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Program Agenda

European Healthcare Industry Training: Compliance Certificate Program

[email protected] | 973-642-8871 or 973-761-9000 ext. 8871

PROGRAM SCHEDULED for June 3-7, 2019 | 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 Julie Bonhomme, EFPIA (Brussels) 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) Alexandre Regniault, Simmons & Simmons LLP (Paris)
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 a Corruption Investigation for Pharmaceutical and Medical Device Companies: Legal & Compliance Issues Kirk Ogrosky, Arnold & Porter Kaye Scholer (Washington, D.C.)
15:55 - 16:10	Break
16:10 - 17:00	Compliance Issues in Clinical Studies Robin Blaney, Covington & Burling LLP (Brussels) Charlotte Ryckman, Covington & Burling LLP (Brussels)
17:00 - 18:00	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: 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	Overview of UK and Other EU Anti-Bribery Laws John Rupp, Steptoe & Johnson LLP (London)
10:45 - 11:00	Break
11:00 - 12:20	Doing Business in Eastern Europe and Russia: Key Risks and Compliance Challenges David Smith, Ernst & Young (Moscow)
12:20 - 13:20	Networking Lunch
13:20 - 14:00	Behavior and Compliance Betania Glorio, Merck KGaA (Germany)
14:20 - 15:50	Overview of EMA Approval Processes for Drugs and Devices Geneviève Michaux, Mayer Brown Europe LLP (Brussels)
15:50 - 16:05	Break
16:05 - 18:00	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? Claudia Hirawat, VOZ Advisors (New York) Veronica Lopez, MPH, VOZ Advisors (London)
09:55 - 10:15	Break
10:15 - 11:45	Advertising Medicinal Products and Medical Devices in the EU Annabelle Bruyndonckx, Simmons & Simmons LLP (Brussels)
11:45 - 12:45	Networking Lunch
12:45 - 13:35	Group Case Studies Workshop Group Teamwork
13:35 - 16:05	Classroom Discussion of Case Studies Sue Egan, Sue Egan Associates (London) Robert Skinner, GSK (London)
DAY 5
09:00-15:00	Schedule for the last day of the program is currently under development. The additional content will include expanded and deeper coverage of topics relevant to health care compliance professionals, as well as additional interactive exercises, including case studies.
15:00 - 15:30	Closing Remarks & Award of Program Certificates Ela Bochenek, Seton Hall Law School (New Jersey)