Nineteenth Annual Pharmaceutical and Medical Device Compliance Congress

A HYBRID CONFERENCE AND INTERNET EVENT

www.PharmaCongress.com Nineteenth Annual Pharmaceutical and Medical Device Compliance Congress MANDARIN ORIENTAL • WASHINGTON, DC For Early Bird Registration Discount, Register by NOVEMBER 7 – 9, 2018 Friday, October 12!

SPONSOR:

CO-CHAIRS: Jeffrey M. Kawalek, MBA, KEYNOTE SPEAKERS: Christopher B. Harwood, Senior Director, Ethics and JD, Assistant US Attorney and Michael R. Clarke, JD, Vice Thomas W. Abrams, RPh, Compliance, North America, Chief, Civil Health Care Fraud Unit, President, Corporate Compliance, MBA, Director, Office of Ipsen Biopharmaceuticals, Inc. US Attorney’s Office, Southern Indivior Inc. (PCF Co-Chair) Prescription Drug Promotion, FDA (PCF Chair) District of New York, US DOJ Sujata T. Dayal, JD, Vice Presi- Leslie Backschies, MA, Jennifer McGee, JD, Vice Supervisor Special Agent and Tarek Helou, JD, Assistant dent, Health Care Compliance and President and Chief Compliance Privacy, Pharmaceuticals Group, Unit Chief, International Chief, FCPA Unit, Fraud Section, Officer, Otsuka America Pharma- Corruption Unit, FBI Criminal Division, US DOJ Johnson & Johnson (PCF Secretary) ceutical, Inc. (PCF Treasurer) Richard Bistrong, MA, Rachael Honig, JD, First CONTINUING EDUCATION CREDITS: Margaret Sparks, JD, Chief Executive Officer, Front-Line Assistant US Attorney, US ACCOUNTING PROFESSIONALS: Approved for up Associate Vice President, North Anti-Bribery LLC; Contributing Attorney’s Office for the District to 19.0 NASBA CPE credits. America Ethics and Business Editor, FCPA Blog of New Jersey, US DOJ ATTORNEYS: The Congress is currently pending Integrity, Sanofi US (PCF Co-Chair) approval to offer Pennsylvania MCLE Credit. Zachary A. Cunha, JD, Mary E. Riordan, JD, Senior Joe Zimmerman, Vice Assistant US Attorney and Chief, COMPLIANCE PROFESSIONALS: This education President and Chief Compliance Counsel, Office of Counsel to the activity has been submitted to the Compliance Civil Division, US Attorney’s Office, Officer US, Ferring Pharmaceuti- Inspector General, Office of Certification Board (CCB)® and is currently pending District of Rhode Island, US DOJ Inspector General, US DHHS their review for approval of CCB CEUs. cals (PCF Co-Chair) Susan Dentzer, President and Chief Executive Officer, NEHI; Gregg Shapiro, JD, Assistant Analyst on Health Policy, The US Attorney, US Attorney’s Office, CHIEF COMPLIANCE OFFICER ROUNDTABLE: NewsHour; Former Editor, District of Massachusetts, US DOJ Featuring Hui Chen, JD, Ethics and Compliance Advocate and Consultant, Health Affairs Sally Q. Yates, JD, Partner, HC Ethics LLC; Former Compliance Counsel Expert (Consultant), US DOJ Jacob Elberg, JD, Assistant US King & Spalding; Former Acting Attorney, US Attorney’s Office, Attorney General; Former Deputy District of New Jersey, US DOJ Attorney General, US DOJ

GOLD GRANTOR: BRONZE GRANTORS:

SILVER GRANTORS:

MEDIA PARTNERS: 2 NINETEENTH ANNUAL PHARMACEUTICAL AND MEDICAL DEVICE COMPLIANCE CONGRESS B issues and provide a rich opportunity for networking. for opportunity arich provide and issues keynote and minds to you speakers, the brightest together engage panelists bring timely discussion, compliance inaddress meaningful expert our with together stakeholders Yates JD. These JD, Sally JD, and Chen, Hui Shapiro, Gregg by presentations anticipated much welcome to delighted are we FCPA FBI, FDA, and DOJ, SEC, and OIG, from speakers keynote long-standing our back year,This welcome we plans. mitigation and assessment risk and monitoring auditing, your in analytics data leveraging and training procedures, and policies developing in practices best share they as industry the in colleagues esteemed your Join faster. evolve and change adapt, to companies challenge developments These PBMs. and pharmacy specialty groups, advocacy patient and patients with interactions as, such forefront, the to emerged have interactions stakeholder new management, life-cycle third-party and payments open to updates HCO interactions, HCP/ compliance, abuse and fraud and anticorruption on apulse keep to continues industry the While program. ethics and compliance effective an to essential are right” is what “doing of aculture fostering and requirements healthcare payer private with compliance laws, state and federal applicable to Adherence industry. high-risk and ahighly-regulated be to continues industry care health The our industry. impacting requirements program and regulations statutes, applicable to updates timely into insight and direction their for faculty and exhibitors and grantors committee, planning 2018 the (PCF), co-chairs, PCF Forum Compliance Pharmaceutical the sponsor, Congress the thank to like We would Congress). Compliance Pharma PCF (the DC Washington, and Congress); Compliance Pharma American Latin (the City Mexico and Paolo Sao Congress); Compliance Pharma Pacific Asia (the Manila and Lumpur Kuala Shanghai, Singapore, Congress) Compliance Pharma International (the Vienna and Lisbon Warsaw, Rome, Paris, Istanbul, Dubai, Budapest, Brussels, Berlin, in congresses featured has which series congress compliance pharma aglobal of apart is It compliance. regulatory and legal in practices best discuss to annually together come who counsel in-house and professionals compliance device and pharma of gathering largest and oldest the is Congress The address new challenges. to needs organization’s their suit best to programs their evolve to continuing counsel and professionals experienced and program ance acompli developing to new counsel in-house and professionals compliance both for ideal is forum This patients. for outcomes and AGENDA AT AGLANCE • • • • • • • • • • • Mini Summits: THURSDAY, 8 NOVEMBER • • • • Preconference Sessions: An Invitation-only CCO Roundtable Hosted by PCF PhRMA and CCO Chen, Working LLC JD, Ethics Group; HC Hui Featuring WEDNESDAY, 7 NOVEMBER FRIDAY, 9: NOVEMBER • • • • • • Sessions: Plenary Next Generation Data Analytics Data Generation Next Dashboards? Compliance your of Bored Board Is your Pharmacy Specialty with Interactions Now? Shine Sun the Does Where Payments: Open Patient Groups Advocacy Managing and Promotional Programs Report and Monitor Effectiveness, Measure to Strategies CIA Model Draft of Review and CIAs Recent Dissecting Compliance Roundtable Device Annual Medical Management Lifecycle Party Third Harmonization Compliance Function Global a Culture andFostering of Compliance Ethics Advanced Analytics Strategy Analytics Advanced Power to your Questions Risk Right the Asking Advanced Strategies in Auditing and Monitoring to Investigations Handling Approaches Practical Practices Risk Management Best and Risk Programs: Support Patient Pharma and Device Pricing and Cost Containment and Cost Pricing andDevice Pharma Roundtable Programs Patient Support Update SEC FCPADOJ, and FBI Enforcement TamAnnual Qui Roundtable Annual AUSA Roundtable Address Yates Keynote Sally consultants to share ideas for ways to cultivate a culture of compliance with the highest integrity to enable access to better care care better to access enable to integrity highest the with compliance of aculture cultivate to ways for ideas share to consultants industry and attorneys prosecutors, regulators, counsel, in-house professionals, compliance device and pharma Join Congress. Compliance PCF Annual 19th the at professionals device medical and pharmaceutical for event compliance premiere the of e apart

Industry-only BestIndustry-only Practices Roundtable

• • • • Session: Plenary Opening • • • • • • • • Mini Summits (Continued): • • • • • • • • Chief Compliance Officer Roundtable Compliance Chief Officer Miss Might Your Assessment Risk Risks FDA Keynote Address OIG Keynote Address The Compliance Training Revolution GDPR including Update, Compliance Cybersecurity and Privacy Management Crisis Effective in Study Case Interactive An Affairs Medical to related Opportunities and Risks Compliance Considerations in Value-based Contracting in HCP/HCO Practice Best Management Therapy Gene and Aesthetics including Products, “Evolved” for Compliance WatersNavigating of Patient the Murky Programs Your Business Partners “All in Compliance” — Aligning with with —Aligning “All Compliance” in Plans Mitigation and Assessments Risk PBM Relationships with Associated Issues Compliance Companies and Device Pharma Mid-size to Small for Compliance Trail Recruitment Clinical beyond Risks Hidden R&D: Framework Documentation Global Market Access Compliance Considerations Avoiding White Coat Marketing Promotion Professionals: Medical with Featuring AUSA Featuring Shapiro, JD Gregg

