A HYBRID CONFERENCE AND INTERNET EVENT

20th Annual Pharmaceutical and Medical Device Compliance Congress

MANDARIN ORIENTAL • WASHINGTON, DC
NOVEMBER 6 – 8, 2019


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THE 2019 20TH ANNUAL PHARMACEUTICAL AND MEDICAL DEVICE COMPLIANCE CONGRESS CONTENT IS NOW AVAILABLE IN VARIOUS POST CONFERENCE FORMATS

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FEATURING INVITATION-ONLY:
CHIEF COMPLIANCE OFFICER ROUNDTABLE

(Jointly Sponsored by PCF and PhRMA; Special November 6 Morning Session, Invitation-only)

FEATURING

Sally Molloy, JD

Chief, Strategy, Policy & Training Unit, Fraud Section, Former Assistant U.S. Attorney, US Attorney’s Office, Northern District of Georgia, US Department of Justice, Washington, DC

KEYNOTE SPEAKERS

Thomas W. Abrams, RPh, MBA

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

Brian Allen Benczkowski, JD

Assistant Attorney General, Criminal Division, US Department of Justice; Former Principal Deputy Assistant Attorney General for Legislative Affairs; Former Republican Staff Director, Committee on the Judiciary, US Senate; Former Staff, Senator Pete Domenici and Representative Jim Sensenbrenner, Washington, DC

Alexandra Christina, Countess of Frederiksborg

Member, Board of Directors – Chairperson Ethics and Compliance Board Committee, Ferring Pharmaceuticals, Co-author, The Sincerity Edge, Former Poling Chair of Business and Government, Kelley School of Business, Indiana University, Copenhagen, Denmark

Susan Dentzer

Visiting Fellow, Duke-Margolis Center for Health Policy, Former Editor in Chief, Health Affairs, Former Health Correspondent, PBS NewsHour, Washington, DC

Mary E. Riordan, JD

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

A KEYNOTE PANEL ON LESSONS LEARNED FROM
20 YEARS OF PHARMA & DEVICE INVESTIGATIONS,
PROSECUTIONS, ETHICS & COMPLIANCE WITH

Douglas M. Lankler, JD

Executive Vice President, General Counsel, Pfizer, Former Assistant US Attorney, Southern District of New York, US Department of Justice, New York, NY

Daniel Ronald Levinson, JD

Former Inspector General, US Department of Health and Human Services, Former Inspector General, US General Services Administration, Former Chairman, US Merit Systems Protection Board, Former General Counsel, US Consumer Product Safety Commission, Washington, DC

Lori Queisser

Senior Vice President and Global Chief Compliance Officer, Teva Pharmaceuticals; Former Sr. VP Global Compliance and Business Practices; Schering-Plough Corporation; Former Vice President, Chief Compliance Officer, Eli Lilly; Former Member, PCF Executive Committee, Horsham, PA

Arjun Rajaratnam, JD, MS

Chief Compliance Officer, Smith & Nephew; Former Compliance Officer, US Pharmaceuticals, GlaxoSmithKline; Former Member, PCF Executive Committee; Raleigh, NC

James Sheehan, JD

Chief, Charities Bureau at Attorney General of New York, Former Chief Integrity Officer, Executive Deputy Commissioner, City of New York Human Resources Administration, Former NY Medicaid Inspector General, Former Associate United States Attorney, US Attorney’s Office for the Eastern District of Pennsylvania, New York, NY

Susan Winkler, JD, MA

Founder, Winkler Law LLC; Former Assistant US Attorney and Head, Health Care Fraud Unit, US Attorney’s Office for the District of Massachusetts, Boston, MA

Kris Curry, MBA

Principal, Assurance Services, EY, Former Vice President, Global Chief Compliance Officer, Pharma Sector, Johnson & Johnson, Philadelphia, PA (Moderator)

THE ANNUAL CCO ROUNDTABLE WITH

Charlene E. Davis, JD

Vice President & Chief Compliance Officer, Aerie Pharmaceuticals, Inc.; Former Senior Compliance Counsel and Senior Director, Corporate Compliance and Compliance Operations, Otsuka Pharmaceutical, Princeton, NJ

