Michael R. Clarke, JD, Vice President, Corporate Compliance, Indivior Inc. (PCF Co-Chair)

Sujata T. Dayal, JD, Vice Presi-dent, Health Care Compliance and Privacy, Pharmaceuticals Group, Johnson & Johnson (PCF Secretary)

BRONZE GRANTORS:

SILVER GRANTORS:

CO-CHAIRS:Thomas W. Abrams, RPh, MBA, Director, Office of Prescription Drug Promotion, FDALeslie Backschies, MA, Supervisor Special Agent and Unit Chief, International Corruption Unit, FBI Richard Bistrong, MA, Chief Executive Officer, Front-Line Anti-Bribery LLC; Contributing Editor, FCPA Blog Zachary A. Cunha, JD, Assistant US Attorney and Chief, Civil Division, US Attorney’s Office, District of Rhode Island, US DOJ Susan Dentzer, President and Chief Executive Officer, NEHI; Analyst on Health Policy, The NewsHour; Former Editor, Health Affairs Jacob Elberg, JD, Assistant US Attorney, US Attorney’s Office, District of New Jersey, US DOJ

KEYNOTE SPEAKERS:

CONTINUING EDUCATION CREDITS: ACCOUNTING PROFESSIONALS: Approved for up to 19.0 NASBA CPE credits.ATTORNEYS: The Congress is currently pending approval to offer Pennsylvania MCLE Credit.COMPLIANCE PROFESSIONALS: This education activity has been submitted to the Compliance Certification Board (CCB)® and is currently pending their review for approval of CCB CEUs.

Jeffrey M. Kawalek, MBA, Senior Director, Ethics and Compliance, North America, Ipsen Biopharmaceuticals, Inc. (PCF Chair)Jennifer McGee, JD, Vice President and Chief Compliance Officer, Otsuka America Pharma-ceutical, Inc. (PCF Treasurer)Margaret Sparks, JD, Associate Vice President, North America Ethics and Business Integrity, Sanofi US (PCF Co-Chair)Joe Zimmerman, Vice President and Chief Compliance Officer US, Ferring Pharmaceuti-cals (PCF Co-Chair)

GOLD GRANTOR:

Nineteenth Annual Pharmaceutical

and Medical Device Compliance CongressMANDARIN ORIENTAL • WASHINGTON, DC

NOVEMBER 7 – 9, 2018

A HYBRID CONFERENCE AND INTERNET EVENT

MEDIA PARTNERS:

SPONSOR:

www.PharmaCongress.com

For Early Bird Registration Discount, Register by

Friday, October 12!

Christopher B. Harwood, JD, Assistant US Attorney and Chief, Civil Health Care Fraud Unit, US Attorney’s Office, Southern District of New York, US DOJ

Tarek Helou, JD, Assistant Chief, FCPA Unit, Fraud Section, Criminal Division, US DOJ

Rachael Honig, JD, First Assistant US Attorney, US Attorney’s Office for the District of New Jersey, US DOJ

Mary E. Riordan, JD, Senior Counsel, Office of Counsel to the Inspector General, Office of Inspector General, US DHHS

Gregg Shapiro, JD, Assistant US Attorney, US Attorney’s Office, District of Massachusetts, US DOJ

Sally Q. Yates, JD, Partner, King & Spalding; Former Acting Attorney General; Former Deputy Attorney General, US DOJ

CHIEF COMPLIANCE OFFICER ROUNDTABLE:Featuring Hui Chen, JD, Ethics and Compliance Advocate and Consultant, HC Ethics LLC; Former Compliance Counsel Expert (Consultant), US DOJ

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ESS PARTICIPATION OPTIONS

WHO SHOULD ATTEND:• Pharmaceutical and Health Care Executives and Board Members• Compliance Executives• Health Plan, Health System and Physician Organizations• Medical Directors• Physicians• Pharmacists and Pharmacy Technicians• Purchasers, including Private Employers and Public Purchasers• Pharmaceutical Manufacturers• Generic Pharmaceutical Manufacturers• Site Management Organizations• Clinical Research Organizations• Pharmacy Benefit Management Companies• Nurses• Health Plans and Health Insurers• Wholesale, Retail, Mail Order and 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 Researchers and Academics• Auditors

Onsite

At your office . . .

. . . or home

TRADITIONAL ONSITE ATTENDANCESimply register, travel to the conference city and attend in person.PROS: subject matter immersion; professional networking opportunities; faculty interaction.

LIVE AND ARCHIVED INTERNET ATTENDANCEWatch the conference in live streaming video over the Inter-net and at your convenience at any time 24/7 for six months following the event.The archived conference includes speaker videos and coordinated PowerPoint presentations.PROS: Live digital feed and 24/7 Internet access for the next six months; accessible in the office, at home or anywhere worldwide with Internet access; avoid travel expense and hassle; no time away from the office.

Be a part of the premiere compliance event for pharmaceutical and medical device professionals at the 19th Annual PCF Compliance Congress. Join pharma and device compliance professionals, in-house counsel, regulators, prosecutors, attorneys and industry consultants to share ideas for ways to cultivate a culture of compliance with the highest integrity to enable access to better care

and outcomes for patients. This forum is ideal for both compliance professionals and in-house counsel new to developing a compli-ance program and experienced professionals and counsel continuing to evolve their programs to best suit their organization’s needs to address new challenges.

The Congress is the oldest and largest gathering of pharma and device compliance professionals and in-house counsel who come together annually to discuss best practices in legal and regulatory compliance. It is a part of a global pharma compliance congress series which has featured congresses in Berlin, Brussels, Budapest, Dubai, Istanbul, Paris, Rome, Warsaw, Lisbon and Vienna (the International Pharma Compliance Congress) Singapore, Shanghai, Kuala Lumpur and Manila (the Asia Pacific Pharma Compliance Congress); Sao Paolo and Mexico City (the Latin American Pharma Compliance Congress); and Washington, DC (the PCF Pharma Compliance Congress).

We would like to thank the Congress sponsor, the Pharmaceutical Compliance Forum (PCF), the 2018 PCF co-chairs, planning committee, grantors and exhibitors and faculty for their direction and insight into timely updates to applicable statutes, regulations and program requirements impacting our industry.

The health care industry continues to be a highly-regulated and high-risk industry. Adherence to applicable federal and state laws, compliance with private payer healthcare requirements and fostering a culture of “doing what is right” are essential to an effective compliance and ethics program. While the industry continues to keep a pulse on anticorruption and fraud and abuse compliance, HCP/HCO interactions, updates to open payments and third-party life-cycle management, new stakeholder interactions have emerged to the forefront, such as, interactions with patients and patient advocacy groups, specialty pharmacy and PBMs. These developments challenge companies to adapt, change and evolve faster. Join your esteemed colleagues in the industry as they share best practices in developing policies and procedures, training and leveraging data analytics in your auditing, monitoring and risk assessment and mitigation plans.

This year, we welcome back our long-standing keynote speakers from OIG, DOJ, SEC, FBI, FCPA and FDA, and we are delighted to welcome much anticipated presentations by Gregg Shapiro, JD, Hui Chen, JD, and Sally Yates JD. These stakeholders together with our expert keynote speakers, panelists and you bring together the brightest minds to engage in meaningful discussion, address timely compliance issues and provide a rich opportunity for networking.

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THURSDAY, NOVEMBER 8

AGENDA AT A GLANCE

Preconference Sessions: • Patient Support Programs: Risk and Risk Management Best Practices• Practical Approaches to Handling Investigations• Advanced Strategies in Auditing and Monitoring• Asking the Right Risk Questions to Power your Advanced Analytics Strategy

Plenary Sessions: • Sally Yates Keynote Address• Annual AUSA Roundtable• Annual Qui Tam Roundtable• DOJ, FBI and SEC FCPA Enforcement Update• Patient Support Programs Roundtable• Pharma and Device Pricing and Cost Containment

Mini Summits:• Fostering a Culture of Ethics and Compliance• Global Compliance Function Harmonization• Third Party Lifecycle Management• Annual Medical Device Compliance Roundtable• Dissecting Recent CIAs and Review of Draft Model CIA• Strategies to Measure Effectiveness, Monitor and Report• Managing Promotional Programs and

Patient Advocacy Groups• Open Payments: Where Does the Sun Shine Now?• Interactions with Specialty Pharmacy• Is your Board Bored of your Compliance Dashboards?• Next Generation Data Analytics

Opening Plenary Session: • OIG Keynote Address• FDA Keynote Address• Risks Your Risk Assessment Might Miss• Chief Compliance Officer Roundtable

FRIDAY, NOVEMBER 9: Industry-only Best Practices Roundtable Featuring AUSA Gregg Shapiro, JD

WEDNESDAY, NOVEMBER 7 An Invitation-only CCO Roundtable Hosted by PCF and PhRMA CCO Working Group; Featuring Hui Chen, JD, HC Ethics LLC

• Promotion with Medical Professionals: Avoiding White Coat Marketing

• Market Access Compliance Considerations• Global Documentation Framework• R&D: Hidden Risks beyond Clinical Trail Recruitment• Compliance for Small to Mid-size Pharma

and Device Companies• Compliance Issues Associated with PBM Relationships• Risk Assessments and Mitigation Plans• “All in Compliance” — Aligning with

