KEYNOTE SPEAKERS
Nicola Bedlington
Secretary General, European Patients Forum (EPF), Former Director, European Disability Forum, Brussels, Belgium
Serge Bernasconi, MA, MIM
Chief Executive Officer, MedTech Europe, Former CEO, Eucomed, Former CEO, European Diagnostic Manufacturers Association, Brussels, Belgium
Richard Bistrong, MA
Chief Executive Officer, Front-Line Anti-Bribery LLC, Contributing Editor, FCPA Blog, Former Confidential Human Source (CHS) and Cooperating Witness, FBI and US DOJ, Former Cooperating Witness, City of London Police, HMRC and CPS, UK, New York, NY, USA
Giovanni Buttarelli
European Data Protection Supervisor, Former Secretary General, Italian Data Protection Authority, Brussels, Belgium
Charles Cain, JD
Chief, FCPA Unit, US Securities and Exchange Commission (SEC), Washington, DC, USA
Paul Csiszár, JD
Director, DG Competition, European Commission, Brussels, Belgium
Tarek Helou, JD
Assistant Chief, FCPA Unit, Fraud Section, Criminal Division, US Department of Justice, Assistant US Attorney, Northern District of California, Washington, DC, USA
Jan Oliver Huber, DR JUR
General Secretary, Association of the Austrian Pharmaceutical Industry (PHARMIG), Vienna, Austria
José F. Zamarriego Izquierdo, MBA, PhD
Director, Code of Practice Surveillance Unit, Farmaindustria, Chair, EFPIA’s Code Committee, Coordinator, EFPIA e4ethics Initiative, Chairman, IFPMA’s Code Complaint Procedure Appeal Group, Madrid, Spain
George “Ren” McEachern, CFE, CAMS
Managing Director, Exiger, Former Supervisory Special Agent, International Corruption Squad, US Federal Bureau of Investigation, Washington, DC, USA
Sofie Melis
Senior Manager, Ethics and Compliance, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Geneva, Switzerland
Marie-Claire Pickaert
Deputy Director General, Chief Financial Officer and Ambassador to the Medical Communities, European Federation of Pharmaceutical Industries and Associations (EFPIA), Brussels, Belgium
Camilla de Silva
Joint Head of Bribery and Corruption, Serious Fraud Office, London, UK
Professor N. Craig Smith
Chaired Professor of Ethics and Social Responsibility, INSEAD; Academic Director, CSR & Ethics Research Group, INSEAD Social Innovation Centre, Fontainebleau, France
Tamara Tubin
International Compliance Director, Corporate Compliance, Wright Medical Group N.V., Vice Chair, Ethics & Compliance Committee, MedTech Europe, Member, Strategic Committee, International Society of Healthcare, Ethics and Compliance Professionals (ETHICS), Zürich, Switzerland
Chris Wigley, MA
Chief Operating Officer, QuantumBlack, Partner, McKinsey & Company, Trustee, New Entrepreneurs Foundation, Former Diplomat, British Foreign Office, London, UK
AGENDA-AT-A-GLANCE
- Morning Complimentary Precons
- Luncheon your Own
- Afternoon Opening Plenary Session
- Welcome PHARMIG and Co-Chairs
- C-suite Keynote
- OECD Update
- EU Commission Keynote
- US DOJ and SEC FCPA Update
- UK SFO Update
- Annual CCO Roundtable
- Welcome PHARMIG and Co-Chairs
- Evening Networking Reception
- Morning Plenary Session
- Global Compliance Codes Update
- Richard Bistrong Behind the Bribe
- Annual Anti-corruption Roundtable
- Global Compliance Codes Update
- Networking Luncheon
- Afternoon Mini Summits: Round I
- Managing Third Party Relationships