Adam Dubow, JD

Global Chief Compliance and Ethics Officer, Bristol-Myers Squibb, Princeton, NJ

Keith Korenchuk, MPH, JD

VP and Chief Compliance Officer Danaher Diagnostics and Beckman Coulter Diagnostics, DANAHER Corporation; Former Partner, Arnold & Porter Kaye Scholer; Chevy Chase, MD

Dominique Laymand, JD

Executive Vice President, Chief Ethics and Compliance Officer, Ipsen; Honorary President, International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France

Sunitha Ramamurthy, JD

Head of Compliance, Loxo Oncology, wholly owned subsidiary of Eli Lilly; Former Executive Director, Office of Ethics and Compliance, Boehringer Ingelheim Pharmaceuticals; Stamford, CT

Thomas J. Schumacher, JD

Vice President and Global Chief, Ethics and Compliance Officer, Medtronic, Fridley, MN

Paul Silver

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

THE ANNUAL DOJ AND SEC FCPA
ENFORCEMENT UPDATE WITH

Robert I. Dodge, JD

Assistant Director, FCPA Unit, US Securities & Exchange Commission, Former Assistant U.S. Attorney, US Attorney’s Office, Western District of Michigan, Former Assistant Section Chief, Environmental Defense Section, US Department of Justice, Washington, DC

David Last, JD

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

Gary F. Giampetruzzi, JD

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

THE ANNUAL AUSA ROUNDTABLE WITH

John Claud, JD

Assistant Director, Consumer Protection Branch, US Department of Justice, Washington, DC

Rachael A. Honig, JD

First Assistant U.S. Attorney, U.S. Attorney’s Office, District of New Jersey, US Department of Justice; Former Corporate Counsel, Litigation, Celgene; Newark, NJ

Amanda Masselam Strachan, JD

Assistant US Attorney and Chief, Health Care Fraud Unit, US Attorney’s Office, District of Massachusetts, US Department of Justice, Boston, MA

John T. Bentivoglio, JD

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


AND A FRIDAY, NOVEMBER 8 INDUSTRY-ONLY
BEST PRACTICES ROUNDTABLE

(Industry-only session for pharma and medical device compliance
professionals and in-house counsel only)

FEATURING

Jacob T. Elberg, JD

Associate Professor of Law, Seton Hall Law School, Former Chief, Health Care & Government
Fraud Unit and Assistant US Attorney, US Attorney’s Office, District of New Jersey, US
Department of Justice, Newark, NJ


AGENDA AT A GLANCE

WEDNESDAY, NOVEMBER 6

7:45 am
AN INVITATION-ONLY CCO ROUNDTABLE
Hosted by the PCF and the PhRMA CCO Working Group
8:00 am
PRECONFERENCE SESSIONS:
— Risk Assessment Recommendations Based on DOJ Updated Guidance
— Third Party Interactions, Including Distributors and Non-Distributor 3rd Party Vendor Compliance (begins at 10:00 am)
— Investigations: Interconnectivity of Auditing, Monitoring, and Investigations, Including Privilege
— Emerging Role of Analytics, Big Data & AI Opportunities for Life Sciences…
1:00 pm
OPENING PLENARY SESSION:
— Welcome and Introduction: PCF Co-chairs
— 20th Anniversary Dialogue: Lessons Learned
— Keynote: OIG Update
— US DOJ Keynote
— FDA Keynote
— What Pharma/Medical Device Industries Can Learn from the Opioid Cases
— Annual Chief Compliance Officer Roundtable

