Virtual 21st Annual Pharmaceutical
and Medical Device Ethics and
Compliance Congress

Virtual Online Video Live and Archived
November 4 – 6, 2020


Follow Pharma Congress on:
 

Home

THE VIRTUAL TWENTY-FIRST PHARMA/MEDICAL
DEVICE CONGRESS CONTENT IS NOW
AVAILABLE FOR PURCHASE

The Virtual Twenty-First Pharmaceutical/Medical Device Congress conference content is now available for purchase via online archive access (6 months) and Flash Drive.

Online Archive or Flash Drive of the Virtual Twenty-First Pharmaceutical/Medical
Device Congress Presentations!


Online Archive of Virtual Twenty-First Pharmaceutical/Medical Device Congress Presentations

Complete conference: $195

Order Now


Flash Drive of Virtual Twenty-First Pharmaceutical/Medical Device Congress Presentations

$195

Order Now


  • Access from any computer or mobile device with internet connection
  • Includes presenter slides in PDF format
  • Contains video, audio, and synchronized PowerPoint slides
  • 6 months access from date of purchase

  • Easy navigation of all sessions
  • Contains video, audio, and synchronized PowerPoint slides
  • Includes presenter slides in PDF format
  • No internet access required

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

Assistant Director, 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 CHIEF COMPLIANCE
OFFICERS 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

Senior 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


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 – 12:20 pm EST)
10:00 am
Welcome & Introductions
10:10 am
Leveraging Artificial Intelligence (AI), Predictive Analytics and Other Technologies to Conduct Oversight and Enforcement
10:40 am
PhRMA and AdvaMed Update
11:00 am
CCO Connection Program- Partner Experience
11:10 am
Interview with an AUSA: The High-Risk Activity of Speaker Programs
11:40 pm
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 (11:15 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

OPENING PLENARY SESSION (1 pm EST – 5:15 pm EST)
1:00 pm
Welcome and Introduction: PCF Co-Chairs
1:15 pm
Keynote: OIG Update with Gregory Demske and Mary Riordan
2:15 pm
US DOJ Keynote
3:30 pm
FDA Keynote
4:00 pm
Annual Chief Compliance Officer Fireside Chat
5:15 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
— Mini Summit 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 – 4:30 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
— XXVIII: 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 – 4:15 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
3:30 pm
The Post-Pandemic Compliance Department of the Future: Virtual, Ethics, Integrity and More
4:15 pm
Congress Adjournment

FEATURING THE ANNUAL CHIEF COMPLIANCE
OFFICERS FIRESIDE CHAT

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

Chief Deputy Ethics and Compliance Officer, 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

Global & US Leader, Health & Life Sciences, Forensic & Integrity Services, EY, Atlanta, GA (Moderator)

AND A ROUNDTABLE ON IMPLEMENTING
EQUITY, DIVERSITY AND INCLUSION BY

Michael R. Clarke, JD, 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, JD

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

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

Bill Aprea, JD

Former Executive Director, Senior Franchise and Compliance Counsel, JD; Celgene/Bristol-Myers Squibb; Chatham, NJ

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

Yogesh Bahl, CPA, MBA

Managing Director, AlixPartners New York, NY

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

Eric Bolesh

Chief Operating Officer, Cutting Edge Information, Research Triangle Park, NC

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

Shelby Buettner, JD

Associate Chief Counsel, Office of the Chief Counsel Food and Drug Administration, Washington, DC

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

Ethan Davis, JD

Partner King & Spalding LLP; Former Acting Assistant Attorney General, Civil Division, US, Department of Justice; Washington, DC

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, PLLC; Adjunct Professor, Drug & Device Law, Mitchell Hamline School of 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

James Jacobson, JD

Senior Data Privacy Counsel and Chief Privacy Officer, U.S, Merck KGaA, Darmstadt, Germany

Michael Joachim, JD

Head of Ethics & Business Integrity, Specialty Care, Sanofi Genzyme, Cambridge, MA

Elizabeth Jobes, JD

Global Chief Compliance Officer Amryt Pharma; Former Senior Vice President, Chief Compliance Officer North America at EMD Serono Inc.; Former Head of Corporate Compliance and Legal Counsel Company, Spark Therapeutics, Inc.; 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, Novartis Gene Therapies; Former Global Head Integrity & Compliance Risk Review & Prevention, Novartis; Switzerland

Jonathon L. Kellerman

Executive Advisor, Office of Ethics & Compliance, Abbvie; Former Executive Vice President, Global Chief Compliance Officer, Allergan, Former Partner, PwC; Madison, NJ