Your Business Partners• Navigating the Murky Waters of Patient Programs• Compliance for “Evolved” Products,

including Aesthetics and Gene Therapy• Best Practice in HCP/HCO Management• Compliance Considerations in Value-based Contracting• Risks and Opportunities related to Medical Affairs• An Interactive Case Study in Effective Crisis Management• Privacy and Cybersecurity Compliance

Update, including GDPR• The Compliance Training Revolution

Mini Summits (Continued):

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WHO SHOULD ATTEND:• Pharmaceutical and Health Care Executives and Board Members• Compliance Executives• Health Plan, Health System and Physician Organizations• Medical Directors• Physicians• Pharmacists and Pharmacy Technicians• Purchasers, including Private Employers and Public Purchasers• Pharmaceutical Manufacturers• Generic Pharmaceutical Manufacturers• Site Management Organizations• Clinical Research Organizations• Pharmacy Benefit Management Companies• Nurses• Health Plans and Health Insurers• Wholesale, Retail, Mail Order and 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 Researchers and Academics• Auditors

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ABOUT THE PHARMACEUTICAL COMPLIANCE FORUM

The Pharmaceutical Compliance Forum (PCF) is a not-for-profit membership coalition of compliance professionals and legal counsel from 70 distinguished research-based pharmaceutical manufacturers and biotech companies.

The PCF was founded in early 1999 by compliance professionals from the pharmaceutical industry to promote effective corporate compli-ance programs. The members meet twice a year, for two days, focusing on open and informal sharing of compliance information, best prac-tices, and current developments in the field. PCF sponsors a three-day Compliance Congress each Fall.

Generally, representatives from the companies who attend the meetings are compliance officers, compliance attorneys or other professionals with responsibility for oversight or other aspects of their respective corporate compliance programs.

MISSION STATEMENTThe purpose of the Pharmaceutical Compliance Forum is to discuss education and other industry practices regarding compliance with the ultimate aim of promoting ef-fective pharmaceutical corporate compliance and ethics programs in accordance with the Federal Organization Sentencing Guidelines and the OIG Compliance Guidance for Pharmaceutical Manufacturers.

JOIN PCFNon-member companies who are interested in joining PCF may contact Debra Scanlon, Administrator, Pharmaceutical Compliance Forum at info@pharmacomplianceforum.org.

BENEFITS OF BECOMING A PCF COMPANY MEMBER• Save $500 off your first year’s membership dues when becoming a member

• Unlimited number of employees can join — No additional fees! All included in your annual corporate membership dues.

• All members have access to our exclusive Member Only website for networking with fellow members and viewing of past meeting materials, benchmarking surveys and other valuable resources!

• Exclusive invitation to the members only PCF Annual Spring and complimentary Fall Regional Meetings

• Monthly newsletter to stay informed on the latest news and meeting information.

• Save up to $500 with discounted registration fees for each employee to PCF sponsored Pharma Congress in Washington DC each year

• Save up to $500 with discounted registration fees for each employee to International Pharmaceutical Regulatory and Compliance Congress and the Asia Pacific Pharmaceutical and Medical Device Compliance Congress

• Complimentary compliance and legal job postings on the PCF website. A superior recruiting tool! Non-members companies pay $600 per posting.

• Special PCF Member discount on subscriptions to Life Science Compliance Update.

For more information go to www.pharmacomplianceforum.org.

CO-CHAIRSMichael R. Clarke, JD, Vice President, Corporate Compliance, Indivior Inc. (PCF Co-Chair)

Sujata T. Dayal, JD, Vice President, Health Care Compliance and Privacy, Pharmaceuticals Group, Johnson & Johnson (PCF Secretary)

Jeffrey M. Kawalek, MBA, Senior Director, Ethics and Compliance, North America, Ipsen Biopharmaceuticals, Inc. (PCF Chair)

Jennifer McGee, JD, Vice President and Chief Compliance Officer, Otsuka America Pharmaceutical, Inc. (PCF Treasurer)

Margaret Sparks, JD, Associate Vice President, North America Ethics and Business Integrity, Sanofi US (PCF Co-Chair)

Joe Zimmerman, Vice President and Chief Compliance Officer US, Ferring Pharmaceuticals (PCF Co-Chair)

MEMBERSKamil Ali-Jackson, JD, Co-Founder, Chief Legal Officer, Chief Compliance Officer and Corporate Secretary, Aclaris Therapeutics, Inc.Michael Arbini, Global Marketing Communications Leader, Polaris ManagementTimothy Ayers, JD, MPH, Group Vice President, Chief Compliance Officer, Horizon Pharma PLCDennis K. Barnes, JD, CPA, Vice President, Global Governance, Risk and Compliance, Mayne PharmaScott Bass, JD, Partner and Head, Global Life Sciences Team, Sidley Austin LLPAnn E. Beasley, JD, Director, Navigant ConsultingJohn T. Bentivoglio, JD, Partner, Skadden Arps LLP Kathleen M. Boozang, JD, LLM, Dean and Pro-fessor of Law, Seton Hall University School of LawScott Boyance, Associate Director, Forensic and Integrity Services, EYJoseph Calarco, Chief Compliance Officer, Neos TherapeuticsChristie Camelio, Vice President and US Health-care Compliance Officer, Celgene Corporation Thomas Costa, JD, Member, US Board of Directors, Sanofi; Former Vice President, US Compliance and Ethics, Bristol-Myers Squibb Paul Curtin, JD, CFE, Vice President, Global Chief Compliance Officer, Intercept Pharmaceuticals Jill Fallows-Macaluso, BSN, JD, Vice President and Chief Compliance Officer, Novo Nordisk Inc. Margaret K. Feltz, MA, JD, Vice President, Ethics and Compliance, Purdue Pharma LPAlison Fethke, JD, Counsel, Ropes & Gray LLPAlex Ganz, JD, Senior Manager of Compliance, Aegerion PharmaceuticalsGary F. Giampetruzzi, JD, Partner, Paul HastingsVirginia “Ginny” A. Gibson, JD, Partner, Hogan LovellsJonathan Glazier, JD, MBA, Head of Legal Compliance, Philips North America LLCWendy C. Goldstein, JD, Partner, Health Care and Life Sciences Regulatory Practice, Cooley, LLP

Ive Grgas, MS, Director, Healthcare Compliance, Puma BiotechnologyKaren L. Hale, JD, Vice President, Chief Ethics & Compliance Officer, Abbvie Bill Hrubes, MS, Vice President and Chief Compliance Officer, ACell, Inc.Erinn Hutchinson, Partner, Advisory Services, PwCMichael Joachim, JD, Compliance Business Partner, Sanofi GenzymeJonathon L. Kellerman, Executive Vice President, Global Chief Compliance Officer, Allergan PLCDaniel A. Kracov, JD, Partner and Head, FDA and Healthcare Practice, Arnold & Porter Kaye Scholer, LLPHolly Kramen, JD, Chief Compliance Officer and Privacy Officer, PolarityTERobert A. Ladd, JD, Vice President, Global Head Integrity & Compliance, Oncology, Novartis Puja Leekha, JD, Vice President, Chief Compliance Officer and Corporate Counsel, Corporate Compliance LundbeckGregory S. Moss, JD, Senior Vice President, Deputy General Counsel, Kadmon CorporationKatherine Norris, Director, Berkeley Research GroupNeil F. O’Flaherty, JD, Partner, Baker MckenzieJohn Patrick Oroho, JD, Executive Vice President and Chief Strategy Officer, Porzio Life Sciences, LLCJennifer O’Toole, Events Manager, Americas, SAI GlobalAmy Pawloski, Compliance Officer, Operations, Endo PharmaceuticalsLori Queisser, Senior Vice President and Global Chief Compliance Officer, TevaDavid Ralston, JD, MPH, Senior Director, Associate General Counsel, Business Conduct, Gilead SciencesKelly N. “Nikki” Reeves, MPA, JD, Partner, King & SpaldingJeffrey Rosenbaum, MBA, Partner, Dovetail Consulting Group, LLCMichael Shaw, JD, Vice President and Compliance Officer, US Pharmaceuticals, GlaxoSmithKline Paul J. Silver, Principal, Deloitte Ann-Marie Tejcek, MA, Senior Director, Ethics and Compliance, Eli Lilly and CompanyBrian Van Hoy, Vice President, G&M Health LLC Donna Wachman, National Industry Marketing Leader, Grant Thornton LLPJulie Wagner, JD, Assistant General Counsel, PhRMA Caroline West, JD, Global Chief Compliance Officer, Olympus CorporationDonna White, Vice President, Contracts and Compliance, Chiesi USA, Inc.Seth B. Whitelaw, JD, LLM, SJD, President and CEO, Whitelaw Compliance Group, LLC

2018 PCF PHARMA CONGRESS PLANNING COMMITTEE

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WEDNESDAY, NOVEMBER 7, 20187:00 am Registration Opens

CHIEF COMPLIANCE OFFICER ROUNDTABLE (Jointly Sponsored by PCF and the PhRMA CCO Workgroup; Special Morning Session, Invitation-only)