- • • • • • • • • • • • • • • • • • • • • • • • • • • WHO SHOULD ATTEND: SHOULD WHO

Auditors Nurses Physicians no time away from the office. the from away time no hassle; and expense travel avoid access; Internet with worldwide anywhere or home at office, the in accessible months; six next the for access Internet 24/7 and feed digital Live PROS: presentations. coordinated PowerPoint and videos speaker includes conference archived The following the event. months six 24/7 for time any at convenience your at and net Inter the over video streaming live in conference the Watch interaction. faculty opportunities; networking immersion; professional matter subject PROS: person. in attend and city conference the to travel register, Simply INTERNET ATTENDANCE ARCHIVED AND LIVE ONSITE ATTENDANCE TRADITIONAL PARTICIPATION OPTIONS Health Services Researchers and Academics Researchers Services Health Makers and Policy Regulators Care Health Capitalists Venture Bankers Investment Consultants Pharmaceutical Attorneys Law Drug and Food Officers Ethics Officers Privacy Officers Compliance Counsel In-house and Attorneys Care Health Pharmacies Internet and Order Mail Retail, Wholesale, PlansHealth Insurers and Health Companies Management Benefit Pharmacy Organizations Research Clinical Organizations Site Management Manufacturers Pharmaceutical Generic Manufacturers Pharmaceutical Public Purchasers and Employers Private including Purchasers, Technicians and Pharmacy Pharmacists Directors Medical Plan,Health System and Physician Organizations Health Executives Compliance and Members Board Executives Care and Health Pharmaceutical

- Onsite Onsite . orhome At your office.

ABOUT THE PHARMACEUTICAL COMPLIANCE FORUM 2018 PCF PHARMA CONGRESS PLANNING COMMITTEE he Pharmaceutical Compliance Forum (PCF) is a not-for-profit CO-CHAIRS Ive Grgas, MS, Director, Healthcare Michael R. Clarke, JD, Vice President, Compliance, Puma Biotechnology membership coalition of compliance professionals and legal Corporate Compliance, Indivior Inc. (PCF Co-Chair) Karen L. Hale, JD, Vice President, Chief Ethics counsel from 70 distinguished research-based pharmaceutical Sujata T. Dayal, JD, Vice President, Health Care & Compliance Officer, Abbvie manufacturers and biotech companies. Compliance and Privacy, Pharmaceuticals Group, Bill Hrubes, MS, Vice President and T Johnson & Johnson (PCF Secretary) Chief Compliance Officer, ACell, Inc. The PCF was founded in early 1999 by compliance professionals from Jeffrey M. Kawalek, MBA, Senior Director, Erinn Hutchinson, Partner, Advisory Services, the pharmaceutical industry to promote effective corporate compli- Ethics and Compliance, North America, Ipsen PwC Biopharmaceuticals, Inc. (PCF Chair) Michael Joachim, JD, Compliance ance programs. The members meet twice a year, for two days, focusing Jennifer McGee, JD, Vice President and Business Partner, Sanofi Genzyme on open and informal sharing of compliance information, best prac- Chief Compliance Officer, Otsuka America Jonathon L. Kellerman, Executive Vice tices, and current developments in the field. PCF sponsors a three-day Pharmaceutical, Inc. (PCF Treasurer) President, Global Chief Compliance Officer, Margaret Sparks, JD, Associate Vice President, Allergan PLC Compliance Congress each Fall. North America Ethics and Business Integrity, Daniel A. Kracov, JD, Partner and Head, Generally, representatives from the companies who attend the meetings Sanofi US (PCF Co-Chair) FDA and Healthcare Practice, Arnold & Porter Joe Zimmerman, Vice President and Chief Kaye Scholer, LLP are compliance officers, compliance attorneys or other professionals Compliance Officer US, Ferring Pharmaceuticals Holly Kramen, JD, Chief Compliance Officer with responsibility for oversight or other aspects of their respective (PCF Co-Chair) and Privacy Officer, PolarityTE corporate compliance programs. Robert A. Ladd, JD, Vice President, Global MEMBERS Head Integrity & Compliance, Oncology, Novartis Kamil Ali-Jackson, JD, Co-Founder, Chief Legal Officer, Chief Compliance Officer and Corporate Puja Leekha, JD, Vice President, Chief MISSION STATEMENT Secretary, Aclaris Therapeutics, Inc. Compliance Officer and Corporate Counsel, Corporate Compliance Lundbeck The purpose of the Pharmaceutical Compliance Forum is to discuss education and Michael Arbini, Global Marketing Gregory S. Moss, JD, Senior Vice President, other industry practices regarding compliance with the ultimate aim of promoting ef- Communications Leader, Polaris Management Deputy General Counsel, Kadmon Corporation fective pharmaceutical corporate compliance and ethics programs in accordance with Timothy Ayers, JD, MPH, Group Vice President, Katherine Norris, Director, Berkeley Chief Compliance Officer, Horizon Pharma PLC the Federal Organization Sentencing Guidelines and the OIG Compliance Guidance for Research Group Dennis K. Barnes, JD, CPA, Vice President, Pharmaceutical Manufacturers. Neil F. O’Flaherty, JD, Partner, Baker Mckenzie Global Governance, Risk and Compliance, Mayne Pharma John Patrick Oroho, JD, Executive Vice President and Chief Strategy Officer, Porzio WHO SHOULD ATTEND: Scott Bass, JD, Partner and Head, Global Life JOIN PCF Life Sciences, LLC • Pharmaceutical and Health Care Executives Non-member companies who are interested in joining PCF may contact Sciences Team, Sidley Austin LLP and Board Members Jennifer O’Toole, Events Manager, Debra Scanlon, Administrator, Pharmaceutical Compliance Forum at Ann E. Beasley, JD, Director, Navigant Consulting • Compliance Executives Americas, SAI Global [email protected]. John T. Bentivoglio, JD, Partner, Skadden Arps LLP • Health Plan, Health System and Physician Organizations Amy Pawloski, Compliance Officer, Kathleen M. Boozang, JD, LLM, Dean and Pro- Operations, Endo Pharmaceuticals • Medical Directors fessor of Law, Seton Hall University School of Law Lori Queisser, Senior Vice President and • Physicians BENEFITS OF BECOMING A PCF COMPANY MEMBER Scott Boyance, Associate Director, Forensic and Global Chief Compliance Officer, Teva • Save $500 off your first year’s membership dues when becoming a member Integrity Services, EY • Pharmacists and Pharmacy Technicians David Ralston, JD, MPH, Senior Director, • Purchasers, including Private Employers and • Unlimited number of employees can join — No additional fees! All included in Joseph Calarco, Chief Compliance Officer, Associate General Counsel, Business Conduct, Public Purchasers your annual corporate membership dues. Neos Therapeutics Gilead Sciences • Pharmaceutical Manufacturers • All members have access to our exclusive Member Only website for networking Christie Camelio, Vice President and US Health- Kelly N. “Nikki” Reeves, MPA, JD, • Generic Pharmaceutical Manufacturers with fellow members and viewing of past meeting materials, benchmarking care Compliance Officer, Celgene Corporation Partner, King & Spalding • Site Management Organizations surveys and other valuable resources! Thomas Costa, JD, Member, US Board of Directors, Jeffrey Rosenbaum, MBA, Sanofi; Former Vice President, US Compliance and Partner, Dovetail Consulting Group, LLC • Clinical Research Organizations • Exclusive invitation to the members only PCF Annual Spring and complimentary Ethics, Bristol-Myers Squibb Michael Shaw, JD, Vice President and • Pharmacy Benefit Management Companies Fall Regional Meetings Paul Curtin, JD, CFE, Vice President, Global Chief Compliance Officer, US Pharmaceuticals, • Nurses • Monthly newsletter to stay informed on the latest news and meeting information. Compliance Officer, Intercept Pharmaceuticals GlaxoSmithKline • Health Plans and Health Insurers • Save up to $500 with discounted registration fees for each employee to PCF Jill Fallows-Macaluso, BSN, JD, Vice President Paul J. Silver, Principal, Deloitte • Wholesale, Retail, Mail Order and Internet Pharmacies sponsored Pharma Congress in Washington DC each year and Chief Compliance Officer, Novo Nordisk Inc. Ann-Marie Tejcek, MA, Senior Director, • Health Care Attorneys and In-house Counsel • Save up to $500 with discounted registration fees for each employee to Margaret K. Feltz, MA, JD, Vice President, Ethics and Compliance, Eli Lilly and Company Ethics and Compliance, Purdue Pharma LP • Compliance Officers International Pharmaceutical Regulatory and Compliance Congress and Brian Van Hoy, Vice President, G&M Health LLC • Privacy Officers the Asia Pacific Pharmaceutical and Medical Device Compliance Congress Alison Fethke, JD, Counsel, Ropes & Gray LLP Donna Wachman, National Industry • Ethics Officers • Complimentary compliance and legal job postings on the PCF website. A superior Alex Ganz, JD, Senior Manager of Marketing Leader, Grant Thornton LLP Compliance, Aegerion Pharmaceuticals • Food and Drug Law Attorneys recruiting tool! Non-members companies pay $600 per posting. Julie Wagner, JD, Assistant General Counsel, Gary F. Giampetruzzi, JD, Partner, Paul Hastings PhRMA • Pharmaceutical Consultants • Special PCF Member discount on subscriptions to Life Science Compliance Update. Virginia “Ginny” A. Gibson, JD, Partner, Caroline West, JD, Global Chief Compliance • Investment Bankers For more information go to www.pharmacomplianceforum.org. Hogan Lovells Officer, Olympus Corporation • Venture Capitalists Jonathan Glazier, JD, MBA, Head of Legal Donna White, Vice President, Contracts • Health Care Regulators and Policy Makers Compliance, Philips North America LLC and Compliance, Chiesi USA, Inc. • Health Services Researchers and Academics Wendy C. Goldstein, JD, Partner, Health Care Seth B. Whitelaw, JD, LLM, SJD, President • Auditors and Life Sciences Regulatory Practice, Cooley, LLP and CEO, Whitelaw Compliance Group, LLC

