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

1. The origins of compliance
2. 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

1. Overview of transparency code & data privacy implications
2. Setting & enforcing a code & vigilance
3. 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

1. OECD overview
2. FCPA legal requirements; anti-bribery books & records
3. 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

1. Current enforcement landscape
2. How an investigation begins
3. Responding to government inquiry
4. 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 >>

10:30 - 11:30

Global Transparency Trends and Challenges

1. U.S. Sunshine/Open Payments Act
2. European laws & pending legislation
3. Voluntary industry codes
4. 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

1. Main changes
2. Phasing out of direct sponsorship
3. 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

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

1. The compliance officer as a profession
2. Regional & global challenges
3. Ensuring a culture of compliance
4. 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

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 >>

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

1. 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

1. Role of forensic accounting in investigations
2. How data analytics can enhance compliance programs
3. 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 >>

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

1. New medicines
2. New medical devices
3. 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

1. National legislation
2. EU harmonization programs on OTC and devices
3. 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

1. Ban on anti-competitive agreements
2. Ban on abuses of dominance/market power
3. 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 >>