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: Monday, 10 June 2024
Welcome, Introductions & Ice Breaker
![Jacob T. Elberg](/images/jacob-elberg-176x176.jpg)
Jacob T. Elberg
Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School (New Jersey)
![Rosa M. Alves](/images/rosa-alves-176x176.jpg)
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](/images/jacob-elberg-176x176.jpg)
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](/images/julie-bonhomme-final.jpg)
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](/images/pablo-rojas-abad-final.jpg)
Pablo Rojas Abad
Senior Legal Counsel, MedTech Europe (Brussels)
DOJ Enforcement Perspective
![Sonali Patel](/images/sonali-patel-final.jpg)
Sonali Patel
Assistant Chief, Foreign Corrupt Practices Act Unit, Fraud
Section, U.S. Department of Justice (Washington, D.C.)
![Jacob T. Elberg](/images/jacob-elberg-176x176.jpg)
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.](/images/albert-stieglitz-5.29.24.jpg)
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](/images/kirk-ogrosky-5.29.24.jpg)
Kirk Ogrosky
Partner, Goodwin Procter LLP (Washington, D.C.)
Day 2: Tuesday, 11 June 2024
Global Transparency Trends and Challenges
- U.S. Sunshine/Open Payments Act
- European laws & pending legislation
- Voluntary industry codes
- Future trends & practical challenges
![Diva Duong](/images/diva-duong-li.jpg)
Diva Duong
Head of Compliance, Safety, Regulatory and Quality Solutions, IQVIA (Paris)
![Alexandre Regniault](/images/alexandre-regniault-final.jpg)
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](/images/genevieve-michaux-final.jpg)
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](/images/annabelle-bruyndonck-final.jpg)
Annabelle Bruyndonckx
Partner, Simmons & Simmons LLP (Brussels)
Role of Compliance Officer and Case Study
![Sue Egan](/images/sue-egan-final.jpg)
Sue Egan
Director & Principal Consultant, Sue Egan Associates Limited (London)
Break
Case Study 1 Assignment & Prep Session - Group Teamwork
Virtual Networking Reception
Day 3: Wednesday, 12 June 2024
Scientific Exchange and Medical Education Activities
![Sue Egan](/images/sue-egan-final.jpg)
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](/images/roeland-van-aelst-final.jpg)
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](/images/vincent-nys-5.30.24.jpg)
Vincent Nys
EMEA Compliance Officer, Kenvue (Belgium)
![Piergiorgio Pepe](/images/piergiorgio-pepe-final.jpg)
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](/images/dominique-laymand-5.30.24.jpg)
Dominique Laymand
Of Counsel, Clifford Chance (Paris)
![Roeland Van Aelst](/images/roeland-van-aelst-final.jpg)
Roeland Van Aelst
EMEA Lead Third Party Intermediary Ethics & Compliance, Johnson & Johnson (Antwerp)
![Michelle Wagner](/images/michelle-wagner.jpg)
Michelle Wagner
Vice President, Compliance International Markets, Cencora (London)
![Dr. Kurt Seiler](/images/kurt-seiler.jpg)
Dr. Kurt Seiler
Strategic Advisor / Coach, KMS Consult (Germany)
![Kathleen M. Boozang](/images/kathleen-boozang-176x176.jpg)
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](/images/dominique-laymand-5.30.24.jpg)
Dominique Laymand
Of Counsel, Clifford Chance (Paris)
Day 4: Thursday, 13 June 2024
EU Competition Law in Health Care
- Ban on anti-competitive agreements
- Ban on abuses of dominance/market power
- Case studies
![Natasha Tardif](/images/natasha-tardif-final.jpg)
Natasha Tardif
Managing Partner, Reed Smith LLP (Paris)
Doing Business in Eastern Europe & Russia: Key Risks and Compliance Challenges
![Mariusz Witalis](/images/mariusz-witalis-5.31.24.jpg)
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](/images/sue-egan-final.jpg)
Sue Egan
Director & Principal Consultant, Sue Egan Associates Limited (London)
Day 5: Friday, 14 June 2024
Interactions with Patients & Patient Organizations
![Piergiorgio Pepe](/images/piergiorgio-pepe-final.jpg)
Piergiorgio Pepe
President, Quantum Ethics (Paris)
Patient Organizations Interactive Exercise
![Piergiorgio Pepe](/images/piergiorgio-pepe-final.jpg)
Piergiorgio Pepe
President, Quantum Ethics (Paris)
Lunch Break
Privacy and Data Protection in Europe
![Ronan Tigner](/images/ronan-tigner-final.jpg)
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](/images/george-fife.jpg)
George Fife
Partner, Compliance, Forensic & Integrity Services, Ernst & Young (EY) (Paris)
Closing Remarks & Award of Program Certificates
![Rosa M. Alves](/images/rosa-alves-176x176.jpg)
Rosa M. Alves
Assistant Dean for Global Compliance & Programming, Seton Hall Law School (New Jersey)