AGENDA: PRECONFERENCES/DAY I
MONDAY, MAY 14, 2018
8:00 am
Registration Opens
(Optional attendance; No additional cost; Included in conference registration)
PRECONFERENCE I: ETHICS Association Highlights on Current Compliance Issues
Preconference open to all. Members of ETHICS Association will introduce the Vision and Mission of the Association followed by facilitated small group discussions of current crucial compliance issues with group conclusions shared and discussed by assembled attendees.
9:00 am
Welcome, Introductions and Facilitated Discussions
Dante Beccaria
Senior Vice President, Global Compliance Officer, Head of Ethics and Business Integrity Department, Sanofi, Paris, France
Dante Beccaria is the Senior Vice-President and Global Compliance Officer at Sanofi. He has over 25 years of experience within Sanofi, having covered both operational and corporate responsibilities. In 1990, he joined the Sanofi Italian affiliate to implement a Treasury Platform, covering all the business activities in the country. In 1992, he was appointed Controlling Director of the Italian Pharma affiliate. In 1997, he moved to Paris to take global responsibilities as Pharma Controller at Sanofi Corporate, then as CFO of the OTC & Generics Division. In 2001, he became Project Director within the Mergers & Acquisitions Corporate department. In 2003, he joined Corporate Internal Audit as Associate Vice President. He was then appointed Vice President Internal Audit after the acquisition of Aventis (2004) and remained in this position until April 2012. He was appointed Global Compliance Officer in May 2012.
Sue Egan
Director and Principal Consultant, Sue Egan Associates, Great Missenden, Buckinghamshire, UK
Sue Egan has been a Compliance Officer at all levels from a single marketing company and region for GlaxoSmithKline to international VP for AstraZeneca. She has more than 30 years of practical experience in various corporate roles and is now an independent consultant.
Sue uses her insights and skills from having been a compliance officer to help her global clients to improve their personal impact and the effectiveness of their compliance programs.
Sue is a Fellow of the Chartered Management Institute and her consultancy is a member of Thames Valley Chamber of Commerce Group.
Sue uses her insights and skills from having been a compliance officer to help her global clients to improve their personal impact and the effectiveness of their compliance programs.
Sue is a Fellow of the Chartered Management Institute and her consultancy is a member of Thames Valley Chamber of Commerce Group.
Cecile Gousset
Head of Compliance Risk Assessment, Policies and Education, Global Ethics and Business Integrity, Sanofi, Paris, France
Cécile has 18 years of experience with 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.
Previously, 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.
Previously, 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, Chief Ethics and Compliance Officer, Ipsen, Paris, France
Dominique Laymand is Executive Vice-President, Chief Ethics and Compliance Officer at Ipsen. She leads the Ethics and Compliance team and program, based on a Business Integrity vision.
In a former role, Dominique acted as EMEA Vice-President Compliance & Ethics at Bristol Myers Squibb.
Dominique Laymand 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, proactively addressing Trust, Reputation and Compliance and Ethics matters. She also plays a key role in various industry associations and provides ethics and compliance education in many different arenas.
In a former role, Dominique acted as EMEA Vice-President Compliance & Ethics at Bristol Myers Squibb.
Dominique Laymand 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, proactively addressing Trust, Reputation and Compliance and Ethics matters. She also plays a key role in various industry associations and provides ethics and compliance education in many different arenas.
Stephen Nguyen Duc
Former Area Director, International Operations, Western Europe and Canada, Office of Ethics and Compliance, AbbVie, Rungis, France
Stephen 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, Office Health Care Compliance and Privacy, Johnson & Johnson, Brussels, Belgium
Roeland joined Johnson & Johnson in 1987 as a Medical Representative for Janssen Pharmaceutica. Currently, he is the Regional Vice President – HCCO MD EMEA and also fulfills the Chairman role of the MedTech Europe Ethics and Compliance Committee.
He has 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. 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 / Sciences Po- and the INSEAD training programs for Compliance professionals and is co-chairman for the International Pharmaceutical and Medical Device Compliance Congress.
He has 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. 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 / Sciences Po- and the INSEAD training programs for Compliance professionals and is co-chairman for the International Pharmaceutical and Medical Device Compliance Congress.