3 WEDNESDAY, NOVEMBER 7, 2018 Keith M. Korenchuk, JD, MPH, Partner, Arnold & Porter LLP, Washington, DC Nicole Serena, Director, PSP Consulting Services, MATRIX Healthcare Strategists Inc.; 7:00 am Registration Opens Former Director, Patient Access, Bayer, Canada Ann E. Beasley, JD, Director, Life Sciences, Governance, Risk and Compliance, Navigant; CHIEF COMPLIANCE OFFICER ROUNDTABLE (Jointly Sponsored Former Senior Vice President, Chief Compliance Officer, Biogen; Former Co-chair, International by PCF and the PhRMA CCO Workgroup; Special Morning Session, Invitation-only) Pharmaceutical and Medical Device Compliance Congress, Boston, MA (Moderator) Noon Preconference Adjournment/Lunch on your Own

Preconference II: Practical Approaches to Handling Investigations 8:15 am Continental Breakfast Hosted by PhRMA and PCF 8:00 am Welcome, Overview, Presentations and Q&A Invited Guest: Hui Chen, JD, Ethics and Compliance Advocate and Consultant, HC Ethics LLC; Michael Dusseau, Vice President, Compliance Operations, Allergan; Former Vice President, Former Compliance Counsel Expert (Consultant), US Department of Justice, Pfizer, New York, NY Compliance, Bayer; Former Divisional Compliance Officer, Merck, Madison, NJ 9:15 am Break 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 9:30 am Welcome and Introductions New Jersey, New York, NY Jennifer McGee, JD, Vice President and Chief Compliance Officer, Otsuka America Pharmaceutical, Inc., Rockville, MD (PCF Treasurer) Roy Pollitt, Managing Director, Americas Head, Investigations, Exiger; Former Special Agent, Federal Bureau of Investigation, New York, NY Antitrust Admonition Seth H. Lundy, JD, Partner, King & Spalding, Washington, DC (Special Antitrust Counsel) William Weinreb, JD, Partner, Quinn Emanuel; Former Acting United States Attorney and First Assistant US Attorney, Boston, Boston, MA 9:45 am Feature Presentation: Measuring Ed Buthusiem, JD, Managing Director, Berkeley Research Group; Adjunct Professor Of Law, Compliance Effectiveness Temple University; Former Senior Vice President, R&D Legal Operations & Vaccines, GSK, Hui Chen, JD, Ethics and Compliance Advocate and Consultant, HC Ethics LLC; Former Devon, PA (Moderator) Compliance Counsel Expert (Consultant), US Department of Justice, Pfizer, New York, NY Noon Preconference Adjournment/Lunch on your Own 10:45 am PhRMA Update Julie Ritchie Wagner, JD, Assistant General Counsel, PhRMA; Former Senior Counsel, Preconference III: Advanced Strategies in Auditing and Office of Counsel to the Inspector General, US Department of Health and Human Services, Monitoring Washington, DC 8:00 am Welcome, Overview, Presentations and Q&A 11:15 am Open Roundtable James Accumanno, JD, Director, Risk, Monitoring and Auditing, Novo Nordisk; Former Associate Counsel, Bayer, Philadelphia, PA 11:55 am Meeting Adjournment Nicole Chandonnet, JD, Associate, Covington & Burling, Washington, DC Amy Pawloski, Compliance Officer, Operations, Endo Pharmaceuticals, Malvern, PA PRECONFERENCE SYMPOSIA (Optional, Choose only one) John Seungjoo Rah, JD, Partner at DLA Piper, Washington DC Preconference I: Patient Support Programs: Risk and Risk Management Best Practices Kathryn “Katie” E. Winson, Senior Manager, US HCC Monitoring, Celgene Corporation, Summit, NJ This is a deep dive workshop focusing on specific risks related to interacting with Patients and Patient Organizations through Patient Emily Huebener, MSA, CPA, Forensic and Integrity Services, EY, Chicago, IL (Moderator) Support Program activities: Noon Preconference Adjournment/Lunch on your Own • Definitions matter — what are we talking about? What are our business colleagues talking about? Is it the same? Preconference IV: Asking the Right Risk Questions to • What are the most common manifestations or structures of Power your Advanced Analytics Strategy Patient Support Programs? 8:00 am Welcome, Overview, Presentations and Q&A • What are the risks associated with these common activities? How do these risks “show up” — especially in relation to other activities? Vahan Minassian, JD, Director, US Promotional Monitoring Lead, Pfizer, Philadelphia, PA • What are best practices for governance and approvals of Katherine Buckley, MBA, Partner, Pharmaceutial and Life Sciences Advisory Practice, these activities? PwC, Philadelphia, PA • How do you monitor these activities? Anthony Greco, MBA, Director, Pharmaceutical and Life Sciences Advisory Services, PwC, 8:00 am Welcome, Overview, Presentations and Q&A Philadelphia, PA Jennifer Chillas, JD, Senior Corporate Counsel, Bristol-Myers Squibb; Former Associate, Joseph Lake, MS, Global Healthcare Compliance & Third Party Monitoring Lead, Bristol-Myers Ropes & Gray, LLP, Princeton, NJ Squibb; Former Group Internal Audit, Sanofi; Former Director, Global Compliance Organization, Merck, Morristown, NJ Nereyda Garcia, JD, Global Heath, Ethics and Compliance, Alnylam Pharmaceuticals; Former Senior Director, Compliance, Biogen Idec, Cambridge, MA Bharathram Lakshmivarahan, MBA, Life Sciences Strategy and Operations Consultant, PwC, San Francisco, CA Casey J. Horton, CFE, Director, Life Sciences, Governance, Risk and Compliance, Navigant, Chicago, IL Noon Preconference Adjournment/Lunch on your Own

EXHIBIT AND SPONSORSHIP OPPORTUNITIES Take 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 [email protected].

