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EFPIA Workshop | Day 1 | Day 2
Agenda: International Pharma Congress: Day III
Thursday, May 12, 2016
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7:30 a.m. |
Registration Commences
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CLOSING PLENARY SESSION
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8:30 a.m.
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Welcome and Introduction
Roeland Van Aelst
Regional Vice President, HCCO MD&D EMEA and Canada, Office of 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)
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8:40 a.m.
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Keynote Address
Eric Cornut, LLM, PhD
Chief Ethics, Compliance and Policy Officer, Novartis; Former Chief Commercial Officer, Novartis, Basel, Switzerland
Speaker Bio
Eric Cornut has been Chief Ethics, Compliance and Policy Officer of Novartis since August 2014. He also serves as the Chairman of Novartis Group Japan.
Previously, Mr. Cornut assumed the role of Chief Commercial Officer of Novartis Pharmaceuticals and earlier, he led Pharma Europe. Prior to that, he served as the Chief Executive Officer for Novartis Netherlands and Novartis France. Earlier in his career, Mr. Cornut played a key role in the merger of Ciba-Geigy and Sandoz.
Mr. Cornut has a Doctoral degree in Law from the University of Basel, Switzerland, and a Master of Law degree from the University of California, Berkeley, in the United States.
Presentation Material (Acrobat)
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9:10 a.m.
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Global Compliance Officer Roundtable: Key Risks for the Industry and the Future of Ethics and Compliance Programs
Dante Beccaria
Vice President Global Compliance, Sanofi, Paris Area, France
Speaker Bio
Mr. Dante Beccaria has been Global Compliance Officer and Vice President of Sanofi since April 2012. 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 1997, he moved to Paris to take global responsibilities as Pharma Controller at Sanofi Corporate, then as Chief Financial Officer of the OTC & Generics Division. 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. He holds a Degree in Economics from the University of Pavia (Italy).
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Martin Fürle, MBA
General Counsel and Chief Compliance Officer, Vice President Risk and Compliance, Daiichi Sankyo Europe GmbH, Munich, Germany
Speaker Bio
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 his current role as General Counsel and Chief Compliance Officer for Daiichi Sankyo in Europe, 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.
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Alessandra Hawthorne, Esq.
Global Chief Ethics and Compliance Officer, Boehringer Ingelheim, Ingelheim, Germany
Speaker Bio
Ali leads BI's global Ethics and Compliance program, designed to ensure that BI's business practices are conducted in compliance with all applicable laws and Company policies,,and are consistent with its high ethical standards. Ali joined BI in 2005, serving most recently as the Chief Compliance Officer for BI's US entity. Ali received her law degree from Tulane Law School (1997) and her undergraduate degree from Smith College (1994). She currently resides in the Frankfurt, Germany area with her husband and two children.
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Maureen McGirr, Esq.
Vice President, Office of Ethics, Global Compliance Organization, Merck & Co., Inc., Kenilworth, NJ
Speaker Bio
Maureen is an experienced legal and compliance leader with over two decades of pharmaceutical industry experience. She is currently Vice President within the Global Compliance Organization at Merck & Co., Inc. where she is responsible for leading the Office of Ethics, including: oversight of global compliance programs for investigations, anti-bribery and corruption, third party, policies, training and communications. Previously, Maureen held a number of positions within Merck's Office of General Counsel.
Maureen also was on international assignment based in Japan as Legal Counsel for two years.
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Uffe Kåre Rasmussen, MSc
Senior Director and Chief Compliance Officer, H. Lundbeck A/S, Copenhagen, Denmark
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Ilya Yuffa, MBA
Vice President, Global Ethics and Compliance Officer, Eli Lilly and Company, Indianapolis, IN, USA
Speaker Bio
Ilya Yuffa was named Vice President, Global Ethics and Compliance Officer at Eli Lilly Company in October, 2015.
Yuffa, originally from St Petersburg, Russia, graduated with a Bachelor of Science degree in Business from Tulane University in 1996, and received his MBA from the London Business School in the UK in 2002. He joined Lilly in June 1996.
Between 1996 and 2000, Yuffa held roles that included Corporate Financial Planning Analyst, Financial Analyst supporting the Evista Product Team and the Women's Health Business Unit, and Senior Business Development Associate. In 2002, Yuffa completed a Lilly-sponsored educational leave and received his MBA from the London Business School.