12:00 pm
Adjournment and Lunch on Your Own
PRECONFERENCE II: Patient Support Programs: Risk and Risk Management Best Practices
This is a deep dive workshop focusing on specific risks related to interacting with Patients and Patient Organizations through Patient Support Programme activities:
- Definitions matter – what are we talking about? What are our business colleagues talking about? Is it the same?
- What are the most common manifestations or structures of Patient Support Programmes?
- What are the risks associated with these common activities? How do these risks “show up” – especially in relation to other activities?
- What are best practices for governance and approvals of these activities?
- How do you monitor these activities?
9:00 am
Welcome and Introductions
Gary F. Giampetruzzi, JD
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head, Government Investigations, Pfizer Inc., New York, NY, USA
Gary Giampetruzzi is a partner in the Investigations and White-Collar practice in the Litigation Department at Paul Hastings, based in the firm’s New York office. Mr. Giampetruzzi routinely advises clients on day-to-day compliance matters, and represents corporations in high-profile federal and state investigations, including those involving federal and state False Claims Act (qui tam suits), State Attorney General consumer protection statutes, 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.
Prior to joining Paul Hastings, Mr. Giampetruzzi most recently served as Vice President, Assistant General Counsel and Head of Government Investigations at Pfizer Inc. He was previously a Deputy Compliance Officer responsible for international compliance investigations and programs.
Prior to joining Paul Hastings, Mr. Giampetruzzi most recently served as Vice President, Assistant General Counsel and Head of Government Investigations at Pfizer Inc. He was previously a Deputy Compliance Officer responsible for international compliance investigations and programs.
Nicolas Honhon
Head, Ethics & Compliance EMEA, UCB Pharma, Vice-Chair, Ethics & Compliance Committee, EFPIA, Brussels, Belgium
Nicolas Honhon is the Head of Ethics & Compliance EMEA at UCB. He has over 10 years of experience within healthcare compliance, having covered both operational and corporate responsibilities. With a nursing and psychology education, he has hands on healthcare experience within hospital care. Moving within the pharmaceutical industry, he started within R&D departments working for major CROs such as PPD and SynteractHCR. Transitioning into quality and audit function, he moved to Amgen prior to joining UCB Ethics & Compliance department where he was appointed Head of EMEA in 2016.
Casey J. Horton, CFE
Director, Healthcare and Life Sciences Disputes, Regulatory, Compliance and Investigations, Navigant Consulting, Chicago, IL, USA
Casey J. Horton has over fifteen years of experience leading numerous risk, compliance and operational improvement projects, both in the US and across the globe. Casey brings Navigant clients a unique perspective and understanding of the regulatory and legal challenges facing life sciences companies. His practice focuses on performing compliance assessments and investigations, reviewing and optimizing organizational processes and implementing effective and sustainable compliance solutions.
Casey is a Director in Navigant’s Global Life Sciences Regulatory & Compliance (“LS R&C”) practice. Casey’s experience includes developing and implementing global compliance programs, assisting client in the development and optimization of organizational processes, supporting clients through settlement and implementation of CIAs, preparing for Independent Review Organization (“IRO”) reviews, and providing IRO services. Prior to joining Navigant, Casey worked internally within a Top 10 pharmaceutical manufacturer’s Office of Ethics and Compliance (“OEC”) during CIA implementation and execution.
Casey is a Director in Navigant’s Global Life Sciences Regulatory & Compliance (“LS R&C”) practice. Casey’s experience includes developing and implementing global compliance programs, assisting client in the development and optimization of organizational processes, supporting clients through settlement and implementation of CIAs, preparing for Independent Review Organization (“IRO”) reviews, and providing IRO services. Prior to joining Navigant, Casey worked internally within a Top 10 pharmaceutical manufacturer’s Office of Ethics and Compliance (“OEC”) during CIA implementation and execution.
Laurence Labey, MD
Ethics and Business Integrity Business Partner for R&D and Chief Medical Officer, Sanofi, Paris, France
Max Tullberg
Chief Compliance Officer and Group Data Protection Officer, Swedish Orphan Biovitrum AB, Stockholm, Sweden
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 (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.
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.
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.
Ann’s legal and regulatory expertise includes advertising and promotion, kick-backs, anti-bribery and anti-corruption, grants and charitable contributions.