4 2:00 pm The Hidden Risks Your WEDNESDAY, NOVEMBER 7, 2018 Risk Assessment Might Miss Richard Bistrong, MA, Chief Executive Officer, Front-Line Anti-Bribery NINETEENTH ANNUAL PHARMACEUTICAL LLC; Contributing Editor, The FCPA Blog; Former Confidential Human Source REGULATORY AND COMPLIANCE CONGRESS (CHS) and Cooperating Witness, FBI and US DOJ; Former Cooperating Witness, City of London Police, HMRC and CPS, UK, New York, NY AND BEST PRACTICES FORUM Lillian S. Hardy, JD, Partner, Hogan Lovells LLP, Washington, DC (Moderator) PHARMA CONGRESS AGENDA DAY I 2:45 pm FDA Keynote 1:00 pm Welcome and Introduction: Thomas W. Abrams, RPh, MBA, Director, Office of Prescription Drug PCF Co-Chairs Promotion, US Food and Drug Administration, Silver Spring, MD Michael R. Clarke, JD, Vice President, Corporate Compliance, Indivior Inc., Richmond, VA (PCF Co-Chair) 3:15 pm Break Sujata T. Dayal, JD, Vice President, Health Care Compliance and Privacy, 3:45 pm Chief Compliance Officer Roundtable Pharmaceuticals Group, Johnson & Johnson, Titusville, NJ (PCF Secretary) Jill Fallows-Macaluso, BSN, JD, Vice President and Chief Compliance Officer, Novo Nordisk Inc., Plainsboro, NJ Jeffrey M. Kawalek, MBA, Senior Director, Ethics and Compliance, Jonathon L. Kellerman, Executive Vice President and Global Chief North America, Ipsen Biopharmaceuticals, Inc., Basking Ridge, NJ Compliance Officer, Allergan PLC; Former Partner, PwC, New York, NY (PCF Chair) Robert A. Ladd, JD, Vice President, Global Head, Integrity and Compli- Jennifer McGee, JD, Vice President and Chief Compliance Officer, ance, Oncology, Novartis; Former General Counsel, GE Healthcare Partners, Otsuka America Pharmaceutical, Inc., Rockville, MD (PCF Treasurer) East Hanover, NJ Puja Leekha, JD, Vice President, Chief Compliance Officer and Corporate Margaret Sparks, JD, Associate Vice President, North America Ethics Counsel, Corporate Compliance, Lundbeck Pharmaceuticals LLC; Former and Business Integrity, Sanofi US, Bridgewater, NJ (PCF Co-Chair) Division Legal Counsel and Compliance Officer, Stryker Corporation, Deerfield, IL Lori Queisser, Senior Vice President and Global Chief Compliance Joe Zimmerman, Vice President and Chief Compliance Officer US, Officer, Teva; Former Senior Vice President, Global Compliance and Ferring Pharmaceuticals, Parsippany, NJ (PCF Co-Chair) Business Practices, Schering-Plough; Former Vice President, Chief Compliance Officer, Eli Lilly; Former Co-chair, PCF, Horsham, PA 1:15 pm Keynote: OIG Update Paul Silver, Principal, Regulatory and Compliance Life Sciences Leader, Deloitte Advisory, Deloitte, Atlanta, GA (Moderator) Mary E. Riordan, JD, Senior Counsel, Office of Counsel to the Inspector General, Office of Inspector General, Department of Health and Human 5:00 pm ADJOURNMENT AND Services, Washington, DC NETWORKING RECEPTION

Nancy Schwalje Travis, MIA, Vice President, International Compliance THURSDAY, NOVEMBER 8, 2018 and Governance, AdvaMed; Former Deputy Director, Office of Economic Policy, Asia-Pacific Bureau, US Department of State, Washington, DC PHARMA CONGRESS: AGENDA DAY II Russell Williams, Vice President, Government Relations and Public 7:00 am Registration Opens; Affairs, Diabetes Canada; Patient Co-Chair, APEC Biopharmaceutical Continental Breakfast in Exhibit Hall Working Group; Former President, Innovative Medicines Canada - Médicaments novateurs Canada, Ottawa, Canada 7:15 am NEW: OPTIONAL BREAKFAST ROUNDTABLES Chrisoula Nikidis, Canadian Head of Compliance and Ethics Solutions, Roundtable I: Adapting an Effective Compliance IQVIA; Former Executive Director, Ethics and Compliance, Innovative Program for a #TimesUp World Medicines Canada, Ottawa, Canada (Moderator) Margaret Erin Rodgers-Schmidt, JD, Partner, Morgan Lewis & Bockius, Philadelphia, PA MORNING PLENARY SESSION Angela Schwartz, JD, Senior Manager, Fraud Investigations & Dispute 8:00 am Co-chair Welcome and Introductions Services, Life Sciences, EY, Philadelphia, PA 8:15 am AUSA Roundtable Roundtable II: The Impact of the Opioid Crisis on Charlene Keller Fullmer, JD, Assistant United States Attorney and the Pharmaceutical Industry Deputy Chief, Affirmative Litigation, United States Attorney’s Office, John C. Richter, Partner, King & Spalding, Washington, DC (Moderator) Eastern District of Pennsylvania, Philadelphia, PA Christopher B. Harwood, JD, Assistant US Attorney and Chief of the Roundtable III: U.S. Leadership to Strengthen Civil Health Care Fraud Unit, US Attorney’s Office, Southern District of Ethical Business Practices Overseas: What New York; Former Assistant US Attorney, US Attorney’s Office for the Compliance Leaders Need to Know District of Columbia, US Department of Justice, New York, NY Andrew Blasi, Director, C&M International, Crowell & Moring; Former Pamela Harriman Foreign Service Fellow, US Embassy in London; Rachael Honig, JD, First Assistant US Attorney, US Attorney’s Office for Former Congressional Liaison, Australian Embassy and Foreign Affairs the District of New Jersey; Former Corporate Counsel, Litigation, Celgene, Subcommittee on Europe, US House of Representatives, Washington, DC New York, NY Tricia Van Orden, Deputy Director, Trade Promotion Coordinating John T. Bentivoglio, JD, Partner, Skadden Arps LLP; Former Special Committee Secretariat, International Trade Administration, US Counsel for Healthcare Fraud and Chief Privacy Officer, US Department of Department of Commerce, Washington, DC Justice, Washington, DC (Moderator)

5 9:00 am FCPA Enforcement Update Clarissa Crain, Senior Manager, Life Sciences Advisory, Deloitte, Philadelphia, PA (Co-moderator) Leslie Backschies, MA, Supervisor Special Agent and Unit Chief, Inter- Laura (Munns) Skinner, MBA, Senior Manager, Life Sciences Advisory, Deloitte, Austin, TX national Corruption Unit, Federal Bureau of Investigation, Los Angeles, CA (Co-moderator)

Jacob Elberg, JD, Assistant US Attorney, US Attorney’s Office, District of Mini Summit III: Third Party Lifecycle Management New Jersey, US Department of Justice, Newark, NJ Anthony Alvizu, CPA, EnCE, CFE, Managing Director, Global Risk and Investigations Practice (GRIP), FTI Consulting, Chicago, IL Tarek Helou, JD, Assistant Chief, FCPA Unit, Fraud Section, Criminal Keith M. Korenchuk, JD, MPH, Partner, Arnold & Porter LLP, Washington, DC Division, US Department of Justice, Washington, DC Alex Ganz, JD, Senior Manager of Compliance, Aegerion Pharmaceuticals; Former Compliance Cheryl J. Scarboro, JD, Partner, Simpson Thacher & Bartlett; Former Manager, Shire and Vertex, Boston, MA Chief, Foreign Corrupt Practices Act Unit, Enforcement Division, US Securities Chrisoula Nikidis, Canadian Head of Compliance and Ethics Solutions, IQVIA; Former Executive and Exchange Commission, Washington, DC Director, Ethics and Compliance, Innovative Medicines Canada; Former Industry Co-Chair Designate, APEC Biopharmaceutical Working Group on Ethics, Ottawa, Canada (Moderator) Gary F. Giampetruzzi, JD, Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc., Mini Summit IV: Annual Medical Device Compliance New York, NY, USA (Moderator) Roundtable Jonathan Glazier, JD, MBA, Head of Legal Compliance, Philips North America LLC; Former 9:45 am Qui Tam Roundtable Senior Director of Corporate Compliance and Privacy Officer, Fresenius Medical Care North Zachary A. Cunha, JD, Assistant US Attorney and Chief, Civil Division, America; Andover, MA US Attorney’s Office, District of Rhode Island, US Department of Justice; Marc Levine, Director of Compliance, Insightec; Former Compliance Officer, Stryker Former AUSA, District of Massachusetts and Eastern District of New York, Corporation; Former Business Conduct Specialist, MAKO Surgical, Fort Lauderdale, FL Providence, RI David Ryan, JD, Vice President and Chief Compliance Officer, Epizyme; Former Vice President, Suzanne E. Durrell, JD, Partner, Whistleblower Law Collaborative, Associate General Counsel and Chief Compliance Officer, Haemonetics; Former Vice President of Legal Taxpayers Against Fraud Education Fund, 2017 Whistleblower Lawyer of Affairs, Associate General Counsel and Chief Compliance Officer, AMAG Pharmaceuticals, Boston, MA the Year, Boston, MA Nancy Schwalje Travis, MIA, Vice President, International Compliance and Governance, Colette G. Matzzie, JD, Partner, Phillips & Cohen LLP; Former Civil AdvaMed; Former Deputy Director, Office of Economic Policy, Asia-Pacific Bureau, US Depart- Appellate Staff and Trial Attorney, Tobacco Litigation Team, US Department ment of State, Washington, DC of Justice, Washington, DC Jean McKiernan, MBA, Director, PwC, Chicago, IL (Moderator) Silvija A. Strikis, JD, Partner, Kellogg, Hansen, Todd, Figel & Frederick; Mini Summit V: Dissecting Recent CIAs and Review of Draft Former Law Clerk, Justice Sandra Day O’Connor, US Supreme Court, Model CIA Washington, DC Christie Camelio, Vice President and US Healthcare Compliance Officer, Celgene; Former Kathleen Meriwether, JD, Principal, Fraud Investigation and Dispute Head of Risk Management, Novartis, Summit, NJ Services, EY; Former Assistant United States Attorney, Eastern District of Regina G. Cavaliere, JD, Principal, Regulatory Enforcement and Compliance, Life Sciences Sector, Pennsylvania, US Department of Justice, Philadelphia, PA (Moderator) KPMG LLP; Former Vice President and Chief Compliance Officer, Otsuka America, Short Hills, NJ 10:30 am Break 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 11:00 am – Noon MINI SUMMITS BLOCK A Fraud and Chief Privacy Officer, US Department of Justice, Washington, DC (Moderator) Mini Summit I: Fostering a Culture of Ethics and Compliance beyond just Laws and Regulations Mini Summit VI: Advanced Strategies to Measure Effectiveness, Thomas Beimers, JD, Partner, Hogan Lovells; Former Senior Counsel, Office of Counsel Monitor and Report on Compliance Programs to the Inspector General, US DHHS; Former Special Assistant United States Attorney, Wendy C. Goldstein, JD, Partner, Health Care and Life Sciences Regulatory Practice, US Attorney’s Office, Eastern District of Michigan, Minneapolis, MN and Washington, DC Cooley, LLP New York, NY Stephanie J. Meltzer, JD, Vice President and Assistant General Counsel, Innovative Health, Patricia J. Harned, PhD, Chief Executive Officer, ECI (Ethics and Compliance Initiative); Pfizer; Former Assistant United States Attorney, United States Attorney’s Office, District of Former President, Ethics Resource Center; Member, Standing Advisory Group, Public Company Columbia, US Department of Justice, Boston, MA Accounting Oversight Board, Washington, DC Lori Queisser, Senior Vice President and Global Chief Compliance Officer, Teva; Former Perri Pomper, JD, Former Director – Ethics and Compliance Strategy & Education, Novo Nordisk, Senior Vice President Global Compliance and Business Practices, Schering-Plough; Former Vice New York, NY President, Chief Compliance Officer, Eli Lilly, Horsham, PA Jon Smollen, MA, JD, Practice Professor of Law and Director, Center for Compliance & Eugene F. Soltes, MBA, PhD, Jakurski Family Associate Professor of Business Administration, Ethics, Temple Law; Former Executive Vice President and Chief Compliance Officer, Endo Harvard Business School; Author, Why They Do It: Inside the Mind of the White-Collar International, Philadelphia, PA Criminal, Cambridge, MA Lisa Walkush, EMTM, Partner, Advisory Services and National Life Sciences Sector Leader, Kiley Smith Kelly, MBA, Partner, Forensic & Integrity Services, EY, Philadelphia, PA Grant Thornton, LLP, Philadelphia, PA (Moderator) (Moderator) Mini Summit II: What’s Old is New Again: Global Compliance Mini Summit VII: Compliance 3.0: Managing Promotional Function Harmonization is Needed Now more than Ever Programs, Relationships with Patient Advocacy Groups and Scott Bass, JD, Partner and Head, Global Life Sciences Team, Sidley Austin LLP, New York, NY New Entrants into the Marketplace Terra Buckley, JD, Executive Director, US HCC Business Advisory Center of Excellence, Lindsay Havern, JD (Invited), Vice President and Assistant General Counsel, Pfizer, New York, NY Celgene; Former Head, US Compliance, Helsinn; Former Director, Ethics & Compliance, North Robert A. Ladd, JD, Vice President, Global Head, Integrity and Compliance, Oncology, America, Ipsen, Summit, NJ Novartis; Former General Counsel, GE Healthcare Partners, East Hanover, NJ Michael R. Clarke, JD, Vice President, Corporate Compliance, Indivior Inc., Richmond, VA Melissa Murphy, MBA, Senior Compliance Specialist, Office of Ethics and Compliance, Medtronic, Minneapolis, MN Session Continued Next Page