- EU General Data Protection Privacy Update (GDPR)
- Future of Direct Sponsorships
- Patient Organizations (EFPIA White Paper)
- Annual MEA Compliance Update
- Managing Third Party Relationships
- Afternoon Mini Summits: Round II
- Outcomes-based Value-added Services
- Annual Medical Device Compliance Update
- Social Responsibility: EU Directive 2014/95/EU
- Evolution of Compliance Programs
- Annual CEE Compliance Update
- Outcomes-based Value-added Services
- Afternoon Mini Summits: Round III
- Social Media Compliance
- Compliance Monitoring and Risk Assessments
- Relationships with HCPs, HCOs and Pt Organizations
- Behavioral Economics in Compliance Programs
- Compliance Issues in Market Access
- Social Media Compliance
- Morning Closing Plenary Session
- European Data Protection Supervisor Update
- IFPMA Update
- MedTech Europe Update
- Healthcare Compliance as a Profession
- Challenges and Opportunities of Pursuing the Healthcare Compliance Profession
- Embracing Change in the Digital Health Era
- The Ethics of Artificial Intelligence
- European Data Protection Supervisor Update
- 12:30 pm Adjournment
FEATURED FACULTY
John Alexander
Head of European Compliance, Mundipharma International, Former EMEA Director of Compliance, Ortho Clinical Diagnostics, Former Healthcare Compliance Officer, Janssen-Cilag, Cambridge, UK
David Andersen
Partner, Pharmaceuticals and Life Sciences, PwC, London, UK
Michael Bartke, PhD
Former Director Compliance Management, Daiichi Sankyo Europe GmbH, Strategic Committee, International Society of Healthcare, Ethics and Compliance Professionals (ETHICS), Munich, Germany
Ann Beasley, JD
Director, Navigant Consulting, Former Senior Vice President, Chief Compliance Officer, Biogen, Former Co-chair, International Pharmaceutical and Medical Device Compliance Congress, Boston, MA, USA
Enno Behrendt
Head of Compliance for Diagnostic Imaging, Siemens Healthcare GmbH, Erlangen, Germany
Liesbeth Bergmans, LLM
Senior Legal Counsel, Teva Pharmaceuticals, Amsterdam, Netherlands
Lee Betteridge
Director, Pharmaceutical and Life Sciences, PwC, London, UK
Julie Bonhomme
EFPIA Legal & Compliance Director, European Federation of Pharmaceutical Industries and Associations (EFPIA), Brussels, Belgium
Ceren Aral Desnos, LLM
Interim Director of Legal and Compliance (Consultant), MedTech Europe, Paris, France
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
Kip Ebel, MBA
Principal, Fraud Investigation & Dispute Services, EY, New York, NY, USA
Sue Egan
Director and Principal Consultant, Sue Egan Associates, Former Vice President Compliance, AstraZeneca, Great Missenden, Buckinghamshire, UK
Olga Sanz Escudero
Compliance Advisor, Merck; Former Codes Compliance Officer, Farmaindustria, Madrid, Spain
Karen Eryou
Head, Ethics & Compliance Programs, UCB Pharma, Former Co-chair, Asia Pacific Pharma Compliance Congress, Brussels, Belgium
George Fife
Partner, Fraud Investigation & Dispute Services, EY, Former Executive Director, Compliance & Ethics, Bristol-Myers Squibb, Paris, France
Bernhard Fischer
Health Care Compliance Officer, Medical Devices Germany, Johnson & Johnson Medical GmbH, Hamburg Area, Germany
Jacques Fontas
Executive Counsel, Compliance Leader Europe, GE Healthcare, Member, Strategic Committee, ETHICS, Paris, France
Gary F. Giampetruzzi, Esq.
