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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THE 2018 19TH ANNUAL PHARMACEUTICAL AND MEDICAL DEVICE COMPLIANCE CONGRESS CONTENT IS NOW AVAILABLE IN VARIOUS POST CONFERENCE FORMATS

The Nineteenth Annual Pharma Congress conference content is now available in a variety of formats.
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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

Leslie Backschies, MA

Supervisor Special Agent and Unit Chief, International Corruption Unit, Federal Bureau of Investigation, Los Angeles, CA

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

Hui Chen, JD

Ethics and Compliance Advocate and Consultant, HC Ethics LLC; Former Compliance Counsel Expert (Consultant), US Department of Justice; Former Assistant General Counsel, Pfizer, New York, NY

Zachary 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

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

Jacob Elberg, JD

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

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 US Attorney; Former Assistant US Attorney, US Attorney’s Officer, Northern District of Georgia, US Department of Justice, Washington, DC

AGENDA-AT-A-GLANCE

WEDNESDAY, NOVEMBER 7

FEATURING AN INVITATION-ONLY CCO ROUNDTABLE

  • Hosted by PCF and PhRMA CCO Working Group; Featuring Hui Chen, JD, HC Ethics LLC

    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

    OPENING PLENARY SESSION

  • OIG Keynote Address
  • FDA Keynote Address
  • Risks Your Risk Assessment Might Miss
  • Chief Compliance Officer Roundtable

    THURSDAY, NOVEMBER 8

    MORNING PLENARY SESSION

  • Annual AUSA Roundtable
  • Annual Qui Tam Roundtable
  • DOJ, FBI and SEC FCPA Enforcement Update

    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?

    • MINI SUMMITS, CONTINUED…

  • Interactions with Specialty Pharmacy
  • Is your Board Bored of your Compliance Dashboards?
  • Next Generation Data Analytics 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

    CLOSING PLENARY SESSION

  • Sally Yates Keynote Address
  • Patient Support Programs Roundtable
  • Pharma and Device Pricing and Cost Containment

    FRIDAY, NOVEMBER 9

    INDUSTRY-ONLY BEST PRACTICES ROUNDTABLE

  • Featuring AUSA Gregg Shapiro, JD


    • FEATURED SESSION: ANNUAL CCO ROUNDTABLE WITH

    Jill Fallows-Macaluso, JD

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

    Jonathon Kellerman

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

    Robert A. Ladd, JD

    Vice President, Global Head Integrity & Compliance, 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 & Compliance Officer, Stryker Corporation, Deerfield, IL

    Lori Queisser

    Sr VP and Global CCO, Teva, Former Sr. VP Global Compliance & Business Practices, Schering-Plough, Former VP & CCO, Eli Lilly, Former Co-chair, PCF, Horsham, PA

    Paul Silver

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

    FEATURED FACULTY

    James Accumanno, JD

    Director Risk, Monitoring and Auditing, Novo Nordisk, Former Associate Counsel, Bayer, Philadelphia, PA

    Anthony Alvizu, CPA, EnCE, CFE

    Managing Director, Global Risk & Investigations Practice (GRIP), FTI Consulting, Chicago, IL

    Eliza L. Andonova, JD

    Counsel, Hogan Lovells, Washington, DC

    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

    Yogesh Bahl, CPA, MBA

    Managing Director, Alix Partners, New York, NY

    Minna Bak, MBA

    Senior Manager, Helio Health Group, New York, NY

    Jennifer Barbre, MBS

    Executive Director, Compliance, Spectrum Pharmaceuticals, Inc., Former Director, Compliance and Ethics Program, Avanir, Irvine, CA

    Dennis K. Barnes, JD, MBA, CPA

    Vice President, Global Governance, Risk and Compliance, Mayne Pharma, Raleigh-Durham, NC

    Scott Bass, JD

    Partner and Head, Global Life Sciences Team, Sidley Austin LLP, New York, NY

    Ann E. Beasley, JD

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

    Thomas Beimers, JD

    Partner, Hogan Lovells, Former Senior Counsel, Office of Counsel to the Inspector General, US DHHS, Minneapolis, MN and Washington, DC

    Chuck Bell, JD, BSN

    President, Arete Resources, Inc.; Former Compliance Officer, Kedrion Biopharma Inc.; Former Interim Compliance Officer, Insmed Inc.; New York, NY

    John T. Bentivoglio, Esq.

