A HYBRID CONFERENCE AND INTERNET EVENT

19th Annual Pharmaceutical and Medical Device Compliance Congress

MANDARIN ORIENTAL • WASHINGTON, DC
NOVEMBER 7 - 9, 2018


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KEYNOTE SPEAKERS

Thomas W. Abrams, RPh, MBA

Director, Office of Prescription Drug Promotion, US Food and Drug Administration, Silver Spring, MD

Richard Bistrong, MA

Chief Executive Officer, Front-Line Anti-Bribery LLC, Contributing Editor, 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, USA

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

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

Tarek Helou, Esq.

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

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

Mary E. Riordan, Esq.

Senior Counsel, Office of Counsel to the Inspector General, Office of Inspector General, US Department of Health and Human Services, Washington, DC

Gregg Shapiro, JD

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

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

FEATURING AN INVITATION-ONLY CCO ROUNDTABLE

  • Hosted by the PCF and the PhRMA CCO Working Group

    PRECONFERENCE SESSIONS

  • Patient Support Programs: Risk and Risk Management Best Practices
  • Practical Approaches to Handling Investigations
  • Advanced Strategies in Auditing and Monitoring
  • Advanced Strategies for the Use of Data Analytics in Compliance Programs

    PLENARY SESSION

  • C-Suite Keynote Address
  • OIG Update Keynote Address
  • FDA Keynote Address
  • Sally Yates Keynote Address
  • DOJ, FBI and SEC FCPA Enforcement Update
  • Annual AUSA Roundtable
  • Annual Qui Tam Roundtable
  • Annual Chief Compliance Officer Roundtable
  • The Hidden Risks Your Risk Assessment Might Miss
  • Patient Support Programs Roundtable
  • Recent Developments in Pharmaceutical and Medical Device Pricing and Cost Containment


    THE CONGRESS IS

    • MINI SUMMITS

  • Fostering a Culture of Ethics and Compliance
  • Global Compliance Function Harmonization
  • Third Party Lifecycle Management
  • Annual Medical Device Compliance Roundtable
  • Compliance for Small to Mid-size Pharma and Device Companies
  • Advanced Strategies to Measure Effectiveness, Monitor and Report
  • The Evolution of Promotional Programs
  • Open Payments: Where Does the Sun Shine Now?
  • Interactions with Specialty Pharmacy
  • Is your Board of Directors Bored of your Compliance Dashboards?
  • Next Generation Data Analytics
  • R&D: Hidden Risks beyond Clinical Trail Recruitment
  • Market Access Compliance Considerations
  • Promotion with Medical Professionals: Avoiding White Coat Marketing
  • Dissecting Recent CIAs and Review of Draft Model CIA
  • 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
  • An Interactive Case Study in Effective Crisis Management
  • Privacy and Cybersecurity Compliance Update, including GDPR
  • The Compliance Training Revolution

    AND DAY III INDUSTRY-ONLY PLENARY ROUNDTABLE

  • Featuring AUSA Gregg Shapiro, JD

    • FEATURED FACULTY

    Timothy Ayers, JD, MPH

    Vice President, Chief Compliance Officer, Horizon Pharma PLC, Former VP, Chief Compliance Officer, Dendreon, Chicago, IL

    Eric Baim, JD

    Managing Director, Dovetail Consulting Group, LLC, Former VP, Head of US Compliance, Shire, Boston, MA

    Minna Bak, MBA

    Senior Manager, Helio Health Group, New York, NY

    Ann Beasley, JD

    Director, Life Sciences, Governance, Risk & Compliance, Navigant, Former Senior Vice President, Chief Compliance Officer, Biogen, Boston, MA

    John T. Bentivoglio, Esq.

    Partner, Skadden Arps LLP; Former Special Counsel for Healthcare Fraud, and Chief Privacy Officer, US Department of Justice; Washington, DC

    Brian A. Bohnenkamp, MHA, JD

    Partner, FDA & Life Sciences Practice, King & Spalding LLP, Washington, DC

    Kathleen Boozang

    Dean and Professor of Law at Seton Hall Law, Newark, NJ

    Christine N. Bradshaw, JD

    Vice President, Porzio Life Sciences, LLC, Principal, Porzio, Bromberg & Newman PC, Morristown, NJ

    Joseph Calarco

    Chief Compliance Officer at Neos Therapeutics, Inc., Philadelphia, PA

    Christie Camelio

    Vice President and US Healthcare Compliance Officer, Celgene Corporation, Summit, NJ

    Brian Conner

    Vice President, Head of Corporate Compliance, Strongbridge Biopharma plc, Trevose, PA

    Thomas Costa, JD

    Member, US Board of Directors, Sanofi; Former Vice President, US Compliance & Ethics, Bristol-Myers Squibb, Washington, DC

    Clarissa Crain

    Senior Manager, Life Sciences Advisory, Deloitte, Philadelphia, PA

    Jill Dailey, MBA, JD

    Vice President & Chief Compliance Officer, Incyte, Former Assistant General Counsel, Asia Pacific Compliance Lead, Pfizer, Former Head, US Ethics and Compliance, Novartis, New York, NY

