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

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
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
Sarah Wheeler, MA
Director of Global Industry Engagement, International Association for the Study of Pain, Washington, DC
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
Abhiroop Gandhi
Trust and Compliance Officer, Verily Life Sciences (an Alphabet company); Former Vice President, Corporate Compliance, Mallinckrodt San Francisco, CA, 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
Mirgen Jaku, MA
Ethicon EMEA PMO & Digital Surgery Leader, Johnson & Johnson, Hamburg, Germany
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

Sofie Melis
Director HR and Ethics & Compliance, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Geneva, SwitzerlandEFPIA

Julie Bonhomme
Legal & Compliance Director, European Federation of Pharmaceutical Industries and Associations (EFPIA), Brussels, BelgiumMedTech Europe

Aline Lautenberg
General Counsel and Director, Legal & Compliance, MedTech Europe, Brussels, BelgiumAsia Pac Update

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

Imelda Álvarez, LLB, MBA
Chief Executive Officer, Comply Latam, SC; Former Regional Integrity & Compliance Head Latin America and Canada, Novartis, Mexico City, MexicoDiscussion Coordinator

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
Giota Papamarkou
Vice-President, Business Ethics Global, France, Ipsen Former EMEA Compliance and Ethics Manager, Bristol-Myers Squibb, Paris, France
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
Vanessa Westphal, JD, MS
Head of Compliance Center of Excellence Programs & Support, Merck KGaA, Darmstadt, Frankfurt Am Main Area, Germany
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
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
Sally Molloy, JD
Chief, Strategy, Policy and Training Unit, Fraud Section, US Department of Justice, Washington, DC, USA
Caroline H. West, JD
Former Global Chief Compliance Officer, Olympus Corporation; Former Senior Vice President, Chief Compliance and Risk Officer, Shire, Philadelphia, PA, USA
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
Sobia Akram, MSC
Corporate Vice President, Global Business Ethics Compliance Office & Programme, Novo Nordisk A/S, Copenhagen, Capital Region, Denmark
Brett Hudson, MBIM
Global Head Ethics, Risk & Compliance Strategy, Innovation, & Corporate Functions, Novartis; Former Global Program Director Integrity & Compliance, Sandoz, Zurich, Switzerland
Giota Papamarkou
Vice-President, Business Ethics Global, France North America & Global Monitoring, Ipsen; Former EMEA Compliance and Ethics Manager, Bristol-Myers Squibb, Paris, France
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
Masha Chestukhin, MSJ
Associate Director, Compliance Officer R&D, IA, FMV, Sanofi Genzyme; Former Senior Manager NA Compliance, Sanofi; Jamaica Plain, MA, USA
Ana Christian, JD
Senior Director, Assistant General Counsel, Avanir Pharmaceuticals; Former Corporate Counsel, NantHealth,Los Angeles, CA, USA
Stefanie Deronne, JD
Legal Counsel, Argenx; Former Senior Corporate Legal Counsel R&D - DPO, Ablynx; Ghent, Belgium
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
Ghadeer Al Yacoub, MSc
Regional Head Healthcare Compliance Europe, Middle East and Africa Medical Devices, Johnson & Johnson, Dubai, UAE
Els Janssens, LLM
Counsel, Baker & McKenzie; Former Legal Adviser, European Medicines Agency; Former Senior Legal Counsel, Johnson & Johnson, Brussels, Belgium
Samar Wakim, PharmD
Ethics & Compliance Head MEA, Innovative Medicines, Novartis Pharma Services AG, Dubai, UAE
Joseph W. Henein, PharmD
President and Chief Executive Officer, NewBridge Pharmaceuticals, Dubai, UAE (Co-Discussion Coordinator)
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
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
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
Cerstin Steindorf
Global Account Director Healthcare, MCI, Geneva, Switzerland
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
Chelsea M. Keeton, JD
Director and Senior Counsel, Global Compliance Investigations, Zimmer Biomet; Former Group Ethics & Compliance Counsel, VEON, Amsterdam, Netherlands
Elisabeth Kohoutek
Senior Associate, FDA and Life Sciences, King & Spalding LLP, Frankfurt am Main, Germany
Keith Korenchuk, MPH, JD
Vice President and Chief Compliance Officer, DH Diagnostics, a Danaher Company, Chevy Chase, MD, USA
Sylvain Mansotte
Co-Founder and Chief Executive Officer, Whispli, Sydney, New South Wales, Australia
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
Brian P. Sharkey
Director, US Commercial Compliance & Ethics, Teva Pharmaceuticals, Parsippany, New Jersey, USA
Sara R. Simon, JD
Associate, Porzio, Bromberg & Newman, PC, Morristown, NJ
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

J. Mark Farrar, MSJ, CPA
Managing Director, Compliance Group Leader, Epsilon Life Sciences, Atlanta, GA (Discussion Coordinators)
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

Darren R. Jones
Partner and Leader, Life Sciences Consulting Practice, Baker Tilly, New York, NY
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

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)
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

Brett Hudson, MBIM
Global Head Ethics, Risk & Compliance Strategy, Innovation, & Corporate Functions, Novartis; Former Global Program Director Integrity & Compliance, Sandoz, Zurich, Switzerland (Discussion Coordinator)