THURSDAY, NOVEMBER 7

7:30 am
BREAKFAST WORKSHOPS:
— Compliance Considerations for Gene Therapy and Ultra Rare Disease Products
— HCP Contracting—Benchmarking and Lessons Learned…
— Navigating Drug Price Transparency Laws…
8:30 am
MORNING PLENARY SESSION:
— Co-chair Welcome and Introductions
— Keynote by Alexandra Christina, Countess of Frederiksborg
— US DOJ and US SEC Update on FCPA Enforcement
— AUSA Roundtable
11:15 am
MINI SUMMITS
— Prosecuting Illegal Kickbacks: The Cost of Noncompliance
— Reduce Compliance Risk Using a “Portfolio” Approach to Training! (Microlearning Alone is Not the Answer)
— Setting Your Five-Year Strategic Compliance Plan
— Interactions with Patients Including Benchmarking on Patient Services Compliance
— Enhanced Compliance Monitoring
— Best Practices Calculating Profit Disgorgement in Preparation for Compliance Settlements
— Annual Medical Device Roundtable
— Lessons Learned from Enforcement Actions
— Compliance Program Operations: Building Effective and Right Sized Compliance Programs
— Value-Based Arrangements
— Challenges and/or Considerations When Performing a Fair Market Value (FMV) Analysis
— Patient Support Programs – Helping Patients Access Products
— Issues with Medical Device/Combination Products
— Charitable Contributions Compliance Considerations
— How do you Modernize your Compliance Program to Prepare for the Future of Health?
— Medical Affairs Proactive Communications, Engagement by Manufacturers
— HCP Engagement and Transparency Perspectives
— Compliance – Board Communications: Effective Measurement and Reporting Strategies
— Best Practices when Transitioning from Healthcare Compliance Risk to Enterprise Risk Assessments
— Medical Device Asset Management Risk Considerations
— Responding to CCPA, GDPR and the Tumultuous World of Data Privacy
— Social Media Engagement by Manufacturers
— Conducting R&D Compliance Risk Assessments
— Ensuring a Smooth Transition of Compliance Programs During Mergers & Acquisitions
— Investigations: Properly Executing a Compliance Investigation Initiated by a Whistleblower
— Compliance Interactions with Specialty Pharmacies
— Practice Development Programs (e.g., Free or Discounted Marketing Services)
4:45 pm
CLOSING PLENARY SESSION
— Developments in Pharmaceutical and Medical Device Pricing and Cost Containment…
— The Changing Face of the Qui Tam

FRIDAY NOVEMBER 8

8:30 am
INDUSTRY-ONLY BEST PRACTICES ROUNDTABLE
Featuring Jacob T. Elberg, JD

FEATURED FACULTY

Punkaj T. Amin, MS, MBA

Compliance Officer, US Wound Management and US Privacy Officer, Smith & Nephew, Fort Worth, TX

Meredith S. Auten, JD

Partner, Morgan Lewis, Co-chair, White Collar Committee Qui Tam Subcommittee, ABA Criminal Justice Section, Philadelphia, PA

Timothy Ayers, JD, MPH

Founder, Life Science Compliance Consulting, LLC, Former VP, Chief Compliance Officer, Horizon Pharma plc., Oklahoma City, OK

Samantha Barrett Badlam, JD

Counsel, Ropes & Gray, Washington, DC

Yogesh Bahl, CPA, MBA

Managing Director, AlixPartners, New York, NY

Minna Bak, MBA

Senior Manager, Helio Health Group, 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, Former Special Assistant United States Attorney, US Attorney’s Office, Eastern District of Michigan, Minneapolis, MN and Washington, DC

Kathleen M. Boozang, JD, LLM

Dean and Professor of Law, Seton Hall University School of Law, Newark, NJ

Diana Borges, MBA

Vice President, Compliance Solutions, MediSpend, Miami, FL

Bernadette M. Broccolo, JD

Partner, McDermott Will & Emery LLP, Chicago, IL

Keith Burn

Global Investigations Director, Ipsen; Former Associate Investigator, Parliamentary and Health Service Ombudsman, NHS, Former Detective Constable, London Metropolitan Police, Amersham; Slough, UK

Joseph Calarco

Chief Compliance Officer, NEOS Therapeutics, Blue Bell, PA

Christie Camelio

Vice President, Deputy Global Chief Compliance Officer, Celgene, Former Executive Director, Head of Risk Management Center of Excellence, Novartis Pharmaceuticals, Florham Park, NJ

Masha Chestukhin, MSJ

Associate Director, Compliance Officer R&D IA, FMV, Sanofi Genzyme, Jamaica Plain, MA

