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 II
Tuesday, May 12, 2015

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

Welcome and Overview

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 (Co-chair)
8:45 a.m.

Understanding the New Life Sciences Marketplace

Frank Wartenberg, PhD
President, Central Europe, IMS Health, Frankfurt/Main, Germany

    Speaker Bio

    Frank has been appointed President Central Europe in January 2011. Before his current position he was General Manager Germany and led as Vice President and Practice Leader the Commercial Effectiveness practice in EMEA which shaped superior commercial strategies and resource decisions in marketing and sales for clients and ensures their implementation via a proper change management support. Frank has a deep pharmaceutical market expertise and understanding of organisational implications within the marketing and sales frame.

    In his consulting role Frank has lead projects for big to mid-size pharmaceutical and medical devices companies on marketing and sales strategy, sales and marketing effectiveness in Europe, Latin America, AsiaPac (incl. China and India) and Japan. Focus of projects has been e.g. commercial strategy, market entry, build-up and re-organisation of go-to-market organisation across multiple channels, launch preparation, and customer value management among others.
    Presentation Material (Acrobat)
9:15 a.m.

The New Marketplace: The Purchasers Perspective

Günter Danner, MA, PhD
Associate Director, European Representation, German Social Insurance, Brussels, Belgium
Klaus Hilleke, PhD
Chief Executive Officer and Head, Global Life Science Division, Simon-Kucher & Partners, Bonn, Germany

    Speaker Bio

    Klaus Hilleke is since May 2009 the CEO of SIMON ? KUCHER & PARTNERS. From 2000 to 2013 he led the company's Global Life Sciences division. He was in 1996 the founding partner and until 1999 the managing director of the company's US operations in Boston, Massachusetts. He has been with the company for 27 years and has been a member of the Executive Board since 2005.

    Klaus specializes in the areas of competitive strategy, market segmentation, positioning and pricing for pharmaceutical companies. He has worked on global projects for most of the leading pharmaceutical companies worldwide.
Frank Wartenberg, PhD
President, Central Europe, IMS Health, Frankfurt/Main, Germany

    Speaker Bio

    Frank has been appointed President Central Europe in January 2011. Before his current position he was General Manager Germany and led as Vice President and Practice Leader the Commercial Effectiveness practice in EMEA which shaped superior commercial strategies and resource decisions in marketing and sales for clients and ensures their implementation via a proper change management support. Frank has a deep pharmaceutical market expertise and understanding of organisational implications within the marketing and sales frame.

    In his consulting role Frank has lead projects for big to mid-size pharmaceutical and medical devices companies on marketing and sales strategy, sales and marketing effectiveness in Europe, Latin America, AsiaPac (incl. China and India) and Japan. Focus of projects has been e.g. commercial strategy, market entry, build-up and re-organisation of go-to-market organisation across multiple channels, launch preparation, and customer value management among others.
Andrew White
Head of Medicine Management - NHS, Greater Manchester Commissioning Support Unit, Manchester, UK

    Speaker Bio

    Andrew is currently Head of Medicines Optimisation at the North West Commissioning Support Unit.

    His team provides strategic support to all GM CCGs and runs the locality service in one CCG. He lead the operational aspects of the Greater Manchester Medicines Management Group (GMMMG), which include the GM joint formulary, new therapies, and shared care recommendations for the 12 CCGs and 13 providers across the GM population of 2.8 million.

    He was worked in clinical and managerial roles in the NHS since 2003 and a community pharmacist for 10 years prior to joining the NHS.

    Andrew is a (largely unrewarded) Scottish rugby fan, and is more recently enjoying learning about cricket through his son's team.
    Presentation Material (Acrobat)
Olivier Wong, MD
Specialist in Family Medicine; Former Voting Member, French Transparency Committee, Paris, France

    Speaker Bio

    European Medical development (Phase II/III) in CV diseases [Laboratoire Hoechst- 1992-1993]

    Teaching, research and clinical practice in primary care 1994-2011

    Past member voting member Transparency Committee 1998-2011

    Fully pledge National Payer Guideline Committee & regulator advice [Drug National Agency & HAS] 1996-2014

    Member of the Governance Group [Ministry of Health Fr] 2011

    Has worked has a key advisor for the Ministry of Health & HAS [Electronic Medical Records, Social Security, network of providers, Avian Flu, Hospital certification]

    From now onwards: Consultant on early engagement and emerging markets [and lecturer in Health Policy for various institutions: LSE, Fudan, Peking U], advisor for several payer organizations across Europe and China

    Title: CMO Mediqualité Omega
    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.

Keynote: Business Leader Perspective

Marc de Garidel
Chairman and Chief Executive Officer, Ipsen; Vice President, European Federation of the Pharmaceutical Industries and Associations (EFPIA); Knight, National Order of the Legion of Honor (France), Paris, France

    Speaker Bio

    Marc de Garidel is a graduate from the French Engineering School ESTP, and has an Executive MBA from Harvard Business School.

    Marc de Garidel started his career with Eli Lilly with various responsibilities in countries like US, Germany, France. Between 1995 and 2010, he held Executive positions at Amgen including Corporate Controller of the group in the US as well as increasing line management responsibilities including the biggest region of Amgen International operations.

    Marc de Garidel joined Ipsen as Chairman and CEO in November 2010. He also holds a number of other visible positions for the industry: Chairman of the group of French health care companies (G5 santé), nominated by the last 2 French governments as Vice-President of the French Health Care Strategic Committee.

    Marc de Garidel has been recently appointed Vice-President of EFPIA, the European Pharmaceutical Trade Association, and Chairman of the IMI (Innovative Medicines Initiative) Governing Board.

    He is distinguished as Chevalier de la Légion d'honneur.
10:45 a.m. Break
11:15 a.m.
Roundtable on Compliance Issues Raised by the Changing Marketplace
  • Market Access
  • Value-added Services
  • Tendering
  • Pricing
  • Comparative Effectiveness Research
  • Managing Third Party Relationships
Robert McKague
Chief Compliance Officer, Jazz Pharmaceuticals
David O'Shaughnessy
Vice President, Compliance, Emerging Markets, Quintiles; Board Member, ETHICS; Former Vice President Compliance, International Pharmaceuticals, GSK; Former Vice President, Global Compliance Strategy, AstraZeneca, Reading, UK

    Speaker Bio

    Dave is the VP, Compliance, Emerging Markets, at Quintiles reporting to the Chief Compliance Officer, and works with senior leaders to ensure business units have effective compliance efforts to mitigate business risks.