6 Sujata T. Dayal, JD, Vice President, Health Care Compliance and Privacy, Pharmaceuticals Mini Summit XII: The Fine Line of Promotion with Medical Group, Johnson & Johnson, Titusville, NJ Professionals: Avoiding White Coat Marketing Kelly N. “Nikki” Reeves, MPA, JD, Partner, King & Spalding LLP, Washington, DC Kellie Branson Combs, JD, Counsel, Ropes & Gray LLP, Washington, DC Seth B. Whitelaw, JD, LLM, SJD, President and Chief Executive Officer, Whitelaw Pamela Lonzer, MSJ, Associate Director, Medical Operations, Compliance and Controls, Alexion; Compliance Group, LLC; Editor, Life Science Compliance Update; Senior Fellow and Adjunct Former Associate Director-US Medical Advisor, Global Compliance and Risk Management, Shire; Professor, Life Sciences Compliance, Mitchell Hamline School of Law, West Chester, PA Former Associate Director, Research and Development-Global Compliance, Astellas, Chicago, IL Darren R. Jones, Partner, Global Compliance Consulting Leader, Polaris Management, Margaret Sparks, JD, Associate Vice President, North America Ethics and Business Integrity, New York, NY (Moderator) Sanofi US, Bridgewater, NJ Noon NETWORKING LUNCHEON AND Ravi Tayi, MD, MPH, Chief Medical Officer, US, Ferring Pharmaceuticals; Former Vice MINI SUMMITS BLOCK B 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 MINI SUMMITS BLOCK B 12:15 pm – 1:15 pm Jennifer Vondee, MPH, Manager, Pharmaceutical and Life Sciences Risk Consulting, PwC, Mini Summit VIII: Open Payments: Where Does the Sun Durham, NC (Moderator) Shine Now? Mini Summit XIII: Market Access Compliance Considerations Brian A. Bohnenkamp, MHA, JD, Partner, FDA and Life Sciences Practice, King & Spalding LLP, Washington, DC Meenakshi Datta, JD, Partner and Global Co-leader, Healthcare Practice, Sidley Austin LLP, Chicago, IL Christine N. Bradshaw, JD, Vice President, Porzio Life Sciences, LLC; Principal, Porzio, Bromberg & Newman PC, Morristown, NJ Daryl Kreml, JD, Vice President and Chief Compliance Officer, SageTherapeutics; Former Alex Ganz, JD, Senior Manager of Compliance, Aegerion Pharmaceuticals; Former Head, US Compliance and Global Program Management, Biogen; Former Director and Senior Compliance Manager, Shire and Vertex, Boston, MA Managing Counsel, International Compliance, Boston Scientific, Boston, MA John Patrick Oroho, JD, Executive Vice President and Chief Strategy Officer, Porzio Life Jodi Lindsey, JD, Senior Director and Head of US Healthcare Compliance, Alkermes; Former Sciences, LLC; Principal, Porzio, Bromberg & Newman PC, Morristown, NJ, (Moderator) Associate Director, Commercial Compliance, Biogen, Boston, MA Joe Philipose, JD, Vice President, US and Enterprise Compliance, Alexion; Former Director of Mini Summit IX: Interactions with Specialty Pharmacy Compliance, Salix; Former Director, PwC Life Sciences Consulting, Boston, MA Yogesh Bahl, CPA, MBA, Managing Director, Alix Partners, New York, NY Ann E. Beasley, JD, Director, Life Sciences, Governance, Risk and Compliance, Navigant; Craig Clesson, JD, CIPP/US, Assistant General Counsel and Global Privacy Officer, Syneos Former Senior Vice President, Chief Compliance Officer, Biogen; Former Co-chair, International Health; Former Vice President and Ethics and Compliance Officer, Aegerion, Boston, MA Pharmaceutical and Medical Device Compliance Congress, Boston, MA (Moderator) Sarah diFrancesca, JD, Partner, Health Care and Life Sciences Regulatory Practice, Cooley, LLP, New York, NY 1:15 pm Transition Break Richard Liner, JD, Senior Counsel, Compliance and Investigations, Bayer, Whippany, NJ 1:30 pm – 2:30 pm Katherine Norris, MPA, Director, Berkeley Research Group; Former Senior Director, Com- MINI SUMMITS BLOCK C pliance and Integrity Programs, NSF Health Sciences; Former Director, Corporate Compliance, Mini Summit XIV: Global Documentation Framework: Spectranetics; Former Manager, Corporate Compliance, King, Washington, DC (Moderator) Practical Strategies for Implementing an Effective Document Framework for Global Policies and Procedures Mini Summit X: Is your Board of Directors Bored of your Compliance Dashboards? Adam Oakley, Director, Potomac River Partners, Arlington, VA Susan P. Novak, Director, Corporate Policies Global Compliance, Celgene Corporation; Thomas Costa, JD, Member, US Board of Directors, Sanofi; Former Vice President, US Former Director of Compliance, Sandoz, Summit, NJ Compliance and Ethics, Bristol-Myers Squibb, Washington, DC Jonathan Wilkenfeld, MBA, Partner, Potomac River Partners, Washington, DC (Moderator) Sarah A. Franklin, JD, Partner, Covington & Burling LLP; Former Attorney, Federal Trade Commission, Washington, DC Mini Summit XV: R&D: Hidden Risks beyond Clinical Trial Jennifer McGee, JD, Vice President and Chief Compliance Officer, Otsuka America Recruitment, including FMV, Invoicing Pharmaceutical, Inc., Rockville, MD Dennis K. Barnes, JD, MBA, CPA, Vice President, Global Governance, Risk and Compliance, Brian Van Hoy, Vice President, G&M Health LLC; Former Director, Ethics and Compliance, Mayne Pharma; Former Vice President, Compliance and Risk Management, Global Compliance Eli Lilly, Bridgewater, NJ (Moderator) Officer, PAREXEL; Former Senior Director, North America Compliance, sanofi-aventis, Raleigh-Durham, NC Mini Summit XI: Next Generation Data Analytics Seth H. Lundy, JD, Partner, King & Spalding, Washington, DC Michael Dusseau, Vice President, Compliance Operations, Allergan; Former Vice President, Gregory S. Moss, JD, Senior Vice President, Deputy General Counsel, Kadmon Corporation, Compliance, Bayer; Former Divisional Compliance Officer, Merck, Madison, NJ New York, NY Kellie Fidler, MBA, PMP, Director, Global Compliance Risk Mitigation and Monitoring Sue Seferian, JD, Health Care Compliance Officer, Johnson & Johnson, Titusville, NJ Strategy, Bristol-Myers Squibb, Princeton Pike, NJ Regina G. Cavaliere, JD, Principal, Regulatory Enforcement and Compliance, Life Sciences Virginia “Ginny” A. Gibson, JD, Partner, Hogan Lovells LLP; Former First Assistant US Sector, KPMG LLP; Former Vice President and Chief Compliance Officer, Otsuka America, Attorney, Eastern District of Pennsylvania, US Department of Justice, Philadelphia, PA Short Hills, NJ (Moderator) Bryan Timer, MA Business Analytics, Director, Data Analytics and Transparency, Merck, Mini Summit XVI: Compliance Considerations for Small to North Wales, PA Mid-size Pharma and Device Companies Jeffrey Rosenbaum, MBA, Partner and Co-founder, Dovetail Consulting Group, LLC; Joseph Calarco, MSS, Chief Compliance Officer, Neos Therapeutics, Inc.; Former Director, Former Senior Vice President, Chief Compliance and Risk Officer, Shire; Former Vice President, Compliance and Ethics, US Operations, Bristol-Myers Squibb; Former Director, Corporate Chief Compliance Officer, Vertex Pharmaceuticals; Former Executive Director, Global Head, Compliance, Shire, Philadelphia, PA Ethics and Compliance, Novartis Oncology, Boston, MA (Moderator) Brian 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

