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Program Agenda

European Healthcare Industry Training: Compliance Certificate Program

[email protected] | 973-642-8382 or 973-761-9000 ext. 8382

PROGRAM SCHEDULED for September 19-23, 2022 | In-person | Paris, France.

Sample Agenda. All times are listed in Paris Time.

DAY 1 .
10:00 - 10:45	Welcome and Introductions Rosa Alves Assistant Dean for Global Compliance, Seton Hall Law School (New Jersey) Learn more about Rosa Alves >> Professor Jacob T. Elberg Associate Professor of Law, Seton Hall Law School (New Jersey) Learn more about Prof. Elberg >>
10:45 - 11:35	The Relationship Between Ethics & Compliance The origins of compliance Ethics, values & compliance Professor Jacob T. Elberg Associate Professor of Law, Seton Hall Law School (New Jersey) Learn more about Prof. Elberg >>
11:40 - 12:30	EFPIA Code of Practice Overview of transparency code & data privacy implications Setting & enforcing a code & vigilance Ongoing projects & areas of focus Julie Bonhomme Legal Affairs & Compliance Officer, EFPIA (Brussels) Learn more about Julie Bonhomme >>
12:30 - 13:30	*Break*
13:30 - 14:30	The Impact of the U.S. Foreign Corrupt Practices Act on Europe and Beyond OECD overview FCPA legal requirements; anti-bribery books & records Cases & enforcement Albert B. Stieglitz, Jr. Partner, Alston & Bird LLP (Washington, D.C) Learn more about Albert Stieglitz, Jr. >>
14:35 - 15:25	DOJ Enforcement Perspective Sonali Patel Assistant Chief, FCPA Unit, U.S. Department of Justice Learn more about Sonali Patel >>
15:25 - 15:45	*Break*
15:45 - 16:55	The Anatomy of a Corruption Investigation for Pharmaceutical and Medical Device Companies: Legal and Compliance Issues Current enforcement landscape How an investigation begins Responding to government inquiry Special areas of interest Kirk Ogrosky Partner, Arnold & Porter Kaye Scholer LLP (Washington, D.C.) Learn more about Kirk Ogrosky >>
17:00 - 18:00	Role of Compliance Officer and Case Study Sue Egan Director & Principal Consultant, Sue Egan Associates (London) Learn more about Sue Egan >>
DAY 2 .
10:30 - 11:30	Global Transparency Trends and Challenges U.S. Sunshine/Open Payments Act European laws & pending legislation Voluntary industry codes Future trends & practical challenges Diva Duong Head of Compliance, Safety, Regulatory and Quality Solutions, IQVIA (Paris) Learn more about Diva Duong >> Alexandre Regniault Partner, Sector head--Healthcare and Life Sciences, Simmons & Simmons LLP (Paris) Learn more about Alexandre Regniault >>
11:35 - 12:25	Maintaining Professional Competence: Emerging Standards of Professional Responsibility for Health Care Compliance Professionals in the Health Care Industry Vincent Nys Health Care Compliance Lead Officer EMEA Consumer, Johnson & Johnson Office of Health Care Compliance & Privacy (Belgium) Learn more about Vincent Nys >> Piergiorgio Pepe President, Quantum Ethics (Paris) Learn more about Piergiorgio Pepe >>
12:25 - 13:25	*Break*
13:25 - 14:45	Scientific Exchange and Medical Education Activities Sue Egan Director & Principal Consultant, Sue Egan Associates (London) Learn more about Sue Egan >>
14:50 - 15:40	MedTech Europe Code of Ethics Main changes Phasing out of direct sponsorship Impact so far Aline Lautenberg .., MedTech Europe (Brussels) Learn more about Aline Lautenberg >>
15:40 - 16:00	*Break*
16:00 - 17:25	Case Study 1 Assignment & Prep Session Group Teamwork
17:30 - 18:15	*Optional Networking*
DAY 3 .
10:30 - 11:30	Doing Business in Eastern Europe & Russia: Key Risks and Compliance Challenges Mariusz Witalis Partner, Leader Central, Eastern and Southeastern Europe & Central Asia, Forensic & Integrity Services, EY (Warsaw) Learn more about Mariusz Witalis >>