8:15 am Continental Breakfast Hosted by PhRMA and PCFInvited Guest: Hui Chen, JD, Ethics and Compliance Advocate and Consultant, HC Ethics LLC; Former Compliance Counsel Expert (Consultant), US Department of Justice, Pfizer, New York, NY

9:15 am Break

9:30 am Welcome and IntroductionsJennifer McGee, JD, Vice President and Chief Compliance Officer, Otsuka America Pharmaceutical, Inc., Rockville, MD (PCF Treasurer)

Antitrust AdmonitionSeth H. Lundy, JD, Partner, King & Spalding, Washington, DC (Special Antitrust Counsel)

9:45 am Feature Presentation: Measuring Compliance EffectivenessHui Chen, JD, Ethics and Compliance Advocate and Consultant, HC Ethics LLC; Former Compliance Counsel Expert (Consultant), US Department of Justice, Pfizer, New York, NY

10:45 am PhRMA UpdateJulie Ritchie Wagner, JD, Assistant General Counsel, PhRMA; Former Senior Counsel, Office of Counsel to the Inspector General, US Department of Health and Human Services, Washington, DC

11:15 am Open Roundtable

11:55 am Meeting Adjournment

PRECONFERENCE SYMPOSIA (Optional, Choose only one)Preconference I: Patient Support Programs: Risk and Risk Management Best PracticesThis is a deep dive workshop focusing on specific risks related to interacting with Patients and Patient Organizations through Patient Support Program activities:• Definitions matter — what are we talking about? What are our business colleagues talking about? Is it the same?• What are the most common manifestations or structures of Patient Support Programs?• What are the risks associated with these common activities? How do these risks “show up” — especially in relation to other activities?• What are best practices for governance and approvals of these activities?• How do you monitor these activities?

8:00 am Welcome, Overview, Presentations and Q&A Jennifer Chillas, JD, Senior Corporate Counsel, Bristol-Myers Squibb; Former Associate, Ropes & Gray, LLP, Princeton, NJ

Nereyda Garcia, JD, Global Heath, Ethics and Compliance, Alnylam Pharmaceuticals; Former Senior Director, Compliance, Biogen Idec, Cambridge, MA

Casey J. Horton, CFE, Director, Life Sciences, Governance, Risk and Compliance, Navigant, Chicago, IL

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

Nicole Serena, Director, PSP Consulting Services, MATRIX Healthcare Strategists Inc.; Former Director, Patient Access, Bayer, Canada

Ann E. Beasley, JD, Director, Life Sciences, Governance, Risk and Compliance, Navigant; Former Senior Vice President, Chief Compliance Officer, Biogen; Former Co-chair, International Pharmaceutical and Medical Device Compliance Congress, Boston, MA (Moderator)

Noon Preconference Adjournment/Lunch on your Own

Preconference II: Practical Approaches to Handling Investigations8:00 am Welcome, Overview, Presentations and Q&AMichael Dusseau, Vice President, Compliance Operations, Allergan; Former Vice President, Compliance, Bayer; Former Divisional Compliance Officer, Merck, Madison, NJ

Joe Mack, JD, Senior Compliance Counsel, Bayer; Former Assistant United States Attorney and Deputy Chief, Health Care and Government Fraud Unit, US Attorney’s Office, District of New Jersey, New York, NY

Roy Pollitt, Managing Director, Americas Head, Investigations, Exiger; Former Special Agent, Federal Bureau of Investigation, New York, NY

William Weinreb, JD, Partner, Quinn Emanuel; Former Acting United States Attorney and First Assistant US Attorney, Boston, Boston, MA

Ed Buthusiem, JD, Managing Director, Berkeley Research Group; Adjunct Professor Of Law, Temple University; Former Senior Vice President, R&D Legal Operations & Vaccines, GSK, Devon, PA (Moderator)

Noon Preconference Adjournment/Lunch on your Own

Preconference III: Advanced Strategies in Auditing and Monitoring8:00 am Welcome, Overview, Presentations and Q&AJames Accumanno, JD, Director, Risk, Monitoring and Auditing, Novo Nordisk; Former Associate Counsel, Bayer, Philadelphia, PA

Nicole Chandonnet, JD, Associate, Covington & Burling, Washington, DC

Amy Pawloski, Compliance Officer, Operations, Endo Pharmaceuticals, Malvern, PA

John Seungjoo Rah, JD, Partner at DLA Piper, Washington DC

Kathryn “Katie” E. Winson, Senior Manager, US HCC Monitoring, Celgene Corporation, Summit, NJ

Emily Huebener, MSA, CPA, Forensic and Integrity Services, EY, Chicago, IL (Moderator)

Noon Preconference Adjournment/Lunch on your Own

Preconference IV: Asking the Right Risk Questions to Power your Advanced Analytics Strategy8:00 am Welcome, Overview, Presentations and Q&AVahan Minassian, JD, Director, US Promotional Monitoring Lead, Pfizer, Philadelphia, PA

Katherine Buckley, MBA, Partner, Pharmaceutial and Life Sciences Advisory Practice, PwC, Philadelphia, PA

Anthony Greco, MBA, Director, Pharmaceutical and Life Sciences Advisory Services, PwC, Philadelphia, PA

Joseph Lake, MS, Global Healthcare Compliance & Third Party Monitoring Lead, Bristol-Myers Squibb; Former Group Internal Audit, Sanofi; Former Director, Global Compliance Organization, Merck, Morristown, NJ

Bharathram Lakshmivarahan, MBA, Life Sciences Strategy and Operations Consultant, PwC, San Francisco, CA

Noon Preconference Adjournment/Lunch on your Own

EXHIBIT AND SPONSORSHIP OPPORTUNITIESTake advantage of this unique opportunity to expand your reach! The Congress is attended by highly influential and experienced professionals. Sponsorship offers you strategic positioning as an industry leader. For more information call 206-673-4815 or email exhibits@hcconferences.com.

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2:00 pm The Hidden Risks Your Risk Assessment Might Miss

Richard Bistrong, MA, Chief Executive Officer, Front-Line Anti-Bribery LLC; Contributing Editor, The FCPA Blog; Former Confidential Human Source (CHS) and Cooperating Witness, FBI and US DOJ; Former Cooperating Witness, City of London Police, HMRC and CPS, UK, New York, NY

Lillian S. Hardy, JD, Partner, Hogan Lovells LLP, Washington, DC (Moderator)

2:45 pm FDA KeynoteThomas W. Abrams, RPh, MBA, Director, Office of Prescription Drug Promotion, US Food and Drug Administration, Silver Spring, MD

3:15 pm Break

3:45 pm Chief Compliance Officer Roundtable Jill Fallows-Macaluso, BSN, JD, Vice President and Chief Compliance Officer, Novo Nordisk Inc., Plainsboro, NJJonathon L. Kellerman, Executive Vice President and Global Chief Compliance Officer, Allergan PLC; Former Partner, PwC, New York, NYRobert A. Ladd, JD, Vice President, Global Head, Integrity and Compli-ance, Oncology, Novartis; Former General Counsel, GE Healthcare Partners, East Hanover, NJ Puja Leekha, JD, Vice President, Chief Compliance Officer and Corporate Counsel, Corporate Compliance, Lundbeck Pharmaceuticals LLC; Former Division Legal Counsel and Compliance Officer, Stryker Corporation, Deerfield, ILLori Queisser, Senior Vice President and Global Chief Compliance Officer, Teva; Former Senior Vice President, Global Compliance and Business Practices, Schering-Plough; Former Vice President, Chief Compliance Officer, Eli Lilly; Former Co-chair, PCF, Horsham, PAPaul Silver, Principal, Regulatory and Compliance Life Sciences Leader, Deloitte Advisory, Deloitte, Atlanta, GA (Moderator)

5:00 pm ADJOURNMENT AND NETWORKING RECEPTION

WEDNESDAY, NOVEMBER 7, 2018

NINETEENTH ANNUAL PHARMACEUTICAL REGULATORY AND COMPLIANCE CONGRESS AND BEST PRACTICES FORUM PHARMA CONGRESS AGENDA DAY I 1:00 pm Welcome and Introduction: PCF Co-Chairs

Michael R. Clarke, JD, Vice President, Corporate Compliance, Indivior Inc., Richmond, VA (PCF Co-Chair)

Sujata T. Dayal, JD, Vice President, Health Care Compliance and Privacy, Pharmaceuticals Group, Johnson & Johnson, Titusville, NJ (PCF Secretary)

Jeffrey M. Kawalek, MBA, Senior Director, Ethics and Compliance, North America, Ipsen Biopharmaceuticals, Inc., Basking Ridge, NJ (PCF Chair)

Jennifer McGee, JD, Vice President and Chief Compliance Officer, Otsuka America Pharmaceutical, Inc., Rockville, MD (PCF Treasurer)

Margaret Sparks, JD, Associate Vice President, North America Ethics and Business Integrity, Sanofi US, Bridgewater, NJ (PCF Co-Chair)

Joe Zimmerman, Vice President and Chief Compliance Officer US, Ferring Pharmaceuticals, Parsippany, NJ (PCF Co-Chair)

