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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
Kathleen Boozang, Seton Hall Law School (New Jersey)

10:30 - 10:50

Break

10:50 - 11:50

EFPIA Codes of Practice
Małgorzata Dziomdziora, INFARMA (Warsaw)
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)
Oskar Luty, Fairfield Law Firm (Warsaw)

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
Kathleen Boozang, Seton Hall Law School (New Jersey)

09:10 - 10:10

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

10:10 - 11:30

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

11:30 - 11:45

Break

11:45 - 12:55

Global Transparency Trends & Challenges
Diva Duong, IQVIA (Paris)
Brian Sharkey, Porzio Life Sciences (New Jersey)

12:55 - 13:55

Networking Lunch

13:55 - 14:40

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

14:40 - 15:50

The Anatomy of Corruption Investigations
Tomasz Konopka, Sołtysiński Kawecki Szlęzak (Warsaw)
Mariusz Witalis, Ernst & Young (Warsaw)

15:50 - 16:40

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

16:40 - 16:55

Break

16:55 - 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: Kathleen Boozang, Seton Hall Law School (New Jersey)

18:00 - 19:30

Cocktail Reception sponsored by Helsinn Healthcare SA

DAY 3

08:45

Sign-In

09:00 - 10:00

The Impact of the U.S. Foreign Corrupt Practices Act on Europe and Beyond
Jane Shvets, Debevoise & Plimpton (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 sponsored by Forensic Risk Alliance

11:05 - 12:35

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

12:35 - 13:35

Networking Lunch

13:35 - 14:20

Behavior and Compliance
Abdul Luheshi, Astellas Pharma (London)

14:20 - 15:45

Industry Interactions with Patients: What Is Possible and Appropriate?
Tim Turnham, MK&A (New York)

15:45 - 16:05

Break sponsored by Forensic Risk Alliance

16:05 - 17:45

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

DAY 4

08:15

Sign-In

08:30 - 9:30

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

09:30 - 09:50

Break

9:50 - 11:20

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

11:20 - 12:05

Culture and Compliance
Pawel Wajszczyk, Johnson & Johnson (Warsaw)
Ela Bochenek, Seton Hall Law School (New Jersey)

12:05 - 13:05

Networking Lunch

13:05 - 13:55

Group Case Studies Workshop
Group Teamwork

13:55 - 16:25

Classroom Discussion of Case Studies
Dominique Laymand , Ipsen (Paris)
Robert Skinner, GSK (London)

16:25 - 16:45

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  

 




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