AGENDA: PRECONFERENCES/DAY I
MONDAY, APRIL 8, 2019
8:00 am
Registration Opens
PRECONFERENCE I: A WORKSHOP ON PRACTICAL CASE STUDIES AND EXERCISES IN ETHICS AND COMPLIANCE
Join esteemed panelists in a discussion of four case studies built around analysis and codes-related education. Attendees will review and analyze compliance issues and identify solutions to operationalize, including policies & procedures, training, and auditing & monitoring.
(Optional attendance; additional registration required)
9:00 am
Welcome and Introductions
Stephen Nguyen Duc
Vice-President, Global Head of Human Resources and Ethics & Compliance, Medday Pharmaceuticals; Board Member, Strategic Committee International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France
Vice-President, Global Head of Human Resources and Ethics & Compliance, Medday Pharmaceuticals; Board Member, Strategic Committee International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France
Stephen Nguyen-Duc joined Medday in November 2018 as VP, Global Head of Ethics & Compliance. As part of his career, he has held several senior positions in Clinical Operations, Human Resources and Compliance in multinational companies. In his last position before Medday, he was the Compliance Officer for Europe and Canada at Abbvie Pharmaceuticals. Stephen is an active member of various associations promoting Trust and Integrity in Healthcare. He is Board member and Co-Chair of the Strategic Committee of Ethics, the International association of Healthcare Compliance Officers
Sue Egan
Director and Principal Consultant, Sue Egan Associates, Great Missenden, Buckinghamshire, UK
Director and Principal Consultant, Sue Egan Associates, Great Missenden, Buckinghamshire, UK
Director, SEAL Compliance (a trading name of Sue Egan Associates Limited) Sue established her consultancy in January 2010 to provide practical assistance for small to medium sized companies trying to establish their compliance programs from nothing, improve on existing programs, and / or enable compliance team members to achieve their full potential. She has been a Compliance Officer at all levels from single marketing company and region for GlaxoSmithKline to international VP for AstraZeneca. As a founder member of the organizing committee of the International Pharmaceutical and Medical Device Compliance Congress, she has a high reputation as a speaker and presenter of case studies and practical guidance at conferences in the USA, Europe, Asia Pacific, and Latin America. Sue Egan Associates is also a member of the Thames Valley Chamber of Commerce Group. In addition to her consultancy work, Sue also provides membership assistance to ETHICS Society.
Karen Eryou
Head, Ethics & Compliance Programs, UCB Pharma; Former Co-chair, Asia Pacific Pharma Compliance Congress, Brussels, Belgium
Head, Ethics & Compliance Programs, UCB Pharma; Former Co-chair, Asia Pacific Pharma Compliance Congress, Brussels, Belgium
Karen Eryou is currently the Head of Ethics & Compliance Programs for UCB Pharma. In this role she is responsible for the development of UCB’s program on ethical decision making as well as leading the global compliance operations group. This group includes transparency, third party management, investigations, monitoring & analytics as well as a frameworks programs which encompasses policies, procedures, training, and communication.
From 2010 – 2016, Karen was based in Shanghai, China where she built the compliance function for UCB, initially for China and later for the Asia-Pacific region.
Originally from Vancouver, Canada Karen has over 18 years of international work experience in the pharmaceutical industry including clinical operations, quality assurance, auditing & inspections, medical affairs, and business practice compliance. She has focused on business practices, ethics, and compliance topics for the past 10 years.
From 2010 – 2016, Karen was based in Shanghai, China where she built the compliance function for UCB, initially for China and later for the Asia-Pacific region.
Originally from Vancouver, Canada Karen has over 18 years of international work experience in the pharmaceutical industry including clinical operations, quality assurance, auditing & inspections, medical affairs, and business practice compliance. She has focused on business practices, ethics, and compliance topics for the past 10 years.
