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: EFPIA Stakeholders Workshop Programme (Registration Complimentary)
Monday, May 11, 2015


Sponsored by the European Federation of Pharmaceutical Industries and Associations (EFPIA)
EFPIA STAKEHOLDERS WORKSHOP PROGRAMME
The European Federation of Pharmaceutical Industries and Associations (EFPIA) is offering an independent EFPIA STAKEHOLDER WORKSHOP on Monday, May 11, 2015 from 10:30 am to 3 pm.
10:30 a.m.

Welcome and Introductions

Richard Bergström
Director General, European Federation of Pharmaceutical Industries and Associations (EFPIA), Former Director General, LIF Sweden, Brussels, Belgium

    Speaker Bio

    Richard Bergström has been the Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA) since April 2011. Previously he served for nine years as the Director-General of LIF, the Swedish Association of the Pharmaceutical Industry, following positions in Switzerland in regulatory affairs at the pharmaceutical companies Roche and Novartis. Mr Bergström has also been appointed by the Swedish Government to the Board of the Karolinska Institute. He is a pharmacist by training, receiving his MScPharm degree from the University of Uppsala, Sweden in 1988.
10:40 a.m.

Data Privacy - Implications of the EU Regulation on Data Privacy

Raquel Resendes
Government Affairs Manager, European Federation of Pharmaceutical Industries and Associations (EFPIA), Brussels, Belgium
11:10 a.m.

Working with Patient Organisations

Brendan Barnes
Director IP and Global Health, European Federation of Pharmaceutical Industries and Associations (EFPIA), Brussels, Belgium
Nicola Bedlington
Secretary General, European Patients' Forum (EPF), Former Director, European Disability Forum, Brussels, Belgium
11:40 a.m.

Pharmaceutical Codes of Conduct

Julie Bonhomme
Legal Affairs & Compliance Deputy Director, European Federation of Pharmaceutical Industries and Associations (EFPIA), Brussels, Belgium
Clara Zachmann
Ethics & Policy Manager, European Generic Medicines Association (EGA), Brussels, Belgium
12:10 p.m. Luncheon
1:00 p.m.

Perspectives on Disclosure Implementation

Mieke Goossens
Legal Counsel, bij pharma.be, Brussels, Belgium
Jens Steen Ravn Jensen, MSc
Senior Manager, Novo Nordisk A/S, Denmark
Krzysztof Kałużny
Project Manager, INFARMA, Warsaw, Poland
2:30 p.m.

Communicating Disclosure -- Developing the Right Culture

Andrew Powrie-Smith
Director of Communications, European Federation of Pharmaceutical Industries and Associations (EFPIA), Former Director, The Association of the British Pharmaceutical Industry (ABPI), Brussels, Belgium
3:00 p.m. Adjournment

Agenda: International Pharma Congress: Day I
Monday, May 11, 2015

DAY I OPENING PLENARY SESSION
3:30 p.m.

Welcome

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 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.
3:35 p.m.

The Gabor Danielfy Memorial Keynote Overview: International Pharma Congress Vision and Overview

Ann Beasley
Chief Compliance Officer, Biogen Idec International, GmbH; 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.
Michael Bartke, PhD
Director, Compliance Management, Daiichi Sankyo Europe GmbH; Co- chair, EFPIA Compliance Committee, Munich, Germany (Co-chair)

    Speaker Bio

    Dr. Michael Bartke
    Director Compliance Management
    Compliance Officer Daiichi Sankyo Europe

    CURRENT POSITION
    Since 2008 Daiichi Sankyo Europe GmbH (European HQ),
    Director Compliance Management & Compliance Officer,
    EFPIA member & vice chair of EFPIA Compliance Committee
    IFPMA member of CCN Code Compliance Network

    WORK EXPERIENCE
    joined Daiichi Sankyo 2001 as Head of Marketing Germany
    Daiichi Sankyo Europe GmbH 2006 (European HQ) as Director Strategic
    Marketing Cardiovascular for Europe

  • Experience 30 years within pharmaceutical industry - research based companies ICI (Astra Zeneca) and Bristol Myers Squibb
  • Worked in various functions and national/international projects in marketing, strategic planning, business development
  • Build up compliance organisation and program from scratch
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 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.
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)
4:00 p.m.

Keynote: Innovation, Ethics and Compliance

Richard Bergström
Director General, European Federation of Pharmaceutical Industries and Associations (EFPIA); Former Director General, LIF Sweden, Brussels, Belgium

    Speaker Bio

    Richard Bergström has been the Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA) since April 2011. Previously he served for nine years as the Director-General of LIF, the Swedish Association of the Pharmaceutical Industry, following positions in Switzerland in regulatory affairs at the pharmaceutical companies Roche and Novartis. Mr Bergström has also been appointed by the Swedish Government to the Board of the Karolinska Institute. He is a pharmacist by training, receiving his MScPharm degree from the University of Uppsala, Sweden in 1988.
4:30 p.m.

