Join Representatives of over 225 Organizations Attending the PCF Virtual 21st Anniversary Pharmaceutical and Medical Device Compliance Congress
  • Virtual Online Video Event Live and 6 Months Access to Video Archive
  • Sponsored by the Pharmaceutical Compliance Forum
  • Media Partners: Harvard Health Policy Review, Health Affairs and Life Sciences Compliance Update
  • November 4 - 6, 2020
  • www.PharmaCongress.com

PRESS RELEASE
Phone: 800-503-7419
Email: reginfo@hcconferences.com
Website: www.PharmaCongress.com
AGENDA NOW AVAILABLE
Click here to view the agenda.

SPECIAL PCF REGISTRATION DISCOUNTS
Click here for PCF member reg discounts.


JOIN REPRESENTATIVES OF OVER 225 ORGANIZATIONS ATTENDING THE PCF PHARMA CONGRESS
  • 3M Company
  • Abbott Laboratories
  • Abbvie
  • ABIOMED
  • Acadia
  • Acell
  • Aclaris Therapeutics
  • Adaptimmune Therapeutics
  • Advanced Medical Technology Association
  • Aerin Medical
  • Aesculap
  • Akebia Therapeutics
  • Alexion
  • AlixPartners
  • Alkermes
  • Allergan Aesthetics, an Abbvie Company
  • Almirall, US
  • Alnylam
  • Amarin
  • Amgen
  • Amicus Therapeutics
  • Amryt
  • Aquestive Therapeutics
  • Argenx
  • Arthrex
  • ASP
  • Astellas
  • AstraZeneca
  • Attorney General of New York
  • Aurinia
  • Aurobindo
  • Avanir
  • AveXis
  • Azurity
  • B. Braun Medical
  • Baker & McKenzie
  • Bausch Health
  • Baxter Healthcare
  • Bayer
  • Bayer International
  • Beasley School of Law, Temple Law
  • Beckman Coulter Diagnostics
  • BeiGene
  • Berkeley Research Group
  • BioCryst
  • BioMarin
  • Bioventus
  • Blueprint Medicines
  • BMS
  • Boehringer Ingelheim
  • Boston Scientific
  • Bristol Myers Squibb
  • Cardinal Health
  • Chiesi USA
  • Choate, Hall & Stewart
  • Clovis Oncology
  • Coloplast A/S
  • Convatec
  • Cook Medical
  • Covington & Burling
  • Craig B. Bleifer
  • CSL Behring
  • Cutting Edge
  • Cycle
  • Daichi Sankyo
  • Danaher Diagnostics
  • Davis Wright Tremaine
  • Deloitte
  • Dermira
  • Dinsmore & Shohl
  • DJO Global
  • DLA Piper
  • Dova Pharmaceutical
  • Dr. Reddy's Laboratories
  • DSLR
  • Duke-Margolis Center for Health Policy
  • Edwards Life Sciences
  • Eli Lilly
  • EMD Serono
  • Endo
  • Epizyme
  • Esperion
  • Ethicon
  • Exelixis
  • Exsurco Medical
  • EY
  • F. Hoffman-La Roche
  • Ferring
  • Foamix
  • Fresenius Medical Care
  • Front-Line Anti-Bribery
  • Genentech
  • Gilead Sciences
  • GlaxoSmithKline
  • Greenwich Biosciences
  • Grifols
  • Grunenthal Group
  • Guidehouse
  • Haemonetics
  • Helio Health Group
  • Helsinn Therapeutics, U.S.
  • Heron Therapeutics
  • Hogan Lovells
  • Horizon
  • Idorsia
  • Incyte
  • Indivior
  • Inova Diagnostics
  • Insmed
  • Instrumentation Laboratory Company
  • Integra LifeSciences Corporation
  • Intercept
  • Ipsen
  • IQVIA
  • Jazz
  • Johnson & Johnson
  • JUUL Labs
  • Kadmon Holdings
  • Kaleo
  • Karl Storz
  • Karyopharm Therapeutics
  • King & Spaulding
  • Kyowa Kirin North America
  • Legend Biotech
  • Leo
  • Lextegrity
  • Loxo Oncology
  • Lumos
  • Lundbeck
  • Mallinckrodt
  • Massachusetts Biotechnology Council
  • Mayne
  • Medday
  • Medicem
  • Medicines360
  • MediSpend
  • Medline Industries
  • Medtronic
  • Menarini International
  • Merck
  • Merz Aesthetics
  • Mesoblast
  • Miach Orthopaedics
  • MiMedx
  • MMB Healthcare Portfolio of Life Science Companies
  • Moderna
  • Mylan
  • Nabriva Therapeutics
  • National Pharmaceutical Council
  • Neurocrine Biosciences
  • North Highland
  • Novartis
  • Novo Nordisk
  • Novocure
  • Office of Inspector General, HHS
  • Olympus
  • Ortho Clinical Diagnostics
  • OrthoFix
  • Osmotica
  • Otsuka
  • Paratek
  • Paul Hastings
  • Pfizer
  • PharmaCertify
  • Philips
  • PhRMA
  • PolarityTE
  • Porzio Life Sciences
  • PTC Therapeutics
  • Puma Biotech
  • Purdue
  • Radius Health
  • Reata
  • Reckitt Benckiser
  • Regeneron
  • Relypsa
  • ResMed Corp.
  • Romark Laboratories
  • Ropes & Gray
  • Sage Therapeutics
  • Sanofi Genzyme
  • Saol Therapeutics
  • Sarepta Therapeutics
  • Seattle Genetics
  • Sekisui Diagnostics
  • Sentynl Therpeutics
  • Servier
  • Seton Hall University Law School
  • Shionogi
  • Sidley Austin
  • Siemens
  • Skadden Arps
  • Smith & Nephew
  • Spark Therapeutics
  • Stanford University
  • Stealth BioTherapeutics
  • STERIS
  • Strategic Versatility
  • Strongbridge Biopharmaceutical
  • Stryker
  • Sumitomo Dainippon Pharma
  • Takeda
  • Teleflex
  • TerSera Therapeutics
  • Terumo BCT
  • Teva
  • TG Therapeutics
  • TherapeuticsMD
  • Theravance
  • UCB
  • Ultragenyx
  • United Therapeutics Corporation
  • Upsher-Smith Laboratories
  • UroGen
  • US Attorney's Office, District of New Jersey
  • US Attorney's Office, Southern District of New York
  • US Department of Justice
  • US Food and Drug Administration
  • US Healthcare Supply Co.
  • US Securities & Exchange Commission
  • Veloxis
  • Vertex
  • VMS BioMarketing
  • Vyera
  • W.L. Gore and Associates
  • Whitelaw Compliance Group
  • Wright Medical Group
  • Ximedica
  • Zealand US
  • Zimmer Biomet Holdings
  • Zimmer GmbH
  • Zogenix
  • Zoll Medical Corporation

