10:30 - 11:20

The Relationship Between Ethics & Compliance
Prof. Jacob Elberg, Seton Hall Law School (New Jersey)

11:25 - 12:15

The Impact of the U.S. Foreign Corrupt Practices Act on Europe and Beyond
Tom Best, Paul Hastings, LLP (Washington, D.C.)

12:15 - 13:00

Break

13:00 - 13:50

DOJ & SFO Enforcement Perspective
Albert Stieglitz, Jr., U.S. Department of Justice (Washington, D.C)
Prof. Jacob Elberg, Seton Hall Law School (New Jersey)

13:55 - 14:45

EFPIA Codes of Practice
Julie Bonhomme, EFPIA (Brussels)

14:45 - 15:20

Break

15:20 - 16:30

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.)

16:35 - 17:30

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

10:30 - 11:30

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

11:35 - 12:25

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)

12:25 - 13:10

Break

13:10 - 14:30

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

14:35 - 15:25

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

15:25 - 15:45

Break

15:45 - 17:15

Case Study 1 Assignment & Prep Session
Group Teamwork

10:30 - 11:30

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

11:35-12:45

Compliance Officer Panel Discussion
Anne-Sophie Bricca, Terumo BCT (Brussels)
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)

12:45 - 13:30

Break

13:30 - 14:30

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)

14:35-15:20

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

15:20 - 15:40

Break

15:40 - 17:55

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

10:30 - 12:15

Case Study 2 Prep Session
Group Teamwork

12:15 - 13:00

Break

13:00 - 14:30

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

14:35 - 15:35

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)

15:40 - 16:20

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

16:20-16:40

Break

16:40 - 17:55

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

10:30-11:20

Interactions with Patients & Patient Organizations
Piergiorgio Pepe, Quantum Ethics (Paris)

11:20 - 11:55

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

11:55 - 12:40

Break

12:40 - 14:00

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

14:00 - 14:15

Break

14:15 - 15:45

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

15:50 - 16:40

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

16:45 - 17:00

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