AGENDA: PRECONFERENCE/DAY I
MONDAY, MAY 15, 2017
8:00 am
Registration Opens
EFPIA PRECONFERENCE SESSION: THE PRIVILEGE OF SELF-REGULATION
The session will address the role of self-regulation against the background of applicable laws and regulations, and how global ethical principles translate into the variety of local standards, rules, and procedures in Europe. The session also will discuss the evolution of norms, often following practice, and self-regulation anticipating evolution of new approaches and practices.
9:00 am
Welcome
Marie-Claire Pickaert
Deputy Director General, EFPIA Brussels, Belgium
Ms Pickaert is the Deputy Director General of EFPIA, member of EFPIA’s General Management.
Since 2008, Ms Pickaert is coordinating EFPIA’s ethics and compliance activities. Following the adoption of the 2010 Leadership Statement calling for greater transparency, accountability and ethical behaviour within and industry framework of self-regulation, she took the lead of activities including the creation of the EFPIA e4ethics platform and the development of the EFPIA Disclosure Code. She is acting as the Chief Ethics & Compliance Officer at EFPIA.
In 2015, she was asked to take the role of Ambassador to the Medical Communities, coordinating EFPIA’s relationships with medical & scientific societies, including learned societies, also through professional communities within the pharmaceutical companies that interact with medical communities.
Since 2008, Ms Pickaert is coordinating EFPIA’s ethics and compliance activities. Following the adoption of the 2010 Leadership Statement calling for greater transparency, accountability and ethical behaviour within and industry framework of self-regulation, she took the lead of activities including the creation of the EFPIA e4ethics platform and the development of the EFPIA Disclosure Code. She is acting as the Chief Ethics & Compliance Officer at EFPIA.
In 2015, she was asked to take the role of Ambassador to the Medical Communities, coordinating EFPIA’s relationships with medical & scientific societies, including learned societies, also through professional communities within the pharmaceutical companies that interact with medical communities.
9:05 am
How Can Transparency Enhance Business Integrity?
Marie-Claire Pickaert
Deputy Director General, EFPIA, Brussels, Belgium
Ms Pickaert is the Deputy Director General of EFPIA, member of EFPIA’s General Management.
Since 2008, Ms Pickaert is coordinating EFPIA’s ethics and compliance activities. Following the adoption of the 2010 Leadership Statement calling for greater transparency, accountability and ethical behaviour within and industry framework of self-regulation, she took the lead of activities including the creation of the EFPIA e4ethics platform and the development of the EFPIA Disclosure Code. She is acting as the Chief Ethics & Compliance Officer at EFPIA.
In 2015, she was asked to take the role of Ambassador to the Medical Communities, coordinating EFPIA’s relationships with medical & scientific societies, including learned societies, also through professional communities within the pharmaceutical companies that interact with medical communities.
Since 2008, Ms Pickaert is coordinating EFPIA’s ethics and compliance activities. Following the adoption of the 2010 Leadership Statement calling for greater transparency, accountability and ethical behaviour within and industry framework of self-regulation, she took the lead of activities including the creation of the EFPIA e4ethics platform and the development of the EFPIA Disclosure Code. She is acting as the Chief Ethics & Compliance Officer at EFPIA.
In 2015, she was asked to take the role of Ambassador to the Medical Communities, coordinating EFPIA’s relationships with medical & scientific societies, including learned societies, also through professional communities within the pharmaceutical companies that interact with medical communities.
Q& A
Eveline Loriaux
Eveline Loriaux
LORIOT Consulting, Naarden, The Netherlands
9:30 am
Case Study: Events Supported by Pharma Companies
Jose F. Zamarriego Izquierdo, PhD
Chair, EFPIA Codes Committee; Director Unidad de Supervision Deontologica, Farmainidustria, Madrid, Spain
Mr. José F. Zamarriego is Director of Farmaindustria’s Code of Practice Surveillance Unit, Chair of the Codes Committee and Vice-Chair of EFPIA’s Compliance Committee, Member of EFPIA’s Steering Committee and Coordinator of the EFPIA e4ethics Initiative. He is also Chairman of IFPMA’s Code Complaint Procedure Adjudication Group and Member of the Code Compliance Network (CNN). He has participated in several modifications of the EFPIA, IFPMA and Farmaindustria Codes.
Previously he was standing professor in Universidad Europea de Madrid (UEM), and Dean of the Faculty of Economics and Business Administration and of Executive Director of the UEM General Foundation. These positions were held alongside that of General Secretary and General Director of the Spanish Generic Pharmaceutical Manufacturers Association (AESEG).
He is the author of publications and articles on the Spanish self-regulation system, the Code Surveillance Unit and the Code of Good Practices for the Promotion of Medicines and Interaction with Healthcare Professionals, marketing and generic medicines.
Previously he was standing professor in Universidad Europea de Madrid (UEM), and Dean of the Faculty of Economics and Business Administration and of Executive Director of the UEM General Foundation. These positions were held alongside that of General Secretary and General Director of the Spanish Generic Pharmaceutical Manufacturers Association (AESEG).
He is the author of publications and articles on the Spanish self-regulation system, the Code Surveillance Unit and the Code of Good Practices for the Promotion of Medicines and Interaction with Healthcare Professionals, marketing and generic medicines.
Versina Bregu
e4ethics Project Manager, EFPIA, Brussels, Belgium
10:10 am
Case Study: Addressing Reputational Damage Resulting from Activities that are not Supported by Pharma Companies
Marie-Claire Pickaert
Deputy Director General, EFPIA, Brussels, Belgium
Ms Pickaert is the Deputy Director General of EFPIA, member of EFPIA’s General Management.
Since 2008, Ms Pickaert is coordinating EFPIA’s ethics and compliance activities. Following the adoption of the 2010 Leadership Statement calling for greater transparency, accountability and ethical behaviour within and industry framework of self-regulation, she took the lead of activities including the creation of the EFPIA e4ethics platform and the development of the EFPIA Disclosure Code. She is acting as the Chief Ethics & Compliance Officer at EFPIA.