WASHINGTON, DC USA -- PHARMA UPDATE NEWS SERVICE™ -- OCTOBER 14, 2020: The 21st Anniversary Pharmaceutical and Medical Device Compliance Congress, www.PharmaCongress.com, to be held November 4 - 6, 2020 as a fully virtual event, today announced the conference dates and a call for presentation proposals.

UPDATED AGENDA AT A GLANCE
(sessions subject to change)
WEDNESDAY, NOVEMBER 4
CONCURRENT CCO ROUNDTABLE AND MINI SUMMITS I & II

INVITATION-ONLY, CLOSED CCO ROUNTABLE (10 am EST - 12:15 pm EST)
10:00 am Welcome & Introductions
10:10 am Leveraging AI, Predictive Analytics and Other Technologies to Conduct Oversight and Enforcement
10:40 am PhRMA and AdvaMed Updates
11:00 am CCO Connection Program-Partner Experience
11:10 am Interview with the Department of Justice: Safeguarding the High-Risk Activity of Speaker Programs
11:40 am Interactive Roundtable Discussions
12:20 pm Adjournment


 MINI SUMMITS I & II



MINI SUMMITS I (10 am EST - 11 am EST)
  • I: State-of-the-Art Compliance Training (in Dynamic Times)
  • II: Compliance Challenges with Digital Health Applications
  • III: Key Considerations and Best Practices in Operationalizing Speaker Programs
  • IV: Privacy, GDPR and California Consumer Privacy Act - What’s Next

 MINI SUMMITS II (11 am EST - 12:15 pm EST)
  • V: Third Party Management Beyond Due Diligence: Selecting, Integrating and Managing Third Parties throughout the Relationship Lifecycle
  • VI: FDA Regulatory Updates for Compliance Professionals
  • VII: Best Practices in Operationalizing Updates to the Sunshine Law
  • VIII: Compliance Considerations for Rare and Ultra Rare Drugs

 OPTIONAL LIVE INTERACTIVE TOPIC DISCUSSIONS (12:15 pm EST - 1:00 pm EST)
(Open to all; May move among sessions.)
OPENING PLENARY SESSION (1 pm EST - 5 pm EST)
1:00 pm Welcome and Introduction: PCF Co-Chairs
1:15 pm Keynote: OIG Update by Mary Riordan
2:00 pm US DOJ Keynote
3:15 pm FDA Keynote
3:45 pm Annual Chief Compliance Officer Fireside Chat
5:00 pm Adjournment
THURSDAY, NOVEMBER 5, 2020

CONCURRENT MINI SUMMITS III & IV

MINI SUMMITS III (10 am EST - 11 am EST)
  • IX: Managing Monitorships and Independent Review Organizations to Maximize Effectiveness
  • X: Building Ethics and Integrity into the Foundation of Your Compliance Program
  • XI: Annual Medical Device Roundtable
  • XII: Update on Pharma CIAs, including Changes to OIG's Model CIA Template and Insights on Agency Priorities from Recent CIA Negotiations
  • XIII: Drug Promotion from the Living Room: Navigating Interactions with HCPs and Addressing Compliance Concerns during a Pandemic
  • XIV: Changing Dynamics of State Price Transparency and Reporting Requirements

