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: MEA Compliance Roundtable
Monday, May 5, 2014


Sponsored by International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and Pharmaceutical Research and Manufacturers Association, Gulf (PhRMAG)

No cost; Registration required.
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MEA COMPLIANCE ROUNDTABLE
8:45 a.m.

Welcome and Introductions

Dr. Yacoub Haddad
Chair, Pharmaceutical Research and Manufacturers Association, Gulf (PhRMAG); Government Affairs Director MEAP Region, Abbvie, Dubai, UAE (Co-moderator)
Tamara Music
Manager, Influenza Vaccines and Code Compliance, IFPMA, Geneva, Switzerland (Co-moderator)

    Speaker Bio

    Tamara Music joined the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) in 2007 and is a Manager leading the Influenza Vaccines Supply (IVS) International Task Force as well as the transparency and ethics initiatives which include the IFPMA Code of Practice and the Code Compliance Network (CCN). Previously, Tamara has also worked on global health policy topics related to healthcare systems and market access. Tamara received her B.A. in Political Science from University of California, Berkeley, her Masters in International Affairs from the Graduate Institute in Geneva, and Certificate of Advanced Studies (CAS) in Pharmaceutical Economics and Policy from University of Lausanne, School of Business (HEC).
9:00 a.m.

Opening Presentation and Overview of UAE National Code and Government Enforcement of Ethical Promotional Practices

Dr. Amin Al Amiri
Assistant Undersecretary, Medical Practice and Licenses, Ministry of Health, UAE, Dubai, UAE
9:30 a.m.

Compliance Case Study: Saudi Arabia, the First ME A Country to Launch a National Code, and the Biggest ME A Market

Abdulrahman Al Sultan
Executive Director of Communication and Awareness, Saudi Food & Drug Authority, Riyadh, Saudi Arabia
10:15 a.m.

Our Ethical Business Practices: IFPM A Code and MEA Code Highlights (Video)

Tamara Music
Manager, Influenza Vaccines and Code Compliance, IFPMA, Geneva, Switzerland

    Speaker Bio

    Tamara Music joined the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) in 2007 and is a Manager leading the Influenza Vaccines Supply (IVS) International Task Force as well as the transparency and ethics initiatives which include the IFPMA Code of Practice and the Code Compliance Network (CCN). Previously, Tamara has also worked on global health policy topics related to healthcare systems and market access. Tamara received her B.A. in Political Science from University of California, Berkeley, her Masters in International Affairs from the Graduate Institute in Geneva, and Certificate of Advanced Studies (CAS) in Pharmaceutical Economics and Policy from University of Lausanne, School of Business (HEC).
    Presentation Material (Acrobat)
11:00 a.m.

Private/Public Partnership Best Practice: UK ABPI Code

Heather Simmonds
Director and Chair, Code of Practice Panel, Prescription Medicines Code of Practice Authority, London, UK

    Speaker Bio

    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.
11:20 a.m. Open Discussion
12:00 p.m. Adjournment and Lunch on Your Own

Agenda: International Pharma Congress: Day I
Monday, May 5, 2014

DAY I OPENING PLENARY SESSION -- NEW BUSINESS MODELS DRIVING NEW ETHICS AND COMPLIANCE CHALLENGES
1:00 p.m.

Introduction

Ann Beasley Bacon
Senior Vice President and Chief Compliance Officer, Biogen Idec; 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 Idec. In her role, Ms. Beasley is responsible for developing, coordinating and implementing the Biogen Idec Corporate Compliance Program. Prior to working with Biogen Idec, 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., 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.
Roeland Van Aelst
Vice President, Health Care Compliance, Medical Devices and Diagnostics, EMEA-C, HCC&P, Johnson & Johnson; Board Member and Co-chair, Strategic Committee, International Society of Healthcare, Ethics and Compliance Professionals (ethics); Chairman, EUCOMED Compliance Network, Brussels, Belgium (Co-chair)

    Speaker Bio

    Roeland 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 WWOHCC&P 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. Regional Vice President - HCCO MD&D EMEA & Canada is his current position since October 2012. Currently he also fulfills the Chairman role of the EUCOMED compliance network and is a member of the board and a founding member of ETHICS.
1:05 p.m.