Andrea L. Kocharyan, JD

Vice President, Legal and US Chief Compliance Officer, 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

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 and Global 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

Rore Middleton, JD

Senior Director, Compliance and Privacy, Blueprint Medicines; Former Director, US Compliance and Ethics, Alexion Pharmaceuticals, Inc.; Cambridge, MA

Gary C. Messplay, JD

Partner, FDA and Life Sciences, King & Spalding, Washington, DC

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, JD

Executive Director, Compliance & Ethics, 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

Kristine Mueller, JD, LLM

Global Compliance Operations Manager, North America, Arthrex, Naples, FL

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

Gina Nese

Chief Compliance Officer Advanced Sterilization Products (Fortive/ASP), Everett, WA

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

President, Extrel Therapeutics, 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

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

Laura Skinner, MBA

Director, Life Sciences Consulting Group Paul Hastings LLP, Austin TX

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

Jami Vibbert, JD

Partner, Arnold&Porter, New York, NY

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

Catherine Williams. JD

Director & Privacy Counsel, Privacy Office Novo Nordisk, Plainsboro, NJ

Amy Yuda, MSJ, CCEP, CHC, CQA

Compliance Manager, bioMerieux; Former Compliance Officer, PolarityTE; Former Compliance Officer, US WorldMeds; Salt Lake City, UT

<!–

VIRTUAL CONGRESS PARTICIPATION

Watch the conference in live streaming video over the Internet and at your convenience at any time 24/7 for the six months following the event. The archived conference includes speaker videos and coordinated PowerPoint presentations. Includes live digital feed and 24/7 Internet access for next six months; Accessible in office, at home or anywhere worldwide with Internet access; Avoid travel expense and hassle; No time away from the office.
Watch virtual presentation by Anthony S. Fauci, MD, Director, National Institute of Allergy and Infectious Disease, at GHC, LLC’s recent Virtual Summit on Health System Recovery from COVID-19 Pandemic, June 22 – 25, 2020:

Anthony Fauci

–>

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
March 1 – 4, 2021
www.InternationalPharmaCongress.com


<!–

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

The Twentieth Annual Pharma Congress conference content is now available in a variety of formats.
You may purchase the Congress streaming content in the following formats: Flash Drive or online archive (6 months).
YOU CAN PURCHASE JUST THE TWENTIETH ANNUAL
PHARMA CONGRESS CONTENT AS FOLLOWS:


Online Archive of the Twentieth Annual Pharma Congress Presentations!

Complete conference: $195

Order Now

Flash Drive of the Twentieth Annual Pharma Congress Presentations!

$195

Order Now


–>

<!–

2020 GLOBAL PHARMA COMPLIANCE CONGRESSES


FOURTEENTH INTERNATIONAL PHARMACEUTICAL AND MEDICAL DEVICE ETHICS AND COMPLIANCE CONGRESS

Sponsored by International Society of Healthcare Compliance Professionals (ETHICS)
April 20 – 22, 2020
Sheraton Munich Arabellapark Hotel
Munich, Germany
www.InternationalPharmaCongress.com

TWENTY-FIRST ANNUAL PHARMACEUTICAL AND MEDICAL DEVICE ETHICS AND COMPLIANCE CONGRESS

A Hybrid Conference and Internet Event
Sponsored by Pharmaceutical Compliance Forum
November 4 – 6, 2020
Mandarin Oriental
Washington, DC
www.PharmaCongress.com

PARTICIPATION OPTIONS

TRADITIONAL ONSITE ATTENDANCE


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

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



–>

<!–


–>

<!–

LIVE AND ARCHIVED WEBCAST PARTICIPATION

Watch the conference in live streaming video over the Internet and at your convenience at any time 24/7 for the six months following the event.

The archived conference includes speaker videos and coordinated PowerPoint presentations.

Pros: Live digital feed and 24/7 Internet access for next six months; Accessible in office, at home or anywhere worldwide with Internet access; Avoid travel expense and hassle; No time away from the office.




WEBCAST INTERFACE SAMPLE


Click here for a sample stream

–>

<!–


<!–


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

–>
<!–


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
— 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

–>

<!–

REMEMBER THE FIRST CONGRESS

–>

<!–

STAY CONNECTED

THE SUMMIT IS

–>

<!–

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

–>

<!–

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., Philadelphia, PA
(PCF Chair)

Margaret Sparks, JD

Head of Compliance, Vaccines, North America Ethics and Business Integrity, Sanofi, 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)

–>