 MINI SUMMITS IV (11:15 am EST - 12:15 pm EST)
  • XV: Compliance Challenges and Opportunities for Emerging Life Sciences Organizations
  • XVI: Keeping a Pulse on Social Media Communication, Including Promotion of Products Across Borders
  • XVII: Compliance Risk Assessment Key Insights and Alignment to Enterprise Risk Management
  • XVIII: Government Enforcement Trends
  • XIX: Best Practices of Conducting Investigations
  • XX: Patient Services Compliance Survey (Year 4) Update
PLENARY SESSION (1 pm EST - 5 pm EST)
1:00 pm PCF Co-chair Welcome and Introductions
1:15 pm Equity, Diversity and Inclusion Keynote Address
1:45 pm Implementing, Equity, Diversity, and Inclusion Roundtable
3:00 pm US DOJ and US SEC Update on FCPA Enforcement
3:45 pm Advanced Patient Engagement Strategies
4:30 pm Adjournment
FRIDAY, NOVEMBER 6, 2020

CONCURRENT MINI SUMMITS V & VI


 MINI SUMMITS V (10 am EST - 11 am EST)
  • XXI: Meaningful Board Engagement and Support for Board Oversight of the Compliance Program
  • XXII: How would you Respond to the DOJ's Fundamental Question, "Does the Corporation's Compliance Program Work" in Practice?
  • XXIII: Best Practices from Enforcement Actions on Fraud and Misuse of Patient Support Programs
  • XXIV: SEC Compliance: Living in the Material (Non-Public Information) World
  • XXV: Reflections on a Successful Co-Promotion Partnership

 MINI SUMMITS VI (11:15 am EST - 12:15 pm EST)
  • XXVI: Managing Communication Issues and Leadership during a Crisis or an Emerging Post-Crisis Environment
  • XXVII: Fair Market Value Calculations, Benchmarks and New Standards in a Virtual World
  • XXIII: Compliance Monitoring in a Virtual World
  • XXIX: Fraud and Abuse Risks Related to COVID-19 Relief
  • XXX: Research and Development Compliance Challenges

CLOSING PLENARY SESSION (1 pm EST - 4 pm EST)
1:00 pm PCF Co-chair Welcome and Introductions
1:15 pm Roundtable on Implications of the Election for Lifesciences, including Pricing and Cost Containment Policy
2:00 pm Using Data Analytics and Automation to Drive Smarter, More Effective and Cost-Effective Compliance Programs
2:45 pm Annual AUSA Roundtable
3:00 pm The Post-Pandemic Compliance Department of the Future: Virtual, Ethics, Integrity and More
3:45 pm Adjournment

CO CHAIRS

Indrani Franchini, JD
Executive Vice President Chief Compliance Officer, Alexion Pharmaceuticals, New York, NY (PCF CO-Chair)
Jeffrey M. Kawalek, MBA
Deputy Chief Compliance Officer, Jazz Pharmaceuticals, Inc., Chair, Pharmaceutical Compliance Forum (PCF), Philadelphia, PA (PCF Chair)
Margaret Sparks, JD
Associate Vice President, North America Ethics and Business Integrity, Sanofi US, Bridgewater, NJ (PCF Co-Chair)


Ann Marie Tejcek
Senior Director, Chief Compliance Officer North America, Eli Lilly, Indianapolis, IN (PCF Co-Chair)
Donna White, CCEP
Vice President, Compliance, Chiesi, Cary, NC (PCF Co-Chair)
Joe Zimmerman
Vice President, Chief Compliance Officer & Privacy Officer, Ferring Pharmaceuticals, Inc., Parsippany, NJ (PCF Co-Chair)


VIRTUAL CONGRESS HIGHLIGHTS
  • New content, optimized for online learning
  • Focused on new regulatory developments
  • Managing ethics and compliance programs during the COVID 19 pandemic
  • Engage through polling, Q&A sessions, chat and direct video messaging
  • Network in real time with other attendees through direct attendee to attendee and group video messaging
  • Live and curated sessions streamed directly to you through our easy to navigate virtual platform
  • Access to an extensive video archive of past Congress presentations
  • Virtual exhibit hall featuring innovative solutions, products and services

KEYNOTE SPEAKERS

Craig Carpenito, JD
United States Attorney, US Attorney’s Office, District of New Jersey; Former Senior Counsel, Northeast Regional Office, US Securities and Exchange Commission; Newark, NJ
Gregory E. Demske, JD
Chief Counsel to the Inspector General Office of Inspector General, US Department of Health and Human Service, Washington, DC
Susan Dentzer
Visiting Fellow, Duke-Margolis Center for Health Policy; Former Editor in Chief, Health Affairs; Former Health Correspondent, PBS NewsHour; Washington, DC

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
Robert W. Dubois, MD, PhD
Interim President and CEO, National Pharmaceutical Council (NPC); Former Chief Medical Officer, Cerner LifeSciences; Washington, DC
Gustav W. Eyler, JD
Director, Consumer Protection Branch, Civil Division, US Department of Justice, Washington, DC