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.
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.
Ann’s legal and regulatory expertise includes advertising and promotion, kick-backs, anti-bribery and anti-corruption, grants and charitable contributions.
12:00 pm
Adjournment and Lunch on Your Own
OPENING PLENARY SESSION
1:00 pm
Welcome and International Pharma and Medical Device Compliance Congress
Jan Oliver Huber, DR JUR
General Secretary, Association of the Austrian Pharmaceutical Industry (PHARMIG), Vienna, Austria
General Secretary, Association of the Austrian Pharmaceutical Industry (PHARMIG), Vienna, Austria
Mr. Huber is the secretary general of Pharmig in Vienna. Pharmig – the Association of the Pharmaceutical Industry in Austria – is a voluntary and party-politically independent representation of interests of the pharmaceutical industry in Austria. Previously, he served the petrochemical company BP Austria in Vienna where he held a series of different leading positions with increasing responsibility in Austria as well as abroad. In 2000 Mr Huber moved to LAFARGE Zement in Oberursel in Germany. Mr. Huber is a member in different boards and committees of the international and the european pharmaceutical associations as well as Vice President of Pharmig Academy (Education Center in Pharma and Health Care) and chairman of the board of AMVO – Austrian Medicines Verification Organization.
1:15 pm
International Pharma and Medical Device Compliance Congress Vision and Overview
Dante Beccaria
Senior Vice President, Global Compliance Officer, Head of Ethics and Business Integrity Department, Sanofi, Paris, France (Co-chair)
Dante Beccaria is the Senior Vice-President and Global Compliance Officer at Sanofi. He has over 25 years of experience within Sanofi, having covered both operational and corporate responsibilities. In 1990, he joined the Sanofi Italian affiliate to implement a Treasury Platform, covering all the business activities in the country. In 1992, he was appointed Controlling Director of the Italian Pharma affiliate. In 1997, he moved to Paris to take global responsibilities as Pharma Controller at Sanofi Corporate, then as CFO of the OTC & Generics Division. In 2001, he became Project Director within the Mergers & Acquisitions Corporate department. In 2003, he joined Corporate Internal Audit as Associate Vice President. He was then appointed Vice President Internal Audit after the acquisition of Aventis (2004) and remained in this position until April 2012. He was appointed Global Compliance Officer in May 2012.
Stephen Nguyen Duc
Former Area Director, International Operations, Western Europe and Canada, Office of Ethics and Compliance, AbbVie; Board Member, Strategic Committee International Society of Healthcare, Ethics, and Compliance Professionals (ETHICS), Rungis, France (Co-chair)
Stephen 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.
Dominique Laymand, Esq.
Executive Vice President, Chief Ethics and Compliance Officer, Ipsen; Honorary President, International Society of Healthcare, Ethics and Compliance Professionals (ETHICS), Paris, France (Co-chair)
Dominique Laymand is Executive Vice-President, Chief Ethics and Compliance Officer at Ipsen. She leads the Ethics and Compliance team and program, based on a Business Integrity vision.
In a former role, Dominique acted as EMEA Vice-President Compliance & Ethics at Bristol Myers Squibb.
Dominique Laymand 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, proactively addressing Trust, Reputation and Compliance and Ethics matters. She also plays a key role in various industry associations and provides ethics and compliance education in many different arenas.
In a former role, Dominique acted as EMEA Vice-President Compliance & Ethics at Bristol Myers Squibb.
Dominique Laymand 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, proactively addressing Trust, Reputation and Compliance and Ethics matters. She also plays a key role in various industry associations and provides ethics and compliance education in many different arenas.
Roeland Van Aelst
Regional Vice President – HCCO MD&D EMEA, Office Health Care Compliance and Privacy, Johnson & Johnson; Chairman, International Society of Healthcare, Ethics and Compliance Professionals (ETHICS); Chairman, MedTech Compliance Network, Brussels, Belgium (Co-chair)
Roeland joined Johnson & Johnson in 1987 as a Medical Representative for Janssen Pharmaceutica. Currently, he is the Regional Vice President – HCCO MD EMEA and also fulfills the Chairman role of the MedTech Europe Ethics and Compliance Committee.