    Meenakshi Datta, JD

    Partner and Global Co-leader, Healthcare Practice, Sidley Austin LLP, Chicago, IL

    Mahnu V. Davar, JD

    Partner, Arnold & Porter Kaye Scholer LLP, Lecturer, University of Pennsylvania Law School, Fellow, Salzburg Global Seminar, Washington, DC

    BJ D’Avella

    Senior Manager, Life Sciences Regulatory and Operational Risk, Deloitte & Touche LLP, Atlanta, GA

    Gary Del Vecchio

    Health Care Compliance Officer Cardiovascular & 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, NY

    Mark A. DeWyngaert, MBA, PhD

    Managing Director, Life Sciences Regulatory and Operational Risk, Deloitte & Touche LLP, New York, NY

    Michael Dusseau

    Vice President, Compliance Operations, Allergan, Former Vice President, Compliance, Bayer, Former Divisional Compliance Officer, Merck, Madison, NJ

    Eileen Erdos

    Principal, Forensic and Integrity Services, Ernst & Young LLP, Chicago, IL

    Jill Fallows-Macaluso, JD

    Chief Compliance Officer and Vice President, Novo-Nordisk, Princeton, NJ

    Margaret Feltz, JD, MA

    Executive Director, Acting Chief Compliance Officer, Ethics & Compliance, Purdue Pharma L.P., Former Co-chair, PCF Pharma Compliance Congress, Stamford, CT

    Alison Fethke, JD

    Counsel, Ropes & Gray LLP, Former Division Counsel, Legal, Regulatory and Compliance, AbbVie, Chicago, IL

    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

    Alex Ganz, JD

    Senior Manager of Compliance, Aegerion Pharmaceuticals, Former Compliance Manager, Shire and Vertex, Boston, MA

    Nereyda Garcia, JD

    Global Heath, Ethics and Compliance, Alnylam Pharmaceuticals, Former Sr. Director, Compliance, Biogen Idec, Cambridge, MA

    Gary F. Giampetruzzi, Esq.

    Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc.; New York, NY

    Jonathan 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

    Wendy C. Goldstein, JD

    Partner, Health Care and Life Sciences Regulatory Practice, Cooley, LLP, New York, NY

    Lillian S. Hardy, JD

    Partner, Hogan Lovells LLP, Washington, DC

    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

    Christine Hood

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

    Casey J. Horton, CFE

    Director, Life Sciences, Governance, Risk & Compliance, Navigant, Chicago, IL

    Michael Joachim, JD

    Global Business Partner, Ethics & Business Integrity, Sanofi Genzyme, Former Assistant General Counsel, Blue Cross Blue Shield of Massachusetts, Cambridge, MA

    Marci Juneau, MBA

    Partner, Helio Health Group, Atlanta, GA

    Jonathon Kellerman

    Executive Vice President, Global Chief Compliance Officer, Allergan PLC, Former Partner, PwC, Parsippany, NJ

    Kiley Smith Kelly, MBA

    Partner, Forensic and Integrity Services, Ernst & Young LLP, Philadelphia, PA

    Puja Leekha, JD

    Vice President, Chief Compliance Officer and Corporate Counsel, Corporate Compliance, Lundbeck Pharmaceuticals LLC, Former Division Legal Counsel & Compliance Officer, Stryker Corporation, Deerfield, IL

    Marc Levine

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

    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

    Vickie L. McCormick

    Vice President, Janssen U.S. Commercial Health, Care Compliance & CIA Operations, Johnson & Johnson, Former Chief Compliance Officer, St. Jude Medical, Titusville, NJ

    Jennifer McGee, JD

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

    Jean McKiernan, MBA

    Director, Pharmaceutical and Life Sciences Advisory Practice, PwC, Chicago, IL

    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

    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

    Brian Miller, PhD

    Director Compliance Training and Documentation, Otsuka, Former Senior Manager of Learning Technologies, AstraZeneca, Former Associate Director Learning Design & Technology, Merck, Princeton, NJ

    Katherine Cartwright Norris, MPA

    Director, Berkeley Research Group, Former Senior Director, Compliance, and Integrity Programs, NSF Health Sciences, Former Director, Corporate Compliance, Spectranetics, Former Manager, Corporate Compliance, King, Washington, DC

    Agatha O’Malley, MStPH, JD

    Privacy Officer and Senior Counsel, Otsuka Pharmaceuticals (US), Former Director – Head of Privacy, Shire, Philadelphia, PA

    John Patrick Oroho, JD

    Executive Vice President and Chief Strategy Officer, Porzio Life Sciences, LLC, Principal, Porzio, Bromberg & Newman PC, Morristown, NJ

    Amy Pawloski

    Compliance Officer – Operations at Endo Pharmaceuticals, Former Global Lead, Compliance Risk Mitigation and Monitoring Strategy, Bristol-Myers Squibb; Philadelphia, PA