Upon his return to Lilly, Yuffa held roles that included a short-term sales representative assignment in Washington DC, and served as CFO for the Czech/Slovak affiliate based in Prague. He returned to the US as a Senior District Sales Manager in Diabetes, and went on to lead Lilly's Israeli affiliate based in Tel Aviv as General Manager. In 2011, Yuffa was promoted to Senior Sales Director leading the West Area Osteoporosis sales force and in 2014, Yuffa was promoted to Vice President of Lean Six Sigma to lead a global continuous improvement program.
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Kip Ebel, MBA
Principal, Fraud Investigation and Dispute Services, EY, New York, NY, USA (Moderator)
Speaker Bio
Kip Ebel is a partner in Ernst & Young LLP's Fraud Investigation & Dispute Services practice, where he specializes in conducting global compliance assessments, assisting in the development of compliance structures, and performing investigations in the life sciences industry. Mr. Ebel works with legal counsels, internal audit and compliance functions on global matters arising under the US Foreign Corrupt Practices Act, as well as numerous other country-specific anti-bribery/anti-corruption laws. Mr. Ebel brings an international perspective to his clients and project teams through his field experience with pharmaceutical and medical device industries in over 40 markets around the world.
Polling Question Report (Acrobat)
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10:30 a.m. |
Break
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10:45 a.m.
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Keynote: Report from a Compliance Survey Commissioned by Ethics
Marc Bartel, LLM, MBA
Managing Partner France, Partner, Legal and Board Practices, Heidrick & Struggles, Paris, France
Speaker Bio
Marc Bartel is France Managing Partner at Heidrick & Struggles and is a Partner in the London office. He is the Managing Partner of the Functional Practices in EMEA. He is also the Managing Partner of the Law Firm Practice and the EMEA leader of the Global Legal, Risk & Compliance Practice.
Marc focuses on the Legal sector both in industry and private practice. He specialises in classic Legal in-house positions and Partner searches for law firms for national and international clients within various industries covering Corporate & Regulatory Affairs (Lobbying), Risk, Tax, Audit and Compliance.
In addition, he is a board member of the Youth Business International, a Prince of Wales' charity seeking to tackle youth unemployment around the world.
Marc is fluent in French and English and has a working knowledge of German.
Presentation Material (Acrobat)
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Introduction by Stephen Nguyen-Duc
Area Director Ethics and Compliance Western Europe-Israel and Canada, AbbVie; Former Director, Ethics and Compliance Officer, Eli Lilly and Company, Paris, France (Co-chair)
Speaker Bio
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.
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11:15 a.m.
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Panel Discussion of the Survey Results
Ann Beasley
Chief Compliance Officer, Biogen; Former Global Compliance Officer, Novartis Pharma AG; Board Member and Co-chair, Strategic Committee, International Society of Healthcare, Ethics and Compliance Professionals (ETHICS), Cambridge, MA, USA (Co-chair)
Speaker Bio
Ms. Beasley is Senior Vice President and Chief Compliance Officer at Biogen. In her role, Ms. Beasley is responsible for developing, coordinating and implementing the Biogen Corporate Compliance Program. Prior to working with Biogen, Ms. Beasley led the global compliance functions for Novartis Pharma AG and Novartis Vaccines and Diagnostics. She also held legal and compliance positions with other large and mid-sized pharmaceutical and biotechnology companies, including Sepracor Inc. (now Sunovion), Boehringer Ingelheim Pharmaceuticals, Inc. and Genzyme Corporation. In the course of her practice, Ms. Beasley has provided fraud and abuse/anti-bribery legal analysis, reviewed and developed policies for interactions with healthcare professionals, implemented Compliance Program procedures; developed Codes of Conduct, and advised on U.S. and European Union privacy issues. She has lectured to a variety of groups on healthcare compliance and privacy issues as they impact bio/pharmaceutical and device companies. As well, Ms. Beasley trains various employee groups on selected life sciences compliance topics. Ms. Beasley received her B.A. from the University of Tulsa and her Juris Doctorate from Northeastern University School of Law. Ms. Beasley is admitted to the Massachusetts and U.S. Supreme Court Bar. She is a board member of ETHICS, a professional society for compliance officers operating in the healthcare industry.
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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)
Speaker Bio
Dominique Laymand is President of ETHICS, International Society of Healthcare Ethics and Compliance Professionals, whose mission is to developing and enhancing the highest professional standards in the Healthcare Sector, contributing to the development of professionals and the success of Ethics and Compliance organizations.
Dominique Laymand is Senior vice-president, Chief Ethics and Compliance Officer at Ipsen. Dominique is also member of the Chairman's Committee. Dominique will be further developing the Ipsen Ethics & Compliance Program and Organization.