He has 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. 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 / Sciences Po- and the INSEAD training programs for Compliance professionals and is co-chairman for the International Pharmaceutical and Medical Device Compliance Congress.
He has 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. 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 / Sciences Po- and the INSEAD training programs for Compliance professionals and is co-chairman for the International Pharmaceutical and Medical Device Compliance Congress.
1:45 pm
European Commission Keynote
Paul Csiszár, JD
Director, DG Competition, European Commission, Brussels, Belgium
After graduating from ELTE School of Law of Budapest, Paul Csiszár studied international comparative law and earned a second Juris Doctorate at Loyola Law School in the United States. Following his admission to the Bar in 1986 in California he practiced as a corporate, securities and M&A lawyer in the US and then from 1997 in Central Europe with the international law firm of Squire Sanders until 2003 when he joined the public sector. Currently Mr Csiszár serves as Director of “Basic Industries, Manufacturing and Agriculture” at the Directorate General for Competition of the European Commission.
2:15 pm
Keynote: UK Serious Fraud Office Anti-corruption Enforcement Update
Camilla de Silva
Joint Head of Bribery and Corruption, Serious Fraud Office, London, UK
Camilla di Silva has operational responsibility for a significant number of bribery and corruption investigations involving major British and multi-national institutions in the natural resources, oil and gas, pharma and logistics sectors. She plays a key role in determining the UK’s deployment of the Deferred Prosecution Agreement (DPA) prosecutorial tool and setting strategies on engagement with corporates. Since joining SFO, Camilla has worked in leading roles across the Fraud and Bribery Divisions, including the LIBOR and Rolls Royce plc investigations and was part of the senior negotiation team who settled the landmark global DPA.
Prior to the SFO, Camilla spent her career as a trial advocate at the UK independent Criminal Bar where she prosecuted and defended for over 15 years. Camilla was awarded the Employed Barrister of the Year Award 2017, by the General Council of the Bar of England and Wales, in recognition of her exceptional work on the Rolls Royce DPA.
Prior to the SFO, Camilla spent her career as a trial advocate at the UK independent Criminal Bar where she prosecuted and defended for over 15 years. Camilla was awarded the Employed Barrister of the Year Award 2017, by the General Council of the Bar of England and Wales, in recognition of her exceptional work on the Rolls Royce DPA.
2:45 pm
US DOJ and SEC FCPA Enforcement Update
Charles Cain, JD
Chief, FCPA Unit, US Securities and Exchange Commission (SEC), Washington, DC, USA
Tarek Helou, JD
Assistant Chief, FCPA Unit, Fraud Section, Criminal Division, US Department of Justice; Former Assistant US Attorney, Northern District of California, 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 prosecutors who work with law enforcement agents to investigate and charge violations of the FCPA and related criminal laws. He was an Assistant U.S. Attorney in San Francisco from 2007 to 2012, where he 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.
Gary F. Giampetruzzi, JD
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head, Government Investigations, Pfizer Inc., New York, NY, USA (Moderator)
Gary Giampetruzzi is a partner in the Investigations and White-Collar practice in the Litigation Department at Paul Hastings, based in the firm’s New York office. Mr. Giampetruzzi routinely advises clients on day-to-day compliance matters, and represents corporations in high-profile federal and state investigations, including those involving federal and state False Claims Act (qui tam suits), State Attorney General consumer protection statutes, 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.
Prior to joining Paul Hastings, Mr. Giampetruzzi most recently served as Vice President, Assistant General Counsel and Head of Government Investigations at Pfizer Inc. He was previously a Deputy Compliance Officer responsible for international compliance investigations and programs.
Prior to joining Paul Hastings, Mr. Giampetruzzi most recently served as Vice President, Assistant General Counsel and Head of Government Investigations at Pfizer Inc. He was previously a Deputy Compliance Officer responsible for international compliance investigations and programs.
3:30 pm
Break
4:00 pm
The Ethics of Artificial Intelligence
Chris Wigley, MA
Chief Operating Officer, QuantumBlack, Partner, McKinsey & Company, Trustee, New Entrepreneurs Foundation, Former Diplomat, British Foreign Office, London, UK
Chris Wigley is Chief Operating Officer at QuantumBlack, an advanced analytics firm focused on using data, analytics and design to unlock performance improvements. His role is heavily focused on our overall performance, notably: scaling QuantumBlack’s data-driven client impact; ensuring delivery of their technology; bringing talented people in to work with them; and expanding their reach and presence internationally.