1:15 pm Keynote: OIG UpdateMary E. Riordan, JD, Senior Counsel, Office of Counsel to the Inspector General, Office of Inspector General, Department of Health and Human Services, Washington, DC

THURSDAY, NOVEMBER 8, 2018

PHARMA CONGRESS: AGENDA DAY II7:00 am Registration Opens; Continental Breakfast in Exhibit Hall

7:15 am NEW: OPTIONAL BREAKFAST ROUNDTABLES Roundtable I: Adapting an Effective Compliance Program for a #TimesUp World

Margaret Erin Rodgers-Schmidt, JD, Partner, Morgan Lewis & Bockius, Philadelphia, PA

Angela Schwartz, JD, Senior Manager, Fraud Investigations & Dispute Services, Life Sciences, EY, Philadelphia, PA

Roundtable II: The Impact of the Opioid Crisis on the Pharmaceutical Industry

John C. Richter, Partner, King & Spalding, Washington, DC (Moderator)

Roundtable III: U.S. Leadership to Strengthen Ethical Business Practices Overseas: What Compliance Leaders Need to Know

Andrew Blasi, Director, C&M International, Crowell & Moring; Former Pamela Harriman Foreign Service Fellow, US Embassy in London; Former Congressional Liaison, Australian Embassy and Foreign Affairs Subcommittee on Europe, US House of Representatives, Washington, DC

Tricia Van Orden, Deputy Director, Trade Promotion Coordinating Committee Secretariat, International Trade Administration, US Department of Commerce, Washington, DC

Nancy Schwalje Travis, MIA, Vice President, International Compliance and Governance, AdvaMed; Former Deputy Director, Office of Economic Policy, Asia-Pacific Bureau, US Department of State, Washington, DC

Russell Williams, Vice President, Government Relations and Public Affairs, Diabetes Canada; Patient Co-Chair, APEC Biopharmaceutical Working Group; Former President, Innovative Medicines Canada - Médicaments novateurs Canada, Ottawa, Canada

Chrisoula Nikidis, Canadian Head of Compliance and Ethics Solutions, IQVIA; Former Executive Director, Ethics and Compliance, Innovative Medicines Canada, Ottawa, Canada (Moderator)

MORNING PLENARY SESSION8:00 am Co-chair Welcome and Introductions

8:15 am AUSA RoundtableCharlene Keller Fullmer, JD, Assistant United States Attorney and Deputy Chief, Affirmative Litigation, United States Attorney’s Office, Eastern District of Pennsylvania, Philadelphia, PA

Christopher B. Harwood, JD, Assistant US Attorney and Chief of the Civil Health Care Fraud Unit, US Attorney’s Office, Southern District of New York; Former Assistant US Attorney, US Attorney’s Office for the District of Columbia, US Department of Justice, New York, NY

Rachael Honig, JD, First Assistant US Attorney, US Attorney’s Office for the District of New Jersey; Former Corporate Counsel, Litigation, Celgene, New York, NY

John T. Bentivoglio, JD, 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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9:00 am FCPA Enforcement UpdateLeslie Backschies, MA, Supervisor Special Agent and Unit Chief, Inter-national Corruption Unit, Federal Bureau of Investigation, Los Angeles, CA

Jacob Elberg, JD, Assistant US Attorney, US Attorney’s Office, District of New Jersey, US Department of Justice, Newark, NJ

Tarek Helou, JD, Assistant Chief, FCPA Unit, Fraud Section, Criminal Division, US Department of Justice, Washington, DC

Cheryl J. Scarboro, JD, Partner, Simpson Thacher & Bartlett; Former Chief, Foreign Corrupt Practices Act Unit, Enforcement Division, US Securities and Exchange Commission, Washington, DC

Gary F. Giampetruzzi, JD, Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc., New York, NY, USA (Moderator)

9:45 am Qui Tam RoundtableZachary A. Cunha, JD, Assistant US Attorney and Chief, Civil Division, US Attorney’s Office, District of Rhode Island, US Department of Justice; Former AUSA, District of Massachusetts and Eastern District of New York, Providence, RI

Suzanne E. Durrell, JD, Partner, Whistleblower Law Collaborative, Taxpayers Against Fraud Education Fund, 2017 Whistleblower Lawyer of the Year, Boston, MA

Colette G. Matzzie, JD, Partner, Phillips & Cohen LLP; Former Civil Appellate Staff and Trial Attorney, Tobacco Litigation Team, US Department of Justice, Washington, DC

Silvija A. Strikis, JD, Partner, Kellogg, Hansen, Todd, Figel & Frederick; Former Law Clerk, Justice Sandra Day O’Connor, US Supreme Court, Washington, DC

Kathleen Meriwether, JD, Principal, Fraud Investigation and Dispute Services, EY; Former Assistant United States Attorney, Eastern District of Pennsylvania, US Department of Justice, Philadelphia, PA (Moderator)

10:30 am Break

MINI SUMMITS BLOCK A 11:00 am – NoonMini Summit I: Fostering a Culture of Ethics and Compliance beyond just Laws and RegulationsThomas Beimers, JD, Partner, Hogan Lovells; Former Senior Counsel, Office of Counsel to the Inspector General, US DHHS; Former Special Assistant United States Attorney, US Attorney’s Office, Eastern District of Michigan, Minneapolis, MN and Washington, DC Stephanie J. Meltzer, JD, Vice President and Assistant General Counsel, Innovative Health, Pfizer; Former Assistant United States Attorney, United States Attorney’s Office, District of Columbia, US Department of Justice, Boston, MA Lori Queisser, Senior Vice President and Global Chief Compliance Officer, Teva; Former Senior Vice President Global Compliance and Business Practices, Schering-Plough; Former Vice President, Chief Compliance Officer, Eli Lilly, Horsham, PAJon Smollen, MA, JD, Practice Professor of Law and Director, Center for Compliance & Ethics, Temple Law; Former Executive Vice President and Chief Compliance Officer, Endo International, Philadelphia, PALisa Walkush, EMTM, Partner, Advisory Services and National Life Sciences Sector Leader, Grant Thornton, LLP, Philadelphia, PA (Moderator)

Mini Summit II: What’s Old is New Again: Global Compliance Function Harmonization is Needed Now more than EverScott Bass, JD, Partner and Head, Global Life Sciences Team, Sidley Austin LLP, New York, NYLindsay Havern, JD (Invited), Vice President and Assistant General Counsel, Pfizer, New York, NYRobert A. Ladd, JD, Vice President, Global Head, Integrity and Compliance, Oncology, Novartis; Former General Counsel, GE Healthcare Partners, East Hanover, NJ Melissa Murphy, MBA, Senior Compliance Specialist, Office of Ethics and Compliance, Medtronic, Minneapolis, MN

Clarissa Crain, Senior Manager, Life Sciences Advisory, Deloitte, Philadelphia, PA (Co-moderator)Laura (Munns) Skinner, MBA, Senior Manager, Life Sciences Advisory, Deloitte, Austin, TX (Co-moderator)

Mini Summit III: Third Party Lifecycle ManagementAnthony Alvizu, CPA, EnCE, CFE, Managing Director, Global Risk and Investigations Practice (GRIP), FTI Consulting, Chicago, IL

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

Alex Ganz, JD, Senior Manager of Compliance, Aegerion Pharmaceuticals; Former Compliance Manager, Shire and Vertex, Boston, MA

Chrisoula Nikidis, Canadian Head of Compliance and Ethics Solutions, IQVIA; Former Executive Director, Ethics and Compliance, Innovative Medicines Canada; Former Industry Co-Chair Designate, APEC Biopharmaceutical Working Group on Ethics, Ottawa, Canada (Moderator)

Mini Summit IV: Annual Medical Device Compliance RoundtableJonathan Glazier, JD, MBA, Head of Legal Compliance, Philips North America LLC; Former Senior Director of Corporate Compliance and Privacy Officer, Fresenius Medical Care North America; Andover, MA

Marc Levine, Director of Compliance, Insightec; Former Compliance Officer, Stryker Corporation; Former Business Conduct Specialist, MAKO Surgical, Fort Lauderdale, FL

David Ryan, JD, Vice President and Chief Compliance Officer, Epizyme; Former Vice President, Associate General Counsel and Chief Compliance Officer, Haemonetics; Former Vice President of Legal Affairs, Associate General Counsel and Chief Compliance Officer, AMAG Pharmaceuticals, Boston, MA

Nancy Schwalje Travis, MIA, Vice President, International Compliance and Governance, AdvaMed; Former Deputy Director, Office of Economic Policy, Asia-Pacific Bureau, US Depart-ment of State, Washington, DC

Jean McKiernan, MBA, Director, PwC, Chicago, IL (Moderator)

Mini Summit V: Dissecting Recent CIAs and Review of Draft Model CIA Christie Camelio, Vice President and US Healthcare Compliance Officer, Celgene; Former Head of Risk Management, Novartis, Summit, NJ

Regina G. Cavaliere, JD, Principal, Regulatory Enforcement and Compliance, Life Sciences Sector, KPMG LLP; Former Vice President and Chief Compliance Officer, Otsuka America, Short Hills, NJ

