international pharmaceutical compliance congress
international pharmaceutical compliance congress
international pharmaceutical compliance congress
international pharmaceutical compliance congress
international pharmaceutical compliance congress
international pharmaceutical compliance congress



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Agenda: International Pharma Congress: Day III
Wednesday, May 13, 2015

7:30 a.m. Registration Commences
MORNING PLENARY SESSION
8:30 a.m.

Welcome and Introductions

Ann Beasley
Chief Compliance Officer, Biogen Idec International, GmbH; Former Global Compliance Officer, Novartis Pharma AG; Board Member and Co-chair, Strategic Committee, 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.
8:45 a.m.

IFPMA International Codes Update

Brendan Shaw, PhD
Assistant Director General, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA); Former Chief Executive, Medicines Australia, Geneva, Switzerland

    Speaker Bio

    Brendan Shaw is Assistant Director General at the IFPMA and was appointed in 2014. Brendan assists the Director General in leading on a range of policy and representational functions particularly in innovation policy, intellectual property, trade, health technology assessment, ethics, compliance and vaccines. Prior to joining the IFPMA, Brendan was Chief Executive of the Australian pharmaceutical industry association, Medicines Australia, and before that was the senior executive at MA in charge of health policy and research. Brendan has also worked as an economist and policy advisor in government and politics, in academia and as a consultant. Brendan holds an honours degree in economics from the University of Queensland and a PhD in management, business and economics from Monash University.
    Presentation Material (Acrobat)
9:15 a.m.

Global Transparency Roundtable

Holger Diener, PhD
Managing Director, Association of Voluntary Self-Regulation for the Pharmaceutical Industry, Berlin, Germany

    Speaker Bio

    Holger (born 1976), has been Managing Director of the Association of Voluntary Self-Regulation for the Pharmaceutical Industry (Freiwillige Selbstkontrolle für die Arzneimittelindustrie e.V. -- FSA) since January 2012. He previously worked in the legal department of the German Association of Research-based Pharmaceutical Companies (Verband der forschenden Arzneimittelindustrie e.V. -- VFA). In addition to his compliance work within the association, Holger was responsible there for the introduction and further development of the FSA Code of Conduct. He also represented the member companies on compliance processes in Germany and abroad. After working initially for an international law firm, including the field of Healthcare Compliance, Holger joined the German Association of Research-based Pharmaceutical Companies (VFA) in 2006.

    From 1994-2001, Holger studied Law at the Phillips University of Marburg and, during the preparation of his dissertation, obtained a pharmaceutical law certificate in 2004 from the research center for pharmaceutical law at the University of Marburg.
George Fife
Executive Director, Fraud investigation and Dispute Services, EY, Former Executive Director, Compliance and Ethics, Bristol-Myers Squibb, Former, Compliance and Internal Audit Leader, EMEA, GE Healthcare, Paris, France

    Speaker Bio

    George Fife is an Executive Director with the Life Sciences FIDS practice of EY. He has extensive experience on the development and implementation of effective compliance programs, driving complex cross-jurisdiction investigations, anti-bribery and anti-corruption reviews, due diligence as well as compliance turn-around and remediation plans. Prior to EY, George worked at Bristol-Myers Squibb (BMS) where he oversaw the Europe, Middle-East & Africa, Russia & Turkey Compliance & Ethics program and globally the Third-Parties Compliance program. He was also a member of the BMS France and EU Markets Management Teams. George contributed with the EFPIA ComCom to the crafting and issuance of the Disclosure Code and revisions to HCP code. Prior to BMS, George worked as EMEA Compliance Manager in GE Healthcare and started is career in GE Capital Europe.
    Presentation Material (Acrobat)
Dr. Gudula Petersen
Chief Compliance Officer, Europe and Australia, Grunenthal, Aachen, Germany

    Speaker Bio

    Gudula Petersen joined Grünenthal Pharma as Director Global Compliance Management and Chief Compliance Officer Europe & Australia in January 2011. In this position, Gudula is in charge to establish and maintain a compliance program in Europe & Australia. Her special focus is on global transparency of healthcare interactions. Gudula is based in Grünenthal's headquarters in Aachen, Germany.

    Prior in joining Grünenthal, Gudula worked 18 years for Wyeth Pharmaceuticals and 6 months for Pfizer in Germany in various positions in the fields of medical and business compliance, vaccine business, medical affairs and clinical research. Gudula studied nutritional sciences in Giessen and made her thesis at the institute of atherosclerosis research in Münster.
    Presentation Material (Acrobat)
Jose F. Zamarriego Izquierdo
Director Unidad de Supervision Deontologica, FARMAINDUSTRIA, Madrid, Spain

Presentation Material (Acrobat)
Michael Bartke, PhD
Director Compliance Management, Daiichi Sankyo Europe GmbH; Co-chair, EFPIA Compliance Committee, Munich, Germany (Moderator)
10:15 a.m. Break

10:30 a.m.