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

    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

    Brian A. Bohnenkamp, MHA, JD

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

    Christine N. Bradshaw, JD

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

    Julianne Brierley

    Director, Head of Compliance Learning, Novartis, New York, NY

    Katherine Buckley, MBA

    Partner, Pharmaceutical and Life Sciences Advisory Practice, PwC, Philadelphia, PA

    Terra Buckley, JD

    Executive Director, US HCC Business Advisory Center of Excellence, Celgene, Former Head, US Compliance, Helsinn, Summit, NJ

    Ed Buthusiem, JD

    Managing Director, Berkeley Research Group, Adjunct Professor Of Law, Temple University, Former SVP, R&D Legal Operations & Vaccines, GSK, Devon, PA

    Joseph Calarco

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

    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 & Compliance, Life Sciences Sector, KPMG LLP, Former VP and CCO, Otsuka America, Short Hills, NJ

    Nicole Chandonnet, JD

    Associate, Covington & Burling, Washington, DC

    Katherine Chaurette, JD

    Senior Director, Assistant General Counsel, Regeneron Pharmaceuticals, Inc., Boston, MA

    Jennifer Chillas, JD

    Senior Corporate Counsel, Bristol-Myers Squibb; Former Associate, Ropes & Gray, LLP; Princeton, NJ

    Craig Chiulli, MBA

    Group Product Director, Metabolic Franchise, Johnson & Johnson, Titusville, NJ

    Craig Clesson, JD, CIPP/US

    Assistant General Counsel and Global Privacy Officer, Syneos Health; Former Vice President and Ethics and Compliance Officer, Aegerion; Boston, MA

    William Connelly, JD

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

    Kellie Branson Combs, JD

    Partner, Ropes & Gray LLP, Washington, DC

    Lynn Costa

    Senior Policy Advisor for the Western Hemisphere, U.S. Department of Commerce, Washington, DC

    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 AG, Asia Pac 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, MBA

    Senior Manager, Life Sciences Advisory, Deloitte & Touche LLP, Parsippany, NJ

    Sharon R. Delshad, JD

    Director, Compliance and Legal Affairs, Nalpropion, Former Director, Compliance and Legal Affairs, Orexigen Therapeutics, San Diego, CA

    Gary Del Vecchio

    Health Care CO Cardiovascular & Metabolism, Janssen, Former ED US Pharma Compliance & 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

    Sarah diFrancesca, JD

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

    Christian A. Dingler

    Managing Consultant, Navigant Consulting, Richmond, VA

    Stefanie A. Doebler, JD

    Of Counsel, Covington & Burling LLP, Washington, DC

    Suzanne E. Durrell, JD

    Managing Member, Whistleblower Law Collaborative, LLC, Taxpayers Against Fraud Education Fund, 2017 Whistleblower Lawyer of the Year, Boston, MA

    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

    Melanie Fagan

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

    J. Mark Farrar, CPA, CFE, CFF

    Managing Director, Navigant; Former Interim Global Chief Compliance Officer, Beckman Coulter, Atlanta, GA, USA

    Alison Fethke, JD

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

    Kellie Fidler, MBA, PMP

    Director, Global Compliance Risk Mitigation & Monitoring Strategy, Bristol-Myers Squibb, Princeton Pike, NJ

    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

    Sarah A. Franklin, JD

    Partner, Covington & Burling LLP, Former Attorney, Federal Trade Commission, Washington, DC

    Charlene Keller Fullmer, JD

    Assistant United States Attorney and Deputy Chief, Affirmative Litigation, United States Attorney’s Office, Eastern District of Pennsylvania, Philadelphia, PA

    Andrew Furlow, JD

    Senior Associate, Hogan Lovells US LLP, New York, NY

    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

    Virginia “Ginny” A. Gibson, JD

    Partner, Hogan Lovells LLP, Former First Assistant U.S. Attorney, Eastern District of Pennsylvania, US Department of Justice, Philadelphia, PA

    Jonathan Glazier, JD, MBA

    Head, Legal Compliance, Philips, Former Sr. Dir., Corporate Compliance and Privacy Officer, Fresenius, Andover, MA

    Wendy C. Goldstein, JD

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

    Anthony Greco, MBA

    Director, Pharmaceutical & Life Sciences Advisory Services, PwC, Philadelphia, PA

    Adam Greene, JD, MPH

    Partner and Co-chair, Health Information & HIPAA Practice, Davis Wright Tremaine LLP, Former Senior HIT & Privacy Specialist, OCR, DHHS, Washington, DC

