Corporate WayPalm Desert, CA 92260USA

(Address for Return Mail Only)

Forwarding Service Requested

PREPARING FOR THE NEXT WAVE OF CHANGE

THE ELEVENTH ANNUAL

October 20 –22, 2010JW Marriott HotelWashington, DCwww.PharmaCongress.com • 800-503-7419

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PALM DESERT, CA