Partner, Paul Hastings, Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc., New York, NY, USA
Cecile Gousset
Head of Compliance Risk Assessment, Policies & Education, Global Ethics & Business Integrity, Sanofi, Paris, France
Tom Gregory
Partner, Fraud Investigation & Dispute Services, Ernst & Young, LLP, Atlanta, GA
Ulf H. Grundmann
Partner, FDA and Life Sciences, King & Spalding LLP, Frankfurt am Main, Germany
Joseph W. Henein, PharmD
President and Chief Executive Officer, NewBridge Pharmaceuticals FZ LLC, Dubai, UAE
Nicolas Honhon
Head, Ethics & Compliance EMEA, UCB Pharma, Vice-Chair, Ethics & Compliance Committee, EFPIA, Brussels, Belgium
Casey J. Horton, CFE
Director, Healthcare and Life Sciences Disputes, Regulatory, Compliance and Investigations, Navigant Consulting, Chicago, IL, USA
Els Janssens, LLM
Senior Associate, Baker & McKenzie Habib Al Mulla, Former Legal Adviser, European Medicines Agency, Former Senior Legal Counsel, Johnson & Johnson, Abu Dhabi, UAE
Carl Judge
Partner, Fraud Investigation & Dispute Services, EY, London, UK
Isaure Kergall-Gayet, DEA-Law, CAPA
Legal Director, France, Amgen, Former VP, Chief Ethics & Compliance Officer, Ipsen, Paris, France
Maria Khoury
Compliance Officer Levant, Roche, Chair, Lebanese Group of International Pharmaceutical Companies, and Iraq LAWG(Local Area Working Group), Beirut, Lebanon
Keith M. Korenchuk, JD, MPH
Partner, Arnold & Porter LLP, Washington, DC, USA
Tomasz Kruk
Head of Compliance, Vifor Pharma, Former Director International Compliance, Mallinckrodt Pharmaceuticals, Former Director Global Ethics & Compliance, Actavis plc (now Allergan), Zurich, Switzerland
Anita Kyung-Hee Kim-Reinartz
Partner, Fraud Investigation & Dispute Services, EY, Düsseldorf, Germany
Laurence Labey, MD
Ethics and Business Integrity Business Partner for R&D and Chief Medical Officer, Sanofi, Paris, France
Evelyne Lemaire, MA
Head of Compliance, Europe & Canada, Takeda Pharmaceuticals International GmbH, Zurich, Switzerland
Abdul Luheshi, MBA
Executive Director, Global Operations, Ethics & Compliance, Astellas Pharma EMEA, Former Vice President, Health Care Compliance, Johnson & Johnson, Chertsey, UK
John McLoughlin, JD
Counsel, Friedman & Wittenstein, Washington, DC
Paul J. Melling, JD
Founding Partner, Baker & McKenzie – CIS, Limited, Moscow, Russia
Laura Nassar
Head of Compliance Middle East, Roche Pharmaceuticals, Former Regional Pharma HCC Officer Emerging Markets, Johnson & Johnson, Beirut, Lebanon
Chrisoula Nikidis
Canadian Head of Compliance and Ethics Solutions, IQVIA; Former Executive Director, Ethics and Compliance, Innovative Medicines Canada; Former Industry Co-Chair Designate, APEC Biopharmaceutical Working Group on Ethics, Ottawa, Canada
Nicola Orlandi
Head Data Privacy Pharma, Global Privacy Office, Novartis International AG, Former Head of Legal and Compliance, Sandoz S.p.A., Basel, Switzerland
Dave O’Shaughnessy
HCCO Janssen R&D EMEA, Office of Healthcare Compliance & Privacy, Johnson & Johnson, Board of Directors, ETHICS, Former VP, Compliance, Emerging Markets, IQVIA, Former VP, Global Compliance, AstraZeneca, Former VP Compliance Officer, Int’l Pharmaceuticals, GSK, London, UK
Pascale Paimbault
CEO, CONSULTING ALLEY: Member of ETHICS Board and Strategic Committee; Former Executive Director Ethics & Compliance EMEA, Astellas Pharma; Former Compliance Officer, France -Benelux,Biogen; Former Compliance Officer, EMEA, Wright Medical, Former Senior Director EMEA Compliance & ETHICS, Bristol-Myers Squibb, Paris, France
Giota Papamarkou
Senior Director Ethics & Compliance, Ipsen, Former EMEA Compliance and Ethics Manager, Bristol-Myers Squibb, Paris, France
Piergiorgio Pepe
Compliance and Ethics Lecturer and Advisor; Former Compliance Director Western Europe & Canada, AbbVie, Paris, France
Oscar Perdomo
Director, Pharmaceutical and Life Sciences, PwC, Basil, Switzerland
Nathalie Pirlot
Third Party Compliance Management Lead, UCB, Brussels, Belgium
Madina Plieva, PhD
Legal and Compliance Head, Russia, Bristol-Myers Squibb, Moscow, Russia
Ethan M. Posner, JD
Partner, Covington, Former Deputy Associate Attorney General, US Department of Justice, Washington, DC, USA
Mario Prohasky
Principal, Polaris Management Partners, London, United Kingdom
Uffe Kåre Rasmussen, MSc
Senior Director, Chief Compliance Officer, Corporate Compliance & Corporate Social Responsibility, H. Lundbeck A/S, Copenhagen, Denmark
Ulrich Matthias Reese, Esq.
