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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 June 10-14, 2024 | Virtual
PROGRAM SCHEDULED for October 21-25, 2024 | In-Person |Paris, France

 
Agenda. All times are listed in CET/Paris Time.

Day 1

 

10:00 - 10:45 

Welcome, Introductions & Ice Breaker 


Jacob T. Elberg

Jacob T. Elberg

Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School (New Jersey)

Learn more about Jacob T. Elberg

Rosa M. Alves

Rosa M. Alves

Assistant Dean for Global Compliance & Programming, Seton Hall Law School (New Jersey)

Learn more about Rosa M. Alves

10:50 - 11:40

The Relationship Between Ethics & Compliance 

  • The origins of compliance
  • Ethics, values & compliance

Jacob T. Elberg

Jacob T. Elberg

Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School (New Jersey)

Learn more about Jacob T. Elberg

11:45 - 12:45 

EFPIA Code of Practice

  • EFPIA Ethics & Compliance mission, vision and priorities
  • Introduction to the EFPIA Code: rationale, scope, applicability 

Julie Bonhomme

Julie Bonhomme

Legal Affairs & Compliance Director, EFPIA (Brussels)

Learn more about Julie Bonhomme

12:45 - 13:45 

Lunch Break


13:45 - 14:45 

MedTech Europe Code of Ethics

  • Main changes
  • Phasing out of direct sponsorship

Pablo Rojas Abad

Pablo Rojas Abad

Senior Legal Counsel, MedTech Europe (Brussels)

Learn more about Pablo Rojas Abad 

14:50 - 15:40

DOJ Enforcement Perspective


Sonali Patel

Sonali Patel

Assistant Chief, Foreign Corrupt Practices Act Unit, Fraud
Section, U.S. Department of Justice (Washington, D.C.)

Learn more about Sonali Patel

Jacob T. Elberg

Jacob T. Elberg

Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School (New Jersey)

Learn more about Jacob T. Elberg

15:40 - 15:55 

Break


15:55 - 16:55

The Impact of the U.S. Foreign Corrupt Practices Act on Europe and Beyond

  • Elements of the FCPA’s Anti-Bribery and Accounting Provisions
  • Key enforcement players and policies
  • Recent enforcement actions
  • Compliance programs and FCPA enforcement 
  • DOJ Enforcement

Albert B. Stieglitz, Jr.

Albert B. Stieglitz, Jr.

Partner, Alston & Bird LLP (Washington, D.C.)

Learn more about Albert B. Stieglitz, Jr.

17:00 - 18:10

The Anatomy of a Corruption Investigation for Pharmaceutical and Medical Device Companies

  • Current enforcement landscape
  • How an investigation begins
  • Responding to government inquiry
  • Special areas of interest

Kirk Ogrosky

Kirk Ogrosky

Partner, Goodwin Procter LLP (Washington, D.C.)

Learn more about Kirk Ogrosky

Day 2

 

10:00 - 11:10 

Global Transparency Trends and Challenges 

  • U.S. Sunshine/Open Payments Act
  • European laws & pending legislation
  • Voluntary industry codes
  • Future trends & practical challenges

Diva Duong

Diva Duong

Head of Compliance, Safety, Regulatory and Quality Solutions, IQVIA (Paris)

Learn more about Diva Duong

Alexandre Regniault

Alexandre Regniault

Partner, Section Head, Healthcare & Life Sciences, Simmons & Simmons LLP (Paris)

Learn more about Alexandre Regniault

11:15 - 12:35 

Approval Process for Drugs and Medical Devices

  • New medicines
  • New medical devices
  • Special products & clinical trials

Geneviève Michaux

Geneviève Michaux

Partner, King & Spalding LLP (Brussels/Paris)

Learn more about Geneviève Michaux

12:35 - 13:35 

Lunch Break


13:35 - 14:55

Advertising of Medicinal Products and Medical Devices in Europe

  • Advertising of medicinal products
  • Advertising of medical devices
  • Digitalization of information and advertising

Annabelle Bruyndonckx

Annabelle Bruyndonckx

Partner, Simmons & Simmons LLP (Brussels)

Learn more about Annabelle Bruyndonckx

15:00 - 16:00 

Role of Compliance Officer and Case Study


Sue Egan

Sue Egan

Director & Principal Consultant, Sue Egan Associates Limited (London)

Learn more about Sue Egan

16:00 - 16:15

Break


16:15 - 18:00 

Case Study 1 Assignment & Prep Session - Group Teamwork


18:00 - 19:00 

Virtual Networking Reception 


Day 3

 