Session Continued Next Page 7 Daryl Kreml, JD, Vice President and Chief Compliance Officer, SageTherapeutics; Former Gregory S. Moss, JD, Senior Vice President, Deputy General Counsel, Kadmon Corporation, Head, US Compliance and Global Program Management, Biogen; Former Director and Senior New York, NY Managing Counsel, International Compliance, Boston Scientific, Boston, MA Sarah Whipple, JD, Senior Corporate and Compliance Counsel, Akebia Therapeutics, Inc.; Eric Baim, JD, Managing Director, Dovetail Consulting Group, LLC; Former Vice President, Former Vice President, Global Compliance and Privacy Officer, Aegerion; Former Chief Compli- Head of US Compliance, Shire, Boston, MA (Moderator) ance Officer and Associate General Counsel, AMAG, Boston, MA Mini Summit XVII: Compliance Issues Associated with Minna Bak, MBA, Senior Manager, Helio Health Group, New York, NY (Moderator) PBM Relationships 2:30 pm Transition Break Eliza L. Andonova, JD, Counsel, Hogan Lovells, Washington, DC Katherine Chaurette, JD, Senior Director, Assistant General Counsel, Regeneron Pharmaceuticals, Inc.; Former Vice President Legal, Head of Health Law, Regulatory, MINI SUMMITS BLOCK D 2:45 pm – 3:45 pm Market Access, Marketed and Launched Products, Sanofi, Boston, MA Mini Summit XXI: Compliance Considerations for “Evolved” Richard Liner, JD, Senior Counsel, Compliance and Investigations, Bayer, Whippany, NJ Pharmaceutical Product, including Gene Therapy, Aesthetics, Eileen Erdos, Principal, Forensic and Integrity Services, EY, Chicago, IL (Moderator) and Ultra Rare Disease Products Elizabeth Jobes, JD, Head of Corporate Compliance and Legal Counsel, Spark Therapeutics, Mini Summit XVIII: Risk Assessments and Mitigation Plans: Inc.; Former Senior Vice President and Chief Compliance Officer, Auxilium; Former Chief, Best Practices and Lessons Learned Repeat Offender Unit, Philadelphia District Attorney’s Office, Philadelphia, PA Christie Camelio, Vice President and US Healthcare Compliance Officer, Celgene; Ali Lyons, Director, Ethics and Compliance, Aegerion Pharmaceuticals; Former Operations Former Head of Risk Management, Novartis Pharmaceuticals, Summit, NJ Lead, Ethics and Compliance, Eli Lilly and Company, Cambridge, MA Gary Del Vecchio, Health Care Compliance Officer, Cardiovascular and Metabolism, The Janssen Marci Juneau, MBA, Partner, Helio Health Group, Atlanta, GA (Moderator) Pharmaceutical Companies of Johnson & Johnson; Former Executive Director, US Pharmaceutical Compliance and Ethics, Bristol-Myers Squibb; Former PCF Co-chair, New York, NY Mini Summit XXII: Best Practice in HCP/HCO Management Francisco Ribeiro Filho, MBA, Senior Director & Head of US Compliance, Tesaro, Inc.; to Reduce Compliance Risk and Enhance Efficiency Former Senior Director, Corporate Compliance, Biogen; Former Senior Director, Corporate Sharon R. Delshad, JD, Director, Compliance and Legal Affairs, Nalpropion Pharmaceuticals, Compliance, International Markets, Sandoz, A Novartis Company; Former Senior Manager, Inc.; Former Director, Compliance and Legal Affairs, Orexigen Therapeutics, San Diego, CA Compliance Operations, LatAm, Johnson & Johnson, Boston, MA Kamleh J. Nicola, LLB, Partner, Baker & McKenzie LLP, Toronto, Canada Melanie Fagan, HCP Engagement Lead, Medical Affairs Compliance, GlaxoSmithKline, Philadelphia, PA Christian A. Dingler, Managing Consultant, Navigant Consulting, Richmond, VA (Co-Moderator) Jeffrey M. Kawalek, MBA, Senior Director, Ethics and Compliance, North America, Ipsen J. Mark Farrar, CPA, CFE, CFF, Managing Director, Navigant; Former Interim Global Chief Biopharmaceuticals, Inc., Basking Ridge, NJ Compliance Officer, Beckman Coulter, Atlanta, GA (Co-Moderator) Dennis McCloskey, JD, Compliance Officer, Olympus Corporation of the Americas; Former Mini Summit XIX: “All in Compliance” — Aligning with Your Assistant District Attorney, Homicide Unit, Philadelphia District Attorney’s Office, Philadelphia, PA Business Partners Mark Scallon, MHA, Senior Principal, Polaris, IQVIA Global Compliance, Richmond, VA Craig Chiulli, MBA, Group Product Director, Metabolic Franchise, Johnson & Johnson, (Moderator) Titusville, NJ Mini Summit XXIII: Compliance Considerations in Jill Dailey, MBA, JD, Vice President and Chief Compliance Officer, Incyte; Former Assistant Value-based Contracting General Counsel, Asia Pacific Compliance Lead, Pfizer; Former Head, US Ethics and Compliance, Novartis, New York, NY Jennifer Barbre, MA, Executive Director, Compliance, Spectrum Pharmaceuticals, Inc.; Former Director, Compliance and Ethics Program, Avanir; Former Director, Commercial Alison Fethke, JD, Counsel, Ropes & Gray LLP; Former Division Counsel, Legal, Regulatory Compliance, Boehringer Ingelheim, Irvine, CA and Compliance, AbbVie Chicago, IL William Connelly, JD, Senior Counsel, Amgen; Former Staff Attorney, US DHHS, Washington, DC Michael Joachim, JD, Global Business Partner, Ethics and Business Integrity, Sanofi Genzyme; Former Assistant General Counsel, Blue Cross Blue Shield of Massachusetts, Cambridge, MA Wendy C. Goldstein, JD, Partner, Health Care and Life Sciences Regulatory Practice, Cooley, LLP New York, NY 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- Josh T. O'Harra, MS, JD; Assistant General Counsel, Eli Lilly and Company; Former Senior velopment, Cubist/Optimer; Former Vice President and Chief Medical Officer, Global Medical Associate, King & Spalding, Washington, DC Affairs and Clinical Development, Archimedes, New York, NY Julie Ritchie Wagner, JD, Assistant General Counsel, PhRMA; Former Senior Counsel, Office of Joe Zimmerman, Vice President and Chief Compliance Officer US, Ferring Pharmaceuticals, Counsel to the Inspector General, US Department of Health and Human Services, Washington, DC Parsippany, NJ Patterson Shafer, Managing Director, Health Care and Life Sciences, Grant Thornton, Lisa Walkush, EMTM, Partner, Advisory Services and National Life Sciences Sector Leader, Stamford, CT (Moderator) Grant Thornton, LLP, Philadelphia, PA (Moderator) Mini Summit XXIV: Evolving Risks and Opportunities Mini Summit XX: Giving in the Era of Prosecutorial Scrutiny: related to Medical Affairs, e.g. Professional Medical Navigating the Murky Waters of Patient Programs and Education, Digital Information, etc. Interactions with Patients and Patient Organizations, Stefanie A. Doebler, JD, Of Counsel, Covington & Burling LLP, Washington, DC including Patient Services Compliance Survey Update Philip Lo Scalzo, JD, Senior Vice President, Chief Compliance Officer, BioMarin; Jonathan Levy, JD, Corporate Compliance Counsel, Spark Therapeutics; Former Associate Former Assistant General Counsel, sanofi-aventis, Novato, CA Director of Compliance and Ethics, US Pharmaceuticals, Bristol-Myers Squibb; Philadelphia, PA Stephanie Macholtz, JD, MBA, Director, Compliance and Ethics, Global Medical Affairs Jason P. Mehta, JD, Partner, Bradley Arant Boult Cummings LLP; Former Assistant United States and Business Development, Alexion Pharmaceuticals, Inc.; Former Compliance Officer, Biogen; Attorney, US Attorney’s Office for the Middle District of Florida, US Department of Justice, Tampa, FL Former Associate Director, Compliance, R&D, Eisai, Boston, MA

