AN INTERNATIONAL CONFERENCE EVENT

14th International Pharmaceutical
and Medical Device Ethics &
Compliance Congress


THE CONGRESS, TO HAVE BEEN HELD APRIL 20 - 22, 2020, HAS BEEN CANCELLED



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THE CONGRESS HAS BEEN CANCELLED

The Congress will be rescheduled following the COVID 19 Pandemic.
Refunds of registration, exhibitor and sponsor fees will be made shortly.


KEYNOTE SPEAKERS

Hani Abouhalka

Company Group Chairman, Medical Devices EMEA, Johnson & Johnson, Wokingham, UK

Gemma Aiolfi

Head of Compliance, Corporate Governance and Collective Action, Basel Institute on Governance; Former Advisor, Working Group on Bribery in International Business Transactions, Organisation for Economic Co-operation and Development (OECD); Basel, Switzerland

Julie Bonhomme

EFPIA Legal & Compliance Director, European Federation of Pharmaceutical Industries and Associations (EFPIA), Brussels, Belgium

Robert I. Dodge, JD

Assistant Director, FCPA Unit, US Securities & Exchange Commission; Former Assistant U.S. Attorney, US Attorney’s Office, Western District of Michigan; Former Assistant Section Chief, Environmental Defense Section, US Department of Justice; Washington, DC, USA

Roxana Family, Thèse de Doctorat Droit

Vice-President, Chair in Law & Business Ethics and Program Director, Cergy Pontoise University, Cergy-Pontoise, France

Susanne Friedrich, MA

Director, Group Governance, Human, Rights Division Global Policy, Governance, Alliance for Integrity (AfIn), Bonn, Germany

David Fuhr, JD

Assistant Chief in the FCPA Unit, US Department of Justice, Washington, DC, USA

Iordanis Kerenidis, PhD

Director, Paris Centre for Quantum Computing (PCQC), CNRS Senior Researcher (DR2), Algorithms and Complexity Group, IRIF, University Paris Diderot, Paris, France

Sofie Melis

Head of Ethics and Compliance, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Geneva, Switzerland

Hannes Oswald-Brugel, LLM, PhD

Global Head Pharma Healthcare Compliance, Roche, Vice President, Association of Voluntary Self-Regulation, for the Pharmaceutical Industry (“FSA”), Basel, Switzerland


FEATURING INVITATION-ONLY:
CHIEF COMPLIANCE OFFICER ROUNDTABLE

(Special April 20 Morning Invitation-only, Closed Session)
SPONSORED BY

CO-SPONSORED BY

FEATURING

Sally Molloy, JD

Chief, Strategy, Policy & Training Unit, Fraud Section; Former Assistant U.S. Attorney, US Attorney’s Office, Northern District of Georgia, US Department of Justice; Washington, DC, USA

AGENDA-AT-A-GLANCE

Monday, April 20, 2020

  • Morning Preconferences:

    • Closed-Door, Invitation-Only Chief Compliance Officer Roundtable
    • ETHICS Workshop on Practical Ethics & Compliance Case Studies

  • Afternoon Opening Plenary Session:

    • Congress Welcome, Vision and Overview
    • Keynote Address: Ethics, Compliance and the C-Suite
    • International Anti-Corruption Landscape
    • Senior Ethics & Compliance Professionals Roundtable

Tuesday, April 21, 2020

  • Morning Plenary Session:

    • Embedding Ethics in a Company Governance Model
    • Global Compliance Codes Update


    Minis Summits:

    • I Compliance Considerations for Small to Mid-Sized Organizations
    • II Annual Medical Device Compliance Roundtable
    • III Interconnectivity of Auditing, Monitoring, and Investigations
    • IV Annual Central and Eastern Europe (CEE) Compliance Update
    • V Best Practices for Compliance Training
    • VI How to Build and Manage Compliance Risk Assessments
    • VII Handling Ethics & Compliance When Interacting with 3rd Parties
    • VIII EU Whistleblower Directive

  • Minis Summits, Continued:

    • IX Performing a Fair Market Value (FMV) Analysis
    • X Compliance Considerations for Gene Therapy& Rare Disease Products
    • XI GDPR and the Tumultuous World of Data Privacy
    • XII Patient Relationships, Including Patient Access and Support
    • XIII Enhanced Compliance Monitoring
    • XIV Building Effective and Right Sized Compliance Programs
    • XV Role of Compliance Officers in Complex Global Organizations


  • Afternoon Plenary Session:

    • Value-Based Proposition
    • Ethical Interactions between Health Care & Other Stakeholders
    • Artificial Intelligence and Digital Health

Wednesday, April 22, 2020

  • Mini Summits:

    • XVI Annual Middle East Africa (MEA) Compliance Update
    • XVII The Role of the Industry re: Medical Education
    • XVII The Practical Effect on Implications of Brexit