Jennifer McGee, JD, Vice President and Chief Compliance Officer, Otsuka America Pharmaceutical, Inc., Rockville, MD

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

Mini Summit VI: Advanced Strategies to Measure Effectiveness, Monitor and Report on Compliance ProgramsWendy C. Goldstein, JD, Partner, Health Care and Life Sciences Regulatory Practice, Cooley, LLP New York, NY

Patricia J. Harned, PhD, Chief Executive Officer, ECI (Ethics and Compliance Initiative); Former President, Ethics Resource Center; Member, Standing Advisory Group, Public Company Accounting Oversight Board, Washington, DC

Perri Pomper, JD, Former Director – Ethics and Compliance Strategy & Education, Novo Nordisk, New York, NY

Eugene F. Soltes, MBA, PhD, Jakurski Family Associate Professor of Business Administration, Harvard Business School; Author, Why They Do It: Inside the Mind of the White-Collar Criminal, Cambridge, MA

Kiley Smith Kelly, MBA, Partner, Forensic & Integrity Services, EY, Philadelphia, PA (Moderator)

Mini Summit VII: Compliance 3.0: Managing Promotional Programs, Relationships with Patient Advocacy Groups and New Entrants into the MarketplaceTerra Buckley, JD, Executive Director, US HCC Business Advisory Center of Excellence, Celgene; Former Head, US Compliance, Helsinn; Former Director, Ethics & Compliance, North America, Ipsen, Summit, NJ

Michael R. Clarke, JD, Vice President, Corporate Compliance, Indivior Inc., Richmond, VA

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Sujata T. Dayal, JD, Vice President, Health Care Compliance and Privacy, Pharmaceuticals Group, Johnson & Johnson, Titusville, NJ

Kelly N. “Nikki” Reeves, MPA, JD, Partner, King & Spalding LLP, Washington, DC

Seth B. Whitelaw, JD, LLM, SJD, President and Chief Executive Officer, Whitelaw Compliance Group, LLC; Editor, Life Science Compliance Update; Senior Fellow and Adjunct Professor, Life Sciences Compliance, Mitchell Hamline School of Law, West Chester, PA

Darren R. Jones, Partner, Global Compliance Consulting Leader, Polaris Management, New York, NY (Moderator)

Noon NETWORKING LUNCHEON AND MINI SUMMITS BLOCK B

MINI SUMMITS BLOCK B 12:15 pm – 1:15 pm

Mini Summit VIII: Open Payments: Where Does the Sun Shine Now?Brian A. Bohnenkamp, MHA, JD, Partner, FDA and Life Sciences Practice, King & Spalding LLP, Washington, DCChristine N. Bradshaw, JD, Vice President, Porzio Life Sciences, LLC; Principal, Porzio, Bromberg & Newman PC, Morristown, NJAlex Ganz, JD, Senior Manager of Compliance, Aegerion Pharmaceuticals; Former Compliance Manager, Shire and Vertex, Boston, MAJohn Patrick Oroho, JD, Executive Vice President and Chief Strategy Officer, Porzio Life Sciences, LLC; Principal, Porzio, Bromberg & Newman PC, Morristown, NJ, (Moderator)

Mini Summit IX: Interactions with Specialty PharmacyYogesh Bahl, CPA, MBA, Managing Director, Alix Partners, New York, NY Craig Clesson, JD, CIPP/US, Assistant General Counsel and Global Privacy Officer, Syneos Health; Former Vice President and Ethics and Compliance Officer, Aegerion, Boston, MASarah diFrancesca, JD, Partner, Health Care and Life Sciences Regulatory Practice, Cooley, LLP, New York, NYRichard Liner, JD, Senior Counsel, Compliance and Investigations, Bayer, Whippany, NJ

Katherine Norris, MPA, Director, Berkeley Research Group; Former Senior Director, Com-pliance and Integrity Programs, NSF Health Sciences; Former Director, Corporate Compliance, Spectranetics; Former Manager, Corporate Compliance, King, Washington, DC (Moderator)

Mini Summit X: Is your Board of Directors Bored of your Compliance Dashboards?Thomas Costa, JD, Member, US Board of Directors, Sanofi; Former Vice President, US Compliance and Ethics, Bristol-Myers Squibb, Washington, DC

Sarah A. Franklin, JD, Partner, Covington & Burling LLP; Former Attorney, Federal Trade Commission, Washington, DC

Jennifer McGee, JD, Vice President and Chief Compliance Officer, Otsuka America Pharmaceutical, Inc., Rockville, MD

Brian Van Hoy, Vice President, G&M Health LLC; Former Director, Ethics and Compliance, Eli Lilly, Bridgewater, NJ (Moderator)

Mini Summit XI: Next Generation Data AnalyticsMichael Dusseau, Vice President, Compliance Operations, Allergan; Former Vice President, Compliance, Bayer; Former Divisional Compliance Officer, Merck, Madison, NJ

Kellie Fidler, MBA, PMP, Director, Global Compliance Risk Mitigation and Monitoring Strategy, Bristol-Myers Squibb, Princeton Pike, NJ

Virginia “Ginny” A. Gibson, JD, Partner, Hogan Lovells LLP; Former First Assistant US Attorney, Eastern District of Pennsylvania, US Department of Justice, Philadelphia, PA

Bryan Timer, MA Business Analytics, Director, Data Analytics and Transparency, Merck, North Wales, PA

Jeffrey Rosenbaum, MBA, Partner and Co-founder, Dovetail Consulting Group, LLC; Former Senior Vice President, Chief Compliance and Risk Officer, Shire; Former Vice President, Chief Compliance Officer, Vertex Pharmaceuticals; Former Executive Director, Global Head, Ethics and Compliance, Novartis Oncology, Boston, MA (Moderator)

Mini Summit XII: The Fine Line of Promotion with Medical Professionals: Avoiding White Coat MarketingKellie Branson Combs, JD, Counsel, Ropes & Gray LLP, Washington, DC

Pamela Lonzer, MSJ, Associate Director, Medical Operations, Compliance and Controls, Alexion; Former Associate Director-US Medical Advisor, Global Compliance and Risk Management, Shire; Former Associate Director, Research and Development-Global Compliance, Astellas, Chicago, IL

Margaret Sparks, JD, Associate Vice President, North America Ethics and Business Integrity, Sanofi US, Bridgewater, NJ

Ravi Tayi, MD, MPH, Chief Medical Officer, US, Ferring Pharmaceuticals; Former Vice President, Global Medical Affairs, Mallinckrodt; Former Vice President, Medical Affairs and Clinical Development, Cubist/Optimer; Former Vice President and Chief Medical Officer, Global Medical Affairs and Clinical Development, Archimedes, New York, NY

Jennifer Vondee, MPH, Manager, Pharmaceutical and Life Sciences Risk Consulting, PwC, Durham, NC (Moderator)

Mini Summit XIII: Market Access Compliance ConsiderationsMeenakshi Datta, JD, Partner and Global Co-leader, Healthcare Practice, Sidley Austin LLP, Chicago, IL

Daryl Kreml, JD, Vice President and Chief Compliance Officer, SageTherapeutics; Former Head, US Compliance and Global Program Management, Biogen; Former Director and Senior Managing Counsel, International Compliance, Boston Scientific, Boston, MA

Jodi Lindsey, JD, Senior Director and Head of US Healthcare Compliance, Alkermes; Former Associate Director, Commercial Compliance, Biogen, Boston, MA

Joe Philipose, JD, Vice President, US and Enterprise Compliance, Alexion; Former Director of Compliance, Salix; Former Director, PwC Life Sciences Consulting, Boston, MA

Ann E. Beasley, JD, Director, Life Sciences, Governance, Risk and Compliance, Navigant; Former Senior Vice President, Chief Compliance Officer, Biogen; Former Co-chair, International Pharmaceutical and Medical Device Compliance Congress, Boston, MA (Moderator)

1:15 pm Transition Break

MINI SUMMITS BLOCK C 1:30 pm – 2:30 pm

Mini Summit XIV: Global Documentation Framework: Practical Strategies for Implementing an Effective Document Framework for Global Policies and ProceduresAdam Oakley, Director, Potomac River Partners, Arlington, VASusan P. Novak, Director, Corporate Policies Global Compliance, Celgene Corporation; Former Director of Compliance, Sandoz, Summit, NJ Jonathan Wilkenfeld, MBA, Partner, Potomac River Partners, Washington, DC (Moderator)

Mini Summit XV: R&D: Hidden Risks beyond Clinical Trial Recruitment, including FMV, InvoicingDennis K. Barnes, JD, MBA, CPA, Vice President, Global Governance, Risk and Compliance, Mayne Pharma; Former Vice President, Compliance and Risk Management, Global Compliance Officer, PAREXEL; Former Senior Director, North America Compliance, sanofi-aventis, Raleigh-Durham, NCSeth H. Lundy, JD, Partner, King & Spalding, Washington, DC Gregory S. Moss, JD, Senior Vice President, Deputy General Counsel, Kadmon Corporation, New York, NY