Cecile Gousset
Head of Compliance Risk Assessment, Policies & Education, Global Ethics & Business Integrity, Sanofi, Paris, France
Head of Compliance Risk Assessment, Policies & Education, Global Ethics & Business Integrity, Sanofi, Paris, France
Cécile Gousset has 19 years’ experience in Sanofi, in Regulatory Affairs (French affiliate) and Global Medical Operations (Head of Medical Information Compliance department). She joined the Global Ethics & Business Integrity department in 2013. Outside Sanofi, she spent 6 years in AstraZeneca (Regulatory Affairs) and 2 years in Merieux UK (Marketing/Product Manager). Cécile represents Sanofi at the IFPMA Ethics & Business Integrity Committee and at the EFPIA Ethics & Compliance Committee. Cécile is also a member of the Ethics association.
Dominique Laymand, Esq.
Executive Vice President, Ethics and Social Responsibility, Ipsen; President, International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France
Executive Vice President, Ethics and Social Responsibility, Ipsen; President, International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France
Dominique Laymand is Executive Vice-President, Chief Ethics and Social Responsibility Officer at Ipsen. She is a member of the Executive Leadership Team and leads the Ethics and Social Responsibility Department and Strategy, based on a Business Integrity vision.
In a former role, Dominique acted as EMEA Vice-President Compliance & Ethics at Bristol Myers Squibb.
Dominique is Honorary President of ETHICS, International Society of Healthcare Ethics and Compliance Professionals, whose mission is to be recognized as an independent international association of professionals, which sets standards of Ethics and Compliance, and shapes and influences strategies in the changing Healthcare environment for the ultimate benefit of Patients and Society at large, contributing to the development of Ethics and Compliance professionals.
Dominique is an active member of various Pharmaceutical Industry Associations and committees, and also plays a key role in various industry associations and provides ethics and compliance education.
In a former role, Dominique acted as EMEA Vice-President Compliance & Ethics at Bristol Myers Squibb.
Dominique is Honorary President of ETHICS, International Society of Healthcare Ethics and Compliance Professionals, whose mission is to be recognized as an independent international association of professionals, which sets standards of Ethics and Compliance, and shapes and influences strategies in the changing Healthcare environment for the ultimate benefit of Patients and Society at large, contributing to the development of Ethics and Compliance professionals.
Dominique is an active member of various Pharmaceutical Industry Associations and committees, and also plays a key role in various industry associations and provides ethics and compliance education.
Pablo Rojas Abad, LLM
Manager, Legal and Compliance, MedTech Europe, Brussels, Belgium (Co-moderator)
Manager, Legal and Compliance, MedTech Europe, Brussels, Belgium (Co-moderator)
Pablo Rojas Abad is a Legal & Compliance Manager at MedTech Europe, working on all topics in the Legal & Compliance team, with a focus on the implementation of the MedTech Europe Code of Ethical Business Practice. Pablo’s goal is to provide MedTech Europe members with support on any legal topic that might affect the industry, and also to support their implementation of the MedTech Europe Code of Ethical Business Practice. Pablo has worked for five years in the legal field, after having worked in law firms, the Council of the EU and now for four years in MedTech Europe.
Julie Bonhomme
Legal and Compliance Director, European Federation of Pharmaceutical Industries and Associations (EFPIA), Brussels, Belgium (Co-moderator)
Legal and Compliance Director, European Federation of Pharmaceutical Industries and Associations (EFPIA), Brussels, Belgium (Co-moderator)
Julie Bonhomme joined the European Federation of Pharmaceutical Industries and Associations in December 2014. In her position of Legal Affairs & Compliance Director, she is in charge of heading EFPIA’s Codes and Ethics & Compliance activities and especially contributing to enhancing ethical behavior within a strong and credible self-regulation framework. She also acts as Legal Adviser by providing legal support and assistance in EFPIA’s priority matters. Before joining the EFPIA, Julie worked as Legal and Compliance Manager at Leem (the French Association for Pharmaceutical Companies in France), where she gained more than 7 years’ experience. Prior to her experience with the industry, Julie was a member of the Paris Bar.