Partner and Co-Head Global Healthcare, Life Sciences and Chemicals Group, Clifford Chance; Chair of the Pharmaceutical Law Committee of the Association for Intellectual Property and Copyright Law (GRUR), Düsseldorf, Germany
Vivian Robinson, Esq.
Queen’s Counsel, Partner, McGuire Woods, Former General Counsel of the UK Serious Fraud Office, Former Head, QEB Hollis Whiteman Chambers, Recorder of the Crown Court and Treasurer of Inner Temple, London, UK
Fabien Roy
Counsel, Hogan & Lovells, Brussels, Belgium
Christine M. Sainvil
Compliance Officer, EthicalMedtech, Manager, Conference Vetting System (CVS), European Medical Technology Industry Association (MedTech Europe), Brussels, Belgium
Tjerk Schlufter
Senior Vice President Compliance, Fresenius SE, Former General Counsel, Osram and Siemens Healthcare Imaging Systems, Bad Homburg, Germany
Brian Sharkey, JD
Vice President, Porzio Life Sciences, LLC, Principal, Porzio, Bromberg & Newman, Morristown, NJ, USA
Hubertus Stockmann, MBA
Regional Compliance Officer EMEA, Getinge, Former Compliance Officer Performance Material & Merck Group Functions, Merck Group, Frankfurt Am Main, Germany
Michele Tagliaferri, JD
Partner and Lead, Investigations and Compliance Team, Sidley Austin LLP, Brussels, Belgium
Yuet Ming Tham, JD
Partner, Sidley Austin LLP; Former Asia Pacific Regional Compliance Director, Pfizer; Former Deputy Public Prosecutor, Singapore, Hong Kong
Evgeny Tilezhinsky, MBA, PhD
Law and Compliance Lead for the Central and Eastern Europe, Bristol-Myers Squibb, Uxbridge, Middlesex, UK
Max Tullberg
Chief Compliance Officer and Group Data Protection Officer, Swedish Orphan Biovitrum AB, Stockholm, Sweden
Dumitru Uta, MD, MBA, CCEP
Ethics and Compliance Director, South Eastern Europe, Eli Lilly and Company, Bucharest, Romania
Willy Vanbuggenhout, MBA, LIC, Law
Chief Privacy Officer, Johnson & Johnson, Brussels, Belgium
Pawel Wajszczyk, MBA
Director HCCO Eastern Europe, Russia, CIS MD, Johnson & Johnson, Warsaw, Poland
Mariusz Witalis
Partner, Fraud Investigation and Dispute Services, Ernst & Young LLP, Warsaw, Poland
Christine Zettlemoyer, JD
Head, Americas Compliance and Global Support, CSL Behring, Former Executive/ Head, Global Compliance Oversight and Monitoring, Merck, King of Prussia, PA, USA
2018 GLOBAL PHARMA COMPLIANCE CONGRESSES
TWELFTH INTERNATIONAL PHARMACEUTICAL AND MEDICAL DEVICE COMPLIANCE CONGRESS
Sponsored by International Society of Healthcare Compliance Professionals (ETHICS)
Media Partners: Life Sciences Compliance Update
May 14 – 16, 2018
Hotel Savoyen
Vienna, Austria
www.InternationalPharmaCongress.com
EIGHTH ASIA PACIFIC PHARMACEUTICAL AND MEDICAL DEVICE COMPLIANCE CONGRESS
Sponsored by Asia Pacific Healthcare Industry Compliance Team
Cosponsored by International Society of Healthcare Ethics and Compliance Professionals (ETHICS)
Media Partners: Life Sciences Compliance Update
September 10 – 12, 2018
Singapore
www.AsianPharmaCongress.com
NINETEENTH ANNUAL PHARMACEUTICAL AND
MEDICAL DEVICE COMPLIANCE CONGRESS
A Hybrid Conference and Internet Event
Sponsored by Pharmaceutical Compliance Forum (PCF)
November 7 – 9, 2018
Mandarin Oriental
Washington, DC
www.PharmaCongress.com