AGENDA: DAY III
WEDNESDAY, JUNE 16, 2021
DAY III PLENARY SESSION
10:00 am CET
Ethical Interactions between the Health Care Sector and Other Stakeholders
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Pedro Carrascal, MBA
President, European Multiple Sclerosis Platform (EMSP); Chief Executive Officer, EME (Multiple Sclerosis Spain), Biscay MS Society and MS Basque Foundation Board, Multiple Sclerosis International Federation (MSIF), Bilbao, Spain![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/roth_100.jpg)
Christian-Claus Roth
Global Head Scientific Engagement Governance, Novartis; Co-president, International Pharmaceutical Congress Advisory Association (IPCAA); Member, Ethics and Business Integrity Committee, IFPMA, Basel, Switzerland![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/wheeler_100.jpg)
Sarah Wheeler, MA
Director of Global Industry Engagement, International Association for the Study of Pain, Washington, DC![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/bricca_101.jpg)
Anne-Sophie Bricca, MA, DEA International Law, DES European law
Deputy General Counsel & Senior Director Legal Affairs & Compliance, Terumo BCT, Board Member and Co-chair, Strategic Committee, International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Chair, Ethics and Compliance Group MedTech Europe, Brussels, Belgium (Moderator)10:45 am CET
Artificial Intelligence and Digital Health![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/gandhi_100.jpg)
Abhiroop Gandhi
Trust and Compliance Officer, Verily Life Sciences (an Alphabet company); Former Vice President, Corporate Compliance, Mallinckrodt San Francisco, CA, USA![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/kerenidis_100.jpg)
Iordanis Kerenidis, PhD
Director, Paris Centre for Quantum Computing (PCQC), CNRS Senior Researcher (DR2), Algorithms and Complexity Group IRIF, University Paris Diderot, Paris, France![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/jaku_100.jpg)
Mirgen Jaku, MA
Ethicon EMEA PMO & Digital Surgery Leader, Johnson & Johnson, Hamburg, Germany![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/bricca_101.jpg)
Anne-Sophie Bricca
Deputy General Counsel & Senior Director, Legal Affairs & Compliance, Terumo BCT; Board Member and Co-chair, Strategic Committee, International Society of Healthcare Ethics and Compliance Professionals (ETHICS); Chair, Ethics and Compliance Group MedTech Europe, Brussels, Belgium (Discussion Coordinator)11:30 am CET
Industry Codes Co-creation ApproachIFPMA
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Sofie Melis
Director HR and Ethics & Compliance, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Geneva, SwitzerlandEFPIA
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Julie Bonhomme
Legal & Compliance Director, European Federation of Pharmaceutical Industries and Associations (EFPIA), Brussels, BelgiumMedTech Europe
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Aline Lautenberg
General Counsel and Director, Legal & Compliance, MedTech Europe, Brussels, BelgiumAsia Pac Update
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Lei Li, LLM
Managing Partner, Beijing and Shanghai Offices, Sidley Austin Former Third Secretary, Ministry of Commerce, People’s Republic of China, Beijing, ChinaLATAM Update
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Imelda Álvarez, LLB, MBA
Chief Executive Officer, Comply Latam, SC; Former Regional Integrity & Compliance Head Latin America and Canada, Novartis, Mexico City, MexicoDiscussion Coordinator
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Arthur Muratyan, Esq.
Secretary General, International Society of HealthCare Ethics and Compliance Professionals (ETHICS), Chair, MedTech Compliance Panel; Former VP-Head of Legal Corporate and Global Compliance Officer, Sanofi, Paris, France (Discussion Coordinator)12:30 pm CET
Plenary Session Adjournment/ Luncheon Break/Visit Exhibit Hall
AFTERNOON MINI SUMMITS
MINI SUMMITS ROUND IV
MINI SUMMIT 14
Best Practices in Virtual Monitoring1:00 pm CET
Introductions, Panel Discussion and Q&A![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/papamarkou_100.jpg)
Giota Papamarkou
Vice-President, Business Ethics Global, France, Ipsen Former EMEA Compliance and Ethics Manager, Bristol-Myers Squibb, Paris, France![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/pennington_100.jpg)
Carrie (Ashcom) Pennington, MBA, PhD
Vice President, Global Compliance Monitoring & Internal Controls, Zimmer Biomet; Former Global Compliance Manager, Books & Records, GE Healthcare, Warsaw, IN, USA![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/westphal_100.jpg)
Vanessa Westphal, JD, MS
Head of Compliance Center of Excellence Programs & Support, Merck KGaA, Darmstadt, Frankfurt Am Main Area, Germany![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/kim-reinartz_100.jpg)
Anita Kyung-Hee Kim-Reinartz
Partner, Forensic & Integrity Services, EY Düsseldorf, Germany (Discussion Coordinator)MINI SUMMIT 15: US DOJ’s Evaluation of Corporate Compliance