    Dave spent almost 20 years at GlaxoSmithKline in a variety of R&D and Commercial roles including VP and Compliance Officer for the commercial business in Emerging Markets, Asia Pacific and Japan, and Senior Director, International Clinical Compliance in R&D, during which time he spent 6 years living in Asia. In his earlier career, Dave worked operationally in data management and subsequently training and auditing across clinical development activities managed in-house and at CROs.

    Dave was also previously the VP, Global Compliance Strategy and Implementation at AstraZeneca Headquarters in London and managed a central, global team with responsibility for the definition and delivery of the Global Compliance Program infrastructure.
Jeff Rosenbaum
Chief Compliance Officer, Vertex Pharmaceuticals, Boston, MA
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.
Oscar Perdomo
Health Industries Advisory, PwC, San Francisco, CA (Moderator)
12:15 p.m. Networking Luncheon

AFTERNOON MINI SUMMITS - ROUND I
MINI SUMMIT I: BASIC COMPLIANCE CONCEPTS AND SKILLS I
  • The Basics of a Compliance Program: The Global Standard for Effective Programs
  • The Role of Values Based Ethics in a Compliance Program
  • The Role of Governance, Decision Making and Escalation
  • The Roles and Responsibilities of the Compliance Officer
  • The Basics of Disclosure/Transparency
1:30 p.m. Introductions, Panel Discussion and Q&A

Sue Egan
Director and Principal Consultant, Sue Egan Associates; Former Vice President Compliance, AstraZeneca, Great Missenden, Buckinghamshire, UK

    Speaker Bio

    Sue has worked in compliance roles since 1999, and has been a Compliance Officer at all levels from single marketing company and European Compliance Officer for GlaxoSmithKline (GSK) to International VP for AstraZeneca (AZ). She also has over 20 years' experience in IT and related fields, including Computer Systems Validation.

    Since 2010, Sue has been a consultant in her own firm, providing a range of services focused on Compliance, Corporate Governance, Risk Management and Change Management.
Keith M. Korenchuk, JD, MPH
Partner, Arnold & Porter LLP, Washington, DC, USA (Moderator)

    Speaker Bio

    Keith Korenchuk is a partner in the FDA and Healthcare practice of Arnold & Porter, LLP in Washington D.C. He counsels and advises pharmaceutical, life sciences, medical device, biotechnology, and specialty pharmacy companies in the United States and worldwide on regulatory and compliance matters, including on the following matters:
  • US and global compliance systems design, implementation, and ongoing assessment
  • Regulatory matters involving healthcare professionals, including fraud and abuse, off-label promotion, False Claims Act and transparency related issues
  • Global anti-bribery legislation, including the US Foreign Corrupt Practices Act, the Organization for Economic Co-operation and Development (OECD) Anti-bribery Convention, and related national implementing legislation
  • Internal and government initiated investigations
  • State legislation involving pharmaceutical and medical device marketing and disclosure
  • Global, regional, and country specific codes of practice and conduct, including codes issues by Pharmaceutical Research and Manufacturers of America (PhRMA), AdvaMed, International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), and Eucomed
  • Enterprise-wide risk management systems and programs
  • Pharmaceutical price reporting and third party/managed markets negotiations
  • Presentation Material (Acrobat)
2:45 p.m. Transition Break

MINI SUMMIT II: HOW TO ENGAGE WITH MEDICAL SOCIETIES AND CONGRESS ORGANIZERS IN ORDER TO ENSURE THAT INDUSTRY STANDARDS ARE UNDERSTOOD AND TAKEN INTO CONSIDERATION
1:30 p.m. Introductions, Panel Discussion and Q&A

Annalisa Ponchia Baccara, CMP, CMM
Executive Officer, European Society for Organ Transplantation (ESOT), Padova, Italy

    Speaker Bio

    Over 29 years of experience in the event management field, specialized in global congress organization and association management services with particular emphasis on the scientific and medical fields. As Association Executive is managing a fully independent core structure she founded for ESOT, 8 years ago. Annalisa has deep roots in the event industry and a career as entrepreneur running her own PCO company specialized in medical meetings. Annalisa is a certified professional with CMP and CMM designations and a speaker at association and meeting industry events.

    As director of the Society headquarter office, she is responsible, with an internal team, dedicated to the organization of all scientific and education events of the ESOT, as well as to the association management. She holds a position in the Executive Board and in Council of the Association, for which she is consulted for strategic planning, partnership projects with the Pharmaceutical Industry and fund raising activities, marketing and communication developments. She has a substantial knowledge of the association environment and processes.
    Presentation Material (Acrobat)
Gregoire Pavillon
Executive Director, European Association for the Study of the Liver (EASL), The Home of Hepatology, Geneva, Switzerland

    Speaker Bio

    Gregoire joined the non-for-profit sector over 10 years ago when he started working for a professional congress organiser supervising the association management branch in Geneva. He started his professional career as a chef and completed a Bachelor and Masters Degree at the Ecole Hoteliere (Hotel Management School) in Lausanne, Switzerland. He also succeed is Master of Advanced Studies in Non for profit Management at the University of Geneva, Switzerland in 2013. Gregoire has been a member of the EASL Governing Board since April 2015 and also volunteer at the position of Secretary at the Swiss Foundation against Liver Cancer as well as the Board of the AC Forum.
    Presentation Material (Acrobat)
Cerstin Steindorf
Global Account Director Healthcare, MCI, Geneva, Switzerland

    Speaker Bio

    Cerstin leads the dedicated global Healthcare Practice across MCI, one of the world's leading association, communications and event management companies, with 61 offices in 31 countries. A highly skilled meetings and events professional, Cerstin's career has spanned 30 years in the meeting industry. With 17 years specializing in the Healthcare sector, she has assisted many leading global pharmaceutical companies in their quest to find the right solution to maximise the impact of their face-to-face engagements. Originating from a Hotel Management background, Cerstin's finely honed skills include a broad mix of HR, Sales & Marketing, Accommodation and Food & Beverage Management. Joining MCI in 1995, Cerstin began in the Destination Management field where she managed accounts for corporate clients across a wide range of industry sectors. In 1999, Cerstin established the inaugural Healthcare Practice in MCI, serving global, regional and local companies in the healthcare and life sciences industries. Cerstin's comprehensive knowledge of these industries led to her nomination as Subject Matter Expert for the MCI Institute (MCI's in-house training facility). Cerstin regularly shares her knowledge on issues affecting the Healthcare industry, such as compliance, through training sessions and thought leadership engagements.
Christian-Claus Roth
Head Global Event Governance, Novartis Pharma; Co-President, International Pharmaceutical Congress Advisory Association (IPCAA), Basel, Switzerland (Moderator)

    Speaker Bio

    Christian-Claus Roth has been employed at Novartis Pharma since 2001, in different roles of increasing responsibility. After his studies in Business Administration he started his career with the International Pharmaceutical wholesaler GEHE Pharma Handel GmbH and later Celesio AG, in Germany.