    Closing Plenary Session:

    • Drivers for a Sustainable Ethical Culture
    • Trust in Business
    • The Role of Governance
    • Co-chairs Closing Thoughts

FEATURED FACULTY

Pablo Rojas Abad, LLM

Manager, Legal and Compliance, MedTech Europe, Brussels, Belgium

Bas Amesz

Partner, Vintura, Baarn, Utrecht, Netherlands

Natalie Ammerlaan, LLM

Compliance Director International Operations, Novo Nordisk, Zürich, Switzerland

Michael Bartke, PhD

Member, Strategic Committee, ETHICS; Former Director Ethics & Compliance, Alexion; Former Director Compliance Management, Daiichi Sankyo Europe; Munich, Germany

Dante Beccaria

Global Compliance Officer and Vice President, Sanofi; Former Vice President of Internal Audit, Sanofi; Former Co-chair, International Pharmaceutical and Medical Device Compliance Congress; Paris, France

Enno Behrendt

Associate Director, Guidehouse; Former Head of Compliance for Diagnostic Imaging, Siemens Healthcare GmbH; Berlin, Germany

Sadek Beloucif, MD

University Professor, Hospital Practitioner and Head of Anesthesia-Resuscitation, University of Paris and University Hospital, Bobigny, Chair, National Union of Physicians, Surgeons, Specialists, and Biologists of Public Hospitals, Paris, France

Duygu Beyazo

Senior Associate, NSN Law Firm; Former Compliance Manager (Secondment), Business Conduct, Gilead Sciences; Istanbul, Turkey

Stefano Biondi, LLB, PhD

Group Data Protection Officer, Menarini Group, Florence, Italy

Eric Bolesh

Chief Operating Officer, Cutting Edge Information, Raleigh-Durham, NC, USA

Kara Bonitatibus, JD

Head of Product, Lextegrity; Former Assistant General Counsel, Compliance Lead for Digital, Policy, and Patient & Health Impact, Pfizer, New York, NY

Keith Burn

Global Investigations Director, Ipsen; Former Associate Investigator, Parliamentary and Health Service Ombudsman, NHS; Former Detective Constable, London Metropolitan Police; Amersham, Slough, UK

Parth Chanda, JD, MPA

Founder & CEO, Lextegrity; Former Global Anti-Corruption Lead and Chief Compliance Counsel, Oncology, Pfizer; New York, NY, USA

Alice Choy, MS

Manager, Anti Bribery Anti-Corruption (ABAC), Compliance, Internal Audit, Risk Assessment, IQVIA; Former Lead Specialist, Transparency and Reporting, Johnson & Johnson; London, UK

Thomas Costa, JD

Member, US Board of Directors, Sanofi; Former Vice President, US Compliance & Ethics, Bristol-Myers Squibb; Washington, DC, USA

Holger Diener

Managing Director, Association of Voluntary Self-Regulation for the Pharmaceutical Industry (“FSA”), Member, Ethics and Compliance Committee and Vice Chair, Code Committee, EFPIA, Member, IFPMA Code Compliance Network, Berlin, Germany

Peter Dieners, Esq.

Partner and Head, Global Healthcare and Life Sciences Group, Clifford Chance, Co-chair, Legal Affairs Focus Group (LA FG), EUCOMED, Co-chair, Compliance Network (CN), EUCOMED, Düsseldorf, Germany

Julien Durand, MBA, PhD

Vice President, Head of Transformation, Global Ethics and Compliance, Takeda, Chair, IFPMA Future Health Technologies & Bioethics Working Groups, Former Executive Director, Compliance and Ethics, Amgen, Former Chief Privacy Officer and Global Technology Compliance Head, AstraZeneca, Zürich, Switzerland

Sue Egan

Director and Principal Consultant, Sue Egan Associates; Former Vice President Compliance, AstraZeneca; Great Missenden, Buckinghamshire, UK

Liisa Eisenlohr, PhD, MBA, CCRA, BCMAS

Associate Director, Guidehouse; Former Senior Director, Global Medical Information, Clovis Oncology, London, UK (Discussion Coordinator)

Karen Eryou

Head, Ethics & Compliance Programs, Global, UCB Pharma; Former Co-chair, Asia Pacific Pharma Compliance Congress; Brussels, Belgium

Steffen Esche

Senior Manager, PwC, Frankfurt, Germany

J. Mark Farrar, MSJ, CPA, CFE, CFF

Partner, Life Sciences Governance, Risk Management and Compliance, Guidehouse, Atlanta, GA

Alex Fell

Head Ethics and Compliance International; Amicus Therapeutics; Former VP Global Ethics & Compliance, Head of Strategy, Planning and Operations, GSK; London, UK