1:00 pm CET
Introductions, Panel Discussion and Q&A![](https://www.pharmacongress.com/wp-content/themes/ipc/faculty/luheshi_100.jpg)
Abdul Luheshi, MBA
Independent Consultant, Ethics and Compliance; Former Compliance Officer, International Markets, Myriad Genetics; Former Executive Director, Global Operations, Ethics & Compliance, EMEA, Astellas; London, UK![](https://www.pharmacongress.com/wp-content/themes/ipc/faculty/molly_100.jpg)
Sally Molloy, JD
Chief, Strategy, Policy and Training Unit, Fraud Section, US Department of Justice, Washington, DC, USA![](https://www.pharmacongress.com/wp-content/themes/ipc/faculty/west_100.jpg)
Caroline H. West, JD
Former Global Chief Compliance Officer, Olympus Corporation; Former Senior Vice President, Chief Compliance and Risk Officer, Shire, Philadelphia, PA, USA![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/raad_100.jpg)
Amanda N. Raad, JD
Partner and Co-Chair of Global Anti-Corruption and International Risk Practice and R&G Insights Lab, Ropes & Gray, LLP, London, UK (Discussion Coordinator)MINI SUMMIT 16: Company Principle-based Professional Codes (Not Industry Codes)
1:00 pm CET
Introductions, Panel Discussion and Q&A![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/akram_100.jpg)
Sobia Akram, MSC
Corporate Vice President, Global Business Ethics Compliance Office & Programme, Novo Nordisk A/S, Copenhagen, Capital Region, Denmark![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/hudson_100.jpg)
Brett Hudson, MBIM
Global Head Ethics, Risk & Compliance Strategy, Innovation, & Corporate Functions, Novartis; Former Global Program Director Integrity & Compliance, Sandoz, Zurich, Switzerland![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/papamarkou_100.jpg)
Giota Papamarkou
Vice-President, Business Ethics Global, France North America & Global Monitoring, Ipsen; Former EMEA Compliance and Ethics Manager, Bristol-Myers Squibb, Paris, France![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/paimbault_100.jpg)
Pascale Paimbault
President, CEO and Founder, Consulting Alley; Strategic Committee, Strategic Committee International Society of Healthcare Ethics and Compliance Professionals (ETHICS); Former Executive Director, EMEA Ethics and Compliance, ABAC, Astellas Pharma Europe, Paris, France (Moderator)MINI SUMMIT 17: Compliance in Clinical Trials and Investigations
1:00 pm CET
Introductions, Panel Discussion and Q&A![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/chestukhin_100.jpg)
Masha Chestukhin, MSJ
Associate Director, Compliance Officer R&D, IA, FMV, Sanofi Genzyme; Former Senior Manager NA Compliance, Sanofi; Jamaica Plain, MA, USA![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/christian_100.jpg)
Ana Christian, JD
Senior Director, Assistant General Counsel, Avanir Pharmaceuticals; Former Corporate Counsel, NantHealth,Los Angeles, CA, USA![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/deronne_100.jpg)
Stefanie Deronne, JD
Legal Counsel, Argenx; Former Senior Corporate Legal Counsel R&D - DPO, Ablynx; Ghent, Belgium![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/michaux_100.jpg)
Genevieve Michaux, JD
Partner, King & Spalding, Brussels, Belgium (Discussion Coordinator)2:00 pm CET
Transition BreakMINI SUMMITS ROUND V
MINI SUMMIT 18: Annual Middle East Africa (MEA) Compliance Update
2:15 am CET
Introductions, Panel Discussion and Q&A![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/alyacoub_100.jpg)
Ghadeer Al Yacoub, MSc
Regional Head Healthcare Compliance Europe, Middle East and Africa Medical Devices, Johnson & Johnson, Dubai, UAE![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/janssens_100.jpg)
Els Janssens, LLM
Counsel, Baker & McKenzie; Former Legal Adviser, European Medicines Agency; Former Senior Legal Counsel, Johnson & Johnson, Brussels, Belgium![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/wakim_100.jpg)
Samar Wakim, PharmD
Ethics & Compliance Head MEA, Innovative Medicines, Novartis Pharma Services AG, Dubai, UAE![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/henein_100.jpg)
Joseph W. Henein, PharmD
President and Chief Executive Officer, NewBridge Pharmaceuticals, Dubai, UAE (Co-Discussion Coordinator)![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/nassar_100.jpg)
Laura Nassar, PharmD
Vice President, Head of Ethics & Business Integrity, AEME Region, Sanofi; Former Head of Compliance Middle East, Roche Pharmaceuticals; Former Regional Pharma HCC Officer Emerging Markets, Johnson & Johnson, Beirut, Lebanon (Co-Discussion Coordinator)MINI SUMMIT 19: Industry's Evolving Role in Medical Education
2:15 pm CET
Introductions, Panel Discussion and Q&A![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/diener_100.jpg)
Holger Diener
Healthcare Compliance Officer, Janssen-Cilag GmbH, Johnson & Johnson; Former Managing Director, Association of Voluntary Self-Regulation for the Pharmaceutical Industry (“FSA”), Berlin, Germany![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/roth_100.jpg)
