Program Agenda
European Healthcare Industry Training: Compliance Certificate Program
[email protected] | 973-642-8382 or 973-761-9000 ext. 8382
PROGRAM SCHEDULED for October 21-25, 2024 | In-Person | Paris, France
PROGRAM SCHEDULED for June 9-13, 2025 | Virtual
Day 1: Monday, 21 October 2024
Registration & Coffee
Welcome, Introductions & Ice Breaker
Kathleen M. Boozang
Professor of Law & Dean Emeritus, Seton Hall Law School (New Jersey)
Rosa M. Alves
Assistant Dean for Global Compliance & Programming, Seton Hall Law School (New Jersey)
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)
Morning 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)
MedTech Europe Code of Ethics
- Main changes
- Phasing out of direct sponsorship
Pablo Rojas Abad
Senior Legal Counsel, MedTech Europe (Brussels)
Lunch Break
DOJ Enforcement Perspective
Vanessa Sisti
Fraud Prosecutorial Liaison to the United Kingdom, United States Department of Justice
Moderator: Kathleen M. Boozang
Professor of Law & Dean Emeritus, Seton Hall Law School (New Jersey)
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.)
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.)
Day 2: Tuesday, 22 October 2024
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 and Quality Solutions, IQVIA (Paris)
Alexandre Regniault
Partner, Section Head, Healthcare & Life Sciences, Simmons & Simmons LLP (Paris)
Augustin Bricaire
Supervising Associate, Simmons & Simmons LLP (Paris)
Morning Break
Interactions with Patients & Patient Organizations
Piergiorgio Pepe
President, Quantum Ethics (Paris)
Patient Organizations Interactive Exercise
Piergiorgio Pepe
President, Quantum Ethics (Paris)
Lunch Break
Role of Compliance Officer and Case Study
Sue Egan
Director & Principal Consultant, Sue Egan Associates Limited (London)
Case Study 1 Assignment & Prep Session - Group Teamwork
Networking Reception: Clifford Chance Europe
Day 3: Wednesday, 23 October 2024
Registration & Coffee
Scientific Exchange and Medical Education Activities
Sue Egan
Director & Principal Consultant, Sue Egan Associates Limited (London)
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, Johnson & Johnson (Antwerp)
Maintaining Professional Competence: Emerging Standards of Professional Responsibility for Health Care Compliance Professionals in the Health Care Industry
Piergiorgio Pepe
President, Quantum Ethics (Paris)
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)
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 (Paris)
Stephen Nguyen-Duc
COO & Executive Global Head of Ethics & Compliance, GE Healthcare (Paris)
Roeland Van Aelst
EMEA Lead Third Party Intermediary Ethics & Compliance, Johnson & Johnson (Antwerp)
Alban Briard
Director Ethics & Business Integrity France, Sanofi (Paris)
Moderator: Kathleen M. Boozang
Professor of Law & Dean Emeritus, Seton Hall Law School (New Jersey)
Day 4: Thursday, 24 October 2024
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)
Morning 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)
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)
Day 5: Friday, 25 October 2024
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)
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)
Lunch Break
Privacy and Data Protection in Europe
Ronan Tigner
Technology Lawyer (Belgium)
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)
Closing Remarks & Award of Program Certificates
Rosa M. Alves
Assistant Dean for Global Compliance & Programming, Seton Hall Law School (New Jersey)
Platinum Program Sponsor
