Healthcare Compliance Certificate - European Program

ZOOM Log-On/Attendance 

Welcome, Introductions & Ice Breaker

Kathleen M. Boozang

Professor of Law & Dean Emeritus, Seton Hall Law School (New Jersey)

View Bio

Rosa M. Alves

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

View Bio

The Relationship Between Ethics & Compliance

• The origins of compliance
• Ethics, values & compliance

Kathleen M. Boozang

Professor of Law & Dean Emeritus, Seton Hall Law School (New Jersey)

View Bio

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.)

View Bio

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)

View Bio

Albert B. Stieglitz, Jr.

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

View Bio

Moderator: Kathleen M. Boozang

Professor of Law & Dean Emeritus, Seton Hall Law School (New Jersey)

View Bio

Role of Compliance Officer and Case Study

Sue Egan

Director & Principal Consultant, Sue Egan Associates Limited (London)

View Bio

Afternoon Break

Case Study 1 Assignment & Prep Session - Group Teamwork

ZOOM Log-On/Attendance 

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)

View Bio

Classroom Discussion of Case Study 1

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

Dominique Laymand

Founder & Executive Coach, EthiCoaching (Paris)

View Bio

Lunch Break

EFPIA Code of Practice

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

Julie Bonhomme

Legal Affairs & Compliance Director, EFPIA (Brussels)

View Bio

MedTech Europe Code of Ethics

• Main changes
• Phasing out of direct sponsorship

Pablo Rojas Abad

Senior Legal Counsel, MedTech Europe (Brussels)

View Bio

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.

View Bio

Laetitia Ducroquet

Vice President, Deputy Chief Business Ethics Officer, Ipsen Pharma (Paris)

View Bio

Nadège Rochel

Vice Chair, Strategic Committee, ETHICS

View Bio

Stephen Nguyen-Duc

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

View Bio

Roeland Van Aelst

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

View Bio

Moderator: Kathleen M. Boozang

Professor of Law & Dean Emeritus, Seton Hall Law School (New Jersey)

View Bio

Virtual Networking Reception

ZOOM Log-On Attendance

Interactions with Patients and Patient Organizations

Piergiorgio Pepe

President, Quantum Ethics (Paris)

View Bio

Patient Organizations Interactive Exercise

Piergiorgio Pepe

President, Quantum Ethics (Paris)

View Bio

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)

View Bio

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)

View Bio

Afternoon Break

Scientific Exchange and Medical Education Activities 

Sue Egan

Director & Principal Consultant, Sue Egan Associates Limited (London)

View Bio

ZOOM Log-On/Attendance

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

Piergiorgio Pepe

President, Quantum Ethics (Paris)

View Bio

Global Transparency Trends and Challenges:

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

Diva Duong

Head of Compliance, Safety, Regulatory & Quality Solutions, IQVIA (Paris)

View Bio

Alexandre Regniault

Partner, Section Head—Healthcare and Life Sciences, Simmons & Simmons LLP (Paris)

View Bio

Lunch Break

Privacy and Data Protection in Europe

Ronan Tigner

Technology Lawyer, Ronan Tigner LLP (Brussels)

View Bio

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)

View Bio

Afternoon Break

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

Mariusz Witalis

Partner, Leader Central, Eastern and Southeastern Europe & Central Asia, Forensic & Integrity Services, Ernst & Young (EY) (Warsaw)

View Bio

ZOOM Log-On/Attendance 

EU Competition Law in Health Care

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

Natasha Tardif

Managing Partner, Reed Smith LLP (Paris)

View Bio

Lucile Chneiweiss

Counsel, Reed Smith LLP (Paris)

View Bio

Case Study 2 Prep Session - Group Teamwork

Lunch 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 Limited (London)

View Bio

Closing Remarks & Award of Program Certificates 

Rosa M. Alves

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

View Bio