Program Agenda
European Healthcare Industry Training: Compliance Certificate Program
[email protected] | 973-642-8382 or 973-761-9000 ext. 8382
PROGRAM SCHEDULED for June 10-14, 2024 | Virtual
PROGRAM SCHEDULED for October 21-25, 2024 | In-Person |Paris, France
Day 1
Welcome, Introductions & Ice Breaker
Jacob T. Elberg
Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, 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
Jacob T. Elberg
Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School (New Jersey)
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)
Lunch Break
MedTech Europe Code of Ethics
- Main changes
- Phasing out of direct sponsorship
Pablo Rojas Abad
Senior Legal Counsel, MedTech Europe (Brussels)
DOJ Enforcement Perspective
Sonali Patel
Assistant Chief, Foreign Corrupt Practices Act Unit, Fraud
Section, U.S. Department of Justice (Washington, D.C.)
Jacob T. Elberg
Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School (New Jersey)
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.)
The Anatomy of a Corruption Investigation for Pharmaceutical and Medical Device Companies
- Current enforcement landscape
- How an investigation begins
- Responding to government inquiry
- Special areas of interest
Kirk Ogrosky
Partner, Goodwin Procter LLP (Washington, D.C.)
Day 2
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)
Approval Process for Drugs and Medical Devices
- New medicines
- New medical devices
- Special products & clinical trials
Geneviève Michaux
Partner, King & Spalding LLP (Brussels/Paris)
Lunch 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)
Role of Compliance Officer and Case Study
Sue Egan
Director & Principal Consultant, Sue Egan Associates Limited (London)
Break
Case Study 1 Assignment & Prep Session - Group Teamwork
Virtual Networking Reception
Day 3
Scientific Exchange and Medical Education Activities
Sue Egan
Director & Principal Consultant, Sue Egan Associates Limited (London)
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)
Lunch Break
Maintaining Professional Competence: Emerging Standards of Professional Responsibility for Health Care Compliance Professionals in the Health Care Industry
Vincent Nys
EMEA Compliance Officer, Kenvue (Belgium)
Piergiorgio Pepe
President, Quantum Ethics (Paris)
Learn more about Piergiorgio Pepe
Leadership in Compliance: Emerging Challenges & Essential Skills
- 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)
Roeland Van Aelst
EMEA Lead Third Party Intermediary Ethics & Compliance, Johnson & Johnson (Antwerp)
Michelle Wagner
Vice President, Compliance International Markets, Cencora (London)
Dr. Kurt Seiler
Strategic Advisor / Coach, KMS Consult (Germany)
Moderator: Kathleen M. Boozang
Professor of Law & Dean Emeritus, Seton Hall Law School (New Jersey)
Break
Classroom Discussion of Case Study 1
- Teams to present their analysis and recommendations. Interactive class discussion.
Dominique Laymand
Of Counsel, Clifford Chance (Paris)
Day 4
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)
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
Case Study 2 Prep Session - Group Teamwork
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
Interactions with Patients & Patient Organizations
Piergiorgio Pepe
President, Quantum Ethics (Paris)
Patient Organizations Interactive Exercise
Piergiorgio Pepe
President, Quantum Ethics (Paris)
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)