In 2015, she was asked to take the role of Ambassador to the Medical Communities, coordinating EFPIA’s relationships with medical & scientific societies, including learned societies, also through professional communities within the pharmaceutical companies that interact with medical communities.
Since 2008, Ms Pickaert is coordinating EFPIA’s ethics and compliance activities. Following the adoption of the 2010 Leadership Statement calling for greater transparency, accountability and ethical behaviour within and industry framework of self-regulation, she took the lead of activities including the creation of the EFPIA e4ethics platform and the development of the EFPIA Disclosure Code. She is acting as the Chief Ethics & Compliance Officer at EFPIA.
In 2015, she was asked to take the role of Ambassador to the Medical Communities, coordinating EFPIA’s relationships with medical & scientific societies, including learned societies, also through professional communities within the pharmaceutical companies that interact with medical communities.
10:30 am
Case Study: Collaborations with Patient Organisations
Holger Diener
Vice-Chair, EFPIA Codes Committee; Managing Director, Association of Voluntary Self-Regulation for the Pharmaceutical Industry; Vice-Chair, Ethics and Business Integrity Committee (eBIC), International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Berlin, Germany
11:10 am
Transparency is an Asset
Heather Simmonds
Vice-Chair, EFPIA Codes Committee; 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.
11:50 am
Concluding Remarks
12:00 pm
Adjournment
OPENING PLENARY SESSION
1:00 pm
Welcome to Lisbon from APIFARMA
Heitor Costa
Executive Director, Portuguese Association of the Pharmaceutical Industry (APIFARMA), Lisbon, Portugal
Executive Director, Portuguese Association of the Pharmaceutical Industry (APIFARMA), Lisbon, Portugal
Heitor Costa is APIFARMA’s Executive Director and EFPIA European Markets Committee member. As APIFARMA’s representative he belongs to the medicines evaluation commission of the Portuguese national authority (INFARMED). Previously, he was EFPIA Economic and Social Policy Committee member, EFPIA Executive Committee member. He was Executive Secretary of the Medicines Evaluation Commission, and coordinator of the Health Products Surveillance Unit, Director of Health Products Evaluation, President of the in vitro Diagnostic Medical Devices Evaluation Committee and Director of Medicines and Health Products, with the coordination of the Community Affairs, Medicines for Human Use, Veterinary Medicines and Medical Devices Departments. He was the Chairman of the Coordinating Group on Market Surveillance of Medical Devices of the Competent Authorities in Medical Devices (European Commission). He joined the Medinfar Group as Medical Director, and coordinated the Medical, Regulatory Affairs and R&D departments. He was also Institutional Relations and Communication Director including Market Access Department for Sanofi-Aventis.
1:10 pm
Congress Co-Chair Welcome and Overview
Dante Beccaria
Senior Vice President, Global Head of Ethics and Business Integrity, Sanofi, Paris, France (Co-chair)
Mr. Dante Beccaria is the Global Compliance Officer and Senior Vice President of Sanofi. Mr. Beccaria began his career in 1985 in the field of Financing & Treasury and bank relationships first at Shell Italy and then Alcatel Italy. He has over 20 years’ experience within Sanofi, having covered both operational and Corporate responsibilities. In 1990, he joined the Sanofi Italian affiliate to implement a Treasury Platform, gathering all the Business activities in the country. Since 1992, he served as Controlling Director of the Italian Pharma affiliate. In 2001, he became Projects Director within the Mergers & Acquisitions Corporate department. In 2003, he joined the Corporate Internal Audit as Associate Vice President. He served as Vice President of Internal Audit after the acquisition of Aventis.
Dominique Laymand, Esq.
Senior Vice President, Chief Ethics and Compliance Officer, Ipsen; President, International Society of Healthcare, Ethics and Compliance Professionals (ETHICS), Paris, France (Co-chair)
Dominique Laymand is Senior Vice-President, Chief Ethics and Compliance Officer at Ipsen in charge of leading the strategy, maintenance and monitoring of the Global Compliance & Ethics program, based on an integrated risk mitigation approach and on strong Business Integrity Standards.
Dominique Laymand reports directly to David Meek, Chief Executive Officer.
In a former role Dominique acted as Vice-President Ethics & Compliance of Bristol Myers Squibb, setting up and managing the Ethics & Compliance Europe, Middle East, Africa, Turkey and Russia program.
Dominique Laymand also chairs the Compliance Committee of the European Federation of Pharmaceutical Industry and Associations (EFPIA).
Dominique Laymand is the President of ETHICS, which is an association which members are International Ethics and Compliance Professionals, in the Healthcare sector.
Dominique Laymand reports directly to David Meek, Chief Executive Officer.
In a former role Dominique acted as Vice-President Ethics & Compliance of Bristol Myers Squibb, setting up and managing the Ethics & Compliance Europe, Middle East, Africa, Turkey and Russia program.
Dominique Laymand also chairs the Compliance Committee of the European Federation of Pharmaceutical Industry and Associations (EFPIA).
Dominique Laymand is the President of ETHICS, which is an association which members are International Ethics and Compliance Professionals, in the Healthcare sector.
Stephen Nguyen-Duc
Former Area Director Ethics & Compliance Western, Europe-Israel and Canada, AbbVie; Former Director, Ethics & Compliance Officer, Eli Lilly and Company, Paris, France (Co-chair)
Stephen Nguyen Duc is currently Director for Ethics & Compliance Operations in Western Europe, Canada & Israel for Abbvie Pharmaceuticals. He also covered for a period of time Ethics & Compliance operations for Eastern Europe, Middle East & Africa.
Prior to joining Abbvie, he was Ethics & Compliance Director at Eli Lilly in France.
He also previously held multiple roles in Human Resources, Sales training, Six Sigma and Clinical research in different companies including Bayer and Glaxo SmithKline in France, Belgium and Turkey.
Stephen is currently member of the Compliance Steering Group of EFPIA and Steering member of Ethics (international Society of Healthcare Ethics & Compliance professionals).
