Healthcare Compliance Certificate - European Program

Registration and Coffee

Welcome, Introductions & Ice Breaker

Kathleen M. Boozang

Professor of Law & Dean Emeritus, Seton Hall Law School

View Bio

Rosa M. Alves

Asst. Dean, Global Compliance, Seton Hall Law School

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

View Bio

Morning 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

View Bio

MedTech Europe Code of Ethics

• Main changes
• Phasing out of direct sponsorship

Pablo Rojas Abad

Senior Legal Counsel, MedTech Europe

View Bio

Lunch Break

DOJ Enforcement Perspective

Vanessa Sisti

Fraud Prosecutorial Liaison to the United Kingdom, United States Department of Justice 

Learn more about Vanessa Sisti

Moderator: Kathleen M. Boozang

Professor of Law & Dean Emeritus, Seton Hall Law School

View Bio

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

View Bio

Afternoon Break

The Anatomy of a Corruption Investigation for Pharmaceutical and Medical Device Companies: Legal and Compliance Issues 

• Current enforcement landscape
• How an investigation begins
• Responding to government inquiry
• Special areas of interest

Allan Medina

Partner, Goodwin (Washington, D.C.)

Registration and 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

View Bio

Alexandre Regniault

Partner, Head, Healthcare & Life Sciences, Simmons & Simmons

View Bio

Augustin Bricaire

Supervising Associate, Simmons & Simmons LLP (Paris)

View Bio

Morning Break

Interactions with Patients & Patient Organizations

Piergiorgio Pepe

President, Quantum Ethics

View Bio

Patient Organizations Interactive Exercise

Piergiorgio Pepe

President, Quantum Ethics

View Bio

Lunch Break

Role of Compliance Officer and Case Study

Sue Egan

Director & Principal Consultant, Sue Egan Associates Limited

View Bio

Case Study 1 Assignment & Prep Session - Group Teamwork

Networking Reception: Clifford Chance Europe

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

View Bio

Registration & Coffee

Scientific Exchange and Medical Education Activities

Sue Egan

Director & Principal Consultant, Sue Egan Associates Limited

View Bio

Morning Break

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

Roeland Van Aelst

EMEA Lead Third Party Intermediary Ethics & Compliance, J&J

View Bio

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

Lunch Break

Classroom Discussion of Case Study 1

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

Dominique Laymand

Of Counsel, Clifford Chance (Paris)

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

Dominique Laymand

Of Counsel, Clifford Chance

View Bio

Roeland Van Aelst

EMEA Lead Third Party Intermediary Ethics & Compliance, J&J

View Bio

Stephen Nguyen-Duc

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

View Bio

Alban Briard

Director Ethics & Business Integrity France, Sanofi (Paris)

View Bio 

Kathleen M. Boozang

Professor of Law & Dean Emeritus, Seton Hall Law School

View Bio

Registration & Coffee

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

Morning Break

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

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

Annabelle Bruyndonckx

Partner, Simmons & Simmons LLP (Brussels)

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

View Bio

Registration & Coffee

EU Competition Law in Health Care

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

Lucile Chneiweiss

Senior Associate, Reed Smith LLP (Paris)

View Bio

Morning 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, EY (Warsaw)

View Bio

Lunch Break

Privacy and Data Protection in Europe

Ronan Tigner

Technology Lawyer (Belgium)

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

Closing Remarks & Award of Program Certificates 

Rosa M. Alves

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

View Bio