Sue Seferian, JD, Health Care Compliance Officer, Johnson & Johnson, Titusville, NJRegina G. Cavaliere, JD, Principal, Regulatory Enforcement and Compliance, Life Sciences Sector, KPMG LLP; Former Vice President and Chief Compliance Officer, Otsuka America, Short Hills, NJ (Moderator)

Mini Summit XVI: Compliance Considerations for Small to Mid-size Pharma and Device CompaniesJoseph Calarco, MSS, Chief Compliance Officer, Neos Therapeutics, Inc.; Former Director, Compliance and Ethics, US Operations, Bristol-Myers Squibb; Former Director, Corporate Compliance, Shire, Philadelphia, PABrian Conner, Vice President, Head of Corporate Compliance, Strongbridge Biopharma plc; Former Senior Director, Assistant Compliance Office, Shire; Former General Manager, Vice President, Regulatory, Synageva; Former Compliance Officer of the Americas, Stiefel, Trevose, PA

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Daryl Kreml, JD, Vice President and Chief Compliance Officer, SageTherapeutics; Former Head, US Compliance and Global Program Management, Biogen; Former Director and Senior Managing Counsel, International Compliance, Boston Scientific, Boston, MAEric Baim, JD, Managing Director, Dovetail Consulting Group, LLC; Former Vice President, Head of US Compliance, Shire, Boston, MA (Moderator)

Mini Summit XVII: Compliance Issues Associated with PBM RelationshipsEliza L. Andonova, JD, Counsel, Hogan Lovells, Washington, DCKatherine Chaurette, JD, Senior Director, Assistant General Counsel, Regeneron Pharmaceuticals, Inc.; Former Vice President Legal, Head of Health Law, Regulatory, Market Access, Marketed and Launched Products, Sanofi, Boston, MARichard Liner, JD, Senior Counsel, Compliance and Investigations, Bayer, Whippany, NJEileen Erdos, Principal, Forensic and Integrity Services, EY, Chicago, IL (Moderator)

Mini Summit XVIII: Risk Assessments and Mitigation Plans: Best Practices and Lessons LearnedChristie Camelio, Vice President and US Healthcare Compliance Officer, Celgene; Former Head of Risk Management, Novartis Pharmaceuticals, Summit, NJGary Del Vecchio, Health Care Compliance Officer, Cardiovascular and Metabolism, The Janssen Pharmaceutical Companies of Johnson & Johnson; Former Executive Director, US Pharmaceutical Compliance and Ethics, Bristol-Myers Squibb; Former PCF Co-chair, New York, NYFrancisco Ribeiro Filho, MBA, Senior Director & Head of US Compliance, Tesaro, Inc.; Former Senior Director, Corporate Compliance, Biogen; Former Senior Director, Corporate Compliance, International Markets, Sandoz, A Novartis Company; Former Senior Manager, Compliance Operations, LatAm, Johnson & Johnson, Boston, MAKamleh J. Nicola, LLB, Partner, Baker & McKenzie LLP, Toronto, Canada Christian A. Dingler, Managing Consultant, Navigant Consulting, Richmond, VA (Co-Moderator)J. Mark Farrar, CPA, CFE, CFF, Managing Director, Navigant; Former Interim Global Chief Compliance Officer, Beckman Coulter, Atlanta, GA (Co-Moderator)

Mini Summit XIX: “All in Compliance” — Aligning with Your Business PartnersCraig Chiulli, MBA, Group Product Director, Metabolic Franchise, Johnson & Johnson, Titusville, NJ

Jill Dailey, MBA, JD, Vice President and Chief Compliance Officer, Incyte; Former Assistant General Counsel, Asia Pacific Compliance Lead, Pfizer; Former Head, US Ethics and Compliance, Novartis, New York, NY

Alison Fethke, JD, Counsel, Ropes & Gray LLP; Former Division Counsel, Legal, Regulatory and Compliance, AbbVie Chicago, IL

Michael Joachim, JD, Global Business Partner, Ethics and Business Integrity, Sanofi Genzyme; Former Assistant General Counsel, Blue Cross Blue Shield of Massachusetts, Cambridge, MA

Ravi Tayi, MD, MPH, Chief Medical Officer, US, Ferring Pharmaceuticals; Former Vice President, Global Medical Affairs, Mallinckrodt; Former Vice President, Medical Affairs and Clinical De-velopment, Cubist/Optimer; Former Vice President and Chief Medical Officer, Global Medical Affairs and Clinical Development, Archimedes, New York, NY

Joe Zimmerman, Vice President and Chief Compliance Officer US, Ferring Pharmaceuticals, Parsippany, NJ

Lisa Walkush, EMTM, Partner, Advisory Services and National Life Sciences Sector Leader, Grant Thornton, LLP, Philadelphia, PA (Moderator)

Mini Summit XX: Giving in the Era of Prosecutorial Scrutiny: Navigating the Murky Waters of Patient Programs and Interactions with Patients and Patient Organizations, including Patient Services Compliance Survey UpdateJonathan Levy, JD, Corporate Compliance Counsel, Spark Therapeutics; Former Associate Director of Compliance and Ethics, US Pharmaceuticals, Bristol-Myers Squibb; Philadelphia, PA

Jason P. Mehta, JD, Partner, Bradley Arant Boult Cummings LLP; Former Assistant United States Attorney, US Attorney’s Office for the Middle District of Florida, US Department of Justice, Tampa, FL

Gregory S. Moss, JD, Senior Vice President, Deputy General Counsel, Kadmon Corporation, New York, NY

Sarah Whipple, JD, Senior Corporate and Compliance Counsel, Akebia Therapeutics, Inc.; Former Vice President, Global Compliance and Privacy Officer, Aegerion; Former Chief Compli-ance Officer and Associate General Counsel, AMAG, Boston, MA

Minna Bak, MBA, Senior Manager, Helio Health Group, New York, NY (Moderator)

2:30 pm Transition Break

MINI SUMMITS BLOCK D 2:45 pm – 3:45 pm

Mini Summit XXI: Compliance Considerations for “Evolved” Pharmaceutical Product, including Gene Therapy, Aesthetics, and Ultra Rare Disease ProductsElizabeth Jobes, JD, Head of Corporate Compliance and Legal Counsel, Spark Therapeutics, Inc.; Former Senior Vice President and Chief Compliance Officer, Auxilium; Former Chief, Repeat Offender Unit, Philadelphia District Attorney’s Office, Philadelphia, PA

Ali Lyons, Director, Ethics and Compliance, Aegerion Pharmaceuticals; Former Operations Lead, Ethics and Compliance, Eli Lilly and Company, Cambridge, MA

Marci Juneau, MBA, Partner, Helio Health Group, Atlanta, GA (Moderator)

Mini Summit XXII: Best Practice in HCP/HCO Management to Reduce Compliance Risk and Enhance EfficiencySharon R. Delshad, JD, Director, Compliance and Legal Affairs, Nalpropion Pharmaceuticals, Inc.; Former Director, Compliance and Legal Affairs, Orexigen Therapeutics, San Diego, CA

Melanie Fagan, HCP Engagement Lead, Medical Affairs Compliance, GlaxoSmithKline, Philadelphia, PA

Jeffrey M. Kawalek, MBA, Senior Director, Ethics and Compliance, North America, Ipsen Biopharmaceuticals, Inc., Basking Ridge, NJ

Dennis McCloskey, JD, Compliance Officer, Olympus Corporation of the Americas; Former Assistant District Attorney, Homicide Unit, Philadelphia District Attorney’s Office, Philadelphia, PA

Mark Scallon, MHA, Senior Principal, Polaris, IQVIA Global Compliance, Richmond, VA (Moderator)

Mini Summit XXIII: Compliance Considerations in Value-based ContractingJennifer Barbre, MA, Executive Director, Compliance, Spectrum Pharmaceuticals, Inc.; Former Director, Compliance and Ethics Program, Avanir; Former Director, Commercial Compliance, Boehringer Ingelheim, Irvine, CA

William Connelly, JD, Senior Counsel, Amgen; Former Staff Attorney, US DHHS, Washington, DC

Wendy C. Goldstein, JD, Partner, Health Care and Life Sciences Regulatory Practice, Cooley, LLP New York, NY

Josh T. O'Harra, MS, JD; Assistant General Counsel, Eli Lilly and Company; Former Senior Associate, King & Spalding, Washington, DC

Julie Ritchie Wagner, JD, Assistant General Counsel, PhRMA; Former Senior Counsel, Office of Counsel to the Inspector General, US Department of Health and Human Services, Washington, DC

Patterson Shafer, Managing Director, Health Care and Life Sciences, Grant Thornton, Stamford, CT (Moderator)

Mini Summit XXIV: Evolving Risks and Opportunities related to Medical Affairs, e.g. Professional Medical Education, Digital Information, etc.Stefanie A. Doebler, JD, Of Counsel, Covington & Burling LLP, Washington, DC

Philip Lo Scalzo, JD, Senior Vice President, Chief Compliance Officer, BioMarin; Former Assistant General Counsel, sanofi-aventis, Novato, CA

Stephanie Macholtz, JD, MBA, Director, Compliance and Ethics, Global Medical Affairs and Business Development, Alexion Pharmaceuticals, Inc.; Former Compliance Officer, Biogen; Former Associate Director, Compliance, R&D, Eisai, Boston, MA