Stephen is graduated from the Pharmacy School of Paris with a major in industrial pharmacy and pharmacology and from the YMP of INSEAD Business School.
Prior to joining Abbvie, he was Ethics & Compliance Director at Eli Lilly in France.
He also previously held multiple roles in Human Resources, Sales training, Six Sigma and Clinical research in different companies including Bayer and Glaxo SmithKline in France, Belgium and Turkey.
Stephen is currently member of the Compliance Steering Group of EFPIA and Steering member of Ethics (international Society of Healthcare Ethics & Compliance professionals).
Stephen is graduated from the Pharmacy School of Paris with a major in industrial pharmacy and pharmacology and from the YMP of INSEAD Business School.
Roeland Van Aelst
Regional Vice President – HCCO MD&D EMEA & Canada, Office Health Care Compliance and Privacy, Johnson & Johnson; Board Member, International Society of Healthcare, Ethics and Compliance Professionals (ETHICS), Chairman, MedTech Compliance Network, Brussels, Belgium (Co-chair)
Roeland Van Aelst joined Johnson & Johnson in 1987 as a Medical Representative for Janssen Pharmaceutica. He held various positions of increasing responsibility in both sales and marketing and joined the Corporate Office of Health Care Compliance in May 2005 for the EMEA region with extension to Asia, Latin-America and Canada in 2008. In 2010 Roeland became responsible for EMEA & Canada cross sector. Since October 2012 he is the Regional Vice President – HCCO MD EMEA. Today he also fulfills the Chairman role of the MedTech Europe Ethics and Compliance Committee. He is a member of the board and a founding member of ETHICS, an association for Compliance professionals in the Health Care industry. Roeland is an active contributor to the Seton Hall/ Sience Poand the INSEAD training programs for Compliance professionals and is co-chairman for the International Pharmaceutical and Medical Device Compliance Congress.
1:30 pm
Keynote Speech from INFARMED (Portugal National Authority on Medicines and Health Products)
Rui Santos Ivo
Vice president, INFARMED (Portugal National Authority on Medicines and Health Products), Member of the Management Board, European Medicines Agency (EMA), Lisbon, Portugal
Rui Santos Ivo is currently Vice-President of INFARMED – National Authority of Medicines and Health Products, I.P., since January 2016. Member of the Management Board of the EMA since March 2016. He is also a member of the Executive Board of EUnetHTA- the European Network for Health Technology Assessment, since 2016. In addition, he is an Invited Assistant Professor of Medicines Regulation, at the University of Lisbon Faculty of Pharmacy, where he is a member of the School Council. He is an external elected member of the General Council of the University of Coimbra, since 2017.
2:00 pm
Chief Compliance Officer Roundtable: Key Risks for the Industry and the Future of Ethics and Compliance Programs
Dante Beccaria
Senior Vice President, Global Head of Ethics and Business Integrity, Sanofi, Paris, France
Mr. Dante Beccaria is the Global Compliance Officer and Senior Vice President of Sanofi. Mr. Beccaria began his career in 1985 in the field of Financing & Treasury and bank relationships first at Shell Italy and then Alcatel Italy. He has over 20 years’ experience within Sanofi, having covered both operational and Corporate responsibilities. In 1990, he joined the Sanofi Italian affiliate to implement a Treasury Platform, gathering all the Business activities in the country. Since 1992, he served as Controlling Director of the Italian Pharma affiliate. In 2001, he became Projects Director within the Mergers & Acquisitions Corporate department. In 2003, he joined the Corporate Internal Audit as Associate Vice President. He served as Vice President of Internal Audit after the acquisition of Aventis.
Sujata Dayal, JD
Vice President, Health Care Compliance and Privacy, Global Chief Compliance Officer, Pharmaceuticals, Johnson and Johnson; Former Chief Compliance Officer and Corporate Vice President, Biomet, Inc.; Former Ethics and Compliance Officer, Abbott Laboratories, Titusville, NJ, USA
Sujata Dayal is the Chief Compliance Officer for a 3 billion dollar global medical device company. Responsible for development, implementation and oversight of global compliance program with a focus on healthcare compliance and anti-corruption, Attorney with general corporate transactional and FDA regulatory experience. Experienced in setting up global compliance programs, including conducting risk-assessments, policy and procedure writing, training, monitoring and promotional review. Areas of expertise include health care compliance, FCPA and regulatory law.
Specialties: Compliance Programs, Anti-corruption, Contracts, Regulatory Law, Promotional Review, Fraud and Abuse, Privacy
Specialties: Compliance Programs, Anti-corruption, Contracts, Regulatory Law, Promotional Review, Fraud and Abuse, Privacy
Dominique Laymand, Esq.
Senior Vice President, Chief Ethics and Compliance Officer, Ipsen; President, International Society of Healthcare, Ethics and Compliance Professionals (ETHICS), Paris, France
Dominique Laymand is Senior Vice-President, Chief Ethics and Compliance Officer at Ipsen in charge of leading the strategy, maintenance and monitoring of the Global Compliance & Ethics program, based on an integrated risk mitigation approach and on strong Business Integrity Standards.
Dominique Laymand reports directly to David Meek, Chief Executive Officer.
In a former role Dominique acted as Vice-President Ethics & Compliance of Bristol Myers Squibb, setting up and managing the Ethics & Compliance Europe, Middle East, Africa, Turkey and Russia program.
Dominique Laymand also chairs the Compliance Committee of the European Federation of Pharmaceutical Industry and Associations (EFPIA).
Dominique Laymand is the President of ETHICS, which is an association which members are International Ethics and Compliance Professionals, in the Healthcare sector.
Dominique Laymand reports directly to David Meek, Chief Executive Officer.
In a former role Dominique acted as Vice-President Ethics & Compliance of Bristol Myers Squibb, setting up and managing the Ethics & Compliance Europe, Middle East, Africa, Turkey and Russia program.
Dominique Laymand also chairs the Compliance Committee of the European Federation of Pharmaceutical Industry and Associations (EFPIA).