Jennifer Chillas, JD

Senior Corporate Counsel, Bristol-Myers Squibb, New York, NY

Michael R. Clarke, CCEP, JD

Vice President, Global Chief Compliance Officer, ConvaTec, Former Vice President, Corporate Compliance, Indivior, Inc., Bridgewater, NJ

Thomas Costa, JD

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

Jared D. Crafton

Principal, Assurance Services, Forensic & Integrity Services, EY, Boston, MA

Tiffany Cummings-Damiani, MBA

Vice President, Corporate and Healthcare Compliance, Global Compliance, Insmed, Former Senior Director, Global Compliance, Teva, Philadelphia, PA

Meenakshi Datta, JD

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

BJ D’Avella, MBA

Senior Manager, Deloitte Advisory, Deloitte & Touche LLP, New York, NY

Danielle Davis, LLB

Director, Compliance Counsel, Heron Therapeutics, Inc; Former Senior Director Compliance, Sentynl Therapeutics; Phoenix, AZ

CJ DeKreek, CFA

Senior Director, Ankura, Atlanta, GA

Julie DeLong, CFA

Senior Managing Director, Ankura Consulting Group, LLC, Atlanta, GA

Noël (Giglio) Denice, JD

Legal Counsel, Legal Compliance, Philips North America, LLC, Andover, MA

Mark A. DeWyngaert, PhD

Managing Director, Deloitte Advisory, Deloitte & Touche LLP, Stamford, CT

Sarah diFrancesca, JD

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

Christian A. Dingler

Associate Director, Navigant, Life Sciences, Richmond, VA

Stefanie A. Doebler, JD

Of Counsel, Covington & Burling LLP, Washington, DC

Kip F. Ebel, MBA

Principal, Forensic and Integrity Services, EY

Eileen Erdos

Principal, Forensic & Integrity Services, EY, Chicago, IL

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, NJ

Elaina Filauro

Senior Manager, Deloitte Advisory, Deloitte & Touche LLP, New York, NY

Jeffrey (Jeff) Fleming, JD

Assistant General Counsel, Pharma R&D, GlaxoSmithKline, Philadelphia, PA

Maya P. Florence, JD

Partner, Health Care and Life Sciences, Skadden Arps LLP, Boston, MA

Sarah A. Franklin, JD

Partner, and Vice-chair, Life Sciences Litigation and Investigations, Covington & Burling LLP, Former Attorney, Bureau of Consumer Protection, FTC, Washington, DC

Nereyda Garcia, JD

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

Deeona R. Gaskin, MPH, JD

Associate, Sidley Austin LLP, Former Associate Chief Council, FDA, Washington, DC

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

Abraham Gitterman, JD

Senior Associate, Life Sciences/Healthcare Regulatory, Arnold & Porter LLP; Publications Peer Review Committee, Food and Drug Law Institute (FDLI); Washington, DC

Thomas M. Glavin, JD

Chief Compliance Officer for the Americas, Olympus Corporation of the Americas; Former Vice President, US/Americas Compliance Officer, Shire, Center Valley, PA

Jonathan Glazier, MBA, JD

Head of Legal Compliance, Philips North America, Former Sr Director of Corporate Compliance and Privacy Officer, Fresenius Medical Care North America, Andover, MA

Betania Glorio, LLM

Global Compliance Officer, Healthcare, Merck KGaA, Darmstadt, Germany

Kimberly J. Gold, JD, CIPP/US

Partner, Life Sciences Health Industry and Data Privacy Groups, Reed Smith, New York, NY

Wendy C. Goldstein, JD

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

Christine Gordon, JD

Deputy Chief Compliance Officer, Olympus Corporation of the Americas; Director, Board of Directors, ESSA Bancorp, Inc; Former Assistant District Attorney, Office of the District Attorney, City of Philadelphia, Bethlehem, PA

Kimi Gorman, CCEP, CFE

Sr. Director, Ethics & Compliance – Operations & Government Accountability, Monitoring & Auditing, Novo Nordisk Inc.; Former Compliance Manager, B. Braun Medical; Princeton, NJ