Transparency International Keynote Address

Robert Barrington, PhD
Executive Director, Transparency, International-UK, London, UK

    Speaker Bio

    Robert joined Transparency International UK in 2008 and was appointed as Executive Director in 2013. His areas of expertise include the Bribery Act, integrity in the private sector and corruption within the UK. Recent projects and publications include 'Anti-Bribery Due Diligence for Transactions', 'Adequate Procedures -- Guidance to the UK Bribery Act' and 'Corruption in the UK'. He was previously Director of Governance & Sustainable Investment at F&C Asset Management, and CEO (Europe) of the environmental research group Earthwatch Institute. He was a member of the Ministry of Justice's Experts Group drafting the official guidance on the Bribery Act and formerly a member of the of the UK Government's Export Guarantees Advisory Committee. He has a degree from Oxford University, where he recently held a 3-year Visiting Fellowship, and a PhD from the European University Institute.
    Presentation Material (Acrobat)
5:00 p.m.

Global Chief Compliance Officer Roundtable

Martin Fürle
Vice President, General Counsel and Chief Compliance Officer, 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 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. from Steinbeis School of International Business and Entrepreneurship.
Thomas K. Hauser, LLM
Chief Compliance Officer, Siemens Healthcare, Board Member, ETHICS, Nürnberg, Germany

    Speaker Bio

    Since beginning of 2010, Global Chief Compliance Officer of Siemens Healthcare, headquartered in Erlangen, Germany.

    Siemens Healthcare is one of the world's largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers' needs.

    In fiscal 2014, Siemens Healthcare had around 43,000 employees worldwide and posted a revenue worth 11.7 billion euros, and profits of more than 2 billion euros.

    Prior to that current mission, Thomas K. Hauser was 2,5 years Chief Compliance Officer of Siemens Building Technologies, headquartered in Zug, Switzerland and 2 years regional head of a Siemens Group in Switzerland.

    Prior to Siemens, Mr. Hauser has been engaged as Chief Operating Officer, Business- or Country Manager at international and national companies in the IT and Tele- communication market.
Evelyne Lemaire
Head of Compliance, Europe & Canada, Takeda Pharmaceuticals International GmbH, Zurich, Switzerland
Jeff Rosenbaum
Vice President, Chief Compliance Officer, Vertex Pharmaceuticals; Former Executive Director, Global Head of Ethics and Compliance, Novartis Oncology, Boston, MA, USA

    Speaker Bio

    Jeff Rosenbaum is Vertex Pharmaceuticals' Chief Compliance Officer with global responsibility for the company's compliance program. Prior to joining Vertex, Jeff was the Global Head of Ethics & Compliance at Novartis Oncology where he is responsible for developing, implementing, and monitoring organization's compliance program, globally.

    Prior to his appointment at Novartis, Jeff was a Director in PricewaterhouseCoopers' Global Pharmaceutical Advisory Practice advising pharmaceutical, biotechnology, and medical device companies around various matters of corporate governance, non-financial risk, and regulatory compliance. His global consulting work at PwC ranged from corporate compliance program development to designing and implementing effective compliance controls to rolling out and executing compliance auditing.

    Jeff began his career in the pharmaceutical industry working for Wyeth Pharmaceuticals where he worked in a number of line functions, including: product marketing, business development, and field sales.

    Jeff holds a B.A. from the University of Pennsylvania and a M.B.A. from the University of Virginia's Darden School of Business.
Kris Curry
Principal, Fraud Investigation and Dispute Services, EY; Former Vice President, Health Care Compliance, Pharmaceuticals Group, Johnson & Johnson, Philadelphia, PA, USA (Moderator)

    Speaker Bio

    Kris Curry is a Principal with Ernst & Young's Fraud Investigation & Dispute Services practice. Kris specializes in assisting health sciences companies with global risk and compliance assessments and analyses. Kris works closely with management teams and chief compliance officers to identify enforcement risks, determine potential vulnerabilities and recommend solutions from business and operational perspectives. Kris also assists clients in fraud investigations, compliance inquires and in strategizing responses to government subpoenas and other inquiries.

    Kris is a compliance and regulatory professional with more than 20 years of life science experience. Prior joining EY, Kris was the Vice President and Chief Compliance Officer for the Pharmaceutical Sector of Johnson & Johnson. As the CCO she was responsible for the development and implementation of a comprehensive global compliance program. She has first-hand experience managing and responding to government investigations, including the negotiating of settlements agreements.

    Kris brings deep, relevant experience in health care and life sciences, and she is a frequent lecturer at industry events. Her significant regulatory and compliance experience includes such diverse areas such as promotional compliance, research and development, sales and marketing practices, including off-label, fraud and abuse, government pricing and relationships with third parties.
6:15 p.m. Adjournment and Networking Reception


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