Session Continued Next Page

8 Donna White, Vice President, Contracts and Compliance, Chiesi USA, Inc.; Former Senior Mini Summit XXVII: The Compliance Training Revolution Director, Contracts and Compliance, Cornerstone Therapeutics, Cary, NC Julianne Brierley, Director, Head of Compliance Learning, Novartis, New York, NY Mark A. DeWyngaert, MBA, PhD, Managing Director, Life Sciences Regulatory and Christine Hood, Director, Learning and Development, Chiesi; Former District Sales Operational Risk, Deloitte, New York, NY (Co-moderator) Manager, Boehringer Ingelheim; Former Sales Trainer, Biovail, Apex, NC Oliver Steck, Principal, Life Sciences Regulatory and Operational Risk, Deloitte, New York, NY Vickie L. McCormick, Vice President, Janssen US Commercial Health Care Compliance and CIA (Co-moderator) Operations, Johnson & Johnson; Former Chief Compliance Officer, St. Jude Medical, Titusville, NJ Mini Summit XXV: Biopharma Product in Crisis: An Brian Miller, MS, PhD Candidate (Invited), Director Compliance Training and Documentation, Interactive Case Study in Effective Crisis Management Otsuka; Former Senior Manager of Learning Technologies, AstraZeneca; Former Associate Mahnu V. Davar, JD, Partner, Arnold & Porter Kaye Scholer LLP; Lecturer, University of Director Learning Design and Technology, Merck, Princeton, NJ Pennsylvania Law School; Fellow, Salzburg Global Seminar, Washington, DC Chad Londeree, Healthcare Industry Group Leader, SAI Global, Richmond, VA (Moderator) Paul Fishman, JD, Partner and Head, Crisis Management and Strategic Response Team, 3:45 pm Transition Break 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 CLOSING PLENARY SESSION New Jersey, New York, NY 4:15 pm Keynote Virginia MacSuibhne, JD, CCEP (Invited), Chief Compliance Officer, Roche Molecular Sally Q. Yates, JD, Partner, King and Spalding; Former Acting Attorney Solutions, Pleasanton, CA General; Former Deputy Attorney General; Former Assistant US Attorney; Ann-Marie Tejcek, MA, Senior Director, Ethics and Compliance, Eli Lilly and Company, US Attorney’s Office, Northern District of Georgia, US Department of Indianapolis, IN Justice, Washington, DC Daniel A. Kracov, JD, Partner, Arnold & Porter Kaye Scholer LLP, Washington, DC (Moderator) 4:45 pm Patient Support Programs, including Mini Summit XXVI: Privacy and Cybersecurity Compliance Reimbursement Support and Co-payment Update, including GDPR Compliance Waivers, Roundtable Laura G. Hoey, JD, Co-leader, Government Enforcement and White Paul Flanagan, JD, Assistant Professor of Law, Thomas R. Kline School of Law, Drexel University; Collar Group, Health Care and Life Sciences Industry Group, Ropes & Gray, Former Chief Compliance and Privacy Officer, 21st Century Oncology, West Chester, PA LLP, Chicago, IL 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 Gregg Shapiro, JD, Assistant US Attorney, US Attorney’s Office, District President Barack Obama, Washington, DC of Massachusetts, US Department of Justice, Boston, MA Adam Greene, JD, MPH, Partner and Co-chair, Health Information and HIPAA Practice, Davis Wright Tremaine LLP, Former Senior Health Information Technology and Privacy Erinn Hutchinson, Partner, Advisory Services, PwC, Philadelphia, PA Specialist, Office for Civil Rights, DHHS, Washington, DC (Moderator) Agatha O’Malley, MStPH, JD, Privacy Officer and Senior Counsel, Otsuka Pharmaceuticals (US); Former Director- Head of Privacy, Shire, Philadelphia, PA 5:30 pm Recent Developments in Pharmaceutical and David W. Opderbeck, JD, Professor of Law, Seton Hall University Law School; Counsel, Medical Device Pricing and Cost Containment Gibbons PC, Newark, NJ (Moderator) 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

Jennifer McGee, JD, Vice President and Chief Compliance Officer, FRIDAY, NOVEMBER 9, 2018 Otsuka America Pharmaceutical, Inc., Rockville, MD (PCF Treasurer)

PHARMA CONGRESS: AGENDA DAY III Margaret Sparks, JD, Associate Vice President, North America Ethics and Business Integrity, Sanofi US, Bridgewater, NJ (PCF Co-Chair) INDUSTRY-ONLY COMPLIANCE BEST PRACTICES THINK TANK Joe Zimmerman, Vice President and Chief Compliance Officer US, Ferring Pharmaceuticals, Parsippany, NJ (PCF Co-Chair) (Industry-only session for pharmaceutical company Compliance professionals and in-house counsel only) 8:30 am Introduction to Day Three Interview Presentation, Moderated Discussion and Q&A Michael R. Clarke, JD, Vice President, Corporate Compliance, Indivior Inc., Richmond, VA (PCF Co-Chair) Gregg Shapiro, JD, Assistant US Attorney, US Attorney’s Office, District of Massachusetts, US Department of Justice, Boston, MA Sujata T. Dayal, JD, Vice President, Health Care Compliance and Privacy, Pharmaceuticals Group, Johnson & Johnson, Titusville, NJ (PCF Secretary) John T. Bentivoglio, JD, Partner, Skadden Arps LLP; Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, US Department of Jeffrey M. Kawalek, MBA, Senior Director, Ethics and Compliance, Justice, Washington, DC (Moderator) North America, Ipsen Biopharmaceuticals, Inc. Basking Ridge, NJ (PCF Chair) Noon CONGRESS ADJOURNMENT

9 THE FOLLOWING REGISTRATION TERMS AND CONDITIONS APPLY HOW TO REGISTER: Fully complete the form on page 11 (one form per REGARDING WEBCAST REGISTRATIONS registrant, photocopies acceptable). Payment must accompany each registra- 1. Individuals or groups may register for Internet access. Organizations may register tion (US funds, payable to Health Care Conference Administrators, LLC). for group access without presenting specific registrant names. In such instances the registering organization will be presented a series of user names and passwords to ONLINE: Secure online registration at www.PharmaCongress.com. distribute to participants. FAX: 206-319-5303 (include credit card information with registration) 2. Each registrant will receive a user name and password for access. Registrants will be able to change their user names and passwords and manage their accounts. MAIL: Conference Office, 12330 N.E. 8th Street, Suite 101, Bellevue, WA 98005-3187 3. 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REGARDING ONSITE ATTENDANCE REGISTRATION, CANCELLATIONS A recommended maximum of 19.0 credits based on a 50-minute hour will be AND SUBSTITUTIONS granted for the entire learning activity for onsite attendance only. This program 1. For onsite group registrations, full registration and credit card information is re- addresses topics that are of a current concern in the compliance environment. This quired for each registrant. List all members of groups registering concurrently on fax is an update, group-live activity. For more information regarding administrative or scanned cover sheet. policies such as complaints or refunds, call 206-757-8053 or [email protected]. 2. For onsite registrants there will be no refunds for “no-shows” or for cancellations. You COMPLIANCE CERTIFICATION BOARD CONTINUING EDUCATION UNITS may send a substitute or switch to the webcast option. Please call the Conference (CCB CEUs) Office at 800-503-7419 or 206-452-5662 for further information. 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10 PHARMACEUTICAL AND MEDICAL DEVICE CONGRESS COMPLETE THE FOLLOWING. PLEASE PRINT CLEARLY: ❏ Dr. ❏ Mr. ❏ Mrs. ❏ Ms. ADDRESS