Catherine (Katie) Gray, PharmD
Acting Director, Office of Prescription Drug Promotion (OPDP), US Food and Drug Administration, Silver Spring, MD
Matthew J. Lash, JD
Trial Attorney, Consumer Protection Branch, US Department of Justice, Washington, DC
David Last, JD
Assistant Chief, FCPA Unit, Fraud Section, Criminal Division, US Department of Justice, Washington, DC

Andy Mao, JD
Deputy Director, Fraud Section, Civil Division, Elder Justice Initiative Coordinator, US Department of Justice, Washington, DC
Dan Mendelson, MPP
Founder, Avalere Health, Operating Partner, Welsh, Carson, Anderson & Stowe, Board, Centrexion Therapeutics Corp., 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

Gregg Shapiro, JD
Assistant US Attorney and Chief, Affirmative Civil Enforcement Unit, US Attorney's Office, District of Massachusetts, US Department of Justice, Boston, MA
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
Edie Stringfellow, MS
Director, Diversity & Inclusion, Massachusetts Biotechnology Council, Cambridge, MA

FEATURING THE ANNUAL INVITATION-ONLY CHIEF COMPLAINCE OFFICER ROUNDTABLE
November 4, 2020; Invitation-only; No Cost. CCOs interested in attending may contact Debra Scanlon, Administrator, Pharmaceutical Compliance Forum at info@pharmacomplianceforum.org.
AdvaMed UPDATE

Christopher L. White, JD
Chief Operating Officer & General Counsel, Advanced Medical Technology Association (AdvaMed), AdvaMed COVID Action Team Leader, Washington, DC
PhRMA UPDATE

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 (HHS); Washington, DC
OIG ANALYTICS/AI UPDATE

Renata Maziarz Miskell, MPS
Acting Chief Data and Analytics Officer, Office of Inspector General (OIG), US Department of Health and Human Services, Washington, DC
DOJ SPEAKER PROGRAMS UPDATE

Jake Lillywhite, JD
Assistant US Attorney, Civil Division, US Attorney's Office, Southern District of New York, US Department of Justice, New York, NY

FEATURING THE ANNUAL CHIEF COMPLIANCE OFFICER FIRESIDE CHAT WITH

Dennis K. Barnes, JD CPA
Vice President, Global Governance, Risk & Compliance, Mayne Pharma; Former Vice President, Compliance & Risk Management, Global Compliance Officer, PAREXEL International; Raleigh-Durham, NC
Mark Graves, JD, MBA
Senior Vice President and Chief Compliance Officer, MiMedx; Former Director, Global Patient Experience & Value, UCB; Former Senior Director, Pharmaceutical Products Division, Abbott; Marietta, GA
Nancy A. Grygiel, JD
Senior Vice President, Chief Compliance Officer, Amgen; Former VP Compliance, Corporate & International, Allergan; Former Senior Director Global Compliance, Mylan; Newbury Park, CA

John Knighton, JD
Chief Compliance Officer, TherapeuticsMD; Former Vice President, Head of Global Compliance, Orexigen Therapeutics; Boca Raton, FL
Tara R. Shewchuk, JD, LLM
Vice President and Deputy, Office of Ethics & Compliance, Medtronic; Former Senior Director, Ethics and Compliance, Abbott (now AbbVie); Former VP, Chief Compliance, Privacy & Security Officer, Resurrection Health Care (now Ascension/AMITA); Minneapolis, MN
Tom Gregory, MBA
Partner, Forensic & Integrity Services, EY, Atlanta, USA (Moderator)

AND A ROUNDTABLE ON IMPLEMENTING EQUITY, DIVERSITY AND INCLUSION BY

Michael R. Clarke, CCEP
Vice President, Global Chief Compliance Officer, ConvaTec; Former VP, Corporate Compliance, Indivior; Former VP, Ethics & Compliance, Americas, Actavis; Former VP & Compliance Officer, Biomet Spine & Bone Healing Technologies; Bridgewater, NJ
Sujata Dayal, JD
Vice President & Global Chief Compliance Officer, Medline Industries; Former VP Healthcare Compliance & Privacy, Johnson & Johnson; Former Global Chief Compliance Officer and Corporate VP, Biomet; Chicago, IL
Jill Fallows Macaluso
Corporate Vice President, Chief Ethics, Compliance & Privacy Officer, Novo Nordisk, Princeton, NJ

Robert A. Ladd, JD
Vice President, Global Head Integrity & Compliance, Novartis, Oncology; Former General Counsel, GE Healthcare; Former Global Head of Compliance Training, Goldman Sachs; Former Senior Corporate Counsel, Pfizer; New York, NY
Latarsha Stewart, JD, MS
Vice President, Head of Compliance, Servier Pharmaceuticals; Former Head of Compliance, Global Oncology Business Unit, Takeda Oncology; Boston, MA


SPONSORED BY

The Pharmaceutical Compliance Forum (PCF) is a coalition of compliance professionals including compliance officers and senior legal counsels from 80+ distinguished researched-based pharmaceutical manufacturers and biotech companies. The PCF was founded in early-1999 by compliance professionals from the pharmaceutical industry to promote effect corporate compliance programs.


