08:30 - 09:00

Arrival & Registration

09:00 - 09:10

Welcome
 

09:10 - 09:40

Introductions
 

09:40 - 10:30

Aligning the “Why” and “How” of Compliance

10:30 - 10:50

Break

10:50 - 11:50

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

11:50 - 12:35

DOJ & SFO Enforcement Perspective
Ben Morgan, Freshfields Bruckhaus Deringer (London)
Albert Stieglitz, Jr., U.S. Department of Justice (on detail to the United Kingdom’s Serious Fraud Office) (London)

12:35 - 13:35

Networking Lunch

13:35 - 14:45

The Anatomy of a Corruption Investigation for Pharmaceutical and Medical Device Companies: Legal and Compliance Issues
Speaker TBD

14:45 - 15:35

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

15:35 - 15:55

Break

15:55 - 17:25

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

08:45

Sign-In

09:00 - 09:10

Day One Review

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

EFPIA Codes of Practice
Julie Bonhomme, EFPIA (Brussels)

12:30 - 13:30

Networking Lunch

13:30 - 14:30

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

14:30 - 14:50

Break

14:50 - 16:20

Group Case Study 1 Workshop

16:20 - 17:30

Compliance Officer Panel Discussion
Dominique Laymand, Ipsen (Paris)
Vincent Nys, Johnson & Johnson Consumer (Antwerp)
Roeland Van Aelst, Johnson & Johnson (Antwerp)
Moderator: TBD

17:30 - 19:00

Cocktail Reception

08:30

Sign-In

08:45 - 10:00

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

10:00 - 10:20

Break

10:20 - 11:10

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

11:10 - 12:00

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

12:00 - 13:00

Networking Lunch

13:00 - 13:30

Group Case Study 1 Workshop (continued)

13:30 - 15:10

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

15:10 - 15:30

Break

15:30 - 17:40

Group Case Studies 2 & 3 Workshop

08:45

Sign-In

09:00 - 09:30

Group Case Studies 2 & 3 Workshop (continued)

09:30 - 09:50

Break

09:50 - 12:00

Classroom Discussion of Case Studies 2 & 3
Dominique Laymand, Ipsen (Paris)

12:00 - 13:00

Networking Lunch

13:00 - 14:00

Compliance Issues in Clinical Studies
Mark Barnes, Ropes & Gray LLP (Boston)

14:00 - 14:15

Break

14:15 - 16:00

Privacy and Data Protection in Europe
Mark Barnes, Ropes & Gray LLP (Boston)

16:00 - 16:20

Break

16:20 - 17:45

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

08:45

Sign-In

09:00-10:30

Approval Process for Drugs and Medical Devices
Geneviève Michaux, Mayer Brown Europe LLP (Brussels)

10:30 - 10:50

Break

10:50 - 12:35

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

12:35 - 13:35

Networking Lunch

13:35 - 14:35

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

14:35 - 14:55

Break

14:55 - 16:20

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

16:20 - 16:50

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

16:50 - 17:00

Closing Remarks & Award of Program Certificates