PCF Virtual 21st Anniversary Pharmaceutical and Medical Device Compliance Congress Features DOJ Keynote, FCPA Update and AUSA Roundtable
  • 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.



FEATURING US DOJ KEYNOTE ADDRESS

Gustav W. Eyler, JD
Director, Consumer Protection Branch, Civil 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
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


US DOJ AND US SEC UPDATE ON FCPA ENFORCEMENT

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


THE ANNUAL AUSA ROUNDTABLE

Matthew J. Lash, JD
Assistant Director, Consumer Protection Branch, US Department of Justice, 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
John T. Bentivoglio, JD
Partner, Skadden Arps LLP; Former Special Counsel for Healthcare Fraud, and Chief Privacy Officer, US Department of Justice; Washington, DC


AND FEATURING THE PHARMA CONGRESS ADVANCED VIDEO BROADCAST PLATFORM

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)


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
11:05 am Interview with the Department of Justice: Safeguarding the High-Risk Activity of Speaker Programs
11:35 am Facilitated, Interactive Discussion Video Roundtables on Promotional Programs
12:00 pm Sharing from Roundtable Discussions
12:15 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: Key Learnings in Electronic Health Record Enforcement Actions
  • 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
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 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

 OPTIONAL LIVE INTERACTIVE TOPIC DISCUSSIONS (12:15 pm EST - 1:00 pm EST)
(Open to all; May move among sessions.)



PLENARY SESSION (1 pm EST - 5 pm EST)
1:00 pm Welcome and Introduction: PCF Co-Chairs
1:15 pm Equity, Diversity and Inclusion
1:45 pm Implementing, Equity, Diversity, and Inclusion Roundtable
2:30 pm Visit Exhibit Hall
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: DOJ’s Fundamental Question: “Does the Corporation’s Compliance Program Work” in Practice?
  • 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: Compliance Challenges with Digital Health Applications
  • XXVII: Managing Communication Issues and Leadership during a Crisis or an Emerging Post-Crisis Environment
  • XXVIII: Fair Market Value Calculations, Benchmarks and New Standards in a Virtual World
  • XXIX: Compliance Monitoring in a Virtual World
  • XXX: Fraud and Abuse Risks Related to COVID-19 Relief
  • XXXI: Research and Development Compliance Challenges

 OPTIONAL LIVE INTERACTIVE TOPIC DISCUSSIONS (12:15 pm EST - 1:00 pm EST)
(Open to all; May move among sessions.)

CLOSING PLENARY SESSION (1 pm EST - 4 pm EST)
1:00 pm Welcome and Introduction: PCF Co-Chairs
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

WASHINGTON, DC USA -- PHARMA UPDATE NEWS SERVICE™ -- OCTOBER 21, 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.

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
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, NovoNordisk, 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


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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

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, Navigant; 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
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
Group Leader, Life Sciences Consulting Group, Paul Hastings, New York, NY
Anisa Dhalla
Global Chief Compliance Officer, UCB, Inc.; Former Manager, Regulatory Affairs, Solvay and Mikart; 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, CPA, CFE, CFF
Managing Director, Navigant; Former Interim Global Chief 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
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
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
Casey J. Horton, CFE
Director, Life Sciences, Governance, Risk & Compliance, Navigant, 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
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, Senior Counsel, GE Healthcare; Wayland, MA
Michael Joachim, JD
Head of Ethics & Business Integrity, Specialty Care, Sanofi Genzyme, Cambridge, MA

Marci Juneau, MBA
Partner, Helio Health Group, Atlanta, GA
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 at 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, a Division of NXLevel Solutions, 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

John Seungjoo Rah, JD
Partner, DLA Piper, Washington, DC
Kristin Rand, JD, MA
Head, Corporate Compliance and Global Risk Officer, Moderna; Former Vice President & Chief Compliance Officer, Seattle Genetics; 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
Russell Rose
Senior, Regulatory & Compliance Life Sciences Leader, Deloitte, Atlanta, GA

Kevin Ryan, MS, JD
Vice President, Chief Compliance Officer, ACADIA; Former Director, Ethics & Compliance, Novo Nordisk; San Diego, CA
Jennifer Santos, MPH, JD
Head of Global Corporate Compliance Operations, Vertex Pharmaceuticals; Former Associate General Counsel, Tufts Medical Center; Boston, MA
Jonathan Sayegh, JD
Associate Director, Compliance & Ethics, Sunovion, Marlborough, 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
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
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
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
Ron L. Wisor, Jr, JD
Partner, Hogan Lovells, Washington, DC
Amy Yuda, MSJ, CHC, CQA, CCEP
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.