Welcome

Nabil Daoud, MA
Vice President and Area Director, TMEA-CIS, Eli Lilly; Chair, MEA Regional Ethics Group (LERB), Dubai, United Arab Emirates

    Speaker Bio

    Nabil Daoud was named V.P and Area Director for Turkey, the Middle East, Africa, Russia and the CIS in 2012. He is managing an area covering 70 countries, with very diversified healthcare systems, market potentials, market structures, policies and regulations as well as cultures.

    Native of Lebanon, Daoud has been a Lilly employee since 1994 when he joined the company as pricing analyst in Switzerland. He then held several sales and marketing positions in the United States before becoming country manager for Lilly in Colombia in 1999. In 2004, he relocated to the Middle East region to manage Lilly Egypt and then the MENA region, before assuming his current role.

    Nabil received his bachelor's degree in economics and finance from Paris Dauphine University and completed his post graduate studies in Business and Management at the HEC School of Management in Paris.

    Nabil has been chairing the Ethics Review board (LERB) for PhRMA Middle East Africa since 2009.
1:10 p.m. International Pharma Congress Vision and Overview: New Business Models and New Compliance Challenges

Changing Business Models:
  • Context:
    • Rising Costs
    • Decline of Blockbuster Model
    • Rise of Specialty Care/Biologics
  • Industry Trends:
    • Consolidation
    • Patent Cliff
    • Mature Markets
    • Growth of Emerging Markets
    • Diversification into Diagnostics and Devices, Generics and Consumer Health
    • More Partnerships, Collaborations, and Licensing Agreements
  • Old Model Centered on Company/HCP Relationship
  • New Model in US; ACA; Increased Governmental Funding and Negotiations with Insurers
  • New Model Globally; Negotiation with Government
  • Emerging of Comparative Effectiveness Research
New Ethics and Compliance Issues Arise around:
  • Market Access; Affordability; Infrastructure and Knowledge in Emerging Markets; Limiting Health Care Systems
  • Managing Third Party Relationships; Increased Risk; Less Transparency
  • Pricing and Reimbursement; Conditional upon Post Marketing Confirmation of Effectiveness
  • Tendering
  • R&D; Clinical Trials; Publications
  • Medical Education
  • New National Anticorruption Initiatives
  • Proliferation of Transparency Initiatives
  • The Role of Compliance Codes
Overview
Brian Riewerts
Principal, Global Governance, Risk and Compliance Leader, Pharmaceutical and Life Sciences Advisory, PwC, Baltimore, MD, USA

    Speaker Bio

    Brian Riewerts is the Principal, Global Governances Risk and Compliance Leader in PwC's Pharmaceutical and Life Sciences Advisory Practice and has global responsibility for our Life Sciences governance, risk management, and compliance practice. With over eighteen years of experience, Brian focuses his practice in the areas of compliance and enterprise-wide risk management program strategy and design, compliance auditing and monitoring, and CIA/IRO negotiation and implementation support. Brian is a frequent speaker and author on regulatory and compliance issues related to the pharmaceutical, bio-technology, and medical device industries.
Commentary
Ann Beasley Bacon
Senior Vice President and Chief Compliance Officer, Biogen Idec; 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 Idec. In her role, Ms. Beasley is responsible for developing, coordinating and implementing the Biogen Idec Corporate Compliance Program. Prior to working with Biogen Idec, 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., 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.
Dr. Michael Bartke
Director, Compliance Management, DAIICHI SANKYO EUROPE GmbH; Co-chair, EFPIA Compliance Workgroup, Munich, Germany (Co-chair)

    Speaker Bio

    Dr. Bartke has about 30 years experience within pharmaceutical industry. He worked for research based companies ICI ( Zeneca), Bristol Myers Squibb in various positions, Marketing and Business Development. He also has experience in various national and international projects.

    In 2001 he joined Daiichi Sankyo as Head of Marketing Germany, 2006 passed to European Headquarter Daiichi Sankyo Europe, Director Strategic Marketing and Business Development (Cardiovascular drugs)

    Since 2008 Director Compliance Management - experience in various areas of Compliance and risk management. Activity in associations e.g. VfA/FSA (Germany) and EFPIA, Belgium (Co-Chair Compliance Committee)
Dominique Laymand
Vice President, Compliance and Ethics EMEA, (Europe, Middle-East, Africa, Russia and Turkey), Bristol-Myers Squibb; President, International Society of Healthcare, Ethics and Compliance Professionals (ethics), Paris, France (Co-chair)

    Speaker Bio

    Dominique Laymand is Vice-President Compliance & Ethics EMEA (Europe, Middle East, Turkey, Russia and Africa). In this role, Dominique is responsible for maintaining, monitoring and controlling the Compliance & Ethics program based on an integrated approach of risks in terms of prevention, detection and control. She works closely with the EMEA Business leadership teams to establish policy oversight and governance via an efficient and effective Compliance & Ethics Program. She has a particular focus on Business Practices and is a member of operational committees as well as the Bristol-Myers Squibb Corporate Compliance Council and Anti-Bribery Committee.