Adam Greene, JD, MPH

Partner and Co-chair, Health Information & HIPAA Practice, Davis Wright Tremaine LLP, Former Senior Health Information Technology and Privacy Specialist, Office for Civil Rights, HHS, Washington, DC

Christine Handel, JD

Vice President, Global Compliance Operations, Walgreens Boots Alliance, Deerfield, IL

David Heard, JD

Senior Corporate Counsel, Pfizer Inc., Dallas, TX

Michael G. Hercz, JD

Senior Vice President & General Counsel, Sentynl Therapeutics, Inc., Solana Beach, CA

Casey J. Horton, CFE

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

William Hrubes, MS

Vice President and Chief Compliance Officer, ACell, Inc. Former Healthcare Compliance Officer, DePuy Orthopaedics, Columbia, MD

Pearl Hsieh, JD

Senior Counsel, US Commercial, Group Counsel, Smith & Nephew, Columbia, MD

Franziska Janorschke

Global Head, Business Practices Office, Novartis International AG, Basel Area, Switzerland

Elizabeth Jobes, JD

Senior Vice President, Chief Compliance Officer North America, EMD Serono, Inc; Former PCF Co-chair; Boston, MA

Karen Johnson, MBA

Executive Director, Compliance and Ethics, Corporate Ombudsman, Bristol-Myers Squibb, Princeton Pike, NJ

Paul Johnson, JD

Executive Director, US Healthcare Compliance, Amgen, Los Angeles, CA

Darren R. Jones, CIA

Senior Principal, Commercial Compliance, Global Consulting Practice Leader, IQVIA, New York, NY

Marci Juneau, MBA

Partner, Helio Health Group, Atlanta, GA

Shannon Kelley, JD

Vice President, Head of North America Compliance, Sanofi, Former Assistant US Attorney and Deputy Chief of Litigation, Boston US Attorney’s Office, US Department of Justice, Cambridge, MA

Elizabeth “Beth” Kolbe, JD

Associate, Sidley Austin LLP, Washington, DC

Joanne Kwan, JD, PhD

Corporate Counsel, Commercial, Exelixis, San Francisco, CA

Cheryl Lee, MBA

Vice President, Worldwide Markets Healthcare Compliance, Global Compliance, Celgene Corporation, Summit, NJ

Puja Leekha, JD

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

Richard Liner, JD, MPH

Senior Counsel, Compliance & Investigations, Bayer Healthcare, Whippany, NJ

Mark Linver, MS

Managing Director, Deloitte & Touche LLP, Stamford, CT

Carrie Sarhangi Love, JD

Litigation Partner, Armstrong Teasdale LLP; Former Assistant District Attorney, Philadelphia; Philadelphia, PA

Seth H. Lundy, JD

Partner, King & Spalding, LLP, Washington, DC

Ali Lyons

Senior Director, Ethics & Compliance, Aegerion Pharmaceuticals, a Novelion Therapeutics Company, Former Operations Lead, Ethics and Compliance, Eli Lilly and Company, Cambridge, MA

Nicholas Mandala

Senior Director, Medical Devices Technical Program Lead, Pfizer, Inc., New York, NY

Susan Markel

Managing Director, AlixPartners, Former Chief Accountant, Division of Enforcement, US Securities and Exchange Commission, Washington, DC

Joshua Marks, JD

Vice President, Chief Ethics & Compliance Officer, Boehringer Ingelheim, Ridgefield, C

Heather McCollum, JD, MHA, CCEP-I

Director Compliance, Shionogi Inc., Florham Park, NJ

William A. McConagha, JD

Partner, Sidley Austin, LLP, Former Health Policy Advisor, Health, Education, Labor and Pensions Committee, US Senate, Former Assistant Commissioner, FDA, Washington, DC

Jean McKiernan, MBA

Managing Director, Dovetail Consulting Group, LLC, Chicago, IL

Jenny McVey, PhD

Associate Director, Risk Strategy and Mitigation, Novo Nordisk, Inc., Former Compliance Officer, Hands International, Princeton, NJ