12:00 pm
Adjournment and Lunch on Your Own
PRECONFERENCE II: ADVANCED INVESTIGATIONS
(Optional attendance; additional registration required)
This dynamic and interactive session will kick-off with the results of 2019 NCI survey on Internal Investigations, including specific talking points that tie in legal issues. Next, Global Head of Investigations NCI, as Moderator, will address:
- How to organize and determine what to- vs. what not to- investigate
- Resources (dedicated Investigators vs. HR vs. Internal Audit)
- Use of data analytics
- Issues for a big vs. a small company
- Legal issues and privacy concerns
Finally, the panel will address questions related to Investigation outcomes:
- Presentations to management and the Board
- Ensure topics get re-integrated into the compliance program
- Effective relationships with the business
- Creating an effective investigations culture
9:00 am
Welcome and Introductions
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
Director, Navigant Consulting; Former Senior Vice President, Chief Compliance Officer, Biogen; Former Co-chair, International Pharmaceutical and Medical Device Compliance Congress, Boston, MA, USA
Ann Beasley is a Director with over 18 years’ experience as an in-house Compliance Officer and lawyer in building, managing and optimizing corporate compliance programs in life sciences companies. Ann brings an understanding of the issues clients’ face in implementing all the elements of an effective compliance program across global biotech, pharmaceutical, and device companies’ international operations. This includes a deep understanding of anti-bribery and anti-corruption (domestic and international), conflicts of interest, and regulatory matters as they manifest in daily operations and which require practical risk management controls. She has practiced in both legal and compliance departments and just prior to joining Navigant, was the Chief Compliance Officer and Senior Vice President at Biogen. Ann has significant international experience having built and led global compliance programs for major pharmaceutical and biotechnology companies, including developing the organizational infrastructure of the function and the individual skill development of compliance professionals.
Keith Burn
Global Investigations Director, Ipsen; Former Associate Investigator, Parliamentary and Health Service Ombudsman, NHS; Former Detective Constable, London Metropolitan Police, Amersham, Buckinghamshire, UK
Global Investigations Director, Ipsen; Former Associate Investigator, Parliamentary and Health Service Ombudsman, NHS; Former Detective Constable, London Metropolitan Police, Amersham, Buckinghamshire, UK
Betania Glorio
Global Compliance Officer Healthcare at Merck KGaA; Former Senior Director, Legal and Compliance EMEA, Horizon; Former Senior Counsel, Regional Compliance, Director, EUCAN, Pfizer, Darmstadt, Germany
Global Compliance Officer Healthcare at Merck KGaA; Former Senior Director, Legal and Compliance EMEA, Horizon; Former Senior Counsel, Regional Compliance, Director, EUCAN, Pfizer, Darmstadt, Germany
Betania Glorio is an experienced legal counsel focused for more than 10 years within legal and compliance positions across several territories within well-known pharmaceutical companies. She started her career within compliance as Regional Compliance Director for Latin America and Canada at Pfizer where she was responsible for the implementation of the first Anti-Corruption and Anti-Bribery procedure in said territory as well as to lead several investigations continuing with other territories such as Western Europe. She was also Senior Director Legal & Compliance EMEA at Raptor Pharmaceuticals. Betania is currently the Global Compliance Officer healthcare at Merck KGaA.
Franziska Janorschke
Global Head Business Practices Office, Novartis International AG, Basel, Switzerland
Global Head Business Practices Office, Novartis International AG, Basel, Switzerland
Franziska Janorschke leads the Novartis SpeakUp program for all speak up and whistleblower complaints re Novartis business practices. She is of German origin and is a qualified lawyer with work expertise in private practice and industry. She worked in several corporate functions e.g. HR, Security, Legal and currently in a specific Assurance and Advisory function next to Internal Audit and Security which has a reporting line to CEO and Board.
Gary F. Giampetruzzi, Esq.