    Dominique has a broad experience at Bristol-Myers Squibb, having started with the company in 1983 as Legal Counsel.

    Dominique is an active member of various Pharmaceutical Industry Associations and committees, proactively addressing Trust, Reputation and Compliance matters. She is the President of ETHICS Association; President of the Compliance Committee at the European Federation of Pharmaceutical Industries and Associations (EFPIA) and at the Compliance Committee at the LEEM (French Pharmaceutical Industry Association).
Roeland Van Aelst
Vice President, Health Care Compliance, Medical Devices and Diagnostics, EMEA-C, HCC&P, Johnson & Johnson; Board Member and Co-chair, Strategic Committee, International Society of Healthcare, Ethics and Compliance Professionals (ethics); Chairman, EUCOMED Compliance Network, Brussels, Belgium (Co-chair)

    Speaker Bio

    Roeland 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 WWOHCC&P 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. Regional Vice President - HCCO MD&D EMEA & Canada is his current position since October 2012. Currently he also fulfills the Chairman role of the EUCOMED compliance network and is a member of the board and a founding member of ETHICS.
1:45 p.m.

Gabor Danielfy Memorial Keynote Address

Jane Griffiths, PhD
Company Group Chairman Janssen, Europe, Middle East and Africa (EMEA), Janssen-Cilag Ltd., EMEA; Chairman, EFPIA Executive Committee; Chairman, PhRMA Europe Committee, Buckinghamshire, UK

    Speaker Bio

    Completing her PhD in Biochemistry at the University of Aberystwyth, UK in 1982, Jane Griffiths has worked her way up the Johnson & Johnson career ladder, starting as a sales representative. The straight-talking Brit is now the first female Company Group Chairman of Janssen in EMEA, the pharmaceutical division of the Johnson & Johnson family. She is responsible for this business across the entire region.

    As a senior female executive, Jane acknowledges the tension between family and work. She is a sponsor for the Women's Leadership Initiative in Janssen and a Senior Advisory Board member of the EMEA Healthcare Businesswomen's Association (HBA). Other industry roles include Chairwoman of the EFPIA Executive Committee and member of the EFPIA Board.
    Presentation Material (Acrobat)
2:15 p.m.

MEA Compliance Best Practices Overview
(For greater detail please attend related Mini Summit II.)

Nabil Daoud, MA
Vice President and Area Director, TMEA-CIS, Eli Lilly; Chair, MEA Regional Ethics Group (LERB), Dubai, United Arab Emirates

    Speaker Bio

    Nabil Daoud was named V.P and Area Director for Turkey, the Middle East, Africa, Russia and the CIS in 2012. He is managing an area covering 70 countries, with very diversified healthcare systems, market potentials, market structures, policies and regulations as well as cultures.

    Native of Lebanon, Daoud has been a Lilly employee since 1994 when he joined the company as pricing analyst in Switzerland. He then held several sales and marketing positions in the United States before becoming country manager for Lilly in Colombia in 1999. In 2004, he relocated to the Middle East region to manage Lilly Egypt and then the MENA region, before assuming his current role.

    Nabil received his bachelor's degree in economics and finance from Paris Dauphine University and completed his post graduate studies in Business and Management at the HEC School of Management in Paris.

    Nabil has been chairing the Ethics Review board (LERB) for PhRMA Middle East Africa since 2009.
2:45 p.m.

India Compliance Best Practices Overview
(For greater detail please attend related Mini Summit VII.)

Parichay Mittal
Director - Compliance, South Asia, Compliance & Business Integrity Department, Sanofi, Member, Working Group on Ethics and Compliance, Organization of Pharmaceutical Producers of India (OPPI), Mumbai, India

    Speaker Bio

    Parichay Mittal is Compliance Director, Sanofi South Asia operations. Parichay is responsible to ensure the development, implementation and the maintenance of an effective regional compliance program aligned with the corporate compliance program.