George Fife

Partner, Forensic & Integrity Services, EY; Former Executive Director, Compliance & Ethics, Bristol-Myers Squibb; Paris, France

Indrani M. Lall Franchini, JD

Executive Vice President & Chief Compliance Officer, Alexion Pharmaceuticals, Inc.; Former Assistant General Counsel, Pfizer; New York, NY, USA

Caroline Franco, MBA

Ethics and Compliance Manager, Boehringer Ingelheim, Amsterdam, Netherlands

Abhiroop Gandhi

Trust and Compliance Officer, Verily Life Sciences (an Alphabet company); Former Vice President, Corporate Compliance, Mallinckrodt; San Francisco, CA, USA

Klaus Geldsetzer, MBA

Chief Compliance Officer EMEA, Santen GmbH, Chairman, Eye-Care Industries European Economic Interest Grouping; Former Head of R&D Office and Global Project Leader, Allergan Ltd; Munich, Germany

Gary F. Giampetruzzi, Esq.

Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc.; New York, NY, USA

Laura Coll Gil, LLM

Ethics and Compliance Officer, Boehringer Spain, Barcelona, Catalonia, Spain

Betania Glorio, LLM

Global Compliance Officer, Healthcare, Merck KGaA; Former Senior Director, Legal and Compliance EMEA, Horizon Pharma plc and Raptor Pharmaceuticals; Darmstadt, Germany

Tom Gregory, MBA

Partner, Forensic & Integrity Services, EY, Atlanta, GA, USA

Ulf H. Grundmann

Partner, FDA and Life Sciences, King & Spalding LLP, Lecturer, Frankfurt School of Finance and Management, Frankfurt am Main, Germany

Joseph W. Henein, PharmD

President and Chief Executive Officer, NewBridge Pharmaceuticals, Dubai, UAE

Casey J. Horton, CFE

Director, Life Sciences, Governance, Risk and Compliance, Guidehouse, Chicago, IL

Bella Hovhannisyan

Business Integrity and Compliance Lead, Intercontinental Commercial Operations, CSL Behring, Bern, Switzerland

Mirgen Jaku, MA

Lead of Market Readiness, Digital Surgery, EMEA, Johnson & Johnson, Hamburg, Germany

Franziska Janorschke

Global Head, Business Practices Office, Novartis International AG, Basel, Switzerland

Els Janssens, LLM

Associate, Baker & McKenzie; Former Legal Adviser, European Medicines Agency; Former Senior Legal Counsel, Johnson & Johnson; Brussels, Belgium

Larisa K. Jasnic, LLB, LLM

Senior Director, Ethics & Compliance, CEMEA, Alnylam Pharmaceuticals; Former Regional Compliance Officer, Region Europe, Novartis; Zug, Switzerland

Anita Kyung-Hee Kim-Reinartz

Partner, Forensic & Integrity Services, EY, Düsseldorf, Germany

Elisabeth Kohoutek

Senior Associate, FDA and Life Sciences, King & Spalding LLP, Frankfurt am Main, Germany

Adem Koyuncu, MD, PhD (Law)

Partner and Chair, Food, Drug & Device Practice Group, Covington, Brussels, Belgium

Tomasz Kruk, LLM, MBA

Head of Compliance, Vifor Pharma; Former Director International Compliance, Mallinckrodt; Former Director Global Ethics & Compliance, Actavis; Zürich, Switzerland

Edoardo Lazzarini, PhD

Healthcare Compliance Consultant; Former EuCan Ethics and Compliance Initiatives Director, Takeda Pharmaceuticals; Former Compliance Officer EMEA (Europe, Middle East & Africa), Zimmer Biomet; Milan, Italy

Lei Li, LLM

Managing Partner, Beijing and Shanghai Offices, Sidley Austin; Former Third Secretary, Ministry of Commerce, People’s Republic of China, Beijing, China; Beijing, China

Bruno Lichtinger

Managing Director, INTERPLAN Congress, Meeting & Event Management AG, Munich, Germany

Michael K. Loucks, JD

Partner, Skadden Arps LLP; Former Acting United States Attorney, District of Massachusetts, United States, Department of Justice; Washington, DC, USA

Marcel Maderitsch, LLM

Senior Compliance Officer, Vifor Pharma; Former Compliance Manager EMEA, Zimmer Biomet; Zurich, Switzerland

Rosa Magistri, Esq., CIPP/E

Head of Legal and Compliance Europe, SeaGen International GmbH; Former Regional Director Office of Ethics and Compliance, Western Europe & Canada, Region South & Israel, AbbVie; Former Associate Compliance Director, Shire; Zug, Switzerland

Anthony McQuillan, LLB

Vice President Legal & Compliance EMEA, Medtronic International; Former Senior Attorney EMEA, Hewlett-Packard; London, UK

