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Program Agenda


 

European Healthcare Industry Training: Compliance Certification Program

healthlaw@shu.edu | 973-642-8871 or 973-761-9000 ext. 8871

PROGRAM SCHEDULED for November 5-8, 2018 | Program will be held in Paris, France

 

This schedule is subject to change and will be provided on the first day of the Program.

 

DAY 1

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
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)

DAY 2

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)
Brian Sharkey, Porzio Life Sciences (New Jersey)

13:00 - 14:00

Networking Lunch

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 Corruption Investigations
Kirk Ogrosky, Arnold & Porter Kaye Scholer (Washington, D.C.)

15:55 - 16:10

Break

16:10 - 17:00

Compliance Issues in Clinical Studies
Speaker TBA

17:00 - 18:00

Compliance Officer Panel Discussion
Diva Duong, IQVIA (Paris)
Dominique Laymand, Ipsen (Paris)
Vincent Nys, Johnson & Johnson Consumer (Antwerp)
Jolanta Wyszynska, AstraZeneca (Warsaw)
Moderator: Timothy Glynn, Seton Hall Law School (New Jersey)

18:00 - 19:30

Cocktail Reception

DAY 3

08:45

Sign-In

09:00 - 10:00

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

10:00 - 10:45

The Changing Health Care Environment and the Impact on Health Care Compliance
Roeland Van Aelst, Johnson & Johnson (Antwerp)

10:45 - 11:05

Break

11:05 - 12:25

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

12:25 - 13:25

Networking Lunch

13:25 - 14:10

Behavior and Compliance
Speaker TBA

14:10 - 15:10

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

15:10 - 15:30

Break

15:30 - 17:15

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

DAY 4

08:15

Sign-In

08:30 - 9:55

Industry Interactions with Patients: What Is Possible and Appropriate?
Speaker TBA

09:55 - 10:10

Break

10:10 - 11:40

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

11:40 - 12:25

Culture and Compliance
Speaker TBA

12:25 - 13:25

Networking Lunch

13:25 - 14:15

Group Case Studies Workshop
Group Teamwork

14:15 - 16:25

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

16:45 - 17:00

Closing Remarks & Award of Program Certificates
Ela Bochenek, Seton Hall Law School (New Jersey)

 

 

 



Supporters

 

  SciencesPo   INSEAD   EFPIA   ADVAMED   MECOMED   AESGP   IFPMA   MEDTECH EUROPE   ETHICS Clifford Chance IQVIA Sponsor  

 




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