Kathleen M. Boozang
Professor of Law & Dean Emeritus, Seton Hall Law School
[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
Agenda: All times are listed in CET/Paris Time.
8:30 - 9:00
Registration and Coffee
9:30 - 10:20
The Relationship Between Ethics & Compliance
Kathleen M. Boozang
Professor of Law & Dean Emeritus, Seton Hall Law School
10:20 - 10:35
Morning Break
10:35 - 11:35
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
11:40 - 12:40
MedTech Europe Code of Ethics
- Main changes
- Phasing out of direct sponsorship
Pablo Rojas Abad
Senior Legal Counsel, MedTech Europe
12:40 - 13:40
Lunch Break
13:40 - 14:30
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
14:35 - 15:45
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
15:45 - 16:00
Afternoon Break
16:00 - 17:00
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.)
8:30 - 9:00
Registration and Coffee
9:00 - 10:00
Global Transparency Trends and Challenges
- U.S. Sunshine/Open Payments Act
- European laws & pending legislation
- Voluntary industry codes
- Future trends & practical challenges
10:10 - 10:25
Morning Break
10:25 - 11:40
Interactions with Patients & Patient Organizations
Piergiorgio Pepe
President, Quantum Ethics
11:45 - 13:00
Patient Organizations Interactive Exercise
Piergiorgio Pepe
President, Quantum Ethics
13:00 - 14:00
Lunch Break
14:00 - 15:00
Role of Compliance Officer and Case Study
Sue Egan
Director & Principal Consultant, Sue Egan Associates Limited
15:05 - 17:00
Case Study 1 Assignment & Prep Session - Group Teamwork
17:00 - 18:00
Networking Reception: Clifford Chance Europe
13:35 - 14:55
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
8:30-9:00
Registration & Coffee
9:00 - 10:20
Scientific Exchange and Medical Education Activities
Sue Egan
Director & Principal Consultant, Sue Egan Associates Limited
10:20-10:35
Morning Break
10:35 - 11:35
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
11:40-12:30
Maintaining Professional Competence: Emerging Standards of Professional Responsibility for Health Care Compliance Professionals in the Health Care Industry
Piergiorgio Pepe
President, Quantum Ethics (Paris)
12:35 - 13:30
Lunch Break
13:30 - 15:30
Classroom Discussion of Case Study 1
Dominique Laymand
Of Counsel, Clifford Chance (Paris)
15:30 - 15:45
Afternoon Break
15:45 - 17:15
Compliance Officer Panel Discussion
Dominique Laymand
Of Counsel, Clifford Chance
Roeland Van Aelst
EMEA Lead Third Party Intermediary Ethics & Compliance, J&J
Stephen Nguyen-Duc
COO & Executive Global Head of Ethics & Compliance, GE Healthcare (Paris)
Alban Briard
Director Ethics & Business Integrity France, Sanofi (Paris)
Kathleen M. Boozang
Professor of Law & Dean Emeritus, Seton Hall Law School
8:30-9:00
Registration & Coffee
9:00 - 10:15
Approval Process for Drugs and Medical Devices:
- New medicines
- New medical devices
- Special products & clinical trials
Geneviève Michaux
Partner, King & Spalding LLP (Brussels/Paris)
10:15 - 10:30
Morning Break
10:30 - 12:00
Doing Business in Eastern Europe & Russia: Key Risks and Compliance Challenges
Annabelle Bruyndonckx
Partner, Simmons & Simmons LLP (Brussels)
12:00 - 13:00
Lunch Break
13:00 - 14:30
Case Study 2 Prep Session - Group Teamwork
14:30 - 15:00
Afternoon Break
15:00 - 17:00
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
8:30 - 9:00
Registration & Coffee
9:00 - 10:15
EU Competition Law in Health Care
Lucile Chneiweiss
Senior Associate, Reed Smith LLP (Paris)
10:15 - 10:30
Morning Break
10:30 - 11:45
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)
11:45 - 12:45
Lunch Break
12:45 - 14:00
Privacy and Data Protection in Europe
Ronan Tigner
Technology Lawyer (Belgium)
14:05 - 15:15
Data Driven Analysis for Compliance Programs: Forensic Accounting and Data Analytics
George Fife
Partner, Compliance, Forensic & Integrity Services, Ernst & Young (EY) (Paris)
15:15
Closing Remarks & Award of Program Certificates
Rosa M. Alves
Assistant Dean for Global Compliance & Programming, Seton Hall Law School (New Jersey)
