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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)