Paul J. Melling, MA

Partner, Baker McKenzie Moscow, Moscow, Russia

Vahan Minassian, JD

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

Gregory S. Moss, LLB

Executive Vice President, General Counsel and Corporate Secretary, Chief Compliance Officer, Kadmon Holdings, Inc., New York, NY

Brad Mroski, CPA, CFE

Managing Director, AlixPartners; Former Assistant Chief Accountant, Division of Enforcement, U.S. Securities & Exchange Commission; Dallas, TX

Kamleh J. Nicola, LLB

Partner, Baker & McKenzie LLP, Toronto, Canada

Katherine Norris, MPA

Director, Corporate Compliance & Risk Management, Berkeley Research Group LLC, Washington, DC

Dan O’Connor

Senior Vice President, PharmaCertify, a Division of NXLevel Solutions, New York, NY

Michael O’Connor

Vice President of Compliance Technology, Porzio Life Sciences, LLC, Former Global Head Compliance and Ethics Operations, Alexion, Former Executive Director, Global Head, IS Business Consulting, Boehringer Ingelheim, New York, NY

Josh Tomas O’Harra, MS, JD

Assistant General Counsel, Eli Lilly and Company, Washington, DC

Casper Partovi, JD

Vice President, Global Commercial Operations Law Group, Los Angeles, CA

Gregory Paw, JD

Partner, Freeh, Sporkin & Sullivan, Former Director, New Jersey Division of Criminal Justice, Former Assistant US Attorney, US Attorney’s Office, Eastern District of Pennsylvania, New York, NY

Amy Pawloski, CPA, PMP, CCEP

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

Kelliann H. Payne, JD

Partner, Hogan Lovells LLP, Former Assistant General Counsel at QVC, Inc., Philadelphia, PA

Patrick Phelan, JD

Partner, Covington & Burling LLP, Washington, DC

Erica Powers

Director, Compliance Operations, Sage Therapeutics, Former Director Corporate Compliance, Vertex, Cambridge, MA

Kristin Rand, JD, MA

Vice President and Compliance Officer, Seattle Genetics, Former Compliance Director, Policy, Ethics, Training & Communication, Genentech, New York, NY

Marc Stephen Raspanti, JD

Partner, Pietragallo Gordon Alfano Bosick & Raspanti, LLP, Co-chair, White Collar Committee Qui Tam Subcommittee, ABA Criminal Justice Section, Philadelphia, PA

Kelly N. “Nikki” Reeves, MPA, JD

Partner and Co-chair, Life Sciences and Healthcare Industry Group, King & Spalding LLP, Washington, DC

Chapman Richardson

Global Head, Data Consumerization, Sanofi; Former Global Head Next Generation Digital, Novartis; Bridgewater, NJ

John C. Richter, JD

Partner, King & Spalding, Former Acting Assistant Attorney General, Criminal Division , US Department of Justice, Former US Attorney, Western District of Oklahoma, Washington, DC

Ashley Riley, JD

Senior Manager Deloitte Advisory, Deloitte & Touche LLP, Charlotte, NC

Tim Robinson, JD

Chief Legal and Privacy Officer, MediSpend, Portsmouth, NH

Angela Rodin, MBA

Principal, KPMG, Former Vice President, Global Head of Investigations and Monitoring, GlaxoSmithKline Pharma GmbH, Washington, DC

Oscar Rodriguez

Senior Director, Innovation & Technology, BlackThorn Therapeutics; Co-chair, Technology and Standards Subcommittee, The Alliance for Artificial Intelligence in Healthcare (AAIH), New York, NY

Mark Scallon, MHA

Senior Principal, IQVIA Global Compliance, Richmond, VA

Katie Schottmiller, MAcc, MS, CPA

Director, North America Independent Business Monitoring, GSK, Raleigh-Durham, NC

Jessica C. Sergi, JD

Senior Legal Counsel, Neurology & Immunology, EMD Serono, Rockland, MA

Laura Skinner, MBA

Senior Manager, Deloitte Advisory, Deloitte & Touche LLP, Austin, TX

Edward Sleeper, MS

Director, Global Healthcare Compliance Learning & Communications, Celgene, Summit, NJ

