Healthcare Compliance Certificate - European Program

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Welcome, Introductions & Ice Breaker

Kathleen M. Boozang

Professor of Law, Seton Hall Law School (New Jersey)

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Rosa M. Alves

Assistant  Dean for Global Compliance & Programming, Seton Hall Law School (New Jersey)

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The Relationship Between Ethics & Compliance

• The origins of compliance
• Ethics, values & compliance

Kathleen M. Boozang

Professor of Law, Seton Hall Law School (New Jersey)

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Lunch Break

The Impact of the U.S. Foreign Corrupt Practices Act on Europe and Beyond

• Elements of the FCPA’s Anti-Bribery and Accounting Provisions
• Key enforcement players and policies
• Recent enforcement actions
• Compliance programs and FCPA enforcement 
• DOJ Enforcement

Albert B. Stieglitz, Jr.

Partner, Alston & Bird LLP (Washington, D.C.)

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International Anti-Corruption Enforcement

• International Anti-Corruption Prosecutorial Task Force
• Bribery Prosecutions in EU States

Sabha MacManus

Associate General Counsel, UK Serious Fraud Office (London, England)

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Albert B. Stieglitz, Jr.

Partner, Alston & Bird LLP (Washington, D.C.)

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Moderator: Kathleen M. Boozang

Professor of Law, Seton Hall Law School (New Jersey)

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Role of Compliance Officer and Case Study

Sue Egan

Director & Principal Consultant, Sue Egan Associates (London)

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Afternoon Break

The Importance of Culture and Ethics in Building and Growing a Compliance Team

Roeland Van Aelst

(former) Regional VP, HCC MD&D EMEA, Johnson & Johnson (Antwerp)

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EFPIA Code of Practice

• EFPIA Ethics & Compliance mission, vision and priorities
• Introduction to the EFPIA Code: rationale, scope, applicability 

Anne-Charlotte de Mareschal

Business Ethics Director, Ipsen (Paris)

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MedTech Europe Code of Ethics

• Main changes
• Phasing out of direct sponsorship

Marta Paci

Senior Officer, Legal Counsel, MedTech Europe (Brussels)

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Case Study #1 Assignment & Prep Session 

Lunch Break

Classroom Discussion of Case Study 1

Teams to present their analysis and recommendations. Interactive class discussion.

George Fife

Partner, Compliance, Forensic & Integrity Services, Ernst & Young (EY) (Paris)

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Afternoon Break

Compliance Officer Panel Discussion 

• The compliance officer as a profession
• Regional & global challenges
• Ensuring a culture of compliance
• Q&A from participants

Anne-Sophie Bricca

Deputy General Counsel, Global Compliance Officer, Terumo BCT Europe N.V.

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Ariadna Quesada 

Vice President, Compliance, ZOLL

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Stephen Nguyen-Duc

(Former) COO & Executive Global Head of Ethics & Compliance, GE Healthcare (Paris)

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Nadège Rochel

Vice Chair, Strategic Committee, ETHICS 

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Moderator: Kathleen M. Boozang

Professor of Law, Seton Hall Law School (New Jersey)

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Networking Reception 

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Interactions with Patients & Patient Organizations

Piergiorgio Pepe

President, Quantum Ethics (Paris)

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Patient Organizations Interactive Exercise

Piergiorgio Pepe

President, Quantum Ethics (Paris)

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Lunch Break

Approval Process for Drugs and Medical Devices:

• New medicines
• New medical devices
• Special products & clinical trials

Geneviève Michaux

Partner, King & Spalding LLP (Brussels/Paris)

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Afternoon Break

Advertising of Medicinal Products and Medical Devices in Europe 

• Advertising of medicinal products
• Advertising of medical devices
• Digitalization of information and advertising 

Annabelle Bruyndonckx

Partner, Simmons & Simmons LLP (Brussels)

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Privacy and Data Protection in Europe

Ronan Tigner

Technology Lawyer, Ronan Tigner LLP (Brussels)

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Global Transparency Trends and Challenges: 

• U.S. Sunshine/Open Payments Act
• European laws & pending legislation
• Voluntary industry codes
• Future trends & practical challenges

Diva Duong

Principal, Head of Commercial Compliance Solutions & Services, IQVIA (Paris)

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Alexandre Regniault

Partner, Sector Head, Healthcare & Life Sciences, Simmons & Simmons LLP (Paris)

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Scientific Exchange and Medical Education Activities 

Sue Egan

Director & Principal Consultant, Sue Egan Associates (London)

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Lunch Break

Case Study 2 Prep Session

Afternoon Break 

Classroom Discussion of Case Study 2: 

• Teams to present their analysis and recommendations
• Interactive class discussion

Sue Egan

Director & Principal Consultant, Sue Egan Associates (London)

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Maintaining Professional Competence: Emerging Standards of Professional Responsibility for Health Care Compliance Professionals in the Health Care Industry

Piergiorgio Pepe

President, Quantum Ethics (Paris)

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Doing Business in Eastern Europe & Russia: Key Risks and Compliance Challenges

Mariusz Witalis

Partner, Forensic & Integrity Services, Ernst & Young (EY) (Warsaw)

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Lunch Break

EU Competition Law in Health Care

• Ban on anti-competitive agreements 
• Ban on abuses of dominance/market power
• Case studies

Natasha Tardif

Managing Partner - Paris, Reed Smith LLP (Paris)

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Data Driven Analysis for Compliance Programs: Forensic Accounting and Data Analytics

• Role of forensic accounting in investigations
• How data analytics can enhance compliance programs
• Identify and manage potential risks

George Fife

Partner, Compliance, Forensic & Integrity Services, Ernst & Young (EY) (Paris)

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Bassem Gharbi

Senior Manager, Forensics, Ernst & Young (EY) (Paris)

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Closing Remarks & Award of Program Certificates 

Rosa M. Alves

Assistant  Dean for Global Compliance & Programming, Seton Hall Law School (New Jersey)

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