KEYNOTE SPEAKERS
Hani Abouhalka, MBA
Company Group Chairman, Medical Devices EMEA, Johnson & Johnson, New Brunswick, NJ, USA
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
Aline Lautenberg
General Counsel and Director, Legal & Compliance, MedTech Europe, Brussels, Belgium
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
Christoph Thalheim
Vice CEO and Director External Affairs, European Multiple Sclerosis Platform (EMSP), Brussels, Belgium
FEATURING INVITATION-ONLY:
CHIEF COMPLIANCE OFFICER ROUNDTABLE
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
- Morning Preconferences:
- Closed-Door, Invitation-Only Chief Compliance Officer Roundtable
- ETHICS Workshop on Practical Ethics & Compliance Case Studies
- Closed-Door, Invitation-Only Chief Compliance Officer Roundtable
- 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
- Congress Welcome, Vision and Overview
- Morning Plenary Session:
- Embedding Ethics in a Company Governance Model
- Global Compliance Codes Update
- Embedding Ethics in a Company Governance Model
- 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:
- 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
- IX Performing a Fair Market Value (FMV) Analysis
- Afternoon Plenary Session:
- Value-Based Proposition
- Ethical Interactions between Health Care & Other Stakeholders
- Artificial Intelligence and Digital Health
- Value-Based Proposition
- 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
- XVI Annual Middle East Africa (MEA) Compliance Update
- Drivers for a Sustainable Ethical Culture
- Trust in Business
- The Role of Governance
- Co-chairs Closing Thoughts
Closing Plenary Session:
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
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, Santenb, 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
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
2020 GLOBAL PHARMA COMPLIANCE CONGRESSES
FOURTEENTH INTERNATIONAL PHARMACEUTICAL AND MEDICAL DEVICE ETHICS & COMPLIANCE CONGRESS
Sponsored by International Society of Healthcare Compliance Professionals (ETHICS)
April 20 – 22, 2020
Sheraton Munich Arabellapark Hotel
Munich, Germany
www.InternationalPharmaCongress.com
TWENTY-FIRST ANNUAL PHARMACEUTICAL AND MEDICAL DEVICE COMPLIANCE CONGRESS
A Hybrid Conference and Internet Event
Sponsored by Pharmaceutical Compliance Forum
November 4 – 6, 2020
Mandarin Oriental
Washington, DC
www.PharmaCongress.com