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, SpainChristian-Claus Roth
Global Head Scientific Engagement Governance, Novartis; Co-president, International Pharmaceutical Congress Advisory Association (IPCAA); Member, Ethics and Business Integrity Committee, IFPMA, Basel, SwitzerlandSarah Wheeler, MA
Director of Global Industry Engagement, International Association for the Study of Pain, Washington, DCAnne-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 HealthAbhiroop Gandhi
Trust and Compliance Officer, Verily Life Sciences (an Alphabet company); Former Vice President, Corporate Compliance, Mallinckrodt San Francisco, CA, USAIordanis Kerenidis, PhD
Director, Paris Centre for Quantum Computing (PCQC), CNRS Senior Researcher (DR2), Algorithms and Complexity Group IRIF, University Paris Diderot, Paris, FranceMirgen Jaku, MA
Ethicon EMEA PMO & Digital Surgery Leader, Johnson & Johnson, Hamburg, GermanyAnne-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&AGiota Papamarkou
Vice-President, Business Ethics Global, France, Ipsen Former EMEA Compliance and Ethics Manager, Bristol-Myers Squibb, Paris, FranceCarrie (Ashcom) Pennington, MBA, PhD
Vice President, Global Compliance Monitoring & Internal Controls, Zimmer Biomet; Former Global Compliance Manager, Books & Records, GE Healthcare, Warsaw, IN, USAVanessa Westphal, JD, MS
Head of Compliance Center of Excellence Programs & Support, Merck KGaA, Darmstadt, Frankfurt Am Main Area, GermanyAnita 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&AAbdul Luheshi, MBA
Independent Consultant, Ethics and Compliance; Former Compliance Officer, International Markets, Myriad Genetics; Former Executive Director, Global Operations, Ethics & Compliance, EMEA, Astellas; London, UKSally Molloy, JD
Chief, Strategy, Policy and Training Unit, Fraud Section, US Department of Justice, Washington, DC, USACaroline H. West, JD
Former Global Chief Compliance Officer, Olympus Corporation; Former Senior Vice President, Chief Compliance and Risk Officer, Shire, Philadelphia, PA, USAAmanda 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&ASobia Akram, MSC
Corporate Vice President, Global Business Ethics Compliance Office & Programme, Novo Nordisk A/S, Copenhagen, Capital Region, DenmarkBrett Hudson, MBIM
Global Head Ethics, Risk & Compliance Strategy, Innovation, & Corporate Functions, Novartis; Former Global Program Director Integrity & Compliance, Sandoz, Zurich, SwitzerlandGiota Papamarkou
Vice-President, Business Ethics Global, France North America & Global Monitoring, Ipsen; Former EMEA Compliance and Ethics Manager, Bristol-Myers Squibb, Paris, FrancePascale 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&AMasha Chestukhin, MSJ
Associate Director, Compliance Officer R&D, IA, FMV, Sanofi Genzyme; Former Senior Manager NA Compliance, Sanofi; Jamaica Plain, MA, USAAna Christian, JD
Senior Director, Assistant General Counsel, Avanir Pharmaceuticals; Former Corporate Counsel, NantHealth,Los Angeles, CA, USAStefanie Deronne, JD
Legal Counsel, Argenx; Former Senior Corporate Legal Counsel R&D - DPO, Ablynx; Ghent, BelgiumGenevieve 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&AGhadeer Al Yacoub, MSc
Regional Head Healthcare Compliance Europe, Middle East and Africa Medical Devices, Johnson & Johnson, Dubai, UAEEls Janssens, LLM
Counsel, Baker & McKenzie; Former Legal Adviser, European Medicines Agency; Former Senior Legal Counsel, Johnson & Johnson, Brussels, BelgiumSamar Wakim, PharmD
Ethics & Compliance Head MEA, Innovative Medicines, Novartis Pharma Services AG, Dubai, UAEJoseph 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&AHolger Diener
Healthcare Compliance Officer, Janssen-Cilag GmbH, Johnson & Johnson; Former Managing Director, Association of Voluntary Self-Regulation for the Pharmaceutical Industry (“FSA”), Berlin, GermanyChristian-Claus Roth
Global Head Scientific Engagement Governance, Novartis; Co-president, International Pharmaceutical Congress Advisory Association (IPCAA);Member, Ethics and Business Integrity Committee, IFPMA, Basel, SwitzerlandCerstin Steindorf
Global Account Director Healthcare, MCI, Geneva, SwitzerlandMichael 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&AChelsea M. Keeton, JD
Director and Senior Counsel, Global Compliance Investigations, Zimmer Biomet; Former Group Ethics & Compliance Counsel, VEON, Amsterdam, NetherlandsElisabeth Kohoutek
Senior Associate, FDA and Life Sciences, King & Spalding LLP, Frankfurt am Main, GermanyKeith Korenchuk, MPH, JD
Vice President and Chief Compliance Officer, DH Diagnostics, a Danaher Company, Chevy Chase, MD, USASylvain Mansotte
Co-Founder and Chief Executive Officer, Whispli, Sydney, New South Wales, AustraliaUlf 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&ABrian P. Sharkey
Director, US Commercial Compliance & Ethics, Teva Pharmaceuticals, Parsippany, New Jersey, USASara R. Simon, JD
Associate, Porzio, Bromberg & Newman, PC, Morristown, NJJohn 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.)