Dominique Laymand is the President of ETHICS, which is an association which members are International Ethics and Compliance Professionals, in the Healthcare sector.
Lori V. Queisser, CPA
Senior Vice President and Global Compliance Officer, Teva Pharmaceuticals, Philadelphia, PA, USA
Lori Queisser joined Teva Pharmaceuticals in June of 2015 in the key role of Senior Vice President and Global Chief Compliance Officer. She reports directly to the CEO. In this role, Lori is responsible for leading the organization’s compliance efforts globally, and setting the strategy for the implementation of compliance programs across the business. She will also engage the organization in promoting a culture of compliance, based on our values and Code of Conduct. Lori brings significant, diverse, global experience in the Compliance and Pharmaceutical industry to the Teva team. She has held senior roles in Eli Lilly and Schering Plough before consulting in the field as both President/ Owner of Queisser and Associates and as a Principal at KPMG. Most recently, she was employed at DePuy Synthes, a Johnson and Johnson Company, as their Healthcare Compliance Officer.
Uffe Kåre Rasmussen, M.Sc.
Senior Director and Chief Compliance Officer, H. Lundbeck A/S; Former Principal Scientist, Novo Nordisk A/S, Copenhagen, Denmark
Uffe Kåre Rasmussen, M.Sc
Chief Compliance Officer at Lundbeck. Since 2009, responsible for the global development of Lundbeck’s Compliance Structure, including governance, Code of Conduct and related global procedures and processes. Leading Lundbeck’s Sustainability Strategy and related projects, including Lundbeck’s commitment to the UN Global Compact Principles. More than 15 years of leadership experience in the pharmaceutical industry within the fields of compliance & sustainability, strategy development and implementation, project management, communication and auditing.
Chief Compliance Officer at Lundbeck. Since 2009, responsible for the global development of Lundbeck’s Compliance Structure, including governance, Code of Conduct and related global procedures and processes. Leading Lundbeck’s Sustainability Strategy and related projects, including Lundbeck’s commitment to the UN Global Compact Principles. More than 15 years of leadership experience in the pharmaceutical industry within the fields of compliance & sustainability, strategy development and implementation, project management, communication and auditing.
Mariusz Witalis
Partner, Fraud Investigation & Dispute Services, EY, Warsaw, Poland (Moderator)
Mariusz Witalis is a Partner coordinating the EY Fraud Investigation & Dispute Services (FIDS) activities in Central and Eastern Europe. He is also a member of EY FIDS life 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 frequent speaker at international conferences and seminars devoted to compliance and fraud management and an author of numerous articles on compliance and business fraud. He has a Diploma of Polish Statutory Auditor, Certified Internal Auditor and is a Certified Fraud Examiner.
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 frequent speaker at international conferences and seminars devoted to compliance and fraud management and an author of numerous articles on compliance and business fraud. He has a Diploma of Polish Statutory Auditor, Certified Internal Auditor and is a Certified Fraud Examiner.
3:00 pm
US Department of Justice and US Securities and Exchange Commission Update on FCPA Enforcement
Tarek Helou, Esq.
Assistant Chief, FCPA Unit, Fraud Section, Criminal Division, US Department of Justice, Washington, DC, USA
Tarek Helou is an Assistant Chief in the U.S. Department of Justice’s Foreign Corrupt Practices Act Unit. He has worked in the FCPA Unit since 2012. As an Assistant Chief, Tarek supervises other attorneys who work with law enforcement agents to prosecute and investigate violations of the FCPA and related criminal laws. He was an Assistant U.S. Attorney in San Francisco from 2007 to 2012, where he investigated and prosecuted cases involving drug trafficking, firearms offenses, racketeering, money laundering, tax violations, child exploitation, fraud, and immigration offenses. From 2001 to 2007, Tarek was an associate at Orrick, Herrington, and Sutcliffe in Silicon Valley and San Francisco. He graduated from Johns Hopkins University and New York University School of Law.
Charles Cain, Esq.
Deputy Chief, FCPA Unit, US Securities and Exchange Commission, Washington, DC
Charles Cain is the Deputy Chief of the Foreign Corrupt Practices Act Unit within the Securities and Exchange Commission’s Division of Enforcement. He has been in the SEC’s FCPA Unit since its formation and with the Division of Enforcement for seventeen years. As the Deputy Chief, his roles include oversight of the National FPCA program, coordination with the DOJ and FBI, and supervision of individual investigations. During his tenure with the SEC, he has been responsible for numerous significant FCPA matters, as well as cases across a broad range of other areas including financial fraud, insider trading, offering fraud, market manipulation, disclosure fraud, and broker dealer practices.
Gary F. Giampetruzzi, Esq.
Partner, Paul Hastings, Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc., New York, NY, USA (Moderator)
Gary Giampetruzzi is a Global Vice-Chair of the Investigations and White Collar Department in the Litigation Department, as well as the Life Sciences Department at Paul Hastings, based in the firm’s New York office. Mr. Giampetruzzi routinely advises clients on day-to-day compliance matters and global compliance transactional due diligence, and represents corporations in high-profile federal and state investigations, including those involving federal and state False Claims Act (qui tam suits), the Foreign Corrupt Practices Act (“FCPA”), and oversees other complex civil and criminal litigation matters. While his practice cuts across numerous sectors, Mr. Giampetruzzi possesses particularly deep experience in the life sciences sector, representing many of the world’s most prominent biotech, pharmaceutical, and medical device companies.
3:45 pm
Networking Break
AFTERNOON MINI SUMMITS GROUP I: 4:15 pm — 5:30 pm
MS 1: Transparency: Now that We Have the Data, How Can We Leverage It to Improve Compliance?
