08:30 - 09:00

Arrival & Registration

09:00 - 09:10

Welcome
Speaker TBA

09:10 - 09:40

Introductions
Speaker TBA

09:40 - 10:30

Aligning the “Why” and “How” of Compliance
Kathleen Boozang, 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, Novartis (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 - 15:40

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

15:40 - 16:00

Break

16:00 - 17:30

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

08:45

Sign-In

09:00 - 09:10

Day One Review
Kathleen Boozang, Seton Hall Law School (New Jersey)

09:10 - 10:00

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

10:00 - 10:20

Break

10:20 - 11:30

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

11:30 - 12:30

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

12:30 - 13:30

Networking Lunch

13:30 - 14:40

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

14:40 - 15:00

Break

15:00 - 16:30

Group Case Study 1 Workshop

16:30 - 17:30

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: Kathleen Boozang, Seton Hall Law School (New Jersey)

17:30 - 19:00

Cocktail Reception

08:30

Sign-In

08:45 - 09:45

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

09:45 - 10:00

Break

10:00 - 11:15

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

11:15 - 12:00

Overview of UK and Other EU Anti-Bribery Laws
Speaker TBD

12:00 - 13:00

Networking Lunch

13:00 - 14:00

Behavior and Compliance
Betania Glorio, Merck KGaA (Germany)

14:00 - 15:30

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

15:30 - 15:40

Break

15:40 - 16:10

Group Case Study 1 Workshop (continued)

16:10 - 18:00

Classroom Discussion of Case Study 1
Sue Egan, Sue Egan Associates (London)

08:45

Sign-In

09:00 - 10:25

Industry Interactions with Patients
Pepe Piergiorgio, Quantum Ethics (Paris)

10:25 - 10:45

Break

10:45 - 12:10

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

12:10 - 13:10

Networking Lunch

13:10 - 14:30

Managing New Compliance Challenges: Blockchain, Artificial Intelligence, Cybersecurity, Vertical Integration
John McLoughlin, McLoughlin & Avocats (Paris)

14:30 - 14:50

Break

14:50 - 17:00

Group Case Study 2 Workshop

08:45

Sign-In

09:00-10:45

EU General Data Protection Regulation
Willy Vanbuggenhout, formerly of Johnson & Johnson (Belgium)

10:45 - 11:05

Break

11:05 - 12:50

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

12:50 - 13:50

Networking Lunch

13:50 - 14:20

Group Case Study 2 Workshop (continued)

14:20 - 16:30

Classroom Discussion of Case Study 2
Dominique Laymand, Ipsen (Paris)

16:30 - 16:45

Closing Remarks & Award of Program Certificates
Speaker TBA