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Donna White, Vice President, Contracts and Compliance, Chiesi USA, Inc.; Former Senior Director, Contracts and Compliance, Cornerstone Therapeutics, Cary, NC

Mark A. DeWyngaert, MBA, PhD, Managing Director, Life Sciences Regulatory and Operational Risk, Deloitte, New York, NY (Co-moderator)

Oliver Steck, Principal, Life Sciences Regulatory and Operational Risk, Deloitte, New York, NY (Co-moderator)

Mini Summit XXV: Biopharma Product in Crisis: An Interactive Case Study in Effective Crisis ManagementMahnu V. Davar, JD, Partner, Arnold & Porter Kaye Scholer LLP; Lecturer, University of Pennsylvania Law School; Fellow, Salzburg Global Seminar, Washington, DC

Paul Fishman, JD, Partner and Head, Crisis Management and Strategic Response Team, Arnold & Porter LLP; Former United States Attorney, District of New Jersey, Washington, DC

Joe Mack, JD, Senior Compliance Counsel, Bayer; Former Assistant United States Attorney and Deputy Chief, Health Care and Government Fraud Unit, US Attorney’s Office, District of New Jersey, New York, NY

Virginia MacSuibhne, JD, CCEP (Invited), Chief Compliance Officer, Roche Molecular Solutions, Pleasanton, CA

Ann-Marie Tejcek, MA, Senior Director, Ethics and Compliance, Eli Lilly and Company, Indianapolis, IN

Daniel A. Kracov, JD, Partner, Arnold & Porter Kaye Scholer LLP, Washington, DC (Moderator)

Mini Summit XXVI: Privacy and Cybersecurity Compliance Update, including GDPR Compliance Paul Flanagan, JD, Assistant Professor of Law, Thomas R. Kline School of Law, Drexel University; Former Chief Compliance and Privacy Officer, 21st Century Oncology, West Chester, PA

Kate Heinzelman, JD, Counsel, Sidley Austin LLP; Former Deputy General Counsel, US Department of Health and Human Services; Former Special Assistant and Associate Counsel to President Barack Obama, Washington, DC

Adam Greene, JD, MPH, Partner and Co-chair, Health Information and HIPAA Practice, Davis Wright Tremaine LLP, Former Senior Health Information Technology and Privacy Specialist, Office for Civil Rights, DHHS, Washington, DC

Agatha O’Malley, MStPH, JD, Privacy Officer and Senior Counsel, Otsuka Pharmaceuticals (US); Former Director- Head of Privacy, Shire, Philadelphia, PA

David W. Opderbeck, JD, Professor of Law, Seton Hall University Law School; Counsel, Gibbons PC, Newark, NJ (Moderator)

Mini Summit XXVII: The Compliance Training Revolution Julianne Brierley, Director, Head of Compliance Learning, Novartis, New York, NY

Christine Hood, Director, Learning and Development, Chiesi; Former District Sales Manager, Boehringer Ingelheim; Former Sales Trainer, Biovail, Apex, NC

Vickie L. McCormick, Vice President, Janssen US Commercial Health Care Compliance and CIA Operations, Johnson & Johnson; Former Chief Compliance Officer, St. Jude Medical, Titusville, NJ

Brian Miller, MS, PhD Candidate (Invited), Director Compliance Training and Documentation, Otsuka; Former Senior Manager of Learning Technologies, AstraZeneca; Former Associate Director Learning Design and Technology, Merck, Princeton, NJ

Chad Londeree, Healthcare Industry Group Leader, SAI Global, Richmond, VA (Moderator)

3:45 pm Transition Break

CLOSING PLENARY SESSION4:15 pm Keynote

Sally Q. Yates, JD, Partner, King and Spalding; Former Acting Attorney General; Former Deputy Attorney General; Former Assistant US Attorney; US Attorney’s Office, Northern District of Georgia, US Department of Justice, Washington, DC

4:45 pm Patient Support Programs, including Reimbursement Support and Co-payment Waivers, Roundtable

Laura G. Hoey, JD, Co-leader, Government Enforcement and White Collar Group, Health Care and Life Sciences Industry Group, Ropes & Gray, LLP, Chicago, IL

Gregg Shapiro, JD, Assistant US Attorney, US Attorney’s Office, District of Massachusetts, US Department of Justice, Boston, MA

Erinn Hutchinson, Partner, Advisory Services, PwC, Philadelphia, PA (Moderator)

5:30 pm Recent Developments in Pharmaceutical and Medical Device Pricing and Cost Containment

Susan Dentzer, President and Chief Executive Officer, NEHI (The Network for Excellence in Health Innovation); Analyst on Health Policy, The NewsHour; Former Editor, Health Affairs, Washington, DC

6:00 pm ADJOURNMENT

FRIDAY, NOVEMBER 9, 2018

PHARMA CONGRESS: AGENDA DAY III

INDUSTRY-ONLY COMPLIANCE BEST PRACTICES THINK TANK

(Industry-only session for pharmaceutical company Compliance professionals and in-house counsel only)

8:30 am Introduction to Day ThreeMichael R. Clarke, JD, Vice President, Corporate Compliance, Indivior Inc., Richmond, VA (PCF Co-Chair)

Sujata T. Dayal, JD, Vice President, Health Care Compliance and Privacy, Pharmaceuticals Group, Johnson & Johnson, Titusville, NJ (PCF Secretary)

Jeffrey M. Kawalek, MBA, Senior Director, Ethics and Compliance, North America, Ipsen Biopharmaceuticals, Inc. Basking Ridge, NJ (PCF Chair)

Jennifer McGee, JD, Vice President and Chief Compliance Officer, Otsuka America Pharmaceutical, Inc., Rockville, MD (PCF Treasurer)

Margaret Sparks, JD, Associate Vice President, North America Ethics and Business Integrity, Sanofi US, Bridgewater, NJ (PCF Co-Chair)

Joe Zimmerman, Vice President and Chief Compliance Officer US, Ferring Pharmaceuticals, Parsippany, NJ (PCF Co-Chair)

Interview Presentation, Moderated Discussion and Q&A

Gregg Shapiro, JD, Assistant US Attorney, US Attorney’s Office, District of Massachusetts, US Department of Justice, Boston, MA

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

Noon CONGRESS ADJOURNMENT

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GENERAL TERMS AND CONDITIONS Program subject to cancellation or change. If the program is cancelled the only liability of the Congress will be to refund the registration fee paid. The Congress shall have no liability regarding travel or other costs. Registration form submitted via fax, mail, email or online constitutes binding agreement between the parties.

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PHARMA CONGRESS CONTINUING EDUCATION CREDITS

NASBA CPE CREDIT Health Care Conference Administrators, LLC is registered with the National As-sociation of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE Sponsors. State boards of accountancy have final authority on the acceptance of individual courses for CPE credit. Complaints regarding registered sponsors may be submitted to the National Registry of CPE Sponsors through its website: www.learningmarket.org.A recommended maximum of 19.0 credits based on a 50-minute hour will be granted for the entire learning activity for onsite attendance only. This program addresses topics that are of a current concern in the compliance environment. This is an update, group-live activity. For more information regarding administrative policies such as complaints or refunds, call 206-757-8053 or petergrant@ehcca.com.

COMPLIANCE CERTIFICATION BOARD CONTINUING EDUCATION UNITS (CCB CEUs) The Congress is currently pending approval to offer Compliance Certification Board CCB Credits.

PENDING CONTINUING EDUCATION CREDITS The Congress is currently pending approval to offer Pennsylvania MCLE Credit.

CERTIFICATE OF ATTENDANCE Onsite attendees can request a Certificate of Attendance which they can file with appropriate entities for credit, and webcast attendees can request an Online Cer-tificate of Attendance on which they can certify the number of hours they watched and can file with appropriate entities for credit.

HOTEL INFORMATION/RESERVATIONS The Pharmaceutical and Medical Device Compliance Congress does not contract with any third party organization to make hotel reservations for attendees of the Congress. All attendees should make their hotel reserva-tions directly with the hotel and not with a third party vendor.The Mandarin Oriental, Washington DC is the official hotel for the Nineteenth Annual Pharmaceutical and Medical Device Compliance Congress. A special group rate of $349.00 Deluxe Room per night (plus applicable state and local tax) has been arranged for Congress Attendees. To make reservations at the group rate, go to www.PharmaCongress.com and click on the TRAVEL/HOTEL tab. You may also make reservations by calling the Mandarin Oriental directly at (202) 787-6140 or Toll Free (888) 888-1778. Please ask for the “Pharmaceutical Congress Group Rate” when you call. Reservations at the group rate will be accepted while rooms are available or until the cut-off date of Monday, October 8, 2018. After this date, reservations will be accepted on a space-available basis at the prevailing rate.

Mandarin Oriental • 1330 Maryland Avenue SW • Washington, DC 20024

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PHARMACEUTICAL AND MEDICAL DEVICE CONGRESS

❏ Dr. ❏ Mr. ❏ Mrs. ❏ Ms.