10:00 - 11:20

Scientific Exchange and Medical Education Activities 


Sue Egan

Sue Egan

Director & Principal Consultant, Sue Egan Associates Limited (London)

Learn more about Sue Egan

11:25 - 12:25 

The Importance of Culture and Ethics in Building and Growing a Compliance Team


Roeland Van Aelst

Roeland Van Aelst

EMEA Lead Third Party Intermediary Ethics & Compliance, Johnson & Johnson (Antwerp)

Learn more about Roeland Van Aelst

12:25 - 13:25 

Lunch Break


13:25 - 14:20

Maintaining Professional Competence: Emerging Standards of Professional Responsibility for Health Care Compliance Professionals in the Health Care Industry


Vincent Nys

Vincent Nys

EMEA Compliance Officer, Kenvue (Belgium)

Learn more about Vincent Nys

Piergiorgio Pepe

Piergiorgio Pepe

President, Quantum Ethics (Paris)

Learn more about Piergiorgio Pepe

 

14:25 - 15:45 

Leadership in Compliance: Emerging Challenges & Essential Skills  

  • The compliance officer as a profession
  • Regional & global challenges
  • Ensuring a culture of compliance
  • Q&A from participants

Dominique Laymand

Dominique Laymand

Of Counsel, Clifford Chance (Paris)

Learn more about Dominique Laymand

Roeland Van Aelst

 

Roeland Van Aelst

EMEA Lead Third Party Intermediary Ethics & Compliance, Johnson & Johnson (Antwerp)

Learn more about Roeland Van Aelst

Michelle Wagner

Michelle Wagner

Vice President, Compliance International Markets, Cencora (London)

Learn more about Michelle Wagner

Dr. Kurt Seiler

Dr. Kurt Seiler

Strategic Advisor / Coach, KMS Consult (Germany)

Learn more about Dr. Kurt Seiler

Kathleen M. Boozang

Moderator: Kathleen M. Boozang

Professor of Law & Dean Emeritus, Seton Hall Law School (New Jersey)

Learn more about Kathleen M. Boozang

15:45 - 16:00 

Break


16:00 - 18:00 

Classroom Discussion of Case Study 1

  • Teams to present their analysis and recommendations. Interactive class discussion.

Dominique Laymand

Dominique Laymand

Of Counsel, Clifford Chance (Paris)

Learn more about Dominique Laymand

Day 4

 

10:00 - 11:20

EU Competition Law in Health Care

  • Ban on anti-competitive agreements
  • Ban on abuses of dominance/market power
  • Case studies

Natasha Tardif

Natasha Tardif 

Managing Partner, Reed Smith LLP (Paris)

Learn more about Natasha Tardif  

11:25 - 12:50 

Doing Business in Eastern Europe & Russia: Key Risks and Compliance Challenges


Mariusz Witalis

Mariusz Witalis

Partner, Leader Central, Eastern and Southeastern Europe & Central Asia, Forensic & Integrity Services, EY (Warsaw)

Learn more about Mariusz Witalis

12:50 - 13:50

Lunch Break


13:50 - 15:30

Case Study 2 Prep Session - Group Teamwork 


15:30 - 15:45 

Break


15:45 - 17:45 

Classroom Discussion of Case Study 2

  • Teams to present their analysis and recommendations. Interactive class discussion.

Sue Egan

Sue Egan

Director & Principal Consultant, Sue Egan Associates Limited (London)

Learn more about Sue Egan

Day 5

 

10:00 - 11:15 

Interactions with Patients & Patient Organizations


Piergiorgio Pepe

Piergiorgio Pepe

President, Quantum Ethics (Paris)

Learn more about Piergiorgio Pepe

11:15 - 12:10

Patient Organizations Interactive Exercise


Piergiorgio Pepe

Piergiorgio Pepe

President, Quantum Ethics (Paris)

Learn more about Piergiorgio Pepe

12:10 - 13:10 

Lunch Break


13:10 - 14:30 

Privacy and Data Protection in Europe


Ronan Tigner

Ronan Tigner

Technology Lawyer (Belgium)

Learn more about Ronan Tigner 

14:35 - 15:45 

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

George Fife

George Fife

Partner, Compliance, Forensic & Integrity Services, Ernst & Young (EY) (Paris)

Learn more about George Fife

15:45 

Closing Remarks & Award of Program Certificates 


Rosa M. Alves

Rosa M. Alves

Assistant Dean for Global Compliance & Programming, Seton Hall Law School (New Jersey)

Learn more about Rosa M. Alves