HCCA CORPORATE COMPLIANCE & ETHICS WEEK


CONTINUING EDUCATION CREDITS
Compliance Professionals: Pending approval to offer Compliance Certification Board (CCB)® credits.

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FEATURED FACULTY

Sergio Juan Abreu Regional Compliance Officer, APAC, Merck Group; Former Regional Compliance Officer – LATAM, Merck Serono; Singapore
Peter Agnoletto, CPA Compliance Officer, Primary Care and Consumer Health Care, Sanofi; Former Chief Compliance Officer & Chief Audit, Executive & ERM Leader, Par Pharma; Flemington, NJ
Khelin N. Aiken, JD Partner, Baker & McKenzie LLP; Former Regulatory Counsel, Center for Drug Evaluation and Research, US Food and Drug Administration (FDA), Washington, DC
Sergio Alegre, JD Vice President, Global Compliance, Osmotica; Former Executive Director Compliance, Pacira; Bridgewater, NJ
Punkaj T. Amin, MBA, CFE Compliance Officer - US Wound Management,Office of Ethics and Compliance (OEC), Smith & Nephew; Former Director, Communications & Public Relations - North America, Grifols; Fort Worth, TX

Madelyn Archibald Compliance Education and Training Manager, Merz Aesthetics, Raleigh, NC
Melia Arnett-Archie, JD Senior Privacy & Data Protection Counsel, Stryker; Former Assistant State Attorney, Miami-Dade State Attorney's Office; Fort Lauderdale, FL
Samantha Barrett Badlam, JD Counsel, Litigation and Enforcement Group, Ropes & Gray, Washington, DC
Ann E. Beasley, JD Director, Life Sciences, Governance, Risk & Compliance, Guidehouse; Former Senior Vice President, Chief Compliance Officer, Biogen; 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

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
Craig Bleifer, JD Principal, Craig B. Bleifer, LLC; Former Corporate Vice President, General Counsel North America, Novo Nordisk; Former Senior Vice President, General Counsel and Secretary, Daiichi Sankyo; Summit, NJ
Terra Buckley, JD Vice President, Head of Global Compliance, Mesoblast Limited; Former Executive Director, Head of the Business Advisory Center of Excellence, US Healthcare Compliance, Celgene; New York, NY
Joseph Calarco Vice President, Compliance, Nabriva Therapeutics; Former Chief Compliance Officer, NEOS Therapeutics; Former Director, Compliance & Ethics, US Operations, Bristol-Myers Squibb; Lansdale, PA
Christie Camelio Chief Compliance, Ethics & Risk Management Officer, TG Therapeutics; Former Vice President, Deputy Global Chief Compliance Officer, Celgene; New York, NY

Cynthia Cetani Chief Integrity & Compliance Officer, Indivior; Former Group Integrity & Compliance, Head, Compliance Operations, Novartis International AG; Richmond, VA
Parth Chanda, JD, MPA Founder and CEO, Lextegrity; Former Chief Compliance Counsel, Oncology, Pfizer; New York, NY
Katherine Chaurette, MS, JD Vice President Healthcare Law and Compliance, Blueprint Medicines; Former Sr. Director, Regulatory and Commercial Law, Regeneron; Former VP, Legal, Head of Health Law, Regulatory, Market Access, Marketed and Launch Products, Sanofi; Jamaica Plain, MA
Masha Chestukhin, MSJ Associate Director, Compliance Officer R&D, IA, FMV, Sanofi Genzyme; Former Senior Manager NA Compliance, Sanofi; Jamaica Plain, MA
Yvonne Clark, JD Corporate Compliance Counsel, Spark Therapeutics; Former Commercial Counsel, Merck; Philadelphia, 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, Deloitte; Former Analyst, Commercial Operations, Cephalon; Philadelphia, PA
Emily Cunningham Associate Principal, Compliance Consulting, IQVIA, New York, NY
Meenakshi Datta, JD Partner and Global Co-leader, Healthcare Practice, Sidley Austin LLP, Chicago, IL
BJ D'Avella, MBA Leader, Life Sciences Consulting Group, Paul Hastings, New York, NY

Noël Denice, JD Legal Counsel, Philips North America, LLC; Former Assistant General Counsel, Olympus Scientific Solutions Americas; Boston, MA
Anisa Dhalla Global Chief Compliance Officer, UCB, Inc., Atlanta, GA
Sarah diFrancesca, JD Partner, Dinsmore & Shohl LLP, Cincinnati, OH
Stefanie A. Doebler, JD Of Counsel and Co-chair, Health Care Practice Group, Covington & Burling LLP, Washington, DC
Tara D'Orsi, JD Executive Vice President, Chief Compliance Officer and General Counsel, Kyowa Kirin North America; Former Senior Counsel, Reliant Pharmaceuticals; New York, NY