Paul J. Melling, JD

Founding Partner, Baker & McKenzie – CIS, Limited, Moscow, Russia

Laetitia Ducroquet Minel

Senior Director, Business Ethics, Ipsen, Paris, France

Véronique Monjardet, MS, DEA, PhD

Sales Director, IQVIA, Paris, France

Laura Nassar, PharmD

Vice President, Head of Ethics & Business Integrity, AEME Region, Sanofi, Chair, Compliance Committee, Pharmaceutical Research, and Manufacturers Association, Gulf (PhRMAG); Former Head of Compliance Middle East, Roche Pharmaceuticals; Beirut, Lebanon

Lauri G. Opar

Director, Risk Analytics, Global Ethics & Compliance, Glaxosmithkline, Brentford, Middlesex, UK

Pascale Paimbault

CEO, Consulting Alley, Strategic Committee Member, ETHICS; Former Executive Director, EMEA Compliance Astellas Pharma Inc.; Former Compliance Officer, France -Benelux, Biogen; Former Chief Compliance Officer EMEA, Wright Medical Inc.; Former Senior Director, EMEA, Bristol-Myers Squibb; Paris, France

Giota Papamarkou

Vice President, Business Ethics Global, France, Ipsen; Former EMEA Compliance and Ethics Manager, Bristol-Myers Squibb, Paris, France

Piergiorgio Pepe, MA

EU Law, President, Quantum Ethics, Ethics and Compliance Lecturer, SciencesPo; Former Compliance Director Western Europe & Canada, AbbVie; Former Director, Compliance & Ethics EMEA, Bristol-Myers Squibb; Paris, France

Oscar Perdomo

Director, Pharmaceutical & Life Sciences Advisory Services, PwC Switzerland, Zurich, Switzerland

Mario Prohasky

Global Compliance Consultant, IQVIA, London, UK

Ariadna Quesada, MSJ

Law, Ethics and Compliance Officer, The Netherlands, AbbVie; Former Compliance Manager International, MicroPort Orthopedics; Amsterdam, Netherlands

John Seungjoo Rah, JD

Partner, DLA Piper, Washington, DC

Nadège Rochel

Global Compliance Manager, Hollister Incorporated, Milan, Italy

Christian-Claus Roth

Head Scientific Engagement Governance, Novartis, Basel, Switzerland

Matteo Santi

Group Compliance Officer, Helsinn Healthcare, Ticino, Switzerland

Giuseppe Saporito, LLM

Global Legal & Regulatory Expert, IQVIA, Milan, Italy

Pascale Schmidt

Chief Compliance Officer, F. Hoffmann-La Roche Ltd, Basel, Switzerland

Piyush Sharma, JD

Senior Vice President, Deputy Chief Compliance Officer, International Compliance, Alexion Pharmaceuticals, New Haven, CT

Leonardo Silva, LLM

Vice President, Global Chief Compliance & Privacy Officer, Ferring; Former Head of Compliance, Acino Group; Former Compliance Director, Emerging Markets, Takeda; Lausanne, Switzerland

Robert Stephenson

Senior Manager, PwC UK, London, UK

Madina Torchinova

Vice President, Deputy Head Global Compliance, MorphoSys; Former Regional Head of Compliance, Central & Eastern Europe, Middle East & Africa, and Global OTC, Sandoz; Munich, Germany

Tamara Tubin

International Compliance Director, Corporate Compliance, Wright Medical Group N.V., Vice Chair, Ethics & Compliance Committee, MedTech Europe, Member, Strategic Committee, ETHICS, Zürich, Switzerland

Cláudia Vaz

Global Value Based HealthCare Consultant, Roche, Value-Based Health Care Consultant, International Consortium for Health, Outcomes Measurement (ICHOM), Basel, Switzerland

Samar Wakim, PharmD

Ethics, Risk & Compliance Head MEA, Oncology, Novartis, Dubai, UAE

Vanessa Westphal, JD, LLM

Head of Compliance Programs & Support, Merck KGaA, Frankfurt am Main Area, Germany

Christopher L. White, JD

Chief Operating Officer and General Counsel, Advanced Medical Technology Association (AdvaMed), Washington, DC, USA

Mariusz Witalis

Partner, Forensic & Integrity Services, EY, Warsaw, Poland

Niels Wohlwend, LLM

Senior Director Healthcare Compliance, Europe & Canada, Celgene, Member, Ethics & Compliance Committee, EFPIA; Former Global Head of Compliance, ACINO; Boudry, Switzerland

Elisabethann Wright, LLB

Partner, Hogan Lovells; Former Senior Legal Officer and Hearing Officer, EFTA Surveillance Authority; Brussels, Belgium

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