08:30 - 09:00

Arrival & Registration

09:00 - 09:10

Welcome
Ela Bochenek, Seton Hall Law School (New Jersey)

09:10 - 09:40

Introductions
Ela Bochenek, Seton Hall Law School (New Jersey)

09:40 - 10:30

The "Why" of Corporate Compliance & Ethics
Timothy Glynn, Seton Hall Law School (New Jersey)

10:30 - 10:50

Break

10:50 - 11:50

EFPIA Codes of Practice
Julie Bonhomme, EFPIA (Brussels)
Kyriaki Merakli, Helsinn Pharmaceuticals (Switzerland)

11:50 - 12:50

MedTech Europe Code of Ethics
Pablo Rojas Abad, MedTech Europe (Brussels)
Anne-Sophie Bricca, Terumo BCT (Brussels)

12:50 - 13:50

Networking Lunch

13:50 - 14:40

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

14:40 - 15:55

EU General Data Protection Regulation (GDPR)
Alja Poler De Zwart, Morrison & Foerster LLP (Brussels)

15:55 - 16:15

Break

16:15 - 17:45

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

08:45

Sign-In

09:00 - 09:10

Day One Review
Timothy Glynn, Seton Hall Law School (New Jersey)

09:10 - 10:10

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

10:10 - 11:35

Data Driven Analysis for Compliance Programs: Forensic Accounting and Data Analytics
Yousr Khalil, Forensic Risk Alliance (Paris)

11:35 - 11:50

Break

11:50 - 13:00

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

13:00 - 14:00

Networking Lunch sponsored by Forensic Risk Alliance

14:00 - 14:45

Maintaining Professional Competence: Emerging Standards of Professional Responsibility for Health Care Compliance Professionals in the Health Care Industry
Vincent Nys, Johnson & Johnson Consumer (Antwerp)

14:45 - 15:55

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

15:55 - 16:10

Break

16:10 - 17:00

Compliance Issues in Clinical Studies
Robin Blaney, Covington & Burling LLP (Brussels)
Charlotte Ryckman, Covington & Burling LLP (Brussels)

17:00 - 18:00

Compliance Officer Panel Discussion
Ann-Sophie Bricca, Terumo BCT (Brussels)
Diva Duong, IQVIA (Paris)
Betania Glorio,Merck KGaA (Germany)
Dominique Laymand, Ipsen (Paris)
Vincent Nys, Johnson & Johnson Consumer (Antwerp)
Moderator: Timothy Glynn, Seton Hall Law School (New Jersey)

18:00 - 19:30

Cocktail Reception

08:45

Sign-In

09:00 - 10:00

EU Competition Law in Health Care
Edward Miller, Reed Smith (London)

10:00 - 10:45

Overview of UK and Other EU Anti-Bribery Laws
John Rupp, Steptoe & Johnson LLP (London)

10:45 - 11:00

Break

11:00 - 12:20

Doing Business in Eastern Europe and Russia: Key Risks and Compliance Challenges
David Smith, Ernst & Young (Moscow)

12:20 - 13:20

Networking Lunch

13:20 - 14:00

Behavior and Compliance
Betania Glorio, Merck KGaA (Germany)

14:20 - 15:50

Overview of EMA Approval Processes for Drugs and Devices
Geneviève Michaux, Mayer Brown Europe LLP (Brussels)

15:50 - 16:05

Break

16:05 - 18:00

Group Case Studies Workshop
Ela Bochenek, Seton Hall Law School (New Jersey)

08:15

Sign-In

08:30 - 9:55

Industry Interactions with Patients: What Is Possible and Appropriate?
Claudia Hirawat, VOZ Advisors (New York)
Veronica Lopez, MPH, VOZ Advisors (London)

09:55 - 10:15

Break

10:15 - 11:45

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

11:45 - 12:45

Networking Lunch

12:45 - 13:35

Group Case Studies Workshop
Group Teamwork

13:35 - 16:05

Classroom Discussion of Case Studies
Sue Egan, Sue Egan Associates (London)
Robert Skinner, GSK (London)

16:05 - 16:20

Closing Remarks & Award of Program Certificates
Ela Bochenek, Seton Hall Law School (New Jersey)
Ilaria Milazzo, Sciences Po Executive Education (Paris)