4:15 pm
Introductions, Discussion and Q&A
Anna Byrom, LLM
Associate Director, Compliance EUCA, Intercept Pharmaceuticals; Former Associate Director, Astellas Pharma Europe, London, UK
Anna Byrom joined Intercept as Associate Director, Compliance last year. She is responsible for Compliance for the EUCA region (Europe, Canada and Australasia). Prior to joining Intercept Anna was the Legal lead on a 2 year EFPIA Disclosure Project at Astellas Pharma Europe Ltd delivering disclosure reports across the EMEA Region. Anna has over 10 years pharmaceutical industry experience and has implemented various European and Global process and system projects. Anna has a BSc degree in Biomedicine and LLM Masters in Law.
Filipa Godinho
Business Consultant, Global Transparency, Eli Lilly and Company, Lisbon, Portugal
Filipa Godinho has 23 years of pharmaceutical industry experience and is currently serving as Senior Business Consultant, Global Transparency at Eli Lilly and Company. For the past five years, she has concentrated on ensuring Lilly’s readiness for the EFPIA HCP/HCO Disclosure Code for 16 member countries and being the European Process Owner for all member countries regarding the EFPIA Patient Organisations Code. Previous experiences at Lilly include Sales, Marketing, Medical, Compliance & Anti-Corruption.
Filipa Godinho earned a Bachelor’s of Marketing Management at the Portuguese Institute of Marketing Management and a Certificate on Healthcare Compliance Ethics & Regulation Program by Seton Hall Law/SciencesPo.
Filipa Godinho earned a Bachelor’s of Marketing Management at the Portuguese Institute of Marketing Management and a Certificate on Healthcare Compliance Ethics & Regulation Program by Seton Hall Law/SciencesPo.
Ima Parrondo
Health Care Compliance Officer EMEA-C, Janssen Pharmaceutical Companies of Johnson & Johnson, Madrid, Spain
Dr. Ima Parrondo is the head of the EMEA Health Care Compliance organization for Janssen, Pharmaceutical company of Johnson and Johnson, since 2008.
Before joining Compliance, she served as Area Medical Director for Europe South in Janssen, and previously had Marketing and Sales responsibilities, in national and international roles.
She currently leads the HCPs/HCOs Disclosure of Transfer of Value project within Janssen.
She is an active member of the Efpia Ethics and Compliance Committee and currently leads the Working Group on “Interactions between industry and all the stakeholders: collaborative approach in deepening ethical standards and improvement of the governance”.
She served on the Efpia Compliance Committee Steering Group and led the Working Group on Medical Education who prepared the Efpia Position Paper on Medical Education and collaborated with the Biomed Alliance in the development of their Code.
Before joining Compliance, she served as Area Medical Director for Europe South in Janssen, and previously had Marketing and Sales responsibilities, in national and international roles.
She currently leads the HCPs/HCOs Disclosure of Transfer of Value project within Janssen.
She is an active member of the Efpia Ethics and Compliance Committee and currently leads the Working Group on “Interactions between industry and all the stakeholders: collaborative approach in deepening ethical standards and improvement of the governance”.
She served on the Efpia Compliance Committee Steering Group and led the Working Group on Medical Education who prepared the Efpia Position Paper on Medical Education and collaborated with the Biomed Alliance in the development of their Code.
Fabien Roy, DESS
Senior Associate, Hogan Lovells; Member, EFGCP-MedTech Europe Working Party, Brussels, Belgium
Fabien Roy’s practice focuses on European Union (EU) and national regulatory matters involving pharmaceutical, and medical device laws and guidelines. He has developed close contact with relevant government authorities in these sectors.
Fabien focuses particularly on the different stages of the medical device CE marking process. He advises on a wide variety of topics which include the following: determination of the appropriate classification of individual products; clinical investigation procedure (e.g. authorisation from the EU Member States competent authorities, opinion from Ethics Committee, amendment to the Protocol, informed consent, serious adverse event qualification and notification, handling of personal data); drafting of clinical investigation and clinical trial agreements, distribution agreements and contract manufacturing agreements; clinical evaluation; conformity assessment procedure; review of Instruction For Use, products’ labelling and promotional material including websites; post-marketing surveillance activities including the notification of adverse event, product recall or product withdrawal; reimbursement.
Fabien focuses particularly on the different stages of the medical device CE marking process. He advises on a wide variety of topics which include the following: determination of the appropriate classification of individual products; clinical investigation procedure (e.g. authorisation from the EU Member States competent authorities, opinion from Ethics Committee, amendment to the Protocol, informed consent, serious adverse event qualification and notification, handling of personal data); drafting of clinical investigation and clinical trial agreements, distribution agreements and contract manufacturing agreements; clinical evaluation; conformity assessment procedure; review of Instruction For Use, products’ labelling and promotional material including websites; post-marketing surveillance activities including the notification of adverse event, product recall or product withdrawal; reimbursement.
George Fife
Partner, Fraud Investigation & Dispute Services, EY; Former Executive Director, Compliance & Ethics, Bristol-Myers Squibb, Paris, France (Moderator)
George Fife is a Partner at EY, Corporate Integrity & Investigation Services. George specializes in assisting companies with global risk and compliance assessments and investigations. George works closely with management teams, chief compliance officers, general counsels and chief audit executives to identify enforcement risks, determine potential vulnerabilities and recommend solutions from business and operational perspectives to prevent, detect and respond to compliance risks. He has first-hand international experience in building, managing and assessing effectiveness of compliance programs, in the area of anti-corruption and anti-bribery, anti-trust and competition, Off-label and disguised promotion, Pharmaceutical and Medical Device Self-regulation and codes. Prior EY, George worked at Bristol-Myers Squibb where he served as EMEA Executive Director Compliance & Ethics and globally anticorruption and third-parties. Prior to BMS, George worked at GE Healthcare in a regional EMEA Compliance and Third-Parties Manager role as well as at GE Capital, starting as an FMP and working on several new acquisitions integration.