Excited by the power of technology and analytics to transform organisations from sport to heavy industry to banking to pharmaceuticals, QuantumBlack is the home of a growing number of the world’s leading data engineers, data scientists and designers who are passionate about what we do and the impact we have with clients.
Prior to his role at QuantumBlack he was a Partner at McKinsey, focused on digital strategy and growth with consumer-facing companies. Earlier in his career he founded a web-design company in the first dot com boom, worked at the New Media Strategy Unit at the BBC, and served as a diplomat for the United Kingdom in Afghanistan, Pakistan and Bosnia.
Excited by the power of technology and analytics to transform organisations from sport to heavy industry to banking to pharmaceuticals, QuantumBlack is the home of a growing number of the world’s leading data engineers, data scientists and designers who are passionate about what we do and the impact we have with clients.
Prior to his role at QuantumBlack he was a Partner at McKinsey, focused on digital strategy and growth with consumer-facing companies. Earlier in his career he founded a web-design company in the first dot com boom, worked at the New Media Strategy Unit at the BBC, and served as a diplomat for the United Kingdom in Afghanistan, Pakistan and Bosnia.
4:30 pm
Annual Global Compliance Leads Roundtable
Julie Bonhomme
EFPIA Legal & 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 behaviour within a strong and credible self-regulation framework. She also acts as internal Legal Adviser by providing legal support and assistance in ad hoc areas covered by EFPIA.
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.
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.
Karen Eryou
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. 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 polices, 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.
Tomasz Kruk
Head of Compliance, Vifor Pharma; Former Director, International Compliance, Mallinckrodt Pharmaceuticals; Former Director, Global Ethics and Compliance, Actavis plc (now Allergan), Zurich, Switzerland
Comprehensive experience as a compliance officer and lawyer in roles at the global, regional and local level in the pharmaceutical sector, medical devices, finance and consulting. Real-world compliance and anti-corruption expertise Including China, Russia, Latin America as well as Western, Central, Eastern Europe and Balkans. Thoughtful understanding of effective compliance programs and practical problem solving approach.
Evelyne Lemaire, MA
Head of Compliance, Europe and Canada, Takeda Pharmaceuticals International GmbH, Zurich, Switzerland
Evelyne Lemaire is Head of Compliance, Europe & Canada at Takeda Pharmaceuticals International GmbH. She is based in Zurich.
A graduate of Facultés Universitaires Notre-Dame de la Paix in Namur, Belgium, Evelyne has over 25 years of auditing and advisory experience, with more than 15 years dedicated to projects in the pharmaceutical, biotech and medical device industries. Most recently, Evelyne was a Director in the Global Advisory Practice at PriceWaterhouseCoopers where she led the Life Sciences Governance, Risk and Compliance Team at a regional level.
She has been in her current role at Takeda since May 1st, 2015.
A graduate of Facultés Universitaires Notre-Dame de la Paix in Namur, Belgium, Evelyne has over 25 years of auditing and advisory experience, with more than 15 years dedicated to projects in the pharmaceutical, biotech and medical device industries. Most recently, Evelyne was a Director in the Global Advisory Practice at PriceWaterhouseCoopers where she led the Life Sciences Governance, Risk and Compliance Team at a regional level.
She has been in her current role at Takeda since May 1st, 2015.
Tjerk Schlufter
Senior Vice President Compliance, Fresenius SE, Former General Counsel, Osram and Siemens Healthcare Imaging Systems, Bad Homburg, Germany
Senior Vice President Compliance, Fresenius SE, Former General Counsel, Osram and Siemens Healthcare Imaging Systems, Bad Homburg, Germany
Tjerk Schlufter is the Senior Vice President, Compliance at Fresenius SE. Previously, he was Senior Vice President Compliance at Fresenius Kabi, General Counsel with Siemens Healthcare, Imaging Division and General Counsel at OSRAM.
Mariusz Witalis
Partner, Fraud Investigation & Dispute Services, EY, Warsaw, Poland (Moderator)