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc., New York, NY, USA (Co-moderator)
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc., New York, NY, USA (Co-moderator)
Thomas K. Hauser, MA HSG, MSJ
Director, Life Sciences Governance, Risk Management, and Compliance Practice, Navigant; Former Global Chief Compliance Officer, Siemens Healthcare; Treasurer, International Society of Healthcare, Ethics and Compliance Professionals (ETHICS), London, UK (Co-moderator)
Director, Life Sciences Governance, Risk Management, and Compliance Practice, Navigant; Former Global Chief Compliance Officer, Siemens Healthcare; Treasurer, International Society of Healthcare, Ethics and Compliance Professionals (ETHICS), London, UK (Co-moderator)
Thomas K. Hauser is a director and the European practice leader of the Life Sciences Governance, Risk Management and Compliance practice. This includes a deep understanding of anti-bribery and anti-corruption (domestic and international), conflicts of interest, and regulatory matters as they manifest in daily operations and which require practical risk management controls. Thomas has more than two decades of operational business experience, in management roles as CEO and in operational compliance and consulting. Thomas has significant international experience in medical device and pharmaceutical companies; focusing on the U.S., Europe, Russia/CIS, Middle East and China. Thomas served for more than six years as the global Chief Compliance Officer for a $16B Life Sciences company (covering MedTech and Pharma) with over 100 world-wide locations.
12:00 pm
Adjournment and Lunch on Your Own
OPENING PLENARY SESSION
1:00 pm
SFEE Welcome
Dimitra Lempesi, LLM, MBA
Legal Director, SFEE (Hellenic Association of Pharmaceutical Companies), Athens, Greece
Legal Director, SFEE (Hellenic Association of Pharmaceutical Companies), Athens, Greece
Dimitra Lempesi has been Legal Counsel & director of the Hellenic Association of Pharma Companies (SFEE) since November 2014. She is a regular participant of Efpia working groups in Brussels. Previously, she was Legal Counsel of listed aquaculture, agricultural and technical holding group (Greece, UK, Turkey, Spain) Associate lawyer Professor Calavros & Partners Law Firm, and EU Commission, DGV Employment and Social Affairs, Brussels, B4 Community Initiatives- State subsidies. Dimitra is a Member of the Athens Bar.
1:05 pm
International Pharma Congress Vision and Overview
Stephen Nguyen Duc
Vice-President, Global Head of Human Resources and Ethics & Compliance, Medday Pharmaceuticals; Board Member, Strategic Committee International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France (Co-chair)
Vice-President, Global Head of Human Resources and Ethics & Compliance, Medday Pharmaceuticals; Board Member, Strategic Committee International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France (Co-chair)
Stephen Nguyen-Duc joined Medday in November 2018 as VP, Global Head of Ethics & Compliance. As part of his career, he has held several senior positions in Clinical Operations, Human Resources and Compliance in multinational companies. In his last position before Medday, he was the Compliance Officer for Europe and Canada at Abbvie Pharmaceuticals. Stephen is an active member of various associations promoting Trust and Integrity in Healthcare. He is Board member and Co-Chair of the Strategic Committee of Ethics, the International association of Healthcare Compliance Officers
Suzanne Durdevic, LLM
Associate General Counsel – International, Fortive | ASP; Member, Strategic Committee, International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France (Co-chair)
Associate General Counsel – International, Fortive | ASP; Member, Strategic Committee, International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France (Co-chair)
Dominique Laymand, Esq.
Executive Vice President, Ethics and Social Responsibility, Ipsen; President, International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France (Co-chair)
Executive Vice President, Ethics and Social Responsibility, Ipsen; President, International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France (Co-chair)
Dominique Laymand is Executive Vice-President, Chief Ethics and Social Responsibility Officer at Ipsen. She is a member of the Executive Leadership Team and leads the Ethics and Social Responsibility Department and Strategy, based on a Business Integrity vision.
In a former role, Dominique acted as EMEA Vice-President Compliance & Ethics at Bristol Myers Squibb.
Dominique is Honorary President of ETHICS, International Society of Healthcare Ethics and Compliance Professionals, whose mission is to be recognized as an independent international association of professionals, which sets standards of Ethics and Compliance, and shapes and influences strategies in the changing Healthcare environment for the ultimate benefit of Patients and Society at large, contributing to the development of Ethics and Compliance professionals.
Dominique is an active member of various Pharmaceutical Industry Associations and committees, and also plays a key role in various industry associations and provides ethics and compliance education.
In a former role, Dominique acted as EMEA Vice-President Compliance & Ethics at Bristol Myers Squibb.
Dominique is Honorary President of ETHICS, International Society of Healthcare Ethics and Compliance Professionals, whose mission is to be recognized as an independent international association of professionals, which sets standards of Ethics and Compliance, and shapes and influences strategies in the changing Healthcare environment for the ultimate benefit of Patients and Society at large, contributing to the development of Ethics and Compliance professionals.