J. Mark Farrar, MSJ, CPA, CFE, CFF, CIPP/US Partner, Life Sciences Governance, Risk Management and Compliance, Guidehouse; Former Interim Chief Global Compliance Officer, Beckman Coulter; Atlanta, GA
Margaret Feltz, MA, JD Vice President, Ethics & Compliance, Purdue Pharma; Former Compliance Counsel, Boehringer Ingelheim; Stamford, CT
Christine Fiore, MBA Executive Director, Ethics and Commercial Compliance, Boehringer Ingelheim; Former Group Director Ethics and Compliance, Smith & Nephew; Ridgefield, CT
Hollie K. Foust, JD Senior Vice President, Legal and Compliance, Cardinal Health,Dublin, OH
Nereyda Garcia, JD Compliance Head, Rare Disease and Rare Blood Disorder, Sanofi; Former Global Head, Ethics and Compliance, Alnylam; Former Sr. Director, Compliance, Biogen Idec; Boston, MA

Mark Gardner, MBA, JD Managing Attorney, Gardner Law, Stillwater, MN
Gary F. Giampetruzzi, Esq. Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc.; New York, NY
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; Former Senior Director, Legal and Compliance EMEA, Horizon, Raptor and Onyx; Darmstadt, Germany

Gejaa T. Gobena, JD Partner, Hogan Lovells; Former Deputy Chief, Fraud Section, Criminal Division; Former Trial Attorney, Civil Division, Fraud Section, US Department of Justice; Washington, DC
Thomas Goimarac, MBA, CHFP Managing Consultant, Berkeley Research Group, LLC (BRG), Phoenix, AZ
Christine Gordon, JD Deputy Chief Compliance Officer, Olympus Corporation of the Americas; Former Assistant District Attorney, Philadelphia District Attorney's Office; Bethlehem, PA
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
Amy J. Greer, JD Partner, Baker & McKenzie LLP; Former Regional Trial Counsel (Philadelphia), US Securities and Exchange Commission; New York, NY

Ethan Gumpert Global Ethics, Compliance and Governance, Advanced Medical Technology Association (AdvaMed), Washington, DC
Jeffrey Hagy Associate Director, Corporate Compliance, Regeneron Pharmaceuticals, Inc., Tarrytown, NY
Saul B. Helman, MD, MBA Partner, Life Sciences Functional Practice Leader, Guidehouse; Former Director, Eli Lilly; Zionsville, IN
Michael Hercz, JD Senior Vice President and General Counsel, Sentynl; Former Vice President, Law & Chief Compliance Officer, Victory Pharma; Former Executive Director, Enterprise Risk Management, Amgen; Solana Beach, CA
Susan K. Hibbard Associate Director, Transparency Office of Ethics & Compliance, Boehringer Ingelheim, Ridgefield, CT

Casey J. Horton, CFE Director, Life Sciences, Governance, Risk & Compliance, Guidehouse, Chicago, IL
Emily Huebener, MA Senior Manager, Health and Life Sciences Forensic & Integrity Services, EY, Chicago, IL
Briannon Irwin, JD Senior Managing Consultant, Berkeley Research Group (BRG); Former Judicial Law Clerk, The Supreme Court of Pennsylvania; Washington, DC
Denis Jacob, MBA Vice President, Deputy Chief Compliance Officer, Orthofix; Former Director, Ethics & Compliance, International, BD; Lewisville, TX
David Jacobs, JD, MS Executive Director, Legal Affairs, Intercept Pharmaceuticals; Former Assistant General Counsel, Commercial Brands, Daiichi Sankyo; New York, NY

James Jacobson, JD Senior Data Privacy Counsel and Chief Privacy Officer, U.S, Merck KGaA, Darmstadt, Germany
Adam Janoff, JD Senior Compliance Counsel, EMD Serono, Former Lead Rare Disease Lawyer, Biogen
Michael Joachim, JD Head of Ethics & Business Integrity, Specialty Care, Sanofi Genzyme, Cambridge, MA
Catherine Healy Kanzler Executive Director, Global Compliance Operations, Olympus Corporation of the Americas, Center Valley, PA
Ben Kaye-Smith Senior Vice President Ethics, Risk & Compliance, AveXis; Former Corporate Health Safety Environment Manager; Former Global Head Integrity & Compliance Risk Review & Prevention, Novartis; Switzerland

Jonathon L. Kellerman Executive Vice President, Global Chief Compliance Officer – Advisor, Office of Ethics & Compliance, Allergan Aesthetics, an AbbVie company; Former Executive Vice President, Global Chief Compliance Officer; Allergan, Madison, NJ
Andrea L. Kocharyan, JD Vice President, Head of Legal & Compliance, Zealand US; Former VP, Head of Legal Affairs, Sumitomo Dainippon Oncology; Former VP, US General Counsel & Compliance Officer, EVO Biologics; Cambridge, MA
Keith Korenchuk, MPH, JD Vice President and Chief Compliance Officer, DH Diagnostics, a Danaher Company, Chevy Chase, MD
Kirt Kraeuter, MGA Senior Director, Corporate Compliance, Moderna; Former European Compliance Director, Otsuka; Former, Executive Director, Worldwide Compliance Committee & Monitoring, Bristol-Myers Squibb; Yardley, PA
Daryl Kreml, JD Vice President, Chief Compliance Officer and Investigations Counsel, Sage Therapeutics; Former Head, US Compliance & Global Program Management, Biogen; Former Director & Senior Managing Counsel, Int'l Compliance, Boston Scientific; Cambridge, MA