    Lillian S. Hardy, JD

    Partner, Hogan Lovells LLP, Washington, DC

    Patricia J. Harned, PhD

    Chief Executive Officer, ECI (Ethics and Compliance Initiative), Former President, Ethics Resource Center, Washington, DC

    Kate Heinzelman, JD

    Counsel, Sidley Austin LLP, Former Deputy GC, US DHHS, Former Special Assistant and Associate Counsel, President Barack Obama, Washington, DC

    Laura G. Hoey, JD

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

    Casey J. Horton, CFE

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

    Emily Huebener, MA

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

    Erinn Hutchinson

    Partner, Advisory Services, PwC, Philadelphia, PA

    Elizabeth Jobes, JD

    Head, Corporate Compliance & Legal Counsel, Spark, Former Senior VP & CCO, Auxilium, Former PCF Co-chair, Philadelphia, PA

    Darren R. Jones

    Partner, Global Compliance Consulting Leader, Polaris Management, New York, NY

    Marci Juneau, MBA

    Partner, Helio Health Group, Atlanta, GA

    Kiley Smith Kelly, MBA

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

    Keith M. Korenchuk, JD, MPH

    Partner, Arnold & Porter LLP, Washington, DC

    Daniel A. Kracov, JD

    Partner, Arnold & Porter Kaye Scholer LLP, Washington, DC

    Daryl Kreml, JD

    VP & CCO, Sage, Former Head, US Compliance & Global Program Management, Biogen, Former Dir. & Sen. Managing Counsel, Int’l Compliance, Boston Scientific, Boston, MA

    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

    Marc Levine

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

    Jonathan Levy, JD

    Corporate Compliance Counsel, Spark Therapeutics; Former Associate Director of Compliance and Ethics, US Pharmaceuticals, Bristol-Myers Squibb; Philadelphia, PA

    Jodi Lindsey, JD

    Senior Director & Head of US Healthcare Compliance, Alkermes, Former Associate Director, Commercial Compliance, Biogen, Boston, MA

    Richard Liner, JD

    Senior Counsel, Compliance and Investigations, Bayer, Whippany, NJ

    Chad Londeree

    Healthcare Industry Group Leader, SAI Global, Richmond, VA

    Pamela Lonzer, MSJ

    Ass. Dir., Medical Operations, Compliance & Controls, Alexion, Former Ass. Dir. & US Medical Advisor, Global Compliance & Risk Management, Shire, Chicago, IL

    Seth H. Lundy, JD

    Partner, King & Spalding, Washington, DC

    Ali Lyons

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

    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

    Stephanie Macholtz, JD, MBA

    Director, Compliance and Ethics, Global Medical Affairs and Business Development, Alexion Pharmaceuticals, Inc.; Former Compliance Officer, Biogen, 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

    Tara McCarthy, JD

    Partner, Dovetail Consulting Group, Former Senior Vice President, GC and Secretary at Chiasma, Former Vice President of Commercial Law at Vertex, Boston, MA

    Dennis McCloskey, JD

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

    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

    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, New York, NY

    Kathleen Meriwether, JD

    Americas Leader – Life Science, Forensic & Integrity Services, EY, Former Assistant United States Attorney, Eastern District of Pennsylvania, US Department of Justice, Philadelphia, PA

    Vahan Minassian, JD

    Director, US Promotional Monitoring Lead, Pfizer, Philadelphia, PA

    Gregory S. Moss, JD

    Senior Vice President, Deputy General Counsel, Kadmon Corporation, New York, NY

    Melissa Murphy, MBA

    Senior Compliance Specialist, Office of Ethics & Compliance, Medtronic, Minneapolis, MN

    Aneta Nastaj, MS

    Training Manager, Corporate Research and Investigations, South Quay, London, UK

    Kamleh J. Nicola, LLB

    Partner, Baker & McKenzie LLP, Toronto, Canada

    Chrisoula Nikidis

    Canadian Head of Compliance and Ethics Solutions, IQVIA; Former Executive Director, Ethics and Compliance, Innovative Medicines Canada, Ottawa, Canada

    Katherine Cartwright Norris, MPA

    Dir., Berkeley Research Group, Former Sr Dir., Compliance, NSF Health Sciences, Former Dir., Corporate Compliance, Spectranetics, Washington, DC