Christian-Claus Roth
Global Head Scientific Engagement Governance, Novartis; Co-president, International Pharmaceutical Congress Advisory Association (IPCAA);Member, Ethics and Business Integrity Committee, IFPMA, Basel, Switzerland![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/steindorf_100.jpg)
Cerstin Steindorf
Global Account Director Healthcare, MCI, Geneva, Switzerland![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/bartke_100.jpg)
Michael Bartke, PhD
Strategic Committee, ETHICS; Former Director Ethics & Compliance, Alexion; Former Director Compliance Management, Daiichi, Sankyo, Europe Munich, Germany (Discussion Coordinator)MINI SUMMIT 20: EU Whistleblower Directive
2:15 pm CET
Introductions, Panel Discussion and Q&A![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/keeton_100.jpg)
Chelsea M. Keeton, JD
Director and Senior Counsel, Global Compliance Investigations, Zimmer Biomet; Former Group Ethics & Compliance Counsel, VEON, Amsterdam, Netherlands![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/kohoutek_100.jpg)
Elisabeth Kohoutek
Senior Associate, FDA and Life Sciences, King & Spalding LLP, Frankfurt am Main, Germany![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/korenchuk_100.jpg)
Keith Korenchuk, MPH, JD
Vice President and Chief Compliance Officer, DH Diagnostics, a Danaher Company, Chevy Chase, MD, USA![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/mansotte_100.jpg)
Sylvain Mansotte
Co-Founder and Chief Executive Officer, Whispli, Sydney, New South Wales, Australia![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/grundmann_100.jpg)
Ulf H. Grundmann
Partner, FDA and Life Sciences, King & Spalding LLP, Lecturer, Frankfurt School of Finance and Management, Frankfurt am Main, Germany (Discussion Coordinator)MINI SUMMIT 21: Global Price Transparent Reporting Update
2:15 pm CET
Introductions, Panel Discussion and Q&A![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/sharkey_100.jpg)
Brian P. Sharkey
Director, US Commercial Compliance & Ethics, Teva Pharmaceuticals, Parsippany, New Jersey, USA![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/simon_100.jpg)
Sara R. Simon, JD
Associate, Porzio, Bromberg & Newman, PC, Morristown, NJ![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/oroho_100.jpg)
John Patrick Oroho, JD
Executive VP & Chief Strategy Officer, Porzio Life Sciences, LLC; Principal, Porzio Bromberg & Newman, PC, Morristown, NJ, USA (Discussion Coordinator)3:15 pm CET
Optional Interactive Zoom Video Workgroups
(Attendee may join any Discussion Session. The first 25 attendees will participate via video and audio. Attendees joining thereafter will participate in video/listen-only mode and engage via text chat and Q&A. Attendees may move among the various concurrent discussion sessions.)
Topic V: Ethics & Compliance in a Third Party Management Beyond Due Diligence
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J. Mark Farrar, MSJ, CPA
Managing Director, Compliance Group Leader, Epsilon Life Sciences, Atlanta, GA (Discussion Coordinators)![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/nese_100.jpg)
Gina Nese, JD
Vice President Global Compliance and Ethics Officer, Align Technology; Former Chief Compliance Officer, Advanced Sterilization Products; Bellevue, WA, USA (Discussion Coordinators)Topic VI: Ethics & Compliance Considerations for Small to Mid-sized Companies
![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/jones_darren_100.jpg)
Darren R. Jones
Partner and Leader, Life Sciences Consulting Practice, Baker Tilly, New York, NY![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/nikidis_100.jpg)
Chrisoula Nikidis, LL.L.
Head of Ethics and Compliance, Takeda Canada; Former Vice President, Ethics, Integrity, & Governance, Innovative Medicines Canada, Toronto, Canada (Discussion Coordinator)Topic VII: Does the Corporation’s Compliance Program Work in Practice
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Jacob T. Elberg, JD
Associate Professor, Seton Hall University School of Law; Former Chief, Health Care & Government Fraud Unit, and Assistant US Attorney, US Attorney's Office, District of New Jersey, Newark, NJ, USA (Discussion Coordinator)![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/fell_100.jpg)
Alex Fell
Head Ethics, Compliance and DPO International, Amicus Therapeutics; Former Vice President, Global Ethics and Compliance, Head of Strategy, Planning and Operations, GSK; London, UK (Discussion Coordinator)Topic VIII: Ethics and Compliance Lessons Learned from COVID
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Brett Hudson, MBIM
Global Head Ethics, Risk & Compliance Strategy, Innovation, & Corporate Functions, Novartis; Former Global Program Director Integrity & Compliance, Sandoz, Zurich, Switzerland (Discussion Coordinator)![](https://internationalpharmacongress.com/wp-content/themes/ipc/faculty/gumpert_100.jpg)