David Lazarus, JD Assistant United States Attorney and Unit Chief, US Attorney's Office, District of Massachusetts, US Department of Justice; Former Assistant District Attorney, Bronx District Attorney's Office; Boston, MA
Nancy Libin, JD Partner and Co-Chair, Privacy & Security, and Technology Practice, Davis Wright Tremaine LLP; Former Chief Privacy and Civil Liberties Officer, US Department of Justice; Washington, DC
Jodi Lindsey, JD Vice President, Healthcare Counsel and Head of U.S. Compliance, Alkermes; Former Associate Director, Commercial Compliance, Biogen; West Roxbury, MA
Kari K. Loeser, JD Senior Corporate Counsel & U.S. Healthcare Compliance Officer, Relypsa, Inc; Former Investigator, U.S. Department of Health & Human Services; Former, Policy Analyst, American Medical Association; Redwood City, CA
David J. Ludlow, JD Partner, Sidley Austin LLP, Washington, DC

Joshua Marks, JD Vice President, Chief Ethics & Compliance Officer, Boehringer Ingelheim; Former Executive Division Counsel, Corporate Compliance Officer & Asst. Secretary, Ben Venue Laboratories; Ridgefield, CT
Jill Mason, JD Chief Ethics and Compliance Officer, Orthofix; Former Senior Global Compliance Director, St. Jude Medical; Lewisville, TX
Jane Mathews, LLM, JD Vice President and Chief Compliance Officer, Lexicon; Former Assistant General Counsel, Sunovion; Former Senior Counsel-Managing Attorney - Head of Litigation, Hoffmann-La Roche; Ringwood, NJ
Heather McCollum, JD, MHA, CCEP-I Senior Director, Compliance, Shionogi, Florham Park, NJ
Jennifer McGee, JD Vice President & Chief Compliance Officer, Otsuka America Pharmaceutical, Rockville, MD

Kathleen McGovern, JD Global Investigator, Healthcare & Crisis Management Advisor, EY; Former Senior Deputy Chief, Fraud Section, US Department of Justice; Washington, DC
Jenny McVey, MS, PHD Compliance Risk Strategy & Management, Novo Nordisk, Compliance Lead, Hands International, Editorial Board Member, Policy & Medicine Compliance Update, Princeton, NJ
Lauren Miller, JD Corporate Counsel, Otsuka Pharmaceutical Company; Former Regulatory Counsel, Office of Prescription Drug Promotion, FDA; Washington, DC
Vahan Minassian, JD Director, US Promotional Monitoring Lead, Pfizer, Philadelphia, PA
Patrick Mooty Head of Compliance, Sumitomo Dainippon Pharma America, Marlborough, MA

Craig Moran, JD Senior Investigations Counsel, Stryker, Mahwah, NJ
Gregory S. Moss, LLB Executive Vice President, General Counsel and Corporate Secretary, Chief Compliance Officer, Kadmon Holdings, New York, NY
Kristin Mykulak, JD Assistant General Counsel, Litigation & Compliance, Dr. Reddy's Laboratories, Princeton, NJ
Clint Narver, JD Assistant Director of the Consumer Protection Branch, US Department of Justice; Former Associate Chief Counsel, US Food and Drug Administration; Washington, DC
Katie Norris, MPA Director, West Coast Leader, Life Sciences Governance, Risk Management and Compliance, Guidehouse; Former Senior Director, Compliance & Integrity Programs, NSF Health Sciences; San Francisco, CA

Daniel O'Connor Senior Vice President, PharmaCertify, New York, NY
John Patrick Oroho, JD Executive Vice President and Chief Strategy Officer, Porzio Life Sciences, LLC, Principal, Porzio, Bromberg & Newman, Morristown, NJ
Raj D. Pai, JD Partner, Sidley Austin LLP; Former Attorney, Office of Chief Counsel, US Food and Drug Administration; Washington, DC
Amy Pawloski President, Strategic Versatility; Former Global Compliance Operations Officer, Endo; Phoenixville, PA
Veleka Peeples-Dyer, JD Partner and Chair, North America Food and Drug, Administration (FDA) Practice Group, Baker & McKenzie LLP, Washington, DC

Brad Powers, JD General Counsel and Chief Compliance Officer, Lumos Pharma; Former General Counsel and Chief Compliance Officer, Office of the CEO, NewLink Genetics; Des Moines, IA
Ariadna Quesada, MPP, MSJ Compliance Director International EMEA, Hillrom; Former Ethics and Compliance Officer, The Netherlands, AbbVie; Former Compliance Director International, DaVita Kidney Care; Amsterdam, Netherlands
Arjun Rajaratnam, JD Life Science Executive, DSLR, Inc.; Former, Chief Compliance Officer, Smith & Nephew; Raleigh, NC
Timothy Roberts, MSJ Executive Director, Compliance, AbbVie; Former Executive Director, Commercial Compliance -US Medical Aesthetics, Allergan; Budd Lake, NJ
John Seungjoo Rah, JD Partner, DLA Piper, Washington, DC