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Stephen Nguyen-Duc
Area Director Ethics and Compliance Western Europe-Israel and Canada, AbbVie; Former Director, Ethics and Compliance Officer, Eli Lilly and Company, Paris, France (Co-chair)
Speaker Bio
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.
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Roeland Van Aelst
Regional Vice President, HCCO MD&D EMEA and Canada, Office of Health Care Compliance and Privacy, Johnson & Johnson; Co-chair, Strategic Committee, International Society of Healthcare, Ethics and Compliance Professionals (ETHICS); Chairman, MedTech Compliance Network, Brussels, Belgium (Co-chair)
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Olivier Chaduteau, MA
Managing and Founding Partner, Day One Board Member, Cognacs Camus; Mentor for Entrepreneurs at the IME (French Chamber of Commerce), Paris, France (Moderator)
Speaker Bio
Olivier is the managing partner of Day One, an management consulting firm specialized in strategic alignment for Professional services firms (Auditors, Lawyers, Consultants, CPAs) and Internal corporate functions (Audit, Legal, Compliance, Tax). In this role, Olivier oversees a team of professionals (based in Paris, New York, Stockholm, Casablanca).
Olivier is a Lecturer at SciencesPo Law School on Legal Project Management and at the Management Consulting Executive MBA program at Toulouse Business School, France. Among his various published works are the books "The Legal department of the Future" for Lextenso editions (March 2014).
Presentation Material (Acrobat)
Polling Question Report (Acrobat)
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12:00 p.m.
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Updates on Global Codes
IFPMA Code
Dante Beccaria
Global Compliance Officer and Vice President, Sanofi, Former Vice President of Internal Audit, Sanofi, Paris, France
Speaker Bio
Mr. Dante Beccaria has been Global Compliance Officer and Vice President of Sanofi since April 2012. 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 1997, he moved to Paris to take global responsibilities as Pharma Controller at Sanofi Corporate, then as Chief Financial Officer of the OTC & Generics Division. 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. He holds a Degree in Economics from the University of Pavia (Italy).
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EFPIA Code
Marie-Claire Pickaert
Deputy Director General, European Federation, of Pharmaceutical Industries and Associations (EFPIA), Brussels, Belgium
Speaker Bio
Current Professional Position
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.
Education
Master in Economic Science from the Vrije Universiteit te Brussel (Belgium) ? with honours
Thesis: Economic and Social Impact of Education and the Value of Human Capital ? first class honours
Continued education and specialisation ? postgraduate / executive training
* Applied Psychology in Economics (2 years)
* Auditing and Valuation of Enterprises (2 years)
* Hospital Management (1 year)
Presentation Material (Acrobat)
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EUCOMED and EMA Code
Roeland Van Aelst
Regional Vice President, HCCO MD&D EMEA and Canada, Office of 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)
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MEA Code
Laura Nassar
Head of Compliance, Middle East, Hoffmann-La Roche Ltd., Dubai, UAE
Speaker Bio
Laura Nassar is the Head of Compliance for Middle East at Hoffmann La Roche, based in Dubai. Since Feb 2016, she is appointed Chair of PhRMAG (PhRMA Gulf) Compliance and Legal Working Group.
Laura is a long-standing member of the Middle East Ethics Review Board (LERB), governing body of the MEA Code of Promotional Practices.
She has over 17 years' experience in the healthcare industry, across a wide range of disciplines such as Pharmacy, Sales and Marketing, Skills Training and Compliance.
She worked closely with management teams in Turkey, Middle East, West Asia and Africa to build a strong compliance structure and support sustainable business growth.
Laura holds a Pharm.D degree from St Joseph University in Beirut, Lebanon.
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Moderator
David Andersen
Partner, Pharmaceuticals and Life Sciences, PwC, London, UK
Speaker Bio
David is a Partner in our Risk Assurance Practice in London where he leads our team focussing on Governance, Risk and Compliance advisory and assurance services for the Healthcare Industry, including both Health service providers and the pharmaceutical sector. He also sits on the UK Governance, Risk & Compliance leadership team as the compliance subject matter expert.
David's Governance, Risk & Compliance experience includes: Design and management of regulatory compliance improvement programmes; Risk assessment and control framework design and implementation; Restructuring of global and regional governance and risk functions; designing and leading a global regulatory audit function; developing and deploying risk and control monitoring programmes for both clients internal operations and their 3rd party agents.
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1:00 p.m. |
Adjournment
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