    From there he moved to the Novartis Pharma affiliate in Berne, Switzerland, where he set up the congress & event department for the Swiss market, shortly later being promoted to the Global Headquarter in Basel with responsibility for the Pain and Urology Areas as International Congress Manager, with additional responsibility later for the Bone area. Christian now oversees the strategic global Congress & Conventions team focusing on the impact of external regulatory requirements on global medical event management -- one of several key areas for which the team is responsible. Additionally he regularly participates as a panel member and speaker at conferences.
2:45 p.m. Transition Break

MINI SUMMIT III: COMPETITION/ANTITRUST LAW UPDATE
1:30 p.m. Introductions, Panel Discussion and Q&A

Catherine Higgs, MA
Cantab, Senior Legal Counsel, AstraZeneca, Alderley, UK

    Speaker Bio

    Catherine is AstraZeneca's Global Antitrust Counsel, based in Alderley Edge, UK. After studying medicine at Cambridge University and qualifying as a solicitor Catherine spent 6 years in private practice before moving in-house to AstraZeneca. Catherine's role covers all areas of the business both by function and geography but with a particular focus on matters involving Compliance, Business Development, Intellectual Property and Commercial.
    Presentation Material (Acrobat)
Ulf H. Grundmann, JD
Partner, Life Science Practice Group, King & Spalding, Frankfurt, Germany (Co-moderator)

    Speaker Bio

    Ulf Grundmann is a partner in the Frankfurt office of King & Spalding and a member of the FDA & Life Sciences practice. He regularly advises household names in the life sciences and food and beverage industries on litigation, intellectual property and unfair competition.

    Mr. Grundmann advises European and U.S. clients in the areas of IP and unfair competition law. He focuses on litigation and arbitration as well as extra-judicial advice. Mr. Grundmann advises clients in the pharmaceutical, medical devices and food industries; focusing on regulatory work for these sectors.

    Mr. Grundmann is lecturer at Frankfurt School of Finance. He regularly speaks at seminars and conferences and contributes to various publications: he is author of the Guide to EU Pharmaceutical Regulatory Law.
    Presentation Material (Acrobat)
Fiona Carlin, LLB
Managing Partner, European and Competition Law Practice, Baker & McKenzie, Brussels, Belgium (Co-moderator)

Presentation Material (Acrobat)
2:45 p.m. Transition Break

MINI SUMMIT IV: ADVANCED ISSUES IN GLOBAL TRANSPARENCY, DISCLOSURE AND AGGREGATE SPEND COMPLIANCE
1:30 p.m. Introductions, Panel Discussion and Q&A

Katrina Cahill
Global Transparency Lead, Biogen Idec, Weston, MA, USA

    Speaker Bio

    Katrina Cahill is the Global Transparency Lead in the Global Compliance department at Biogen Idec based in the US headquarters in Cambridge where she is responsible for the design and implementation of all the global disclosure requirements. Katrina was responsible for the Sunshine Act implementation in the US over the past 2 years along with state reporting. Over the past 12 months, Katrina has led an assessment of each country requirement including the EFPIA Disclosure Code to provide strategic direction to Biogen Idec to ensure compliance with all the disclosure Codes and Laws. Prior to joining Biogen Idec, Katrina built and led a US Finance Operations team at Genzyme Corporation. Katrina holds a Masters degree in Modern History from St. Catherine's College, Oxford University and a Bachelors degree from the University of Wales, Swansea.
Audrey F. DeGuarde, MSJ
Director, Aggregate Spend Services, Porzio Life Sciences, Morristown, NJ
Nina Stoeckel, LLM
Head of Group Compliance Programs, Merck KGaA, Darmstadt, Germany

    Speaker Bio

    Nina Stoeckel has served as the Director Global Compliance Program, Merck KGaA since October of 2014. In this capacity she works on the development and implementation of the Compliance program and organization for the Merck Group of Companies, including but not limited to policies, processes, training and communication. She is responsible for setting strategic framework for a risk oriented, state of the art compliance program.
Holly Kramen
Principal, Porzio Bromberg & Newman, P.C., Vice President, Porzio Life Sciences, LLC, Washington, DC (Moderator)

    Speaker Bio

    Holly Kramen brings a wealth of industry experience to Porzio, Bromberg & Newman having been a business leader in life science commercial operations, in-house counsel and an architect and implementer of compliance programs at companies of all sizes. She is a member of the Life Sciences Compliance, Commercialization and Regulatory Counseling Department and is based in our DC office.

    Holly is also a vice president of Porzio Life Sciences, the firm's subsidiary, which offers a range of marketing and sales compliance products and services to pharmaceutical, medical device and biotechnology companies.

    With a substantive career in marketing, sales, consulting and medical affairs in addition to legal and compliance, Holly is focused on assisting pharma, biotech, med device and diagnostic firms build commercialization as they launch, promote and grow their products and their companies, aggressively and compliantly. Holly has served in senior level leadership roles for various companies in the life science industry and successfully managed and collaborated with teams from every discipline.

    She approaches commercial operations with creativity and a practical perspective infusing legal acumen and commercial insight. She is a proven advisor of commercial conduct in pharmaceutical, biotech and medical device companies specializing in dealing with fraud and abuse laws, regulatory advertising and promotional regulations, contracting and sales, general commercial law, anti-kickback and FCPA, Sunshine Act and compliance reporting laws, ACCME, AdvaMed, MEDEC codes, South America compliance laws, privacy, HIPAA and HITECH.

    Holly has designed, led and implemented a spectrum of corporate and compliance initiatives including assessment, remediation, policy creation and revision, training, procedures and monitoring across the corporate enterprise as well as building and implementing aggregate spend systems for reporting under federal and state laws.

    Prior to joining Porzio, she was General Counsel, Americas and US Compliance Officer & Privacy Officer for a midsize medical device company specializing in GI diagnostics where she was responsible for building, leading and executing all legal and compliance functions and operations for the Americas.