    Parichay is a Chartered Accountant from The Institute of Chartered Accountants of India and holds an MBA degree from Herriot Watt University, United Kingdom. He has more than 12 years of forensic and anti-corruption compliance experience. Before joining Sanofi he was working with Deloitte India and PricewaterhouseCoopers in their Forensic Services Department. He assisted multinational companies in development & implementation of compliance program and conducting compliance investigations.
    Presentation Material (Acrobat)
3:15 p.m. Break
3:45 p.m. Global Transparency Regulatory Update Roundtable
(For greater detail please attend related Mini Summit V.)

EFPIA and EU Updates
EFPIA Code Update with Brief Reports on Austria, Belgium, Switzerland and Turkey
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 Bergstrom 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.
    Presentation Material (Acrobat)
Denmark
Carsten Blaesberg
Chief Consultant, LIF Denmark, The Danish Association of the Pharmaceutical Industry, Copenhagen, Denmark

    Speaker Bio

    Carsten Blaesberg is Chief Consultant in the Association of the Pharmaceutical Industry (Lif) in Denmark. He is responsible for strategic communication, partnership and image. For many years he has played an important role in the implementation process of the association's strategic focus on strengthening the sector's image via compliance, self-regulation and transparency - and by making the pharmaceutical industry an active and trustworthy partner in connection with collaborations with authorities, healthcare professionals, patient associations and other key stakeholders.
    Presentation Material (Acrobat)
France
Julie Bonhomme, Esq.
Legal and Compliance Manager, Legal and Compliance Department, LEEM, Paris, France

    Speaker Bio

    Julie Bonhomme has been the legal & compliance manager at Leem (the French Association for Pharmaceutical Companies in France) since 2007. Previously, she was a member of the Paris Bar, working for a major international law firm in Paris, France.

    She specializes in pharmaceutical law (regulatory subjects), transparency issues, relationships between pharmaceutical stakeholders and companies and EU competition law.
Ingrid Callies, LLM, PhD
Permanent Secretary of the CODEEM (the ethics committee of the pharmaceutical industry) French Code Authority, Leem, Paris, France

    Speaker Bio

    Ingrid Callies is a lawyer, member of the New York Bar, as well as an ethicist with a PhD in bioethics, and the coordinator of the ethics committee of the pharmaceutical industry in France (the Codeem). Ingrid is an expert in ethics of research on human beings, health law, pharmaceutical law and compliance. Director of the first French course dedicated to Research on Human Beings and Applied Ethics in France (Institut Pasteur/Universite Paris Descartes), Ingrid is still a member of the Institut Pasteur's Institutional Review Board (IRB) that she chaired for four years."
    Presentation Material (Acrobat)
Germany
Holger Diener, PhD
Managing Director, Association of Voluntary Self-Regulation for the Pharmaceutical Industry (Freiwillige Selbstkontrolle für die Arzneimittelindustrie e. V.), Berlin, Germany

    Speaker Bio

    Holger (born 1976), has been Managing Director of the Association of Voluntary Self-Regulation for the Pharmaceutical Industry (Freiwillige Selbstkontrolle fur 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.
    Presentation Material (Acrobat)
Spain
Jose F. Zamarriego Izquierdo
Director, Unidad de Supervision Deontologica, FARMAINDUSTRIA, Madrid, Spain

    Speaker Bio

    Jose Zamarriego has been the Director of the Code of Practice Surveillance Unit of the National Association of the Pharmaceutical Industry in Spain (Farmaindustria) since the establishment of this Compliance Control Body in 2004. Together with his team he oversees implementation and compliance with the self-regulation system of the pharmaceutical industry, adapting and anticipating to the growing demands of a society in constant evolution. At a European level, Jose is Chair of the EFPIA (European Federation of Pharmaceutical Industries and Associations) Code Compliance Committee and Vice-Chair of the Compliance Committee. He is also Chairman of the IFPMA (International Federation of Pharmaceutical Manufacturers & Associations) Code Complaint Procedure Adjudication Group. He has actively participated in several modifications of national, European and worldwide codes of practice for the pharmaceutical industry. Jose completed his PhD. on Economics & Business Studies in the Universidad Complutense de Madrid, expanding his education with an MBA on Business Administration by the University of Wales and a General Management Program by the IESE Business School. Before joining the innovative pharma association, he was General Secretary and General Director of the Spanish Generic Pharmaceutical Manufacturers Association (AESEG). Jose also has a background as an educator in the Universidad Europea de Madrid (UEM), where he was Dean of the Faculty of Economics and Business Administration and Executive Director of the UEM General Foundation.
    Presentation Material (Acrobat)
United Kingdom
Heather Simmonds
Director, Prescription Medicines Code of Practice Authority, London, UK

