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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 

8:30 - 9:00

 

Registration & Coffee

9:00 - 9:30

Welcome, Introductions & Ice Breaker

Carl Coleman

Carl Coleman
Professor of Law & Associate Dean for Graduate Programs, Seton Hall Law School (New Jersey)

Learn more about Carl Coleman

Rosa Alves

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

Learn more about Rosa M. Alves

9:30  - 10:20

The Relationship Between Ethics and Compliance

  1. The origins of compliance
  2. Ethics, values & compliance
 
Carl Coleman

Carl Coleman
Professor of Law & Associate Dean for Graduate Programs, Seton Hall Law School (New Jersey)

Learn more about Carl Coleman

10:20 - 10:35

 

Morning Break

10:35 - 11:35

Role of Compliance Officer and Case Study

Sue Egan

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

Learn more about Sue Egan

11:40 - 12:40

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

12:40 - 13:40

 

Lunch Break

13:40 - 15:15

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
Dominique Laymand

Dominique Laymand
Of Counsel, Clifford Chance (Paris)

Learn more about Dominique Laymand

Stephen-Nguyen-Duc

Stephen Nguyen-Duc
Chief Ethics & Compliance Officer, Pharmaceutical Diagnostics Division, General Electric Healthcare (GEHC) (Paris)

Learn more about Stephen Nguyen-Duc

Roeland Van Aelst

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

Learn more about Roeland Van Aelst

Willy Cousin

Willy Cousin
Global Compliance Deputy Head, Servier (Paris)

Learn more about Willy Cousin

Carl Coleman

Moderator: Carl Coleman
Professor of Law & Associate Dean for Graduate Programs, Seton Hall Law School (New Jersey)

Learn more about Carl Coleman

15:15 - 15:30

 

Afternoon Break

15:30 - 17:00

Case Study 1 Assignment & Prep Session
Group Teamwork

DAY 2 

8:30 - 9:00

 

Registration & Coffee

9:00 - 10:30

Classroom Discussion of Case Study 1

  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

10:30 - 10:45

 

Morning Break

10:45 - 11:45

EFPIA Code of Practice

  1. EFPIA Ethics & Compliance mission, vision and priorities
  2. Introduction to the EFPIA Code: rationale, scope, applicability
Julie Bonhomme

Julie Bonhomme
Legal Affairs & Compliance Director, EFPIA (Brussels)

Learn more about Julie Bonhomme

11:50 - 12:50

MedTech Europe Code of Ethics

  1. Main changes
  2. Phasing out of direct sponsorship
Aline Lautenberg

Aline Lautenberg
General Counsel and Director General, MedTech Europe (Brussels)

Learn more about Aline Lautenberg

Pablo Rojas Abad

Pablo Rojas Abad
Senior Legal Counsel, MedTech Europe (Brussels)

Learn more about Pablo Rojas Abad

Anne-Sophie Bricca

Anne-Sophie Bricca
Deputy General Counsel, Senior Director Legal Affairs & Compliance EMEA, Terumo BCT & Chair, Ethics and Compliance Committee, MedTech Europe (Brussels)

Learn more about Anne-Sophie Bricca

12:50 - 13:50

 

Lunch Break

13:50 - 14:40

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

Piergiorgio Pepe

Piergiorgio Pepe
President, Quantum Ethics (Paris)

Learn more about Piergiorgio Pepe

14:45 - 15:35

DOJ Enforcement Perspective

Vanessa Sisti

Vanessa Sisti
Fraud Prosecutorial Liaison to the United Kingdom, U.S. Department of Justice

Learn more about Vanessa Sisti

Carl Coleman

Moderator: Carl Coleman
Professor of Law & Associate Dean for Graduate Programs, Seton Hall Law School (New Jersey)

Learn more about Carl Coleman

15:35 - 15:50

 

Afternoon Break

15:50 - 17:00

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

  1. Elements of the FCPA’s Anti-Bribery and Accounting Provisions
  2. Key enforcement players and policies
  3. Recent enforcement actions
  4. Compliance programs and FCPA enforcement
  5. DOJ Enforcement
Isabelle De Smedt

Isabelle De Smedt
Partner, Alston & Bird LLP (Brussels)

Learn more about Isabelle De Smedt

Emily McGowan

Emily McGowan
Partner, Alston & Bird LLP (Charlotte)

Learn more about Emily McGowan

17:00 - 18:00

Networking Reception

DAY 3 

8:30 - 9:00

 

Registration & Coffee

9:00 - 10:15

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

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

10:15 - 10:30

 

Morning Break

10:35 - 11:40

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
Mark Beardsworth

Mark Beardsworth

11:45 - 13:00

Scientific Exchange and Medical Education Activities

Sue Egan

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

Learn more about Sue Egan

13:00 - 14:00

Lunch Break

14:00 - 15:15

Interactions with Patients & Patient Organizations

Piergiorgio Pepe

Piergiorgio Pepe
President, Quantum Ethics (Paris)

Learn more about Piergiorgio Pepe

15:15 - 15:30

 

Afternoon Break

15:30 - 17:00

Patient Organizations Interactive Exercise

Piergiorgio Pepe

Piergiorgio Pepe
President, Quantum Ethics (Paris)

Learn more about Piergiorgio Pepe

DAY 4 

8:30 - 9:00

 

Registration & Coffee

9:00 - 10:15

Approval Process for Drugs and Medical Devices:

  1. New medicines
  2. New medical devices
  3. Special products & clinical trials
Geneviève Michaux

Geneviève Michaux
Partner, King & Spalding LLP (Brussels/Paris)

Learn more about Geneviève Michaux

10:15 - 10:30

 

Morning Break

10:30 - 11:45

Privacy and Data Protection in Europe

Ronan Tigner

Ronan Tigner
Attorney (Brussels)

Learn more about Ronan Tigner

11:50 - 13:20

Case Study 2 Prep Session

13:20 - 14:20

Lunch Break

14:20 - 16:15

Classroom Discussion of Case Study 2

  1. Teams to present their analysis and recommendations. Interactive class discussion.
Sue Egan

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

Learn more about Sue Egan

16:15

 

Afternoon Break

DAY 5 

8:30 - 9:00

 

Registration & Coffee

9:00 - 10:15

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

Natasha Tardif
Managing Partner, Reed Smith LLP (Paris)

Learn more about Natasha Tardif

Lucile Chneiweiss

Lucile Chneiweiss
Senior Associate, Reed Smith LLP (Paris)

Learn more about Lucile Chneiweiss

10:15 - 10:30

Morning Break

10:30 - 11:45

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

11:45 - 13:00

Lunch Break

13:00 - 14:15

Advertising of Medicinal Products and Medical Devices in Europe

  1. Advertising of medicinal products
  2. Advertising of medical devices
  3. Digitalization of information and advertising
Annabelle Bruyndonckx

Annabelle Bruyndonckx
Partner, Simmons & Simmons LLP (Brussels)

Learn more about Annabelle Bruyndonckx

14:20 - 15:30

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
George Fife

George Fife
Partner, Compliance Forensic & Integrity Services, EY (Paris)

Mariusz Witalis

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

Learn more about Mariusz Witalis

15:30

Closing Remarks & Award of Program Certificates

Rosa Alves

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

Learn more about Rosa M. Alves