Healthcare Compliance Certificate - European Program

Registration & Coffee

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

Morning 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

Speakers To Be Announced 

International Anti-Corruption Enforcement

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

Speakers To Be Announced

Lunch Break

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 France – Tunisia / Algeria /
Morocco, Ipsen (Paris)

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

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

Registration & Coffee

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

Morning 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

Lunch Break

Advertising of Medicinal Products and Medical Devices in Europe

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

Nele Jonckers

Supervising Associate, Simmons & Simmons LLP (Brussels)

View Bio

Role of Compliance Officer and Case Study

Sue Egan

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

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

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

Alban Briard

Director Ethics & Business Integrity France, Sanofi (Paris)

View Bio

Moderator: Kathleen M. Boozang

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

View Bio

Networking Reception - Location To Be Announced

Registration & Coffee

Scientific Exchange and Medical Education Activities

Sue Egan

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

View Bio

Morning Break

Case Study 1 Assignment & Prep Session - Group Teamwork 

Lunch Break

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

Afternoon Break

Interactions with Patients & Patient Organizations

Piergiorgio Pepe

President, Quantum Ethics (Paris)

View Bio

Patient Organizations Interactive Exercise

Piergiorgio Pepe

President, Quantum Ethics (Paris)

View Bio

Registration & Coffee 

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

Morning 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, Reed Smith LLP (Paris)

View Bio

Lucile Chneiweiss

Counsel, Reed Smith LLP (Paris)

View Bio

Lunch Break

Case Study 2 Prep Session - Group Teamwork

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 Limited (London)

View Bio

Registration & Coffee

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

Morning Break

Privacy and Data Protection in Europe

Ronan Tigner

Technology Lawyer, Ronan Tigner LLP (Brussels)

View Bio

Lunch Break

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

Bassem Gharbi

Senior Manager, Forensic & Integrity Services, Ernst & Young (EY) (Paris)

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