MS 2: Annual MEA Compliance Roundtable
4:15 pm
Introductions, Discussion and Q&A
Rifat Bozacioglu
Area Compliance Director, Middle East, GlaxoSmithKline plc, Istanbul, Turkey
Rifat Bozacioglu is Director, Ethics & Compliance for ME markets in GSK Pharmaceuticals. In this role, he oversees the company’s Corporate Compliance Program and Internal Control Framework, is responsible to partner with ME business leaders for implementing global policies and supporting projects to help ensure legal, ethical, and proper conduct . He led several projects related to the company’s new ways of working with Healthcare Professional/Organizations and Third Parties at the area level. He is also part of the extended area level Risk Management and Compliance Board team, and charged with review and approval of various scientific and promotional activities as well as management of ethics and compliance related matters incl. employee related matters for his markets. He joined GSK in 2012 as Associate Director, MENACIS Pharmaceuticals. Prior to joining GSK, Mr. Bozacioglu worked at PwC and KPMG, where he was a Senior Manager for Forensic Services.
Laura Nassar
Head of Compliance, Middle East, Roche Pharmaceuticals, Dubai, United Arab Emirates
Laura Nassar is the Head of Compliance for Middle East at Hoffmann La Roche, based in Dubai. She has over 17 years’ experience in the healthcare industry in MEA region, across a wide range of disciplines such as Pharmacy, Sales and Marketing, Skills Training and Compliance. Laura is a long-standing member of the Middle East Ethics Review Board (LERB), governing body of the MEA Code of Promotional Practices and Chair of PhRMAG Compliance and Legal Working Group.
Dream Samir
Consultant, AMICULUM-ME, Secretary General, Pharmaceutical Research and Manufacturers Association, Gulf (PhRMAG), Dubai, United Arab Emirates
Maged Zaki, MD
Health Care Compliance Officer; Europe, Middle East and Africa, Johnson and Johnson Global R&D, Dubai, United Arab Emirates
Maged Zaki has a diverse experience working as a Healthcare Professional and as a Pharmaceutical Industry Professional for more than 23 years through his different roles and responsibilities including Sales & Marketing, Medical Affairs, Medical Compliance & Healthcare Compliance at Johnson & Johnson. Maged is a certified Ethics & Compliance Professional- International by SCCE. Within his current role as HCC Officer for EMEA R&D, he provides support to different R&D activities & intiatives planned & executed across different Therapeutic Areas including regional EMEA Clinical Trials, Infectious Diseases & Vaccines, Janssen Prevention Center, Neuroscience, etc. Through his career at J&J, he could successfully develop Compliance Programs in partnership with Leadership Teams to embed compliance principles into day-to-day business practices and could identify & mitigate risks associated with different business models by development of effective management action plans.
Joe Henein, Pharm.D.
President and Chief Executive Officer, NewBridge Pharmaceuticals FZ LLC, Dubai, United Arab Emirates (Moderator)
Joe Henein is a senior executive with an accomplished career extending over 30 years in the pharmaceutical industry, and covering many geographies including; USA (Global), Europe, and the Middle East/Africa. Joe joined NewBridge as President and CEO- a specialty pharma positioned to be first-in-class licensing only platform for innovative therapeutics, and to bridge the access gap by bringing innovation and technology from West to East. Prior to that Joe worked in Corporate Pharma, mostly Wyeth Pharmaceuticals which ended up in Pfizer, after which he immediately joined NewBridge. Joe served in various Wyeth executive committees during his tenure as; Global Development Council, Global Development Strategy Board, and European Operation Council. On the industry level, he also served as the Vice Chair for the PhRMA MEA Committee and the Chair for the PhRMA MEA Ethics Review Board. Joe often speaks in many Pharma Conferences including International Market Access and International Compliance Forums.
MS 3: Health Economics and Outcomes Research (HEOR)—Emerging Risks of Data Collection, Use, and Secondary Use
4:15 pm
Introductions, Discussion and Q&A
Peter W.L. Bogaert, MA, LJ
Partner, Covington & Burling LLP, Brussels, Belgium
Peter Bogaert is managing partner of the Brussels office of Covington & Burling, and has a broad European life sciences practice. He has detailed regulatory expertise under EC and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the European Courts in Luxembourg and in local litigation in Belgium. Mr. Bogaert’s practice covers pharmaceuticals, biotechnology, medical devices, special foods and feed, cosmetics and other consumer products and he represents numerous innovative life sciences companies, including start-ups, as well as several industry associations. Chambers Global notes that a client said “He is an extremely experienced professional with broad expertise and provides sensible and well-balanced solutions.” He is consistently ranked by PLC as one of the leading life sciences lawyers globally and Legal 500 EMEA and Chambers Europe note Mr. Bogaert’s prominent regulatory pharmaceutical and environmental practice.
Bella Rafael Hovhannisyan
Compliance Director, Intercontinental Commercial Operations, CSL Behring, Former Compliance and Ethics Lead, Spain, Portugal, and Nordic Region, Bristol-Myers Squibb, Bern, Switzerland
Prior to joining CSL Behring as Compliance Director Intercontinental Commercial Operations, Bella worked for almost 10 year at Bristol-Myers Squibb based in Spain and dedicated last 5 years of her professional career to specializing in Compliance. Her previous roles included compliance responsibility for various European Union countries, Russia and Turkey. Prior to working in the pharmaceutical industry, Bella had worked for companies in the United Arab Emirates and in Spain. Bella is active in several compliance associations, including participation as a speaker at compliance conferences. Bella has also successfully completed advanced programs in compliance sponsored by renowned institutions, such as Fontainebleu INSEAD in France. Bella graduated from the Yerevan State University in Armenia with a linguistics degree. She is fluent in Armenian, Russian, English, Spanish and French. She is married and currently based in Bern, Switzerland.