11:35 - 12:45	Compliance Officer Panel Discussion The compliance officer as a profession Regional & global challenges Ensuring a culture of compliance Q&A from participants Betania Glorio Vice President and Global Chief Compliance Officer, EMD Serono (US and Germany) Learn more about Betania Glorio >> Dominique Laymand Executive Vice President, Chief Ethics and Social Responsibility Officer, Ipsen (Paris) Learn more about Dominique Laymand >> Vincent Nys Health Care Compliance Lead Officer EMEA Consumer, Johnson & Johnson Office of Health Care Compliance & Privacy (Belgium) Learn more about Vincent Nys >> Roeland Van Aelst Regional VP, HCC MD&D EMEA, Johnson & Johnson (Antwerp) Learn more about Roeland Van Aelst >> Moderator: Kathleen Boozang Dean & Professor of Law, Seton Hall Law School (New Jersey) Learn more about Dean Boozang >>
12:45 - 13:45	*Break*
13:45 - 14:35	Managing New Ethics and Compliance Challenges: Artificial Intelligence, Blockchain, Cybersecurity, Value-Based Healthcare, and the Internet of Things John McLoughlin Attorney (Washington D.C. and Paris) Learn more about John McLoughlin >>
14:40 - 15:35	The Importance of Culture and Ethics in Building and Growing a Compliance Team Roeland Van Aelst Regional VP, HCC MD&D EMEA , Johnson & Johnson (Antwerp) Learn more about Roeland Van Aelst >>
15:35 - 15:50	*Break*
15:50 - 18:00	Classroom Discussion of Case Study 1 Teams to present their analysis and recommendations. Interactive class discussion. Dominique Laymand Executive Vice President, Chief Ethics and Social Responsibility Officer, Ipsen (Paris) Learn more about Dominique Laymand >>
DAY 4
10:30 - 12:15	Case Study 2 Prep Session
12:15 - 13:15	*Break with Optional Networking*
13:15 - 14:45	Classroom Discussion of Case Study 2 Teams to present their analysis and recommendations. Interactive class discussion. Sue Egan Director and Principal Consultant, Sue Egan Associates (London) Learn more about Sue Egan >>
14:50 - 15:50	Data Driven Analysis for Compliance Programs: Forensic Accounting and Data Analytics Role of forensic accounting in investigations How data analytics can enhance compliance programs Identify and manage potential risks Professor Jacob T. Elberg Associate Professor of Law, Seton Hall Law School (New Jersey) Learn more about Prof. Elberg >> Yousr Khalil Partner, Forensic Risk Alliance (Paris) Learn more about Yousr Khalil >>
15:55 - 16:30	Compliance Issues in Clinical Studies Professor Carl Coleman Professor of Law, Seton Hall Law School (New Jersey) Learn more about Prof. Coleman >>
16:30 - 16:45	*Break*
16:45 - 18:00	Privacy and Data Protection in Europe Ronan Tigner Associate, Morrison & Foerster LLP (Brussels) Learn more about Ronan Tigner >>
DAY 5 .
10:30 - 11:20	Interactions with Patients & Patient Organizations Piergiorgio Pepe President, Quantum Ethics (Paris) Learn more about Piergiorgio Pepe >>
11:20 - 11:55	Patient Organizations Interactive Exercise Piergiorgio Pepe President, Quantum Ethics (Paris) Learn more about Piergiorgio Pepe >>
11:55 - 12:55	*Break/Optional Networking*
12:55 - 14:15	Approval Process for Drugs and Medical Devices New medicines New medical devices Special products & clinical trials Geneviève Michaux Partner, King & Spalding LLP (Brussels/Paris) Learn more about Geneviève Michaux >>
14:15 - 14:30	*Break*
14:30 - 16:00	Advertising of Medicinal Products and Medical Devices in Europe National legislation EU harmonization programs on OTC and devices Social media risks Annabelle Bruyndonckx Counsel, Simmons & Simmons LLP (Brussels) Learn more about Annabelle Bruyndonckx >>
16:05 - 16:45	EU Competition Law in Health Care Ban on anti-competitive agreements Ban on abuses of dominance/market power Case studies Natasha Tardif Managing Partner, Reed Smith LLP (Paris) Learn more about Natasha Tardif >>
16:50 - 17:00	Closing Remarks Kathleen Boozang Dean & Professor of Law, Seton Hall Law School (New Jersey) Learn more about Dean Boozang >>