    Holly's experience includes leadership positions in sales and marketing operations at Pfizer where she played key roles on multiple product launches and sales force initiatives and was the creator and co-author of the first pharmaceutical compliance manual (the Pfizer "Orange Book") and aggregate spend system. She later held the position of Senior Director of Global Compliance at Gilead Sciences and spent several years in multiple consulting roles.
    Presentation Material (Acrobat)
2:45 p.m. Transition Break

MINI SUMMIT V: ANNUAL CEE COMPLIANCE UPDATE
1:30 p.m. Introductions, Discussion and Q&A

Paul J. Melling, Esq.
Founding Partner, Baker & McKenzie - CIS, Limited, Moscow, Russia
Madina Plieva, PhD
Legal Director, Association of International Pharmaceutical Manufacturers (AIPM); Former Head of Legal Department, Kutafin Moscow State Law Academy, Moscow, Russia

    Speaker Bio

    Madina Plieva joined Association of International Pharmaceutical Manufacturers (AIPM) as a Legal Director in 2011. She focuses in her practice on Pharmaceuticals and Healthcare regulations, IP issues, WTO regulations, competition law, tenders, advertsing, etc. Madina drives AIPM Legal and Compliance&Ethics committees and leads implementation of international standards (IFPMA Code of Practice, EFPIA Codes) into AIPM Code of Practice, ensuring its compliance with Russian legal requirements.

    Madina Plieva has extensive experience in academia and holds a Ph.D. in Law. Before joining AIPM she has held position of Head of Legal Department at Kutafin Moscow State Law Academy and lectured on Private International Law.
Katalin Pungor
Director, HCCO Pharma Emerging Markets, Johnson & Johnson, Budapest, Hungary

    Speaker Bio

    Present position at J&J: since March 2014, supervising HCC program in CEE, Turkey, Middle East, Africa. Former region (2010-2014): mid-sized Western and Eastern European countries.

    Former positions at Janssen-Cilag Hungary (1996-2010): CNS Group Manager, Medical Director, Business Unit Manager of different areas, New Business Development Director, HCCO. Was involved in several local, regional and global projects, like strategic brand teams, management consultancy, process excellence, multichannel projects.

    Former business experience (1994-1996): Upjohn Hungary, started as a sales representative and progressed through product manager function to Franchise Manager role.

    Qualifications: Medical Doctor, neurologist, psychiatrist, PhD in CNS, MBA (Buckinghamshire University College/Brunell University, UK).
Dumitru Uta, MD, MBA, CCEP
Ethics and Compliance Director, South-East Europe, Eli Lilly and Company, Bucharest, Romania
Mariusz Witalis
Partner, Fraud Investigation and Dispute Services, EY, Warsaw, Poland (Moderator)
2:45 p.m. Transition Break

MINI SUMMIT VI: HOW TRANSPARENCY INITIATIVES IMPACT LIFE SCIENCES COMMERCIAL MODEL EVOLUTION; CHANGING RELATIONSHIPS WITH HEALTHCARE PROVIDERS
1:30 p.m. Introductions, Panel Discussion and Q&A
Laurent Clerc
Co-founder and Regulatory Affairs Expert, BMI SYSTEM, Paris, France

    Speaker Bio

    Laurent Clerc is a Regulatory Affairs Expert at BMI SYSTEM. He holds a Master of Health Law, a Master of Quality Assurance and an Executive MBA. Co-founder of BMI SYSTEM, he has a professional background of more than 18 years serving the pharmaceutical industry and hospitals within consulting firms specialized in regulatory affairs.
Guillaume Roussel
Director of Strategy, Veeva OpenKey, France

    Speaker Bio

    Guillaume Roussel is Director of Strategy for Veeva OpenKey in Europe. Over the course of 13 years at Cegedim, Roussel launched technology solutions designed to support the unique sales, marketing, and compliance needs of life sciences companies.

    Roussel also led Cegedim's compliance business sector across Europe to help organisations address the region's fast-emerging transparency requirements, and created the global marketing strategy for customer data development. With his unique experience, Roussel is set to drive the industry toward greater transparency, agility, and global harmonisation by delivering a world-class master data solution in the cloud.
2:45 p.m. Transition Break

MINI SUMMITS ROUND II
MINI SUMMIT VII: BASIC COMPLIANCE CONCEPTS AND SKILLS II
  • The Basics of Anticorruption
  • Conducting Effective Third-Party Due Diligence
  • Developing Effective Commercial/Medical Boundaries in Interactions with HCPs
  • The Role of Analytics in Monitoring and Program Oversight
  • Building Effective Relationships with the Business
3:00 p.m. Introductions, Panel Discussion and Q&A
Zeynep Didem Degirmencioglu
Head of Compliance, Intercontinental Region, Merck KGaA, Istanbul, Turkey

    Speaker Bio

    Didem is Head of Group Compliance Intercontinental Region of Merck KGaA. In her role, Didem is responsible for compliance operations of all Merck Group Divisions (Pharma &Consumer Health, Chemicals, Performance Materials) in 81 regional countries.

    Prior to joining Merck KGaA, Didem led the Compliance function at GE Healthcare implementing and developing compliance programme in its Turkey & Central Asia region.

    She has been in private practice as consultant to foreign investors in Turkey. She also held legal and compliance positions with large multinational pharmaceutical, energy and telecommunications companies including Sandoz (Novartis Group), Areva T&D (Alstom Group), Menarini Group, Telecom Italia Mobile. Didem delivered legal consultancy services and in the course of her compliance practice, she has worked on fraud and anti-kickback/bribery legal matters, interactions with healthcare professionals, implemented Compliance Programs and procedures, developed pharma specific Codes of Conducts.

    Didem holds a JD degree from Istanbul University School of Law and LL.M degree from Temple University School of Law.
Keith M. Korenchuk, JD, MPH
Partner, Arnold & Porter LLP, Washington, DC, USA (Moderator)

    Speaker Bio

    Keith Korenchuk is a partner in the FDA and Healthcare practice of Arnold & Porter, LLP in Washington D.C. He counsels and advises pharmaceutical, life sciences, medical device, biotechnology, and specialty pharmacy companies in the United States and worldwide on regulatory and compliance matters, including on the following matters:
  • US and global compliance systems design, implementation, and ongoing assessment
  • Regulatory matters involving healthcare professionals, including fraud and abuse, off-label promotion, False Claims Act and transparency related issues
  • Global anti-bribery legislation, including the US Foreign Corrupt Practices Act, the Organization for Economic Co-operation and Development (OECD) Anti-bribery Convention, and related national implementing legislation
  • Internal and government initiated investigations
  • State legislation involving pharmaceutical and medical device marketing and disclosure
  • Global, regional, and country specific codes of practice and conduct, including codes issues by Pharmaceutical Research and Manufacturers of America (PhRMA), AdvaMed, International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), and Eucomed
  • Enterprise-wide risk management systems and programs
  • Pharmaceutical price reporting and third party/managed markets negotiations
  • Presentation Material (Acrobat)
4:15 p.m. Transition Break

MINI SUMMIT VIII: GLOBAL COMPLIANCE AUDITING AND MONITORING BEST PRACTICES
3:00 p.m. Introductions, Panel Discussion and Q&A

Gary F. Giampetruzzi, Esq.
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc., New York, NY, USA

    Speaker Bio

    Gary F. Giampetruzzi is one of the most recognized anti-corruption/FCPA compliance and enforcement attorneys and thought leaders, and highly regarded by peers, life science industry insiders, and regulators for his strategic thinking and insight into compliance program, internal investigations and government enforcement issues. Mr. Giampetruzzi has extensive experience with all facets of the anti-corruption and FCPA and U.S. healthcare landscapes. He has been a leader in this growing area of practice for the past 15 years, having led the development of cutting edge compliance programs and measures, conducted and overseen hundreds of internal investigations, and been on the ground in more than 40 markets worldwide (including Asia, North Africa, Europe, the Middle East and Latin America).

    A recent addition to Paul Hastings Investigations and White Collar practice in February 2014, Mr. Giampetruzzi spent 13 years at Pfizer Inc. as its Vice President, Assistant General Counsel and Head of Government Investigations, and earlier on served as Pfizer's Deputy Compliance Officer, where he was also responsible for international compliance investigations and the implementation and maintenance of compliance programs throughout the company's international operations, with a particular focus on emerging markets.
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.
Pascale Paimbault
Compliance Officer, France -Benelux, Biogen, Treasurer and Strategic Committee Member, ETHICS, Former Chief Compliance Officer EMEA, Wright Medical Inc., Former Senior Director, Compliance and Ethics, Business Program, EMEA, Bristol-Myers Squibb, Paris, France

    Speaker Bio

    Pascale Paimbault is the Compliance Director, Benelux-France of Biogen, based in Paris (France). She entered Biogen in 2015, to implement the global Biogen Program for these countries, as well as lead the Monitoring Excellence project for Europe and Canada.

    Up to 2014, Pascale Paimbault created and led the EMEA compliance department of Wright Medical Inc. http://www.wmt.com/default.asp, based in Amsterdam (Netherlands). This new department, created in 2012, focused on compliance-integrated program development and deployment, effective tone-at-the-top support, training, and practical guidance implementations.

    She is the treasurer of ETHICS, the International Society of Healthcare Ethics and Compliance Professionals. http://www.ethicspros.com
Fabien Roy, DESS European Law
Senior Associate, Hogan Lovells, Brussels, Belgium

    Speaker Bio

    Fabien Roy's practice focuses on European Union (EU) and national regulatory matters involving pharmaceutical, and medical device laws and guidelines. He has developed close contact with relevant government authorities in these sectors. Fabien is a keen writer and regularly publishes articles concerning developments in the medical device and pharmaceutical sectors. He is also a regular speaker at dedicated conferences.

    Fabien focuses particularly on the different stages of the medical device CE marking process. He advises on a wide variety of topics which include the following: determination of the appropriate classification of individual products; clinical investigation procedure (e.g. authorisation from the EU Member States competent authorities, opinion from Ethics Committee, amendment to the Protocol, informed consent, serious adverse event qualification and notification, handling of personal data); drafting of clinical investigation and clinical trial agreements, distribution agreements and contract manufacturing agreements; clinical evaluation; conformity assessment procedure; review of Instruction For Use, products' labelling and promotional material including websites; post-marketing surveillance activities including the notification of adverse event, product recall or product withdrawal; reimbursement. Fabien also advises on questions regarding marketing authorisation procedures, variation procedures, and clinical trials, promotional and marketing activities in the pharmaceutical sector.

    Fabien joined Hogan Lovells International in 2007 (at that time Hogan & Hartson LLP).
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 has extensive experience in analyzing the processes and controls of pharmaceutical and medical device companies around the management of regulatory risks associated with pharmaceutical sales/ marketing, purchasing, medical affairs, clinical research and adverse events. He works with companies in evaluating and redesigning business practices to comply with applicable regulations. Mr. Ebel brings an international perspective and multi-cultural appreciation to his clients and project teams through his field experience with pharmaceutical and medical device industries in over 35 markets around the world.
4:15 p.m. Transition Break

MINI SUMMIT IX: WHAT'S NEXT IN GLOBAL COMPLIANCE
3:00 p.m. Introductions, Panel Discussion and Q&A

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.
    Presentation Material (Acrobat)
Angelique Lee-Rowley, Esq.
Vice President, Associate General Counsel and Compliance Officer Spectrum Pharmaceuticals, Inc.; Former Director, Compliance, Siemens Healthcare, Irvine, CA, USA
Abdul Luheshi, MBA
Vice President, Health Care Compliance, Johnson & Johnson, Former Co-chair, Asia Pacific Pharma Congress, London, UK

    Speaker Bio

    14 years with Johnson & Johnson of which 5 years as Head of Compliance for LifeScan EMEA and 4 years leading the health care compliance team for Janssen Pharmaceuticals in Asia. Currently based between the UK and China overseeing program enhancement initiatives for Johnson & Johnson

    Originally an organic chemist, post-MBA has held posts in operations management and finance across the chemical, agrichemical and healthcare industries.
    Presentation Material (Acrobat)
Nathalie Raynaud
Corporate Compliance Director, Global Compliance and Business Integrity Department, Sanofi, Paris, France

    Speaker Bio

    Nathalie Raynaud holds a post graduate diploma (DESS) in International Business law from Paris X - Nanterre University and two Masters degrees from the University of Paris II -- Assas, in Business Law and International and European Business Law. Nathalie began her career as a lawyer in a French law firm and then became an in-house lawyer in the textile related products industry (Dolfus Mieg & Cie - DMC) and in an industrial engineering company (FIVES). Nathalie joined Sanofi as a Legal Manager in 2001. She joined the Sanofi Global Compliance & Business Integrity Department in 2007. She is now Corporate Compliance Officer and the Secretary of the Sanofi Executive Compliance Committee.
Andy Bender, MS, MBA
President and Founder, Polaris, New York, NY, USA (Moderator)

    Speaker Bio

    Andy Bender is the founder of Polaris companies. Andy has been involved in a wide variety of pharmaceutical and device manufacturer compliance related engagements ranging from process automation, policy development, organizational implementation and auditing a wide variety of programs such as CME grants, speaker and consultant programs. Polaris employs 90 consultants plus 65 technologists, including 4 health care law attorneys. Polaris has offices in New York, Amsterdam and San Francisco. Andy teaches two half day classes at INSEAD in France to compliance directors and officers on conducting risk assessments and auditing and monitoring.
    Presentation Material (Acrobat)
4:15 p.m. Transition Break

MINI SUMMIT X: CLINICAL TRIALS COMPLIANCE -- THE NEW CLINICAL TRIALS REGULATIONS, THE EFPIA/PhRMA JOINT PRINCIPLES AND THE NEW EMA POLICY
3:00 p.m. Introductions, Panel Discussion and Q&A

Eva Gardyan-Eisenlohr
General Counsel and Compliance Officer, Bayer Pharma AG; Member, Strategic Committee, ETHICS, Berlin, Germany

    Speaker Bio

    Eva Gardyan-Eisenlohr is General Counsel and Compliance Officer of Bayer Pharma AG. With her team of 28 attorneys she advises the global Pharma business of Bayer covering the entire value chain. She currently co-leads a worldwide Compliance Management Project for the Bayer Group covering nine compliance risks areas in 80 countries and the German headquarter organization.

    Prior to her current role, she held diverse positions as Senior Legal and General Counsel in the Bayer Group and advised the Bayer's HealthCare Business as Anti Trust Counsel. Before moving to Schering AG as Legal Counsel she started her career in the Crop Science Industry at Hoechst Schering AgrEvo.

    Mrs. Gardyan-Eisenlohr is attorney at law, admitted to the bar of Berlin. She studied law at the University of Freiburg in Germany and holds a post-graduate degree in Anti Trust Law from the University of Constance. Her academic training led her to study at the Institut d'Etudes Politiques and to graduate from the Ecole Nationale d'Administration, both in Paris.
Alice Lex, PhD
Health Care Compliance Officer, Janssen Research and Development in EMEA, Johnson & Johnson, Neuss, Germany

    Speaker Bio

    Alice Lex is the Health Care Compliance Officer, Pharmaceuticals Group Healthcare Compliance, Johnson & Johnson for Janssen Research and Development in EMEA. In this role, Alice provides Health Care Compliance guidance and support for EMEA based Janssen Research organizations in the Pharmaceutical Sector ranging from early discovery and manufacturing research to clinical study execution. Alice has held previous roles in support of Janssen EMEA Medical Affairs organization as well as roles within R&D and Medical Affairs Janssen Germany. Alice is a certified Project Management Professional and received her Doctor of Biology degree from RWTH-Aachen, Germany.
Hein Van den Bos
Counsel, Hogan, Lovells International LLP, Amsterdam, Netherlands (Moderator)

Presentation Material (Acrobat)
4:15 p.m. Transition Break

MINI SUMMIT XI: DATA ANALYTICS SUPPORTING COMPLIANCE MONITORING, RISK PREVENTION AND MITIGATION
3:00 p.m. Introductions, Panel Discussion and Q&A

Carl Judge
Director, Fraud Investigation and Dispute Services, EY, London, UK

    Speaker Bio

    Carl is a Director in the Forensic Technology & Discovery Services (FTDS) group within EY, specialising and leading the Forensic Data Analytic group. He has worked in professional services for over sixteen years, with nine of those years focused on Forensic Technology services, specifically data analytics and e-discovery. Carl specialises in the analysis of data as part of regulatory investigations, fraud investigations, or compliance monitoring programmes, with experience of delivering a number of large multi-jurisdictional engagements.
Jimi Kehlet
Manager, Assurance intelligence, Group Internal Audit, Novo Nordisk A/S, Bagsvaerd, Denmark

    Speaker Bio

    Jimi is heading up the audit analytics group in Novo Nordisk A/S, a Denmark based pharma company and the world leader within diabetes care. Jimi has a background within Finance and worked with Risk Management and Internal Controls. During the last four years Jimi has worked to build and develop the use of audit and compliance analytics in Novo Nordisk's Group Internal Audit function.
Dario Ghoddousi
Senior Vice President Global Transparency and MDM Solutions, IMS Health, Paris, France (Moderator)

    Speaker Bio

    Dario GHODDOUSI, Senior Vice President of Global Transparency and Master Data Management Solutions, has been with IMS Health since 1993. He has contributed to the growth and development of the company by successfully executing a variety of key roles with increasing responsibilities. These roles include General Manager, Vice President Marketing, Director of Sales and Vice President Global Business Development. Mr. GHODDOUSI earned his degree at University of Pavia in Italy, and has completed several business certification programs.
4:15 p.m. Transition Break

MINI SUMMITS ROUND III
MINI SUMMIT XII: ADVANCED STRATEGIES IN COMPLIANCE TRAINING
4:30 p.m. Introductions, Panel Discussion and Q&A

Jacques Fontas
Executive Counsel, Compliance Leader, GE Healthcare Europe; Member, Strategic Committee, ETHICS, Paris, France
Piergiorgio Pepe, LLB
EEMEA Director, Ethics and Compliance, AbbVie; Former Director, Compliance and Ethics, EMEA, Bristol-Myers Squibb, Paris Area, France

    Speaker Bio

    Piergiorgio Pepe is Regional Director, Office of Ethics & Compliance, EEMEA, AbbVie in Rungis, France.

    Before joining AbbVie in 2013, Piergiorgio worked as Business Program Director EMEA, Bristol-Myers Squibb from 2006 to 2013. Before then he worked at the European Commission and then as senior lawyer in the EU, Competition and Regulatory department of the international law firm Simmons & Simmons, in their Brussels, London and Rome offices, from 1997 to 2006. Piergiorgio is active in the academic field of compliance and ethics; he regularly writes in journals and teaches ethics and compliance-related courses (e.g., INSEAD and SciencesPo). Piergiorgio is a law graduate of the University of Bari (Italy) and has masters in EU Law from the Institute of European Studies (ULB, Brussels). He is a Solicitor of the Supreme Court (Law Society of England and Wales) and an Avvocato at the Court of Bari, Italy.
Marie Vandepaer
Senior Director, Compliance Awareness and Solution-Corporate Compliance, UCB SA, Brussels Area, Belgium

    Speaker Bio

    Overall 35 year of professional experience
    • Educational background:
      • Pharmacist-University of Louvain-Belgium
      • PhD-Toxicology-University of Louvain-Belgium
    • Work experience prior to UCB:
      • Research Fellow and Assistant- University of Louvain
      • SmithKline Beecham: Senior Regulatory Manager-European Headquarters.
    • Various Assignments within UCB:
      • In development: Clinical Operations, Clinical Quality Control, Quality Systems and Business Improvement
      • In Global Medical Affairs and Global Operations: Quality, Business Continuity and Improvement
      • In Global Legal Affairs, Corporate Compliance department: Senior Director Compliance Awareness & Solutions
Cécile Gousset
Associate Vice President Compliance Risk Assessment, Education and Monitoring, Global Compliance, Sanofi; Member, Strategic Committee, ETHICS, Paris, France (Moderator)

    Speaker Bio

    • Education - Background:
      PharmD

    • Experience:
      13 years in Sanofi in Regulatory Affairs (French affiliate) and Global Medical Operations (Head of Medical Information Compliance Department).

      In Global Compliance & Business Integrity department since 2013.

      Outside Sanofi, 6 years in Astra-Zeneca France (Regulatory Affairs) and 2 years in Merieux UK (Product Manager).
    Presentation Material (Acrobat)
5:45 p.m. Adjournment

MINI SUMMIT XIII: ANNUAL MEA COMPLIANCE UPDATE
4:30 p.m. Introductions, Panel Discussion and Q&A

Flavia Bollinger
Head Integrity and Compliance MENA (Middle East, North Africa), Novartis Pharma Services AG, Dubai, UAE

    Speaker Bio

    Swiss, living in Dubai since 2005, proud mother of 2 girls and

    Working with Novartis Pharma since 8 years.

    Heading Compliance & Integrity in the MENA region including 18 countries. In this function I strive to enable and drive integrity and ethical business conduct through MENA and to implement a robust compliance framework that supports to establish, embed and enforce Integrity for Code of Conduct, Anti-Bribery and Professional Practices Policies in Pharma.

    Personally I like to be engaged and act as supportive leader that enables business to be successful while ethical.
Zeynep Didem Degirmencioglu
Head of Compliance, Intercontinental Region, Merck KGaA, Istanbul, Turkey

    Speaker Bio

    Didem is Head of Group Compliance Intercontinental Region of Merck KGaA. In her role, Didem is responsible for compliance operations of all Merck Group Divisions (Pharma &Consumer Health, Chemicals, Performance Materials) in 81 regional countries.

    Prior to joining Merck KGaA, Didem led the Compliance function at GE Healthcare implementing and developing compliance programme in its Turkey & Central Asia region.

    She has been in private practice as consultant to foreign investors in Turkey. She also held legal and compliance positions with large multinational pharmaceutical, energy and telecommunications companies including Sandoz (Novartis Group), Areva T&D (Alstom Group), Menarini Group, Telecom Italia Mobile. Didem delivered legal consultancy services and in the course of her compliance practice, she has worked on fraud and anti-kickback/bribery legal matters, interactions with healthcare professionals, implemented Compliance Programs and procedures, developed pharma specific Codes of Conducts.

    Didem holds a JD degree from Istanbul University School of Law and LL.M degree from Temple University School of Law.
Laura Nassar
Head of Compliance, Middle East Sub-Regions I & II, Hoffmann-La Roche Ltd. (Dubai Branch), Dubai, UAE (Moderator)

    Speaker Bio

    Laura Nassar is the Regional HCC Officer for Turkey, Middle East and Africa. She has been with J&J since 1998. She is a member of the EMEA-C HCC Leadership Team and the International Society of Healthcare Ethics and Compliance Professionals (ethics).

    Laura has 10 years of business experience in the Middle East, prior to joining HCC. She received various compliance awards and is now leading a successful team of HCC Officers.

    She has a Pharm.D degree and fluently speaks Arabic, French and English.

    When not working, Laura enjoys the beautiful beaches of Lebanon.
5:45 p.m. Adjournment

MINI SUMMIT XIV: LESSONS FROM GLOBAL COMPLIANCE ISSUES AND INITIATIVES IN THE MEDICAL DEVICE SECTOR
4:30 p.m. Introductions, Panel Discussion and Q&A

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.
Aline Lautenberg
General Counsel - Director, Legal and Compliance, Eucomed, EDMA and MedTech Europe, Brussels, Belgium

    Speaker Bio

    Aline Lautenberg is the Eucomed, EDMA and MedTech Europe Legal Counsel and the Legal and Compliance Director. She joined Eucomed in February 2004, as Economic and Legal Affairs manager, after having worked for two years for a consultancy specializing in reimbursement of medical technologies. Since May 2013, she is also responsible for EMDA and MedTech Europe's legal and compliance matters.

    Aline is responsible for advising on the three organisations' contractual, regulatory and statutory obligations and for assisting the Eucomed, EDMA and MedTech Europe Chief Executive and Boards of Directors in management decision processes with robust risk assessments within the framework of the Eucomed, EDMA and MedTech Europe strategies.
Christine Sainvil
Compliance Officer, EthicalMedTech, Brussels, Belgium

    Speaker Bio

    Christine Sainvil is a project management consultant with over 10 years of experience in non-profit and humanitarian association management on an international level, particularly in the healthcare sector.

    Christine worked for various US-based professional associations in the capacity of Business Development Manager. She has also acted as Project and Grant Manager with Soros Foundation in DR Congo. She joined Eucomed's initiative on ethics and compliance: Ethicalmedtech, in February 2012. Her role is to manage, develop and act a focal point for the conference vetting system.
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
David Andersen
Partner, Pharmaceutical and Life Sciences Risk Assurance, PwC, London, UK (Moderator)

    Speaker Bio

    David leads the Pharmaceutical & Life Sciences sector Governance, Risk and Compliance practice in Europe and has extensive experience assisting a wide range of pharmaceutical and medical device companies. David's experience includes the building and restructuring of compliance functions, development and implementation of regulatory compliance programmes, risk assessment and control framework design and implementation and, development of commercial and financial control manuals to refine training, monitoring and auditing.
5:45 p.m. Adjournment

MINI SUMMIT XV: ADVANCED ISSUES IN GLOBAL ANTI-BRIBERY COMPLIANCE
4:30 p.m. Introductions, Panel Discussion and Q&A

Suzanne Durdevic, LLM
Senior Director, General Counsel, EMEA, Boston Scientific International; Chair, Legal Affairs Focus Group, EUCOMED; Member, Strategic Committee, ETHICS, Paris, France

    Speaker Bio

    Suzanne Durdevic is Senior Director, General Counsel Europe, at Boston Scientific, a world medical device leader. With her team, Suzanne provides support to businesses in Europe on legal and compliance matters. Before joining BSC in 2004, Suzanne worked over 8 years in private practice in international law firms.