Kristin Rand, JD, MA Head, Corporate Compliance and Global Risk Officer, Moderna, Boston, MA
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 Executive Director, Global Next, Generation Digital, Novartis; Bridgewater NJ
Tim Robinson, JD, LLM Chief Legal and Data Privacy Officer, MediSpend, Hampton Falls, NH
Russell Rose, JD Senior Manager, Deloitte & Touche, LLP, Dallas, TX

Kevin Ryan, MS, JD Vice President, Chief Compliance Officer, ACADIA; Former Director, Ethics & Compliance, Novo Nordisk; San Diego, CA
Jennifer Santos, JD Senior Director, R&D Business Partner, Office of Business Integrity & Ethics, Vertex Pharmaceuticals, Boston, MA
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
Tara R. Shewchuk, JD, LLM Vice President & Deputy, Office of Ethics & Compliance , Medtronic Americas; Former Senior Director, Ethics and Compliance; AbbVie Minneapolis, MN
Eric Siegel, MBA, JD Vice President, Head of Compliance US, Idorsia Pharmaceuticals US Inc.; Former Chief Compliance Officer, Jazz Pharmaceuticals; Former Senior Investigator, Office of the Inspector General, City of Philadelphia; Philadelphia, PA

Paul Silver Principal, Regulatory & Compliance Life Sciences Leader, Deloitte Advisory, Deloitte, Atlanta, GA
Jon Smollen, MA, JD Practice Professor of Law and Executive Director, Center for Compliance and Ethics, Beasley School of Law, Temple University; Board of Directors, Astellas Pharma, US; Former Executive Vice President and Chief Compliance Officer, Endo; Philadelphia, PA
Alexis Stroud, CQA, CCEP Director, Ethics & Compliance: Auditing, Monitoring, and Risk Assessment, Boehringer Ingelheim, President, Fairfield County, CT Chapter, Healthcare Businesswomen's Association, Stamford, CT
Carol B. Stubblefield, JD, LLM Partner, Baker & McKenzie LLP, New York, NY
Tiffany Tang Associate Principal, Global Compliance Consulting, IQVIA; Former Senior Manager, Ethics and Compliance, Novo Nordisk; New York, NY

Jack Tanselle, MBA Managing Director, Deloitte & Touche LLP, Indianapolis, IN
Melissa Tearney, JD Partner and Co-chair, Litigation Department, Choate, Hall & Stewart, Boston, MA
Scott A. Thompson Associate Regional Director, United States Securities and Exchange Commission, Philadelphia Regional Office, Philadelphia, PA
Bryan Timer, MA Director, Data Analytics & Transparency, Merck and Co, Inc., Kenilworth, NJ
Natasha Trifun, JD Executive Director, R&D, Quality, Operations, External Funding and Global Medical Compliance, Alexion; Former Brazil Compliance Officer, Pfizer; Boston, MA

Manny Tzavlakis Managing Partner, Helio Health Group, Editorial Board, Policy & Medicine Compliance Update (formerly LSCU), Morristown, NJ
Elizabeth Weiss, JD Assistant General Counsel, Pfizer; Former Research Chemist, Ortho Clinical Diagnostics; Peapack, NJ
Caroline H. West, JD Global Chief Compliance Officer, Olympus Corporation; Former Senior Vice President, Chief Compliance and Risk Officer, Shire; Philadelphia, PA

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, Mitchell Hamline School of Law; West Chester, PA
Catharine Williams. JD Director & Privacy Counsel, Privacy Office Novo Nordisk, Plainsboro, NJ
Amy Yuda, MSJ, CHC, CQA, CCEP Former Compliance Officer, PolarityTE, Salt Lake City, UT

2020-2021 GLOBAL PHARMA/MED DEVICE ETHICS & COMPLIANCE CONGRESSES

VIRTUAL TWENTY-FIRST ANNUAL PHARMACEUTICAL AND MEDICAL DEVICE COMPLIANCE CONGRESS
Virtual Online Video Event Live and Archived
Sponsored by Pharmaceutical Compliance Forum
Media Partners: Harvard Health Policy Review, Health Affairs and Policy & Medicine Compliance Update
November 4 - 6, 2020
www.PharmaCongress.com
VIRTUAL FOURTEENTH INTERNATIONAL PHARMACEUTICAL AND MEDICAL DEVICE ETHICS & COMPLIANCE CONGRESS
Virtual Online Video Event Live and Archived
Sponsored by International Society of Healthcare Compliance Professionals (ETHICS)
Media Partner: Policy & Medicine Compliance Update
February 22 - 25, 2021
www.International PharmaCongress.com

CONGRESS REGISTRATION
For Congress registration information, visit https://www.pharmacongress.com/registration/, email reginfo@hcconferences.com, or call 800-503-7419.

CONGRESS EXHIBIT & SPONSORSHIP INFORMATION
For sponsorship and exhibit information contact Suzanne Tyler, Exhibit Manager, at (206) 244-4861 phone, (206) 319-5303 fax, or exhibits@hcconferences.com.