Dominique is an active member of various Pharmaceutical Industry Associations and committees, and also plays a key role in various industry associations and provides ethics and compliance education.
1:15 pm
Keynote Address: Pharma Executive
Harout Semerjian, MBA
Executive Vice President and Chief Commercial Officer, Ipsen; Former Senior Vice President and Global Launch Lead, Ribociclib, Novartis Oncology, New York, NY, USA
Harout Semerjian is a global pharma veteran with 25 years’ experience in life sciences, particularly in speciality medicines. Currently based in London, he serves as EVP, Chief Commercial Officer at Ipsen where he oversees specialty medicines in Oncology, Neuroscience and Rare Diseases. With 2,200 employees in over 30 countries and a revenue of €1.5bn, under his leadership, commercial growth has accelerated to 20% year-on-year, and the company has recently broken into the top 20 oncology companies in terms of sales turnover. Before joining Ipsen, Harout spent 16 years at Novartis Oncology where he held multiple worldwide strategic and operational roles. In his last role, he served as SVP, Global Head for Ribociclib. Other roles at Novartis included VP, Head of US Hematology, Region Head Nordics-Baltics, Region Head Middle East-North Africa, Global Brand director Gleevec, and multiple commercial roles with Novartis Canada. Harout started his career in Lebanon as a medical representative with Solvay.
1:45 pm
Compliance and Ethics Issues Raised by Pharma and Device New Business Models: Product vs. Value and Outcome Based Approaches, and the Emergence of Analytics, Big Data and AI
Julien Durand, MBA, PhD
Executive Director Compliance & Ethics, Amgen; Former Chief Privacy Officer and Global Technology Compliance Head, AstraZeneca, Zürich, Switzerland
Executive Director Compliance & Ethics, Amgen; Former Chief Privacy Officer and Global Technology Compliance Head, AstraZeneca, Zürich, Switzerland
Thomas K. Hauser, MA HSG, MSJ
Director, Life Sciences Governance, Risk Management, and Compliance Practice, Navigant; Former Global Chief Compliance Officer, Siemens Healthcare; Treasurer, International Society of Healthcare, Ethics and Compliance Professionals (ETHICS), London, UK and Berlin, Germany
Director, Life Sciences Governance, Risk Management, and Compliance Practice, Navigant; Former Global Chief Compliance Officer, Siemens Healthcare; Treasurer, International Society of Healthcare, Ethics and Compliance Professionals (ETHICS), London, UK and Berlin, Germany
Thomas K. Hauser is a director and the European practice leader of the Life Sciences Governance, Risk Management and Compliance practice. This includes a deep understanding of anti-bribery and anti-corruption (domestic and international), conflicts of interest, and regulatory matters as they manifest in daily operations and which require practical risk management controls. Thomas has more than two decades of operational business experience, in management roles as CEO and in operational compliance and consulting. Thomas has significant international experience in medical device and pharmaceutical companies; focusing on the U.S., Europe, Russia/CIS, Middle East and China. Thomas served for more than six years as the global Chief Compliance Officer for a $16B Life Sciences company (covering MedTech and Pharma) with over 100 world-wide locations.
Kathy Tench, MS
Director, Life Sciences Compliance, KPMG Switzerland, Former Senior Director of Compliance, Optimer Pharmaceuticals, Zürich, Switzerland (Moderator)
Director, Life Sciences Compliance, KPMG Switzerland, Former Senior Director of Compliance, Optimer Pharmaceuticals, Zürich, Switzerland (Moderator)
Kathy Tench leads KPMG’s Swiss Life Sciences Compliance practice where she advises life sciences companies on matters related to anti-bribery and corruption and industry interactions with the medical and patient communities. She has over 20 years of experience in the life sciences sector, both as an advisor and as an in-house compliance professional. Prior to joining KPMG, Kathy held positions as head of compliance at a biopharmaceutical company and as a biostatistician at a Fortune 500 pharmaceutical manufacturer.