    Susan P. Novak

    Director, Corporate Policies Global Compliance, Celgene Corporation; Former Director of Compliance, Sandoz; Summit, NJ

    Adam Oakley

    Director, Potomac River Partners, Arlington, VA

    Josh T. O’Harra, MS, JD

    Assistant General Counsel, Eli Lilly and Company; Former Sr. Associate, King & Spalding, 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

    Tricia Van Orden

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

    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

    Roy Pollitt

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

    Perri Pomper, JD

    Director of Compliance, Clinical Genomics; Former Director, Ethics and Compliance Strategy & Education, Novo Nordisk, New York, NY

    John Seungjoo Rah, JD

    Partner at DLA Piper, Washington, DC

    Kelly N. “Nikki” Reeves, MPA, JD

    Partner, King & Spalding LLP, Washington, DC

    Francisco Ribeiro

    Senior Director & Head of US Compliance, Tesaro, Inc., Former Sr. Dir., Corporate Compliance, Biogen, Former Sr. Dir., International Markets, Sandoz, Boston, MA

    John C. Richter

    Partner, King & Spalding, Washington, DC

    Margaret Erin Rodgers-Schmidt, JD

    Partner, Morgan Lewis & Bockius, Philadelphia, PA

    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, Boston, MA

    Mark Scallon, MHA

    Senior Principal, Polaris, IQVIA Global Compliance, Richmond, VA

    Cheryl J. Scarboro, JD

    Partner, Simpson Thacher & Bartlett, Former, Chief, FCPA Unit, Enforcement Division, US SEC, Washington, DC

    Angela Schwartz, JD

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

    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

    Nicole Serena

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

    Patterson Shafer

    Managing Director, Health Care and Life Sciences, Grant Thornton, Stamford, CT

    Michael Shaw, JD

    Vice President and Compliance Officer, US Pharmaceuticals, GlaxoSmithKline, Former Senior Counsel, Office of Inspector General, US DHHS, Former PCF Co-chair, Philadelphia, PA

    Eric Siegel, JD

    Chief Compliance Officer, Jazz Pharmaceuticals, Inc., Former, Senior Investigator, City of Philadelphia Office of the Inspector General, Philadelphia, PA

    Laura (Munns) Skinner, MBA

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

    Jon Smollen, MA, JD

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

    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

    Tim Stow, JD

    Senior Vice President and Head of Legal International, Shire, Former VP, Head of Legal Europe, International & Asia Pacific, UCB, Boston, MA

    Silvija A. Strikis, JD

    Partner, Kellogg Hansen Todd, Figel & Frederick, Former Law Clerk, Justice Sandra Day O’Connor, US Supreme Court, Washington, DC

    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, New York, NY

    Ann-Marie Tejcek, MA

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

    Bryan Timer, MA Business Analytics

    Director, Data Analytics & Transparency, Merck, North Wales, PA

    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

    Brian Van Hoy

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

    Jennifer Vondee, MPH

    Manager, Pharmaceutical & Life Sciences Risk Consulting, PwC, Durham, NC

    Julie Ritchie Wagner, JD

    Assistant General Counsel, PhRMA; Former Senior Counsel, Office of Counsel to the Inspector General, US DHHS; 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

    Sarah Whipple, JD

    Senior Corporate and Compliance Counsel, Akebia Therapeutics, Inc., Former VP, Global Compliance & Privacy Officer, Aegerion, Former CCO and Assoc. GC, AMAG, Boston, MA

    Donna White

    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, West Chester, PA

    Jonathan Wilkenfeld, MBA

    Partner, Potomac River Partners, 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

    Kathryn “Katie” E. Winson

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

    Christina Woods

    Manager, Pharmaceutical and Life Sciences Advisory, PwC, New York, NY

    2018-2019 GLOBAL PHARMA COMPLIANCE CONGRESSES


    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

    THIRTEENTH INTERNATIONAL PHARMACEUTICAL AND MEDICAL DEVICE COMPLIANCE CONGRESS

    Sponsored by International Society of Healthcare Compliance Professionals (ETHICS)
    Media Partners: Life Sciences Compliance Update
    April 8 – 10, 2019
    Grand Hyatt Athens
    Athens, Greece
    www.InternationalPharmaCongress.com

    NINTH 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, 2019
    Shanghai, China
    www.AsianPharmaCongress.com


    A HYBRID CONFERENCE AND INTERNET EVENT