Pascale Paimbault
Executive Director, EMEA Ethics and Compliance, ABAC, Astellas Pharma Europe; Former Compliance Officer, France -Benelux, Biogen, Treasurer and Strategic Committee Member, ETHICS; Former Chief Compliance Officer EMEA, Wright Medical Inc.; Former Senior Director, Compliance and Ethics, Business Program, EMEA, Bristol-Myers Squibb, Paris, France
Pascale Paimbault is, Executive Director EMEA , Compliance & Ethics of Astellas Pharma Europe. In her role she defines, implements, improves the EMEA Compliance Program, across a variety of EMEA Countries and regions, and various business models. She is the former France -Benelux Compliance Officer of Biogen, US Biotechnology Company ( Boston, MA). Previously, Pascale Paimbault led the creation and implementation of the EMEA compliance department of Wright Medical Inc. Pascale worked for France-based Bristol-Myers Squibb (BMS) as internal audit manager and participated or lead the creation and development of new organizations, such as Global Strategic Sourcing Europe and Worldwide Clinical Resource Management in Princeton, NJ. She served as internal control EMEA and created the METRA Regional Financial group in the Middle East, Turkey, Russia, and Africa. More recently, Mrs Paimbault led major divestitures and strategic projects in the Middle East and Europe, as senior director, Strategic Projects, and she participated in the EMEA Compliance and Ethics group’s development.
Ken Walsh, MA, MSc
Director, Life Sciences Consulting, Navigant, London, UK
Ken Walsh recently joined Navigant as a Director from Evidera where he was a Senior Principal and head of their London based global market access consulting practice., He spent 5 years in industry with GlaxoSmithkline as a Pricing Director and at Sandoz Biosimilars & Oncology Injectibles where he led GPMA.
Ken is active speaker at industry market access conferences and has given numerous public policy presentations to governments across Europe, US and in Japan
Prior to moving to industry, Ken worked in Global PMA strategy consulting while working in the USA for 8 years with firms including Bridgehead (now part of GfK), Kantar Health and Cambridge Pharma (now part of IMS Health). He has also worked in regulatory affairs consulting specializing in biologics approvals in DC and worked at GlaxoSmithKline in their Neurology and G.I Center for Excellence for Drug Development in the United Kingdom
Ken is active speaker at industry market access conferences and has given numerous public policy presentations to governments across Europe, US and in Japan
Prior to moving to industry, Ken worked in Global PMA strategy consulting while working in the USA for 8 years with firms including Bridgehead (now part of GfK), Kantar Health and Cambridge Pharma (now part of IMS Health). He has also worked in regulatory affairs consulting specializing in biologics approvals in DC and worked at GlaxoSmithKline in their Neurology and G.I Center for Excellence for Drug Development in the United Kingdom
Ann Beasley, JD
Director, Healthcare and Life Sciences Disputes, Compliance and Investigations, Navigant Consulting; Former Chief Compliance Officer, Biogen; Former Global Compliance Officer, Novartis, Boston, MA, USA (Moderator)
Ann Beasley is a Director at Navigant Consulting, Inc., in the Healthcare and Life Sciences Disputes, Regulatory, Compliance and Investigations practice. She has over 17 years of in-house healthcare and life sciences experience for companies in pharmaceutical, biologics, vaccine, device and genetic testing.
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.
She has built and managed local and global corporate compliance programs and initiated specific projects including performing complex investigations, building investigation protocols, Codes of Conduct and other structural elements of a Corporate Compliance Program. These elements include risk assessments, policy development, training and communications, and developing robust monitoring plans and requisite data analytics and feedback to management. She also has extensive experience in implementation of business processes and controls and overall program assessment.
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.
She has built and managed local and global corporate compliance programs and initiated specific projects including performing complex investigations, building investigation protocols, Codes of Conduct and other structural elements of a Corporate Compliance Program. These elements include risk assessments, policy development, training and communications, and developing robust monitoring plans and requisite data analytics and feedback to management. She also has extensive experience in implementation of business processes and controls and overall program assessment.
MS 4: Evolving Privacy Requirements: Preparing for the General Data Protection Regulation
4:15 pm
Introductions, Discussion and Q&A
Martin Fuerle, MBA
General Counsel and Chief Compliance Officer, Vice President Risk & Compliance, Daiichi Sankyo Europe GmbH, Munich, Germany
Prior to joining Daiichi Sankyo Europe and starting his career in the pharmaceutical industry in 2007 Martin has been working as legal practitioner and legal in-house counsel for Amadeus in Germany advising around various legal matters and a focus on contracting in the IT/Travel Industry. In his current role as General Counsel and Chief Compliance Officer for Daiichi Sankyo in the EMEA region, Martin holds responsibility for the areas of Legal Affairs, Intellectual Property, Internal Audit & Risk Management as well as Compliance including the implementation of the company’s European Compliance Program. Martin holds a German law degree from the University of Munich and a M.B.A. in General Management from Steinbeis School of International Business and Entrepreneurship.
William Long, LLB
Partner, Sidley Austin LLP, London, UK
William Long heads up the European Data Protection Practice at the international law firm of Sidley Austin LLP. William advises international clients on a wide variety of data protection, information security and life sciences regulatory matters. William has experience with EU and data protection, projects working with some of the world’s largest pharmaceutical companies. William is a regular speaker on data protection and life science matters and is an author of a recent book on the EU General Data Protection Regulation (GDPR). William is also on the editorial board of the publication Digital Health Legal.
William is listed in the 2017 edition of Best Lawyers for Privacy and Data Protection and is on the DataGuidance panel of data protection lawyers. William has been a member of the International Association of Privacy Professionals (IAPP) European Board and is a co-founder of the Social Media Governance Forum, a networking group of companies involved in social media.
William is listed in the 2017 edition of Best Lawyers for Privacy and Data Protection and is on the DataGuidance panel of data protection lawyers. William has been a member of the International Association of Privacy Professionals (IAPP) European Board and is a co-founder of the Social Media Governance Forum, a networking group of companies involved in social media.