2:45 pm
Break
3:15 pm
Global Compliance Codes Update with Special Focus on the New IFPMA Code
IFPMA Code
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
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
Holger Diener has been Managing Director of the Association of Voluntary Self-Regulation for the Pharma-ceutical Industry (Freiwillige Selbstkontrolle für die Arzneimittelindustrie e.V. – FSA) since January 2012. Holger previously worked in the legal department of the German Association of Research-based Pharmaceutical Companies (Verband der forschenden Arzneimittelindustrie e.V. – vfa. He is Vice Chair of the Codes Committee and member of the Ethics and Compliance Committee at EFPIA. Holger is also a Vice Chair of the IFPMA Ethics and Business Integrity Committee (eBIC). Moreover, he is a Member of the International Society of Healthcare Ethics and Compliance Professionals (ETH-ICS).
EFPIA Code
Julie Bonhomme
Legal and Compliance Director, European Federation of Pharmaceutical Industries and Associations (EFPIA), Brussels, Belgium
Julie Bonhomme
Legal and Compliance Director, European Federation of Pharmaceutical Industries and Associations (EFPIA), Brussels, Belgium
Julie Bonhomme joined the European Federation of Pharmaceutical Industries and Associations in December 2014. In her position of Legal Affairs & Compliance Director, she is in charge of heading EFPIA’s Codes and Ethics & Compliance activities and especially contributing to enhancing ethical behavior within a strong and credible self-regulation framework. She also acts as Legal Adviser by providing legal support and assistance in EFPIA’s priority matters. Before joining the EFPIA, Julie worked as Legal and Compliance Manager at Leem (the French Association for Pharmaceutical Companies in France), where she gained more than 7 years’ experience. Prior to her experience with the industry, Julie was a member of the Paris Bar.
MedTech Europe Code
Arthur Muratyan, Esq.
Secretary General, International Society of HealthCare Ethics and Compliance Professionals (ETHICS), Chair, MedTech Compliance Network, Former VP-Head of Legal Corporate, and Global Compliance Officer, Sanofi, Paris, France
Arthur Muratyan, Esq.
Secretary General, International Society of HealthCare Ethics and Compliance Professionals (ETHICS), Chair, MedTech Compliance Network, Former VP-Head of Legal Corporate, and Global Compliance Officer, Sanofi, Paris, France
MEA Code
Laura Nassar, PharmD
Head of Compliance Middle East, Roche Pharmaceuticals; Chair, Compliance Committee, Pharmaceutical Research and Manufacturers Association, Gulf (PhRMAG); Former Regional Pharma HCC Officer Emerging Markets, Johnson & Johnson, Beirut, Lebanon
Laura Nassar, PharmD
Head of Compliance Middle East, Roche Pharmaceuticals; Chair, Compliance Committee, Pharmaceutical Research and Manufacturers Association, Gulf (PhRMAG); Former Regional Pharma HCC Officer Emerging Markets, Johnson & Johnson, Beirut, Lebanon
Laura Nassar is the Head of Compliance for Middle East at Roche Pharmaceuticals, based in Dubai. She is the Lead for PhRMAG (PhRMA Gulf) Compliance and Legal Working Group and Chair of the Middle East Ethics Review Board (LERB), governing body of the MEA Code of Promotional Practices. She has over 18 years’ experience in the healthcare industry, across a wide range of disciplines such as Pharmacy, Sales and Marketing, Skills Training and Compliance. She worked closely with management teams in Turkey, Middle East, West Asia and Africa to build a strong compliance culture and support sustainable business growth. Laura holds a Pharm.D degree from St Joseph University in Beirut, Lebanon.