    Perri Pomper

    Director – Ethics and Compliance Strategy & Education at Novo Nordisk

    Kelly N. “Nikki” Reeves, MPA, JD

    Partner, King & Spalding LLP, Washington, DC

    Jeffrey Rosenbaum, MBA

    Partner and Co-founder, Dovetail Consulting Group, LLC, Former SVP, Chief Compliance and Risk Officer, Shire, Boston, MA

    David Ryan, JD

    Vice President and Chief Compliance Officer, Epizyme, Former Vice President, Associate GC and CCO, Haemonetics, Former Vice President of Legal Affairs, Assistant General Counsel and CCO, AMAG Pharmaceuticals, Boston, MA

    Sue Seferian, JD

    Health Care Compliance Officer, Johnson & Johnson, Titusville, NJ

    George Serafin, MS

    National Health Care and Life Sciences Leader, Grant Thornton, LLP, Iselin, NJ

    Michael Shaw, JD

    Vice President and Compliance Officer, US Pharmaceuticals, GlaxoSmithKline; Former Senior Counsel, Office of Inspector General, US Department of Health and Human Services; Former Member, PCF Executive Committee; Philadelphia, PA

    Paul Silver

    Principal, Regulatory & Compliance Life Sciences Leader, Deloitte Advisory, Deloitte, Atlanta, GA

    Laura (Munns) Skinner, MBA

    Senior Manager, Life Sciences Advisory, Deloitte, Austin, TX

    John Smollen, MA, JD

    Practice Professor of Law and Director, Center for Compliance and Ethics, Temple Law, Former EVP and CCO, Endo International, Philadelphia, PA

    Oliver Steck

    Principal, Life Sciences Regulatory and Operational Risk, Deloitte & Touche LLP, New York, NY

    Ann-Marie Tejcek, MA

    Senior Director Ethics & Compliance, USA/Canada, Eli Lilly and Company, Indianapolis, IN

    Brian Van Hoy

    Vice President, G&M Health LLC, Former Director, Ethics and Compliance, Eli Lilly, Bridgewater, NJ

    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

    Lisa Walkush, EMTM

    Partner, Grant Thornton, LLP, Philadelphia, PA

    William Weinreb, JD

    Partner, Quinn Emanuel, Former Acting United States Attorney and First Assistant US Attorney, Boston, Boston, MA

    Donna White, CCEP

    Vice President, Contracts & Compliance, Chiesi USA, Inc.; Former Sr. Director, Contracts and Compliance, Cornerstone Therapeutics; Cary, NC

    Seth B. Whitelaw, JD, LLM, SJD

    President and Chief Executive Officer, Whitelaw Compliance Group, LLC; Editor, Life Science Compliance Update; Senior Fellow & Adjunct Professor, Life Sciences Compliance at Mitchell Hamline School of Law, West Chester, PA

    Kathryn “Katie” E. Winson

    Senior Manager, US HCC Monitoring, Celgene Corporation, Summit, NJ

    PARTICIPATION OPTIONS

    TRADITIONAL ONSITE ATTENDANCE

    Simply register, travel to the conference city and attend in person.

    Pros: subject matter immersion; professional networking opportunities; faculty interaction

    LIVE AND ARCHIVED WEBCAST PARTICIPATION

    Watch the conference in live streaming video over the Internet and at your convenience at any time 24/7 for the 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 next six months; Accessible in office, at home or anywhere worldwide with Internet access; Avoid travel expense and hassle; No time away from the office.

    WEBCAST INTERFACE SAMPLE

    Click here for a sample stream

    2018 GLOBAL PHARMA COMPLIANCE CONGRESSES

    TWELFTH INTERNATIONAL PHARMACEUTICAL AND MEDICAL DEVICE COMPLIANCE CONGRESS

    Sponsored by International Society of Healthcare Compliance Professionals (ETHICS)
    Media Partners: Life Sciences Compliance Update
    May 14 – 16, 2018
    Hotel Savoyen
    Vienna, Austria
    www.InternationalPharmaCongress.com

    EIGHTH ASIA PACIFIC PHARMACEUTICAL AND MEDICAL DEVICE COMPLIANCE CONGRESS

    Sponsored by Asia Pacific Healthcare Industry Compliance Team
    Cosponsored by International Society of Healthcare Ethics and Compliance Professionals (ETHICS)
    Media Partners: Life Sciences Compliance Update
    September 10 – 12, 2018
    Singapore
    www.AsianPharmaCongress.com

    NINETEENTH ANNUAL PHARMACEUTICAL AND
    MEDICAL DEVICE COMPLIANCE CONGRESS

    A Hybrid Conference and Internet Event
    Sponsored by Pharmaceutical Compliance Forum (PCF)
    November 7 – 9, 2018
    Mandarin Oriental
    Washington, DC
    www.PharmaCongress.com




    A HYBRID CONFERENCE AND INTERNET EVENT