Audrey Mills, JD
Sr. Director Ethics and Compliance and Chief Privacy Officer, Eli Lilly and Company, Indianapolis, IN, USA (Moderator)
Audrey Mills is the Sr. Director Ethics and Compliance and Chief Privacy Officer for Eli Lilly & Company. An attorney by training with 5 years’ litigation experience in a private firm, Audrey started her career with Lilly in 2003 as a Sales Representative in the United States. After 5 years in Sales, Audrey joined Lilly’s Global Ethics and Compliance function. In her eight plus years with Lilly’s E&C team, Audrey has supported various international affiliates and corporate-based functions. She also has led several global Ethics and Compliance-related initiatives, including Lilly’s recent Global Policy Simplification Project — a project that streamlined both Lilly’s Ethics and Compliance-related policies and procedures, as well as its code of conduct. Named as Lilly’s CPO in 2016, Audrey now is responsible for overseeing Lilly’s Global Privacy Program.
MS 5: Managing Medical Device Anti-Corruption Risks
4:15 pm
Introductions, Discussion and Q&A
Anne-Sophie Bricca
Deputy General Counsel, Senior Director Law and Compliance, EMEA, Terumo BCT, Brussels, Belgium
Anne-Sophie Bricca is Deputy General Counsel at Terumo BCT, a global leader in blood components and cellular technologies, member of the Terumo group. With her team, she provides legal and compliance support to Terumo BCT sales entities in EMEA. She is a member of Terumo BCT Executive Leadership Team. She represents Terumo at MedTech Europe (the European association of the medical devices and diagnostic industry) and since January 2016, she assumes the Vice-Chair of the Compliance Group and seat at the Code Committee. Since October 2016, she is also member of the Strategic Committee of ETHICS (International Society of Healthcare Ethics and Compliance).
Before joining Terumo BCT in 2009, Anne-Sophie Bricca worked as in-house counsel for the IT industry with HP and CPG International, Ingram Micro. She also worked as a general counsel for Franco Dragone Entertainment Group for the design and making of the Macao show “The House of Dancing Water”.
Before joining Terumo BCT in 2009, Anne-Sophie Bricca worked as in-house counsel for the IT industry with HP and CPG International, Ingram Micro. She also worked as a general counsel for Franco Dragone Entertainment Group for the design and making of the Macao show “The House of Dancing Water”.
Ariadna Quesada, MPP
Compliance Manager Europe, Middle-East and Africa, MicroPort Orthopedics Inc., Amsterdam, Netherlands
Ariadna L. Quesada is the Compliance Director for DaVita International region.
Ariadna has a bachelor degree in economics and a master degree in Public Policies from Torcuato Di Tella University in Argentina. She is a Certified Fraud Examiner (CFE) and has attended the Healthcare Compliance Certification Program from Seton Hall University School of Law.
Before joining DaVita, Ariadna worked for MicroPort Orthopethis and Royal Dutch Shell in South America and in Europe in different positions in finance, controls and compliance.
Ariadna was born in Buenos Aires, Argentina where she studied and started her professional career before moving to Europe.
Ariadna has a bachelor degree in economics and a master degree in Public Policies from Torcuato Di Tella University in Argentina. She is a Certified Fraud Examiner (CFE) and has attended the Healthcare Compliance Certification Program from Seton Hall University School of Law.
Before joining DaVita, Ariadna worked for MicroPort Orthopethis and Royal Dutch Shell in South America and in Europe in different positions in finance, controls and compliance.
Ariadna was born in Buenos Aires, Argentina where she studied and started her professional career before moving to Europe.
Michele Tagliaferri, Esq.
Partner, Sidley Austin LLP, Brussels, Belgium
Michele Tagliaferri leads the investigations and compliance team in Sidley’s Brussels office. He represents corporate and individual clients in white collar criminal matters, enforcement actions and litigation. He also has significant experience conducting internal investigations and advising clients in international enforcement matters, including matters arising under the FCPA and other anti-bribery legislations.
He also has experience with EU data privacy and cross-border discovery and counsels clients on how to effectively manage data privacy risks, particularly in EU-U.S. cross-border investigations.
A lawyer licensed to practice law in New York, Washington, D.C., Italy and Belgium, Michele speaks widely on topics related to anti-bribery compliance and enforcement, cross-border investigations, and EU data privacy.
He features prominently in The Legal 500 EMEA 2016 and International Who’s Who of Investigations Lawyers 2016. Prior to joining the Brussels office, Michele practiced in Sidley’s Washington, D.C. office.
He also has experience with EU data privacy and cross-border discovery and counsels clients on how to effectively manage data privacy risks, particularly in EU-U.S. cross-border investigations.
A lawyer licensed to practice law in New York, Washington, D.C., Italy and Belgium, Michele speaks widely on topics related to anti-bribery compliance and enforcement, cross-border investigations, and EU data privacy.
He features prominently in The Legal 500 EMEA 2016 and International Who’s Who of Investigations Lawyers 2016. Prior to joining the Brussels office, Michele practiced in Sidley’s Washington, D.C. office.
Andy Bender, MS, MBA
President and Founder, Polaris, New York, NY, USA (Moderator)
Andy Bender is Polaris’ founder. As a hands-on executive, Andy has been involved in a wide variety of compliance-related engagements for pharmaceutical and device manufacturers, ranging from policy development and process automation to organizational change. His expertise ranges from the sales and marketing to medical and clinical departments of the client organization. Andy is still involved in many of Polaris’ client assignments, and has personally led many FMV, auditing and monitoring projects, as well as numerous international transparency reporting and HCP/O implementations.
Andy has designed and developed many of the concepts, programs and methodologies that have made Polaris an international leader in the healthcare law compliance business. Polaris employs over eighty consultants and sixty-five technologists, including five healthcare law attorneys. Polaris has offices in Amsterdam, Boston, Hong Kong, New Brunswick, New York, Paris and San Francisco.
Previously, Andy worked for McKinsey, the Boston Consulting Group, Merck-Medco.
Andy has designed and developed many of the concepts, programs and methodologies that have made Polaris an international leader in the healthcare law compliance business. Polaris employs over eighty consultants and sixty-five technologists, including five healthcare law attorneys. Polaris has offices in Amsterdam, Boston, Hong Kong, New Brunswick, New York, Paris and San Francisco.
Previously, Andy worked for McKinsey, the Boston Consulting Group, Merck-Medco.
5:30 pm
Adjournment and Networking Reception