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SIGNATURE OF REGISTRANT - REQUIRED TELEPHONE

JOB TITLE E-MAIL

ORGANIZATION ❏ Special Needs (Dietary or Physical)

ONSITE CONFERENCE ATTENDANCE WEBCAST CONFERENCE ATTENDANCE CHIEF COMPLIANCE OFFICER ROUNDTABLE ((Invitation-only; November 7) No Cost All webcast registrants are automatically registered for the preconference and conference. (CCOs interested attending may contact Debra Scanlon, Administrator, Webcast conference registration includes the live Internet feed from the Congress, plus six Pharmaceutical Compliance Forum at [email protected].) 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 STANDARD RATES: Congress will not be included in Congress live and archived Internet broadcast. PRECONFERENCES (November 7; Choose one): ❏ I: Patient Support Program . . . $595 ❏ III: Advanced Strategies/Auditing/Monitoring $595 STANDARD RATES: ❏ II: Practical Approaches to Handling Investigations $595 ❏ IV: Asking the Right Risk Questions . . . $595 INDIVIDUAL REGISTRATION (Includes Preconference and Conference): ❏ Through Friday, September 21, 2018* $ 795 CONFERENCE – STANDARD INDIVIDUAL REGISTRATION ❏ Through Friday, October 12, 2018** $ 995 (Does not include Preconference): ❏ After Friday, October 12, 2018 $1,195 ❏ Through Friday, September 21, 2018* $1,995 ❏ Through Friday, October 12, 2018** $2,195 ❏ After Friday, October 12, 2018 $2,395 SPECIAL PHARMACEUTICAL COMPLIANCE FORUM PCF RATES***: GROUP REGISTRATION DISCOUNT – STANDARD INDIVIDUAL REGISTRATION (Includes Preconference and Conference): (Does not include Preconference; rates are per person): Three or more registrations submitted from the same organization at the same time receive ❏ PCF Rate $ 695 the following discounted rates for conference registration only. To qualify, all registrations must be submitted simultaneously: GROUP REGISTRATION: ❏ Through Friday, September 21, 2018* each $1,795 Group registration offers the substantial volume discounts set forth below. All webcast ❏ Through Friday, October 12, 2018** each $1,995 group registrants are enrolled in the preconference and conference. Group registration ❏ After Friday, October 12, 2018 each $2,195 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 SPECIAL PHARMACEUTICAL ❏ 10 or more $495 each ❏ 40 or more $295 each COMPLIANCE FORUM PCF RATES***: See INTELLECTUAL PROPERTY POLICY, page 10. PRECONFERENCES – SPECIAL PCF RATES*** (November 7; Choose one): ❏ I: Patient Support Program . . . $495 ❏ III: Advanced Strategies/Auditing/Monitoring $495 CONFERENCE ELECTRONIC MEDIA: ❏ II: Practical Approaches to Handling Investigations $495 ❏ IV: Asking the Right Risk Questions . . . $495 Webcast attendees — Following the Congress, the video and presentations are made available on a flash drive. To take advantage of the discounted price below, you must reserve CONFERENCE – SPECIAL PCF INDIVIDUAL RATES*** media WITH your Congress registration: ❏ Flash Drive ($129 + $15 shipping) $ 144 (Does not include Preconference): ❏ Through Friday, September 21, 2018* $1,695 (All webcast attendees automatically receive 6 months access on web.) ❏ Through Friday, October 12, 2018** $1,895 ❏ After Friday, October 12, 2018 $2,095

PCF GROUP REGISTRATION DISCOUNTS (Does not include Preconference): * This price reflects a discount for registration and payment received through Friday, Sept. 21, 2018. FIVE OR MORE registrations submitted from the same organization at the same time receive ** This price reflects a discount for registration and payment received through Friday, Oct. 12, 2018. the following discounted rates for conference registration only. To qualify, all registrations must be submitted simultaneously: *** 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. ❏ 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 PAYMENT Discount Code: must be submitted simultaneously: ❏ Pharmaceutical Compliance Forum Group Rate/Conference Only – TOTAL FOR ALL OPTIONS, each of 10 registrations: $1,495 ONSITE OR WEBCAST: SELECT YOUR MINI-SUMMITS – THURSDAY, NOVEMBER 8 (One from each group): Please enclose payment with your registration and return it to the Registrar at Pharma Congress, BLOCK A – 11:00 am BLOCK C – 1:30 pm 12330 N.E. 8th Street, Suite 101, Bellevue, WA 98005-3187, or fax your credit card payment to ❏ I: Fostering a Culture of Ethics and Compliance . . . ❏ XIV: Global Documentation Framework . . . 206-319-5303. ❏ II: What’s Old is New Again . . . ❏ XV: R&D: Hidden Risks beyond Clinical Trial You may also register online at www.PharmaCongress.com. ❏ III: Third Party Lifecycle Management ❏ XVI: Compliance Considerations for Small to Mid-size . . . ❏ Check/money order enclosed (payable to Health Care Conference Administrators LLC) ❏ IV: Annual Medical Device Compliance Roundtable ❏ XVII: Compliance Issues Associated with PBM Relationships ❏ Payment by credit card: ❏ American Express ❏ Visa ❏ Mastercard ❏ V: Dissecting Recent CIAs and Review of Draft Model CIA ❏ XVIII: Risk Assessments and Mitigation Plans . . . If a credit card number is being given to hold registration only until such time as a ❏ VI: Advanced Strategies to Measure Effectiveness . . . ❏ XIX: “All in Compliance” . . . check is received it must be so noted. If payment is not received by seven days prior to ❏ VII: Compliance 3.0 . . . ❏ XX: Giving in the Era of Prosecutorial Scrutiny . . . 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. BLOCK B – 12:15 am BLOCK D – 2:45 pm ❏ VIII: Open Payments: Where Does the Sun Shine Now? ❏ XXI: Compliance Considerations for “Evolved” Pharma . . . REGISTRATION BINDING AGREEMENT ❏ IX: Interactions with Specialty Pharmacy ❏ XXII: Best Practice in HCP/HCO Management . . . Registration (whether online or by this form) constitutes a contract and all of these terms and ❏ X: Is your Board of Directors Bored . . . ❏ XXIII: Compliance Considerations/Value-based Contracting conditions are binding on the parties. In particular, these terms and conditions shall apply in ❏ XI: Next Generation Data Analytics ❏ XXIV: Evolving Risks/Opportunities related to Med Affairs . . . the case of any credit/debit card dispute. For webcast and onsite registrants there will be no ❏ XII: Fine Line of Promotion with Medical Professionals . . . ❏ XXV: Biopharma Product in Crisis: Interactive Case Study . . . refunds for “no-shows” or cancellations. ❏ XIII: Market Access Compliance Considerations ❏ XXVI: Privacy and Cybersecurity Compliance Update . . . ❏ XXVII: The Compliance Training Revolution ACCOUNT # CONFERENCE ELECTRONIC MEDIA: Onsite Attendees — Following the Congress, the audio/video and Powerpoint presentations EXPIRATION DATE SECURITY CODE are made available in the following formats. To take advantage of the discounted prices below, you must reserve media WITH your Congress registration: NAME OF CARDHOLDER ❏ Flash Drive ($129 + $15 shipping) $ 144 ❏ 6 months’ access on Web $ 129 SIGNATURE OF CARDHOLDER 11 CO-CHAIRS Dante Beccaria, Senior Vice President, Global Save the Date: Compliance Officer, Head of Ethics and Business Integrity Department, Sanofi, Paris, France Wikipedia/Mountain Stephen Nguyen Duc, Former Area Director, THIRTEENTH INTERNATIONAL International Operations, Western Europe and Canada, Office of Ethics and Compliance, PHARMACEUTICAL AND AbbVie, Rungis, France Dominique Laymand, Esq., Executive Vice President, Chief Ethics and Compliance Officer, MEDICAL DEVICE Ipsen, Paris, France Roeland Van Aelst, Regional Vice President – HCCO MD&D EMEA and Canada, Office Health COMPLIANCE CONGRESS Care Compliance and Privacy, Johnson & Johnson, Brussels, Belgium APRIL 8 – 10, 2019 • ATHENS, GREECE SPONSORED BY: MEDIA PARTNER: