13:00 - 13:10

Welcome & Format Review
 

13:15 - 13:55

Aligning the “Why” and “How” of Compliance
Prof. Jacob Elberg, Seton Hall Law School (New Jersey)

14:00 - 14:45

The Impact of the U.S. Foreign Corrupt Practices Act on Europe and Beyond
Robin Lööf, Debevoise & Plimpton LLP (London)

14:50 - 15:50

DOJ & SFO Enforcement Perspective
Sara Chouraqui, United Kingdom’s Serious Fraud Office
Albert Stieglitz, Jr., U.S. Department of Justice (Washington, D.C)
Moderator: Prof. Jacob Elberg, Seton Hall Law School (New Jersey)

15:50 - 16:10

Break

16:10 - 16:50

EFPIA Codes of Practice
Julie Bonhomme, EFPIA (Brussels)

16:55 - 17:20

The Anatomy of a Corruption Investigation for Pharmaceutical and Medical Device Companies: Legal and Compliance Issues
Kirk Ogrosky, Arnold & Porter Kaye Scholer LLP (Washington, D.C.)

17:25 - 18:30

Role of Compliance Officer and Case Study
Sue Egan, Sue Egan Associates (London)

13:00 - 13:45

Maintaining Professional Competence: Emerging Standards of Professional Responsibility for Health Care Compliance Professionals in the Health Care Industry
Vincent Nys, Johnson & Johnson (Belgium)
Piergiorgio Pepe, Quantum Ethics (Paris)

13:50 - 14:20

Global Transparency Trends and Challenges
Diva Duong, IQVIA (Paris)
Alexandre Regniault, Simmons & Simmons LLP (Paris)

14:25 - 15:00

Scientific Exchange and Medical Education Activities
Sue Egan, Sue Egan Associates (London)

15:05 - 15:45

MedTech Europe Code of Ethics
Pablo Rojas Abad , MedTech Europe (Brussels)

15:45 - 16:05

Break

16:05 - 17:35

Case Study 1 Assignment & Prep Session
Group Teamwork

Required Video

Doing Business in Russia and Eastern Europe: Key Risks and Compliance Challenges
Mariusz Witalis, Ernst & Young (Warsaw)

13:00 - 14:10

Compliance Officer Panel Discussion
Betania Glorio, Merck KGaA (Germany)
Dominique Laymand, Ipsen (Paris)
Vincent Nys, Johnson & Johnson (Belgium)
Roeland Van Aelst, Johnson & Johnson (Antwerp)
Moderator: Dean Kathleen Boozang, Seton Hall Law School (New Jersey)

14:15 - 15:00

Managing New Ethics and Compliance Challenges: Artificial Intelligence, Blockchain, Cybersecurity, Value-Based Healthcare, and the Internet of Things
John McLoughlin, Attorney (Washington D.C. and Paris)

15:05 - 15:50

The Importance of Culture and Ethics in Building and Growing a Compliance Team
Roeland Van Aelst, Johnson & Johnson (Antwerp)

15:50 - 16:10

Break

16:10 - 18:25

Classroom Discussion of Case Study 1
Dominique Laymand, Ipsen (Paris)

13:00 - 14:45

Case Study 2 Prep Session
Group Teamwork

14:50 - 16:20

Classroom Discussion of Case Study 2
Sue Egan, Sue Egan Associates (London)

16:25 - 16:45

Compliance Issues in Clinical Studies
Prof. Carl Coleman, Seton Hall Law School (New Jersey)

16:45 - 17:05

Break

17:05 - 17:50

Privacy and Data Protection in Europe
Ronan Tigner, Morrison & Foerster LLP (Brussels)

17:55 - 18:25

Data Driven Analysis for Compliance Programs: Forensic Accounting and Data Analytics
Prof. Jacob Elberg, Seton Hall Law School (New Jersey)
Yousr Khalil,Forensic Risk Alliance (Paris)

11:00 - 11:50

Patient and Patient Organization Interactions
Piergiorgio Pepe, Quantum Ethics (Paris)

11:50 - 12:20

Patient Organizations Interactive Exercise
Piergiorgio Pepe, Quantum Ethics (Paris)

12:25 - 13:15

Approval Process for Drugs and Medical Devices
Geneviève Michaux, King & Spalding LLP (Brussels/Paris)

13:15 - 13:35

Break

13:35 - 14:35

Advertising of Medicinal Products and Medical Devices in Europe
Annabelle Bruyndonckx, Simmons & Simmons LLP (Brussels)

14:40 - 15:20

EU Competition Law in Health Care
Natasha Tardif, Reed Smith (London)

15:25 - 15:40

Closing Remarks
Dean Kathleen Boozang, Seton Hall Law School (New Jersey)