Anticorruption 2.0: Thinking Strategically/Managing Risks

France Chain
Senior Legal Analyst, Anti-Corruption Division, Organization for Economic Co-operation and Development (OECD), Paris, France

    Speaker Bio

    France Chain is a senior legal analyst with the OECD Anti-Corruption Division, which she joined in 2003. Her main responsibility is supporting the Working Group on Bribery's monitoring of the OECD Anti-Bribery Convention by its 41 state parties. In particular, she has participated in evaluations of various countries including Australia, Brazil, Colombia, Turkey, South Africa and several EU members. France has also been involved in thematic reviews concerning, for instance, international cooperation or proceeds of bribery. In addition, she is responsible for liaising on anticorruption issues with the G20 Anti-Corruption Working Group and the B20, private sector and civil society organisations, as well as with other international organisations such as the World Bank and INTERPOL.
Peter Dieners, Esq.
Partner and Head, Global Healthcare and Life Sciences Group, Clifford Chance; Co-chair, Legal Affairs Focus Group (LAFG), EUCOMED; Co-chair, Compliance Network (CN), EUCOMED, Düsseldorf, Germany

    Speaker Bio

    Dr. Peter Dieners is a Partner of Clifford Chance based in DUsseldorf, Germany. He is the Regional Managing Partner for Germany and heads the Global Healthcare, Life Sciences and Chemicals industry group of Clifford Chance. Dr. Peter Dieners is specialized in healthcare related regulations, healthcare fraud and abuse prevention, compliance and healthcare-related commercial and corporate transactions. He advises leading pharmaceutical, medical device and chemical companies on all of their business-critical corporate, commercial and compliance matters including investigations and related prevention counselling. He acts for trade associations and companies vis-a-vis government agencies in relation to legislative projects and amendments as well as for the elaboration of compliance related industry codes of conduct.
Paul J. Melling, Esq.
Founding Partner, Baker & McKenzie - CIS, Limited, Moscow, Russia
Joseph B. Tompkins, Jr.
Partner, Sidley Austin LLP; Former Deputy Chief of the Fraud Section, Criminal Division, United States Department of Justice, Washington, DC, USA
Ted Acosta, Esq.
Principal and Americas Vice Chair, Risk Management, EY; Former Senior Counsel, Office of Inspector General, United States Department of Health and Human Services, New York, NY, USA and Paris, France (Moderator)

    Speaker Bio

    Ted Acosta is the EY Americas Vice Chair, Risk Management and a member of the EY Americas Operating Executive. Ted was formally the Global Leader of EY's Life Sciences Fraud Investigation & Dispute Services team.

    Mr. Acosta also serves as the Global Leader of the Life Sciences Fraud Investigation & Dispute Services team. He specializes in assisting pharmaceutical manufacturers, biotechnology and medical device companies with internal and government investigations, global compliance assessments and compliance structure development.

    Mr. Acosta assists in-house and outside counsels in fraud investigations, due diligence, compliance inquiries and litigation strategy issues. Mr. Acosta has vast experience working with legal counsels, internal audit functions, and compliance teams in matters throughout the US, Europe, Asia and Oceania under the Foreign Corrupt Practices Act (FCPA) and numerous country-specific anti-corruption and competition laws, as well as drug/device regulatory schemes.

    Prior to joining EY, Mr. Acosta was a Senior Counsel at the Office of Counsel to the Inspector General of the Office of Inspector General, U.S. Department of Health and Human Services ("OIG - HHS") in Washington, DC.

    Mr. Acosta holds a Juris Doctorate and a Masters in Health Administration degrees. Mr. Acosta works out the New York and Paris EY offices.
11:30 a.m.

Crafting the Compliance Program of the Future and the Evolution of the Roles and Responsibilities of Compliance Professionals

Ann Beasley
Chief Compliance Officer, Biogen Idec International, GmbH; Former Global Compliance Officer, Novartis Pharma AG; Board Member and Co-chair, Strategic Committee, ETHICS, Cambridge, MA, USA

    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.
Michael Bartke, PhD
Director Compliance Management, Daiichi Sankyo Europe GmbH; Co-chair, EFPIA Compliance Committee, Munich, Germany
Isaure Kergall-Gayet, DEA-Law
Compliance and Business Integrity Director, France, Global Compliance and Business Integrity Department, Sanofi; Former Vice President, Chief Ethics and Compliance Officer, Ispen, Paris, France
Dominique Laymand, Esq.
Senior Vice President, Chief Ethics and Compliance Officer, Ipsen; President, International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France

    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 Laymand reports directly to Marc de Garidel, Chairman and Chief Executive Officer. Dominique Laymand is also member of the Chairman's Committee. Dominique will be further developing the Ipsen Ethics & Compliance Program and Organization.

    In a former role, Dominique acted as Vice-President Compliance & Ethics at Bristol Myers Squibb.
Arthur Muratyan, Esq.
Secretary General, International Society of HealthCare Ethics and Compliance Professionals (ETHICS); Former Vice President, Head of Legal, Corporate and Global Compliance Officer, Sanofi, Paris, France

    Speaker Bio

    A. Muratyan is a lawyer with long-standing experience essentially in the pharmaceutical industry. Over the years, he has held various positions in corporate in-house legal departments. Retired since 2011 from Sanofi, where he was VP-Head of Legal Corporate and Global Compliance Officer, Mr. Muratyan was named in March 2013 member of Eucomed's Compliance Panel;he is also Secretary General of ETHICS (International Society of Healthcare Ethics and Compliance Professionals) and member of the Board of Directors of ICC-France (International Chamber of Commerce-France).
Roeland Van Aelst
Regional Vice President - HCCO MD&D EMEA and Canada, Office of Health Care Compliance and Privacy, Johnson & Johnson; Board Member, ETHICS; Chairman, MedTech Compliance Network, Brussels, Belgium
Marc Bartel, MBA
Master of Comparative Law, Master of Comparative Jurisprudence, Managing Partner, France, and Managing Partner EMEA, Legal and Compliance Practice, Heidrick & Struggles, London, UK and Paris, France (Moderator)

    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.
12:30 p.m. Adjournment


Go to Agenda:
EFPIA Workshop | Day 1 | Day 2





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