MECOMED Code
Rami A. Rajab
Chairman, Mecomed Medical Technology, Association Middle East & Africa (MECOMED); Chairman, LIFE (LivaNova International Fellowship), International Corporate Social Responsibility; Former Vice President Market Access, Emerging Markets, LivaNova, Maidenhead, UK
Rami A. Rajab
Chairman, Mecomed Medical Technology, Association Middle East & Africa (MECOMED); Chairman, LIFE (LivaNova International Fellowship), International Corporate Social Responsibility; Former Vice President Market Access, Emerging Markets, LivaNova, Maidenhead, UK
Rami Rajab is the Chairman of MECOMED, the Middle East & Africa Medical Device, Diagnostics and Imaging trade association. He is Also Chairman of LIFE, LivaNova’s International Fellowship (the International Corporate Social Responsibility) Over the last 33 years Rami covered roles in Sales, Distribution Management, Team and Regional Leadership, in various geographies covering the Middle East & Africa, Europe, Latin America, South and South-East Asia and China. He was actively engaged in the Cyberonics – Sorin Group Merger then Integration leading Sorin Group’s Intercontinental Sales Team. He has a solid understanding of the markets dynamics and particularities, engaging and cooperating with various stakeholders at various levels of the Healthcare Ecosystem including governments officials on matters related to health policy, legislation, ethics and compliance and financial reimbursement.
AdvaMed Code
Christopher L. White, JD
Chief Operating Officer and General Counsel, Advanced Medical Technology Association (AdvaMed), Washington, DC, USA
Christopher L. White, JD
Chief Operating Officer and General Counsel, Advanced Medical Technology Association (AdvaMed), Washington, DC, USA
Mr. White is the Chief Operating Officer and General Counsel of Advanced Medical Technology Association (AdvaMed). Mr. White serves as the Association’s Chief Legal Officer and manages AdvaMed’s Legal Committee to develop and promote legal policy positions enhancing patient access to medical technology. Mr. White also leads the Association’s global working groups on legal policy and compliance, including over 1500 in-house medtech lawyers. He testified before state and federal legislative committees on priority legal policy issues; led the drafting team revising the AdvaMed Code; and led the multinational negotiating team to draft the Kuala Lumpur Principles, harmonizing industry Codes of Ethics in Asia. He is an Advisory Board Member to the GWU School of Medicine and Health Sciences. As Chief Operating Officer, he manages the Association’s HR, IT, Facilities, and, governance and provides counsel on contract, corporate, tax exemption, HR, and legislative and regulatory matters.
Country Codes
Heather Simmonds
Director, Prescription Medicines Code of Practice Authority, London, UK
Heather Simmonds
Director, Prescription Medicines Code of Practice Authority, London, UK
Heather Simmonds is the Director of the Prescription Medicines Code of Practice Authority (PMCPA). Heather chairs the Code of Practice Panel, which considers complaints submitted under the Code in the first instance, and is responsible for the overall running of the organisation. Heather also works with IFPMA and EFPIA in relation to their codes of practice.
Heather has a degree in pharmacology and joined the ABPI in 1984. Heather has been working full time on the Code of Practice since 1989 and has been Director of the Authority since 1997.
Heather has a degree in pharmacology and joined the ABPI in 1984. Heather has been working full time on the Code of Practice since 1989 and has been Director of the Authority since 1997.
David Andersen
Partner, Pharmaceuticals and Life Sciences, PwC, London, UK (Moderator)
Partner, Pharmaceuticals and Life Sciences, PwC, London, UK (Moderator)
David Andersen is a Partner in PwC’s Risk Practice in London, focusing on Governance, Risk and Compliance advisory for the pharmaceutical sector across Europe. He also sits on the UK Governance, Risk & Compliance leadership team as the compliance subject matter expert. David’s Governance, Risk & Compliance experience includes: Design and management of regulatory compliance improvement programs; Risk assessment and control framework design and implementation; Restructuring of global and regional governance and risk functions; designing and leading a global regulatory audit function; developing and deploying risk and control monitoring programs for both clients internal operations and their 3rd party agents.
4:15 pm
Chief Compliance Officer Roundtable
Stephen Nguyen Duc
Vice-President, Global Head of Human Resources and Ethics & Compliance, Medday Pharmaceuticals; Board Member, Strategic Committee International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France
Vice-President, Global Head of Human Resources and Ethics & Compliance, Medday Pharmaceuticals; Board Member, Strategic Committee International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France
Stephen Nguyen-Duc joined Medday in November 2018 as VP, Global Head of Ethics & Compliance. As part of his career, he has held several senior positions in Clinical Operations, Human Resources and Compliance in multinational companies. In his last position before Medday, he was the Compliance Officer for Europe and Canada at Abbvie Pharmaceuticals. Stephen is an active member of various associations promoting Trust and Integrity in Healthcare. He is Board member and Co-Chair of the Strategic Committee of Ethics, the International association of Healthcare Compliance Officers
Suzanne Durdevic, LLM
Associate General Counsel – International, Fortive | ASP; Member, Strategic Committee, International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France
Associate General Counsel – International, Fortive | ASP; Member, Strategic Committee, International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France
Dominique Laymand, Esq.