    Suzanne is Chair of EUCOMED (European Medical Device Trade Association) Legal Affairs Group, member of its Code Committee and member of the Strategic Committee of ETHICS (International Society of Healthcare Ethics and Compliance Professionals). Suzanne holds a Master's degree from Harvard Law School and post-graduate degrees in Private laws and Business from University Paris Pantheon-Sorbonne and Assas.
Erinn Hutchinson
Partner, Advisory Services, PwC, Philadelphia, PA

    Speaker Bio

    Erinn Hutchinson is a Partner in PwC's Pharmaceutical and Life Sciences Practice, based in Shanghai. Erinn has fifteen years of experience providing business advisory services to pharmaceutical and medical device companies in the areas of compliance , risk management, and performance improvement. Her expertise includes providing comprehensive risk assessment services on a broad range of health care and pharmaceutical operational issues including corporate compliance, monitoring and auditing, corporate integrity agreements, commercial regulations, reimbursement, anti-bribery, and due diligence for mergers and acquisitions. In addition to extensive experience in the U.S. and China, Erinn has performed compliance assessment reviews in Brazil, Croatia, Czech Republic, Denmark, Egypt, France, Germany, Italy, Mexico, Poland, Portugal, Russia, and the Ukraine.
Michele Tagliaferri, Esq.
Counsel, Sidley Austin LLP, Brussels, Belgium

    Speaker Bio

    MICHELE TAGLIAFERRI is a counsel in Sidley's Brussels office and a member of the firm's White Collar, EU Life Sciences Regulatory and Enforcement, and Complex Commercial Litigation teams.

    Michele Tagliaferri represents corporate and individual clients in white collar criminal matters, and internal investigations, including matters arising under the FCPA and other anti-bribery legislations.

    Michele also assists clients in developing, auditing and enhancing compliance programs, as well as conducting anti-corruption compliance training courses for employees and senior management. He routinely conducts compliance reviews, risk assessments, and due diligence in connection with mergers and acquisitions, joint ventures, and third party engagements.

    Michele has also experience with EU data privacy and cross-border discovery. He counsels clients on how to effectively manage data privacy risks, particularly in EU-US cross border investigations.

    A lawyer licensed to practice law in New York, Washington, DC, Italy, and Belgium, Michele speaks widely on topics related to anti-bribery compliance and enforcement, cross-border investigations, and EU data privacy.
Michael K. Loucks, Esq.
Partner, Skadden Arps LLP; Former Acting United States Attorney, District of Massachusetts, Washington, DC, USA (Moderator)

    Speaker Bio

    Michael K. Loucks, a nationally recognized health care fraud prosecutor, joined the firm as a litigation partner in the Boston office in July 2010. With 25 years in public service, Mr. Loucks most recently was Acting U.S. Attorney and First Assistant U.S. Attorney for the District of Massachusetts, where he led major criminal and civil investigations, as well as many of the most high-profile health care fraud prosecutions of the past two decades.

    Before serving as Acting U.S. Attorney, Mr. Loucks had a long history in the Massachusetts U.S. Attorney's Office. He was First Assistant U.S. Attorney (2005-2009); White Collar Crime Section Chief (2005); Health Care Fraud Unit Chief (1997-2004); and Health Care Fraud Coordinator (1992-2004).

    Mr. Loucks speaks frequently at seminars and symposia on prosecutions, corporate compliance and litigation-related issues associated with the health care, pharmaceutical and medical devices sectors. He also writes extensively on these topics and is the co-author of Prosecuting and Defending Health Care Cases, the leading treatise in the area.

    In 2011, Mr. Loucks received the Burton Award for Legal Achievement, which recognizes excellence in legal scholarship. He was selected in the Boston Business Journal's inaugural "Who's Who in Legal Services" (March 11, 2011).
    Presentation Material (Acrobat)
5:45 p.m. Adjournment

MINI SUMMIT XVI: BEST PRACTICES IN THIRD PARTY SUPPLIER MANAGEMENT
4:30 p.m. Introductions, Panel Discussion and Q&A

Brian K. Beeler, MBA, JD
Senior Vice President, Legal and Chief Compliance Officer, Horizon Pharma, Dublin, Ireland
Gary F. Giampetruzzi, Esq.
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc., New York, NY, USA

    Speaker Bio

    Gary F. Giampetruzzi is one of the most recognized anti-corruption/FCPA compliance and enforcement attorneys and thought leaders, and highly regarded by peers, life science industry insiders, and regulators for his strategic thinking and insight into compliance program, internal investigations and government enforcement issues. Mr. Giampetruzzi has extensive experience with all facets of the anti-corruption and FCPA and U.S. healthcare landscapes. He has been a leader in this growing area of practice for the past 15 years, having led the development of cutting edge compliance programs and measures, conducted and overseen hundreds of internal investigations, and been on the ground in more than 40 markets worldwide (including Asia, North Africa, Europe, the Middle East and Latin America).

    A recent addition to Paul Hastings Investigations and White Collar practice in February 2014, Mr. Giampetruzzi spent 13 years at Pfizer Inc. as its Vice President, Assistant General Counsel and Head of Government Investigations, and earlier on served as Pfizer's Deputy Compliance Officer, where he was also responsible for international compliance investigations and the implementation and maintenance of compliance programs throughout the company's international operations, with a particular focus on emerging markets.
Maurits J.F. Lugard, MA, JD, LLM
Partner, Sidley Austin LLP; Former Member of the European Commission's Legal Service, Brussels, Belgium

    Speaker Bio

    Maurits Lugard leads Sidley's EU Life Sciences Regulatory, Compliance & Enforcement team. He has an uncommon wealth of experience in EU law, drawing on his tenure within the European Commission and years of private practice in Brussels and Washington, D.C. He helps clients navigate the complex web of EU and Member State rules and procedures, including food, drugs and medical devices. He helps clients shape future legislation and advises on the complex legal issues relating to current EU rules on clinical trials, marketing authorizations,advertising and promotional issues, EFPIA Code compliance and anti-bribery compliance.
Stephen Nguyen-Duc
Office of Ethics and Compliance, Regional International Operations, Western Europe and Canada, Abbvie; Former Director, Ethics and Compliance Officer; Member of the Executive Committee, Eli Lilly; Member, Strategic Committee Member, ETHICS, Paris, France

    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.
Melda Tanyeri, MS, MBA
Director, Fraud Investigation and Dispute Services, EY, London, UK (Moderator)

    Speaker Bio

    Melda Tanyeri is a Director with EY and has over 14 years of experience working at EY's Fraud Investigation & Dispute Services practice based in New York, Paris and London. She is a member of EY's Global Life Sciences group. Melda has significant anti-corruption investigation and compliance experience, including working on engagements conducting risk assessments, third party monitoring, pre- / post-acquisition due diligence and conducting customized anti-corruption training sessions. She is a Certified Fraud Examiner.
5:45 p.m. Adjournment



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