David Earl Smith, MBA

Advisor Ethics & Compliance, Eli Lilly & Company, Indianapolis, IN

Jack Tanselle, MBA

Managing Director, Deloitte & Touche LLP, Indianapolis, IN

Meredith Taylor, JD

Vice President Global Compliance and Privacy, Novocure, Malvern, PA

Ann-Marie Tejcek, MA

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

Bryan Timer, MS

Director, Data Analytics & Transparency, Merck & Co., Inc., Kenilworth, NJ

Nancy S. Travis, MS

Vice President, International Compliance and Governance, Advanced Medical Technology Association (AdvaMed), Washington, DC

Jonathan Turner, MSc

Vice President, Global Compliance Leader, Smith & Nephew; Adjunct Faculty, Florida State University and University of Memphis; Association of Certified Fraud Examiners, Memphis, TN

Sarah Venable, JD, MS

Risk Analytics Manager, Independent Business Manager, GlaxoSmithKline, Raleigh, NC

Rena Verma, MBA

Senior Managing Director, Information Governance, Privacy and Security Practice, FTI Consulting, New York, NY

Julie Ritchie Wagner, JD

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

Richard H. Walker, JD

Partner, King & Spalding; Former Director of Enforcement, US Securities and Exchange Commission; New York, NY

John B. Weiner, JD

Associate Director for Policy and Product Classification Officer,Office of Combination Products, FDA, Silver Spring, MD

Beth Weinman, JD

Counsel at Ropes & Gray LLP; Former Associate Chief Counsel, FDA; Washington, DC

Elizabeth Weiss, JD

Chief Compliance Counsel for Patient Support Services and Payer Access, Pfizer, Peapack, NJ

Caroline West, JD

Global Chief Compliance Officer, Olympus Corporation, Former Sr. VP , Chief Compliance and Risk Officer, Shire, Former VP Global Legal Compliance, Aventis, Philadelphia, PA

Sarah L. Whipple, JD

Vice President, Legal & Chief Compliance Officer, Akebia Therapeutics, Inc., Cambridge, MA

Christopher L. White, JD

Chief Operating Officer and General Counsel, Advanced Medical Technology Association (AdvaMed), Washington, DC

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

Jonathan Wilkenfeld, MBA

Partner, Potomac River Partners, Washington, DC

Catherine Williams, JD

Director – Privacy Office, Novo Nordisk, Former Assistant General Counsel, Privacy & K-12, Corrections & Leisure, Aramark, Plainsboro, NJ

Susan Williamson, MBA, CPA

Senior Vice President & Chief Compliance Officer, Endo Pharmaceuticals, Philadelphia, PA

Heather Young, JD

Compliance Officer – Director for Olympus Corporation of the Americas; Former Assistant District Attorney, Office of the District Attorney, City of Philadelphia, Philadelphia, PA

Mark Zaleski, MBA

Director Legal Compliance, Philips; Former Senior Finance Manager, Intel Corporation, Boston, MA

Mehreen Zaman, JD

Senior Attorney, Novo Nordisk; Former Director of Investigations, Endo Pharmaceuticals; Plainsboro, NJ


2019-2020 GLOBAL PHARMA COMPLIANCE CONGRESSES


TWENTIETH ANNUAL PHARMACEUTICAL AND MEDICAL DEVICE COMPLIANCE CONGRESS

A Hybrid Conference and Internet Event
Sponsored by Pharmaceutical Compliance Forum
Media Partners: Harvard Health Policy Review, Health Affairs and Policy & Medicine Compliance Update
November 6 – 8, 2019
Mandarin Oriental, Washington, DC
www.PharmaCongress.com

FOURTEENTH INTERNATIONAL PHARMACEUTICAL AND MEDICAL DEVICE COMPLIANCE CONGRESS

Sponsored by International Society of Healthcare Compliance Professionals (ETHICS)
Media Partner: Policy & Medicine
Compliance Update
April 20 – 22, 2020
Sheraton Munich Arabellapark Hotel
Munich, Germany
www.InternationalPharmaCongress.com