Executive Vice President, Ethics and Social Responsibility, Ipsen; President, International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France
Executive Vice President, Ethics and Social Responsibility, Ipsen; President, International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France
Dominique Laymand is Executive Vice-President, Chief Ethics and Social Responsibility Officer at Ipsen. She is a member of the Executive Leadership Team and leads the Ethics and Social Responsibility Department and Strategy, based on a Business Integrity vision.
In a former role, Dominique acted as EMEA Vice-President Compliance & Ethics at Bristol Myers Squibb.
Dominique is Honorary President of ETHICS, International Society of Healthcare Ethics and Compliance Professionals, whose mission is to be recognized as an independent international association of professionals, which sets standards of Ethics and Compliance, and shapes and influences strategies in the changing Healthcare environment for the ultimate benefit of Patients and Society at large, contributing to the development of Ethics and Compliance professionals.
Dominique is an active member of various Pharmaceutical Industry Associations and committees, and also plays a key role in various industry associations and provides ethics and compliance education.
In a former role, Dominique acted as EMEA Vice-President Compliance & Ethics at Bristol Myers Squibb.
Dominique is Honorary President of ETHICS, International Society of Healthcare Ethics and Compliance Professionals, whose mission is to be recognized as an independent international association of professionals, which sets standards of Ethics and Compliance, and shapes and influences strategies in the changing Healthcare environment for the ultimate benefit of Patients and Society at large, contributing to the development of Ethics and Compliance professionals.
Dominique is an active member of various Pharmaceutical Industry Associations and committees, and also plays a key role in various industry associations and provides ethics and compliance education.
Leonardo Silva, LLM
Global Compliance Officer, Head of Global Compliance, Ferring International Center SA; Former Head of Compliance, Acino Group; Former Compliance Director, Emerging Markets, Takeda, St. Prex, Switzerland
Global Compliance Officer, Head of Global Compliance, Ferring International Center SA; Former Head of Compliance, Acino Group; Former Compliance Director, Emerging Markets, Takeda, St. Prex, Switzerland
Mariusz Witalis
Partner, Forensic & Integrity Services, EY, Warsaw, Poland (Moderator)
Partner, Forensic & Integrity Services, EY, Warsaw, Poland (Moderator)
Mariusz Witalis is a Partner leading the EY Forensic & Integrity Services practice in Central, Eastern and South Eastern Europe & Central Asia (CESA). He is also a member of EY Forensics health sciences management team for Europe, Middle East, India & Africa (EMEIA).
Mariusz specializes in assisting medical device companies, pharmaceutical manufactures and biotechnology companies with internal and government investigations and compliance-related matters.
He has 20 years of experience working with legal counsels, internal audit and compliance functions on the matters arising under the US Foreign Corrupt Practices Act as well as a number of other country-specific anti-corruption and competition regulations. He has been advising a number of medical device, pharmaceutical and biotechnology companies on compliance-related topics in over 40 countries in EMEIA.
Mariusz is a member of the Compliance Committee at the Warsaw Stock Exchange and teaches on compliance and forensic audit at Warsaw universities.
Mariusz specializes in assisting medical device companies, pharmaceutical manufactures and biotechnology companies with internal and government investigations and compliance-related matters.
He has 20 years of experience working with legal counsels, internal audit and compliance functions on the matters arising under the US Foreign Corrupt Practices Act as well as a number of other country-specific anti-corruption and competition regulations. He has been advising a number of medical device, pharmaceutical and biotechnology companies on compliance-related topics in over 40 countries in EMEIA.
Mariusz is a member of the Compliance Committee at the Warsaw Stock Exchange and teaches on compliance and forensic audit at Warsaw universities.