    Speaker Bio

    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.
    Presentation Material (Acrobat)
Moderator
Diva Duong
Vice President Compliance EMEA, Cegedim Relationship Management, Paris, France

    Speaker Bio

    Diva has over fourteen years of consulting and auditing experience related to financial and corporate compliance issues in the life sciences industry. He has conducted many compliance reviews, risk assessments and audits for large and mid-sized pharmaceutical, biotechnology and medical device companies with compliance issues related to sales, marketing and medical affairs.

    Presently as Vice President Compliance EMEA/APAC at Cegedim, Diva is responsible for all compliance activities addressing local and regional transparency regulations requirements (e.g. EFPIA, US sunshine Act, French Transparency Law).

    Prior to joining Cegedim, Diva worked for Polaris, a management consulting firm based in New York. He was a leader in the compliance and auditing practice, performing analyses of policies, processes and systems.
5:30 p.m.

Communicating with Health Care Professionals regarding Participation in Transparency Programs

Michel Ballieu
Chief Executive Officer, European CanCer Organisation, Brussels, Belgium

    Speaker Bio

    As a Chief Executive Officer he joined ECCO -- the European CanCer Organisation in 2006, overseeing a team of 26 professionals in scientific educational programmes, in congress management, in communication, and in policy and regulators awareness campaigns.

    As a volunteer he serves as a Board member of the European Cervical Cancer Association (ECCA), as a Board member of the ecancermedicalscience Foundation (ecms), and as Past-President of the Association's Conferences Forum (AC Forum).
Isabel Bardinet
Chief Executive Officer, European Society of Cardiology, Sophia Antipolis, France

    Speaker Bio

    Isabel Bardinet joined the meetings industry in 1988 when she entered SOCFI, a French PCO company. Here, until 2002, she organized national, international and governmental congresses and presented many international bids and learnt association management.

    In 2002 she joined the Palais des Congrès de Paris as Executive Sales Director and actively participated in the creation and development of the "Leading Venues of Paris".

    In 2005, she joined the European Society of Cardiology (ESC) to become the Congress Division Director. The ESC organizes over nine congresses a year, including the largest medical congress in Europe and biggest cardiovascular disease congress in the world with over 30 000 participants.

    In October 2009 Isabel was appointed Chief Executive Officer of the ESC which currently gathers 6 sub-speciality associations, 18 working groups and 5 councils in addition to the main cardiology association and has members in over 90 countries.

    Isabel Bardinet was president of ACForum from 2010 to 2012 during which time she created the association management chapter and is currently serving as an ACForum board member.
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 Bergstrom 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.
Carin R. Smand, MSc
Managing Director, European Hematology Association, The Hague, The Netherlands

    Speaker Bio

    As of January 1, 2008 Carin Smand is the Managing Director of the European Hematology Association (EHA), a nonprofit organization founded in 1992, promoting excellence in clinical practice, research and education in European hematology.

    After a 10 year career in accountancy and tax she worked for 11 years for the Dutch Health Care Insurance Board as policy maker and Secretary of various medical specialty committees, advising the Minister of Health on the public health care insurance system in The Netherlands. After that she worked as manager organ and tissue donation for the Dutch Transplant Foundation.

    Carin Smand studied Health Sciences (policy and strategy) at the University of Maastricht and Business Economics at the Amsterdam University of Applied Sciences.
Michael Bartke, PhD
Director, Compliance Management, Daiichi Sankyo Europe GmbH; Co-chair, EFPIA Compliance Workgroup, Munich, Germany (Moderator)

    Speaker Bio

    Dr. Bartke has about 30 years experience within pharmaceutical industry. He worked for research based companies ICI ( Zeneca), Bristol Myers Squibb in various positions, Marketing and Business Development. He also has experience in various national and international projects.

    In 2001 he joined Daiichi Sankyo as Head of Marketing Germany, 2006 passed to European Headquarter Daiichi Sankyo Europe, Director Strategic Marketing and Business Development (Cardiovascular drugs)

    Since 2008 Director Compliance Management - experience in various areas of Compliance and risk management. Activity in associations e.g. VfA/FSA (Germany) and EFPIA, Belgium (Co-Chair Compliance Committee)
6:30 p.m. Adjournment and Networking Reception




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