NAME

SIGNATURE OF REGISTRANT - REQUIRED

JOB TITLE

ORGANIZATION

WEBCAST CONFERENCE ATTENDANCEAll webcast registrants are automatically registered for the preconference and conference. Webcast conference registration includes the live Internet feed from the Congress, plus six months of continued archived Internet access, available 24/7. Preconference sessions are audio only. Mini Summit sessions will be audio streamed. The closed sessions on Day III of the Congress will not be included in Congress live and archived Internet broadcast.

STANDARD RATES: INDIVIDUAL REGISTRATION (Includes Preconference and Conference): ❏ Through Friday, September 21, 2018* $ 795 ❏ Through Friday, October 12, 2018** $ 995 ❏ After Friday, October 12, 2018 $1,195

SPECIAL PHARMACEUTICAL COMPLIANCE FORUM PCF RATES***: (Includes Preconference and Conference):

❏ PCF Rate $ 695

GROUP REGISTRATION:Group registration offers the substantial volume discounts set forth below. All webcast group registrants are enrolled in the preconference and conference. Group registration permits the organizational knowledge coordinator either to share conference access with colleagues or to assign and track employee conference participation. Rates are per person.Conference Access: ❏ 5 or more $595 each ❏ 20 or more $395 each ❏ 10 or more $495 each ❏ 40 or more $295 each

See INTELLECTUAL PROPERTY POLICY, page 10.

CONFERENCE ELECTRONIC MEDIA:Webcast attendees — Following the Congress, the video and presentations are made avail-able on a flash drive. To take advantage of the discounted price below, you must reserve media WITH your Congress registration: ❏ Flash Drive ($129 + $15 shipping) $ 144

(All webcast attendees automatically receive 6 months access on web.)

REGISTRATION BINDING AGREEMENTRegistration (whether online or by this form) constitutes a contract and all of these terms and conditions are binding on the parties. In particular, these terms and conditions shall apply in the case of any credit/debit card dispute. For webcast and onsite registrants there will be no refunds for “no-shows” or cancellations.

ACCOUNT #

EXPIRATION DATE SECURITY CODE

NAME OF CARDHOLDER

SIGNATURE OF CARDHOLDER

PAYMENT Discount Code:

TOTAL FOR ALL OPTIONS, ONSITE OR WEBCAST:Please enclose payment with your registration and return it to the Registrar at Pharma Congress, 12330 N.E. 8th Street, Suite 101, Bellevue, WA 98005-3187, or fax your credit card payment to 206-319-5303.You may also register online at www.PharmaCongress.com.❏ Check/money order enclosed (payable to Health Care Conference Administrators LLC)❏ Payment by credit card: ❏ American Express ❏ Visa ❏ MastercardIf a credit card number is being given to hold registration only until such time as a check is received it must be so noted. If payment is not received by seven days prior to the Congress, the credit card payment will be processed. Credit card charges will be listed on your statement as payment to HealthCare (HC) Conf LLC.

* This price reflects a discount for registration and payment received through Friday, Sept. 21, 2018.** This price reflects a discount for registration and payment received through Friday, Oct. 12, 2018.*** To qualify for the PCF member rate an individual must be a employee of a member company of the Pharmaceutical Compliance Forum (PCF), www.PharmaComplianceForum.org.

ONSITE CONFERENCE ATTENDANCECHIEF COMPLIANCE OFFICER ROUNDTABLE ((Invitation-only; November 7) No Cost (CCOs interested attending may contact Debra Scanlon, Administrator, Pharmaceutical Compliance Forum at info@pharmacomplianceforum.org.)

STANDARD RATES:PRECONFERENCES (November 7; Choose one): ❏ I: Patient Support Program . . . $595 ❏ III: Advanced Strategies/Auditing/Monitoring $595❏ II: Practical Approaches to Handling Investigations $595 ❏ IV: Asking the Right Risk Questions . . . $595

CONFERENCE – STANDARD INDIVIDUAL REGISTRATION (Does not include Preconference):❏ Through Friday, September 21, 2018* $1,995 ❏ Through Friday, October 12, 2018** $2,195 ❏ After Friday, October 12, 2018 $2,395

GROUP REGISTRATION DISCOUNT – STANDARD INDIVIDUAL REGISTRATION (Does not include Preconference; rates are per person):Three or more registrations submitted from the same organization at the same time receive the following discounted rates for conference registration only. To qualify, all registrations must be submitted simultaneously:❏ Through Friday, September 21, 2018* each $1,795 ❏ Through Friday, October 12, 2018** each $1,995 ❏ After Friday, October 12, 2018 each $2,195

SPECIAL PHARMACEUTICAL COMPLIANCE FORUM PCF RATES***:

PRECONFERENCES – SPECIAL PCF RATES*** (November 7; Choose one):

CONFERENCE – SPECIAL PCF INDIVIDUAL RATES*** (Does not include Preconference):❏ Through Friday, September 21, 2018* $1,695 ❏ Through Friday, October 12, 2018** $1,895 ❏ After Friday, October 12, 2018 $2,095

PCF GROUP REGISTRATION DISCOUNTS (Does not include Preconference): FIVE OR MORE registrations submitted from the same organization at the same time receive the following discounted rates for conference registration only. To qualify, all registrations must be submitted simultaneously:❏ Pharmaceutical Compliance Forum Group Rate/Conference Only – each of 5 registrations: $1,595

TEN OR MORE registrations submitted from the same organization at the same time receive the following discounted rates for conference registration only. To qualify, all registrations must be submitted simultaneously:❏ Pharmaceutical Compliance Forum Group Rate/Conference Only – each of 10 registrations: $1,495

CONFERENCE ELECTRONIC MEDIA:Onsite Attendees — Following the Congress, the audio/video and Powerpoint presentations are made available in the following formats. To take advantage of the discounted prices below, you must reserve media WITH your Congress registration:❏ Flash Drive ($129 + $15 shipping) $ 144 ❏ 6 months’ access on Web $ 129

ADDRESS

CITY/STATE/ZIP

TELEPHONE

E-MAIL

❏ Special Needs (Dietary or Physical)

COMPLETE THE FOLLOWING. PLEASE PRINT CLEARLY:

SELECT YOUR MINI-SUMMITS – THURSDAY, NOVEMBER 8 (One from each group): BLOCK A – 11:00 am ❏ I: Fostering a Culture of Ethics and Compliance . . . ❏ II: What’s Old is New Again . . . ❏ III: Third Party Lifecycle Management❏ IV: Annual Medical Device Compliance Roundtable❏ V: Dissecting Recent CIAs and Review of Draft Model CIA❏ VI: Advanced Strategies to Measure Effectiveness . . . ❏ VII: Compliance 3.0 . . .

BLOCK B – 12:15 am❏ VIII: Open Payments: Where Does the Sun Shine Now?❏ IX: Interactions with Specialty Pharmacy❏ X: Is your Board of Directors Bored . . . ❏ XI: Next Generation Data Analytics❏ XII: Fine Line of Promotion with Medical Professionals . . . ❏ XIII: Market Access Compliance Considerations

BLOCK C – 1:30 pm❏ XIV: Global Documentation Framework . . . ❏ XV: R&D: Hidden Risks beyond Clinical Trial❏ XVI: Compliance Considerations for Small to Mid-size . . . ❏ XVII: Compliance Issues Associated with PBM Relationships❏ XVIII: Risk Assessments and Mitigation Plans . . . ❏ XIX: “All in Compliance” . . . ❏ XX: Giving in the Era of Prosecutorial Scrutiny . . .

BLOCK D – 2:45 pm❏ XXI: Compliance Considerations for “Evolved” Pharma . . . ❏ XXII: Best Practice in HCP/HCO Management . . . ❏ XXIII: Compliance Considerations/Value-based Contracting❏ XXIV: Evolving Risks/Opportunities related to Med Affairs . . . ❏ XXV: Biopharma Product in Crisis: Interactive Case Study . . . ❏ XXVI: Privacy and Cybersecurity Compliance Update . . . ❏ XXVII: The Compliance Training Revolution

❏ I: Patient Support Program . . . $495 ❏ III: Advanced Strategies/Auditing/Monitoring $495❏ II: Practical Approaches to Handling Investigations $495 ❏ IV: Asking the Right Risk Questions . . . $495

Save the Date:THIRTEENTH INTERNATIONAL PHARMACEUTICAL AND MEDICAL DEVICE COMPLIANCE CONGRESS

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APRIL 8 – 10, 2019 • ATHENS, GREECEMEDIA PARTNER:

www.InternationalPharmaCongress.com

CO-CHAIRSDante Beccaria, Senior Vice President, Global Compliance Officer, Head of Ethics and Business Integrity Department, Sanofi, Paris, France

Stephen Nguyen Duc, Former Area Director, International Operations, Western Europe and Canada, Office of Ethics and Compliance, AbbVie, Rungis, France

Dominique Laymand, Esq., Executive Vice President, Chief Ethics and Compliance Officer, Ipsen, Paris, France

Roeland Van Aelst, Regional Vice President – HCCO MD&D EMEA and Canada, Office Health Care Compliance and Privacy, Johnson & Johnson, Brussels, Belgium

SPONSORED BY: