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
Wednesday, May 11, 2016

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

Welcome and Overview

Michael Bartke, PhD
Director, Compliance Management, DAIICHI SANKYO EUROPE GmbH, Munich, Germany (Co chair)

    Speaker Bio

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

    WORK EXPERIENCE
    joined Daiichi Sankyo 2001 as Head of Marketing Germany Daiichi Sankyo Europe GmbH 2006 (European HQ) as Director Strategic Marketing Cardiovascular for Europe
    • Experience 30 years within pharmaceutical industry - research based companies ICI (Astra Zeneca) and Bristol Myers Squibb
    • Worked in various functions and national/international projects in marketing, strategic planning, business development
    • Build up compliance organisation and program from scratch

    EDUCATION
    PhD and Diploma in organic chemistry
CHALLENGES IN THE NEW MARKETPLACE 2.0
8:35 a.m.

The New Marketplace Overview: A 2016 Update

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

Presentation Material (Acrobat)
9:10 a.m. Roundtable Discussion
  • Market Access
  • Value-added Services
  • Tendering, Pricing, and Innovative Contracting Strategies
  • Comparative Effectiveness Research
Lee Betteridge
Director, Pharmaceuticals and Life Sciences, PwC, London, UK
Hanim Edoo, MSc.
Consultant, MediQualite, Paris, France

    Speaker Bio

    Consultant on early engagement and Market access with a broad international perspective since 2012.

    Background in psychology, public health, and economics. Field work experience in the developing world, such as Africa.

    Special interest in working towards bridging the gap between decision makers and pharma in a multidimensional perspective.

    Fully bilingual in English and French, with a good grasp of Hindi and written skills in Arabic.
Maarten Meulenbelt, Esq.
Partner, Food, Drug, and Medical Device Regulatory Group, Sidley Austin LLP, Brussels, Belgium

    Speaker Bio

    Maarten Meulenbelt is a partner in Sidley's Brussels office and a member of the firm's Global Life Sciences practice and Antitrust practice. Maarten focuses his practice on EU regulatory affairs, litigation and competition law issues affecting the life sciences sector in Europe. In addition to advising on EU life sciences matters, Maarten also handles competition litigation at the EU and national levels. He has extensive litigation experience before the EU Courts, national courts and competition authorities, the European Commission and national regulatory authorities in several EU Member States. Maarten has significant competition law experience in a variety of sectors. Maarten writes and speaks widely on legal issues affecting the life sciences industry and is featured prominently in the life sciences and competition rankings of leading bar publications.
Stephen Nguyen-Duc
Area Director Ethics and Compliance Western Europe-Israel and Canada, AbbVie; Former Director, Ethics and Compliance Officer, Eli Lilly and Company, Paris, France (Co-chair)

    Speaker Bio

    Stephen is currently Director for Ethics & Compliance Operations in Western Europe, Canada & Israel for Abbvie Pharmaceuticals.

    He also covered for a period of time Ethics & Compliance operations for Eastern Europe, Middle East & Africa.

    Prior to joining Abbvie, he was Ethics & Compliance Director at Eli Lilly in France.

    He also previously held multiple roles in Human Resources, Sales training, Six Sigma and Clinical research in different companies including Bayer and Glaxo SmithKline in France, Belgium and Turkey.

    Stephen is currently member of the Compliance Steering Group of EFPIA and Steering member of Ethics (international Society of Healthcare Ethics & Compliance professionals).

    Stephen is graduated from the Pharmacy School of Paris with a major in industrial pharmacy and pharmacology and from the YMP of INSEAD Business School.
Frank Wartenberg, PhD
President, Central Europe, IMS Health, Frankfurt/Main, Germany
Andrew White
Head of Medicine Management - NHS, Greater Manchester Commissioning Support Unit, Manchester, UK
Olivier Wong, MD, MSc
CMO, MediQualité Omega, Early engagement, HTA technology transfer Consultant, Former Voting member, French Transparency committee, Former French guidelines committee member (HAS, ANSM), Paris, France
Michael Bartke, PhD
Director, Compliance Management, DAIICHI SANKYO EUROPE GmbH, Munich, Germany (Moderator)

    Speaker Bio

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

    WORK EXPERIENCE
    joined Daiichi Sankyo 2001 as Head of Marketing Germany Daiichi Sankyo Europe GmbH 2006 (European HQ) as Director Strategic Marketing Cardiovascular for Europe
    • Experience 30 years within pharmaceutical industry - research based companies ICI (Astra Zeneca) and Bristol Myers Squibb
    • Worked in various functions and national/international projects in marketing, strategic planning, business development
    • Build up compliance organisation and program from scratch

    EDUCATION
    PhD and Diploma in organic chemistry
Polling Question Report (Acrobat)
10:15 a.m. Networking Break
MINI SUMMITS - ROUND II
MINI SUMMIT VI: ANTI-CORRUPTION: CONTRACTING WITH THIRD PARTIES AND OPTIMIZING THE RELATIONSHIP
10:45 a.m. Introductions, Panel Discussion and Q&A
Anthony Alvizu, CPA, EnCE, CFE
Managing Director, Global Risk & Investigations Practice, FTI Consulting, Chicago, IL, USA

    Speaker Bio

    Tony Alvizu is a Managing Director at FTI Consulting and is based in Chicago. He has more than 20 years of experience assisting companies, boards and their counsel conduct financial, accounting, computer, corruption and other types of investigations in countries across the globe. Over the past five years Mr. Alvizu has been exclusively focused on proactive, remediation/monitoring and reactive anti-corruption, investigation and compliance matters with a focus on third-party risk management and due diligence. Mr. Alvizu helped develop an anti-corruption compliance solution that continuously manages third-party risk and due diligence.
Betania Glorio, Esq.
Senior Director Legal and Compliance, EMEA, Raptor Pharmaceuticals, Former Senior Director Compliance, Europe, Middle East and Africa, Onyx Pharmaceuticals, Former Senior Corporate Counsel, Regional Compliance Director, EUCAN, Pfizer, Amsterdam, Netherlands

    Speaker Bio

    Betania Glorio is an experienced legal counsel focused for more than 10 years within legal and compliance positions across several territories within well-known pharmaceutical companies. She started her career within compliance as Regional Compliance Director for Latin America and Canada at Pfizer where she was responsible for the implementation of the first Anti-Corruption and Anti-Bribery procedure in said territory as well as to lead several investigations continuing with other territories such as Western Europe. More recently, Betania occupies the position of Senior Director Legal & Compliance EMEA at Raptor Pharmaceuticals where she can make the best use of her in-depth market experience and legal and compliance expertise.
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
Nathalie Raynaud
Corporate Compliance Officer, Ethics and Business Integrity Department, Sanofi, Paris, France
Melda Tanyeri, MS, MBA
Director, Fraud Investigation and Dispute Services, EY, London, UK (Moderator)

Presentation Material (Acrobat)

Polling Question Report (Acrobat)
12:00 p.m. Networking Luncheon

MINI SUMMIT VII: NEW MARKETPLACE CASE STUDY: ENSURING A COMPLIANT PRODUCT LAUNCH
10:45 a.m. Introductions, Panel Discussion and Q&A
Zeynep Didem Degirmencioglu, LLM
Regional Head of Group Compliance, Intercontinental Region, Merck Serono, 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.
George Fife
Executive Director, Fraud Investigation and Dispute Services, EY; Former Executive Director, Compliance and Ethics, Bristol-Myers Squibb, Paris, France

    Speaker Bio

    George Fife is Executive Director at EY, in the EMEIA Life Sciences Compliance, Fraud Investigation & Dispute Services practice. George specializes in assisting companies with global risk and compliance assessments and investigations. George works closely with management teams, chief compliance officers, general counsels and chief audit executives to identify enforcement risks, determine potential vulnerabilities and recommend solutions from business and operational perspectives to prevent, detect and respond to compliance risks.

    George is a compliance and ethics professional with more than 17 years of in-house compliance life science experience. He has first-hand international experience in building, managing and assessing effectiveness of compliance programs, in the area of anti-corruption and anti-bribery (such as US FCPA, UK Bribery Act, Italy d.lgs 231/01,?) amongst others, embedding analytics into monitoring, driving compliance investigations, designing cutting-edge compliance solutions in anticipation of new emerging risk area's such as Transparency. He assists clients to develop pragmatically their compliance and monitoring programs based on company culture and level of maturity.

    Prior EY, George worked at Bristol-Myers Squibb where he served as the EMEA Executive Director, Compliance & Ethics and globally anti-corruption and third-parties. Prior to BMS, George worked at GE Healthcare in a regional EMEA Compliance and Third-Parties Manager role.
Hubertus Stockmann, MBA
Divisional Compliance Officer, Merck KgaA, Frankfurt, Germany
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)
12:00 p.m. Networking Luncheon

MINI SUMMIT VIII: DATA PRIVACY CASE STUDY: EVOLVING REQUIREMENTS FOR DATA PROTECTION AND TRANSFERS
10:45 a.m. Introductions, Panel Discussion and Q&A

Tanya Daniels, Esq.
Senior Legal Director, EU Head of Data Protection, Deputy Global Chief Privacy Officer, Quintiles, Reading, UK

    Speaker Bio

    Tanya is Senior Legal Director in Quintiles's Office of General Counsel, specialising in Data Protection. She is Head of Data Protection - EU and Asia Pacific and Deputy Chief Global Privacy Officer. She is Vice Chair to Quintiles' Council on Data Protection and Chair of the European Sub-Committee to Quintiles' Council on Data Protection. She has extensive experience of data protection and privacy issues, as an in-house lawyer, and Head of Legal Dept. - EMEA region, in various industries including IT and Life Sciences. She is a Barrister, admitted to the Bar of England and Wales and member of Lincoln's Inn.
Madina Plieva, PhD
Legal and Compliance Director, Russia, Bristol Myers-Squibb; Former Legal Director, Association of International Pharmaceutical Manufacturers (AIPM); Former Head of Legal Department, Kutafin Moscow State Law Academy, Moscow, Russia
Agata Szeliga, LLM
Partner, Soltysinski, Kawecki and Szelzak, Warsaw, Poland
Daniela Fabian Masoch, Esq.
Founder and Managing Director, Fabian Privacy Legal GmbH; Member and Chapter Co-Chair, International Privacy Professionals Association (IAPP); Former Global Head Data Privacy, Novartis International AG, Basel, Switzerland (Moderator)

    Speaker Bio

    Daniela is the founder and managing director of FABIAN PRIVACY LEGAL GmbH.
    • In depth knowledge of applicable practices and laws relating to global and Swiss data privacy and related matters, privacy governance, compliance and risk management, Human Resources, Information Technology, Health, Safety and Environment as well as contracts and contract negotiations
    • Designing strategy, building, implementing and managing a global data privacy compliance function and program as well as Binding Corporate Rules (BCR) in a multinational pharmaceutical company
    • Conceptualizing global and local training programs and awareness campaigns tailored to different organizational levels and business functions
    • Designing and implementing effective risk management and privacy controls, including assessment tools and audit frameworks
    Presentation Material (Acrobat)

    Polling Question Report (Acrobat)
12:00 p.m. Networking Luncheon

MINI SUMMIT IX: IMPLEMENTATION OF COMPLIANCE PROGRAMS ACROSS DIFFERENT COUNTRIES -- CULTURAL IMPLICATIONS
10:45 a.m. Introductions, Panel Discussion and Q&A

Tomasz Kruk
Head of Compliance, Vifor Pharma; Former Director International Compliance, Mallinckrodt Pharmaceuticals; Former Director Global Ethics and Compliance, Actavis plc (now Allergan plc), Zürich, Switzerland

    Speaker Bio

    Comprehensive experience as a compliance officer and lawyer in roles at the global, regional and local level in the pharmaceutical sector, medical devices, finance and consulting. Real-world compliance and anti-corruption expertise Including China, Russia, Latin America as well as Western, Central, Eastern Europe and Balkans. Thoughtful understanding of effective compliance programs and practical problem solving approach.

    Specialties:
    • FCPA, UKBA and other national anti-corruption laws,
    • Pharmaceutical regulations (re .:medicinal products, promotion, OTC, Rx, hospital drugs, clinical trials)
    • Pharmaceutical codes (EFPIA, IFPMA, EUCOMED)
    • Data privacy laws,
    • Crisis management,
    • Corporate governance,
    • Antitrust and competition laws,
    • AML laws,
    • Employment laws,
    • Litigation management,
    • General corporate,
    • Corporate policy-making.
    Presentation Material (Acrobat)
Giota Papamarkou
Global Ethics and Compliance Director, Ipsen; Former EMEA Compliance and Ethics Manager, Bristol-Myers Squibb, Paris, France

Presentation Material (Acrobat)
Fiona Maini, M.Sc.
Director, Risk Advisory, Deloittem London, UK

    Speaker Bio

    Fiona is a Director within Deloitte Life Sciences practice, with around nineteen years experience within the Pharmaceutical and Chemicals industries. Fiona commenced her career as a scientist working in a research based environment.

    Over the last sixteen years Fiona has primarily been working in the pharmaceutical and regulatory arenas working on multiple projects relating to the management, oversight and strategic direction with regards to Pharmaceutical governance & compliance. Fiona has performed multiple roles from advisory, programme/project management, CSV validation, quality and compliance management. Fiona's focus and specialisation over the past few years has been on the changing regulations and supporting organizations through the planning and .preparation with particular respect to the new European legislation and general GxP relevant change programmes.
    Presentation Material (Acrobat)
Ulf H. Grundmann, Esq.
Partner, King & Spalding LLP, Frankfurt, Germany (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)
12:00 p.m. Networking Luncheon

MINI SUMMIT X: USING PREDICTIVE ANALYTICS TO ENHANCE RISK MANAGEMENT
10:45 a.m. Introductions, Panel Discussion and Q&A

Timothy Ayers, JD, MPH
Vice President, Chief Compliance Officer, Horizon Pharma plc; Former VP, Chief Compliance Officer, Dendreon; Former Associate General Counsel and Executive Director of Compliance, Seattle Genetics, Chicago, IL, USA

    Speaker Bio

    Tim Ayers is the VP, Chief Compliance Officer for Horizon Pharma plc. In that role, is the global compliance officer and responsible for the compliance program. Prior to that, he was the Vice President, Chief Compliance Officer for Dendreon Corporation. He has held various legal and compliance roles at small oncology biotech companies where he established and implemented the compliance programs, and also provided legal counsel to all areas of the business.

    Prior to joining the in-house ranks, Tim was an attorney in the healthcare group for the Washington, DC Office of Winston & Strawn, LLP. Tim is a graduate of Georgetown University, where he also obtained his J.D. in 1998. He subsequently obtained his Masters in Public Health from Columbia University in 2000.
Elvan Sevi Firat
Founding Partner, Firat - Izgi Attorney Partnership; Board Member, Transparency International Turkey Section, Istanbul, Turkey

    Speaker Bio

    Mrs. Firat regularly supports multinational companies including manufacturers of pharmaceuticals, biotechnology, medical devices, special food and feed, cosmetics and other consumer products on important new legislative projects and policy developments in Turkey. She also advises and provides consultancy on strategic planning of new investments and start-ups in Turkey, regulatory compliance, anti-corruption and anti-trust. She also has broad litigation experience of life science matters, including product liability, advertising, customs controls and promotional activities.

    Mrs. Firat has in depth involvement in the first ever initiated court actions in Turkey in order to protect patent rights, including administrative court actions, as well as regulatory works before the Ministry of Health regarding enforcement of pharmaceutical patent rights, data protection and data exclusivity.

    In addition to her experience in regulatory and compliance matters, Mrs.Firat also regularly represents clients before the Turkish civil, criminal and administrative courts.
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.
Abdul Luheshi, MBA
Director, Life Sciences Regulatory Compliance, KPMG; Former Vice President, Health Care Compliance, Johnson & Johnson, London, UK (Moderator)

    Speaker Bio

    Abdul is a specialist in anti-bribery and corruption compliance with more than 20 years in the life sciences industry. Currently at KPMG leading their UK ABAC compliance practice in their Life Science practice.

    Prior to joining KPMG Abdul spent 15 years with Johnson & Johnson of which 10 were in healthcare compliance where he first led the compliance organisation for LifeScan across EMEA and latterly for J&J across the Asia Pacific region.

    Originally an organic chemist, post-MBA Abdul has held posts in operations management and finance across the chemical, agrichemical and healthcare industries.
12:00 p.m. Networking Luncheon

AFTERNOON PLENARY SESSION
1:15 pm

Welcome and Overview

Dominique Laymand, Esq.
Senior Vice President, Chief Ethics and Compliance Officer, Ipsen; President, International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France (Co-chair)

    Speaker Bio

    Dominique Laymand is President of ETHICS, International Society of Healthcare Ethics and Compliance Professionals, whose mission is to developing and enhancing the highest professional standards in the Healthcare Sector, contributing to the development of professionals and the success of Ethics and Compliance organizations.

    Dominique Laymand is Senior vice-president, Chief Ethics and Compliance Officer at Ipsen. Dominique is also member of the Chairman's Committee. Dominique will be further developing the Ipsen Ethics & Compliance Program and Organization.
1:20 pm

Keynote: Ethics and the Current Industry-Physician Relationship Model -- Are They Compatible?

Sadek Beloucif, MD, PhD
Professor, Department of Anesthesiology and Critical Care Medicine, Avicenne University Hospital; Chairman, Ethics Committee of the Biomedicine Agency, Paris, France

    Speaker Bio

    Sadek Beloucif is University Professor (Université Paris 13 - Training and Research Unit Health, Medicine and Human Biology), head of the hospital Anesthesiology Service Avicenne in Bobigny (Assistance Publique, Hôpitaux de Paris).

    He was a member of the National Ethics Advisory Committee and the Board orientation of the Biomedicine Agency. Currently Chairman of the Subcommittee on Ethics, European Society of Anesthesiology, he is the author of 35 original articles, 21 book chapters, 27 educational articles and numerous invited lectures.
    Presentation Material (Acrobat)
1:50 pm EFPIA Keynote: Reflections on the Eve of Transparency
Marie-Claire Pickaert
Deputy Director General, European Federation of Pharmaceutical Industries and Associations (EFPIA), Brussels, Belgium

    Speaker Bio

    Current Professional Position
    Ms Pickaert is the Deputy Director General of EFPIA, member of EFPIA's General Management.

    Since 2008, Ms Pickaert is coordinating EFPIA's ethics and compliance activities. Following the adoption of the 2010 Leadership Statement calling for greater transparency, accountability and ethical behaviour within and industry framework of self-regulation, she took the lead of activities including the creation of the EFPIA e4ethics platform and the development of the EFPIA Disclosure Code. She is acting as the Chief Ethics & Compliance Officer at EFPIA.

    In 2015, she was asked to take the role of Ambassador to the Medical Communities, coordinating EFPIA's relationships with medical & scientific societies, including learned societies, also through professional communities within the pharmaceutical companies that interact with medical communities.

    Education
    Master in Economic Science from the Vrije Universiteit te Brussel (Belgium) ? with honours

    Thesis: Economic and Social Impact of Education and the Value of Human Capital ? first class honours

    Continued education and specialisation ? postgraduate / executive training

    * Applied Psychology in Economics (2 years)

    * Auditing and Valuation of Enterprises (2 years)

    * Hospital Management (1 year)
    Presentation Material (Acrobat)
PERSPECTIVES ON TRANSPARENCY FROM THE LOCAL COUNTRY LEVEL: VOICES FROM POLAND
2:20 pm Introductory Comments
Dr. Krzysztof Landa
Vice Minister of Health in Charge of Drug Policy, Polish Ministry of Health; Founder, Watch Health Care Foundation; Former President, Central & Eastern European, Society of Technology Assessment in Health Care, Warsaw, Poland
2:50 pm Roundtable Discussion
Professor Jacek Jassem
Head of the Department of Oncology and Radiotherapy, Medical University of Gdansk; Former President of the Polish Society of Oncology, Gdansk, Poland

    Speaker Bio

    Jacek Jassem is a Full Professor of Clinical Oncology and Radiotherapy and the Head of the Department of Oncology and Radiotherapy, Medical University of Gdansk, Poland.

    His main scientific interests are lung cancer, breast cancer, combined modality treatment with chemotherapy and radiation as well as molecular oncology.

    He is the past-chairman of the EORTC Breast Cancer Group and the EORTC Executive Committee, the chairman of the Central and East European Oncology Group, the past chairman of the ASCO International Affairs Committee, and the immediate past-president of the Polish Oncological Society. His is currently an ESMO Executive Board member.

    He undertook nationwide public health initiatives, such as authoring of Polish anti-tobacco legislation (introduced by the Parliament in 2010) and the coordination of Cancer Control Strategy for Poland 2015-2024.
Dr. Krzysztof Landa
Vice Minister of Health in Charge of Drug Policy, Polish Ministry of Health; Founder, Watch Health Care Foundation; Former President, Central and Eastern European Society of Technology Assessment in Health Care, Warsaw, Poland
Dr. Grzegorz Makowski
Director of the Public Integrity Program, Stefan Batory Foundation, the Local Partner with Transparency International in Poland, Warsaw, Poland

    Speaker Bio

    Grzegorz Makowski, PhD - sociologist, Director of the Public Integrity Program at the Stefan Batory Foundation and Assistant Professor at the Collegium Civitas (Warsaw, Poland). In 2002 graduated from the Faculty of Applied Social Sciences at the Warsaw University and awarded by Polish Sociological Society with the 1st Class Florian Znaniecki's prize for the best MA sociological thesis. Author of books and numerous research papers and press articles on corruption, anti-corruption policy, sociology of social problems, civil society and non-governmental organizations.
    Presentation Material (Acrobat)
Pawel Sztwiertnia
Director General, INFARMA; Former Undersecretary of State, Polish Ministry of Health, Warsaw, Poland
Mariusz Witalis
Partner, Fraud Investigation and Dispute Services, EY, Warsaw, Poland (Moderator)

    Speaker Bio

    Mariusz Witalis is a Partner leading the EY Fraud Investigation & Dispute Services (FIDS) practice in Poland and the Baltic countries. He specializes in assisting pharmaceutical manufactures, medical device companies and biotechnology companies with internal and government investigations and in compliance-related matters. He is coordinating EY FIDS life sciences activities across Europe, Middle East, India & Africa.

    He has vast experience working with legal counsels, internal audit and compliance functions on the matters arising under the US Foreign Corrupt Practices Act as well as a number of other country-specific anti-corruption and competition regulations. He has been advising a number of pharmaceutical, medical device, and biotechnology companies on compliance-related topics in over 40 EMEIA countries.

    Mr. Witalis is a frequent speaker at international conferences and seminars devoted to compliance and fraud management and an author of numerous articles on compliance and business fraud. He has a Diploma of Polish Statutory Auditor, Certified Internal Auditor and is a Certified Fraud Examiner.
4:00 p.m. Break
MINI SUMMITS - ROUND III
MINI SUMMIT XI: ADVANCED ISSUES IN THIRD PARTY RELATIONSHIPS: CROSS-BORDER ENGAGEMENTS, FAIR MARKET VALUE, MONITORING AND AUDITING OF ON-GOING RELATIONSHIPS
4:30 p.m. Introductions, Panel Discussion and Q&A

Ela Bochenek, Esq.
Vice President, Global Compliance, Insmed Incorporated, Bridgewater, NJ, USA

    Speaker Bio

    Ela Bochenek is a Vice President, Global Compliance at Insmed Incorporated, a global biotech orphan drug pharmaceutical company in New Jersey, where she leads the company's global compliance function. Prior to joining Insmed, Ela was a Vice President and Associate General Counsel at NPS Pharmaceuticals, Inc., another global biotech orphan drug company, where she was in charge of the international law department and was leading the international compliance and commercial functions. Ela was also Associate General Counsel - International for C.R. Bard, Inc., a New Jersey-based multinational medical device company, where she was responsible for providing legal oversight and counsel to all of Bard's international operations on a variety of commercial and compliance matters. Before joining Bard, Ela was a member of the International Legal Departments of Schering-Plough and Bristol-Myers Squibb Company, where she provided general legal support to the companies' pharmaceutical operations worldwide. Prior to that, she practiced at two Philadelphia law firms, Morgan, Lewis & Bockius and Pepper, Hamilton & Sheetz, as a general corporate attorney with a concentration in international business transactions. Ela's law degree is from the University of Pennsylvania Law School, where she was a member of the Law Review. In 2009, Ela won the Global Counsel Award 2009 in the Best Individual Commercial Lawyer category; the award is sponsored by the International Law Office and the Association of Corporate Counsel.
Maria Teresa Rico Perez, MD
Europe and Canada Regional Compliance Officer, Biogen, Zug, Switzerland
Michele Tagliaferri, Esq.
Partner, Sidley Austin LLP, Brussels, Belgium
Mirjam Weisse, Esq.
Senior Director, Head of Compliance EMEA, Merz Pharma GmbH & Co. KGaA, Frankfurt, Germany

    Speaker Bio

    Mirjam Weisse studied law in Heidelberg and completed her legal training at the Munich appellate court. Being first specialized in Labour Law Mirjam wrote her PhD thesis on collective employment law at the Ruprecht-Karls-University in Heidelberg.

    Mirjam is looking back on 14 Years of professional experience in international Law firms as well as in House. Moving from a focus in HR and employment to Compliance in 2009 Mirjam worked over 5 years in the Compliance Governance and Regulatory department of Siemens being responsible for the company wide design of Compliance Guidelines (e.g. Business Partner, Data deletion and retention?) and processes as well as for major Antitrust and Anti-Corruption investigations on an international scale. Mirjam took over her position as Head of Compliance EMEA over a year ago and has now also gained experience in the pharmaceutical industry as well as filling an operational and a governance role in an international compliance organization.
Andy Bender, MS, MBA
President and Founder, Polaris, New York, NY, USA (Co-moderator)

    Speaker Bio

    As a hands-on executive, Andy has been involved in a wide variety of compliance-related engagements for pharmaceutical and device manufacturers, ranging from policy development and process automation to organizational change. His expertise ranges from the sales and marketing to medical and clinical departments of the client organization. Andy is still involved in many of Polaris' client assignments, and has personally led many FMV, auditing and monitoring projects, as well as numerous international transparency reporting and HCP/O implementations. He has implemented in excess of fifty Request Management Systems for clients, focused on grants, charitable contributions and IIS requests.

    Andy has designed and developed many of the concepts, programs and methodologies that have made Polaris an international leader in the healthcare law compliance business.
    Presentation Material (Acrobat)
Michael O'Connor
Senior Director, Ethics and Compliance Operations, Alexion Pharmaceuticals, Inc., Cheshire, CT (Co-moderator)

    Speaker Bio

    Mike is a consistent big picture, strategic thinker and creative problem solver with a talent for understanding complex situations, implementing solutions, and achieving results. He has over 18 years of international experience assisting clients in the Pharmaceutical industry with addressing business issues in areas such as Corporate Compliance, eDiscovery, Sales and Marketing Optimization, Regulatory Compliance, Document/records Management, Master Data Management and Information Management. Mike also has over 15 years of experience building and managing project teams throughout project life cycles, including business assessments, advisory, vendor selection, and realization with a key focus on delivering business results. Mike is currently at Alexion where he is the Global Head of Compliance Operations.
Polling Question Report (Acrobat)
5:45 p.m. Adjournment

MINI SUMMIT XII: NEW ETHICS-BASED APPROACHES TO POLICIES AND TRAINING
4:30 p.m. Introductions, Panel Discussion and Q&A

Suzana Junaci, MD
Ethics and Compliance Officer, Eli Lilly and Company, Zagreb, Croatia

    Speaker Bio

    Suzana is a physician, licensed in psychiatry. She works for Eli Lilly and Company since 1999. Suzana has an experience in the various fields in the pharmaceutical business: Sales, Sales Operations, Marketing, Medical Affairs, Clinical Operations, and Ethics and Compliance function. Suzana has a strong capabilities in virtual and regional leadership, cross-functional partnership and change management. Last 7 years Suzana is in the E&C organization with the main interest in business consultation, E&C capabilities, risk assessment and monitoring.
Edoardo Lazzarini, PhD
Europe and Canada Compliance Initiative Director, Takeda Pharmaceuticals; Former Compliance Officer EMEA, Biomet; Former Vice-chair of Compliance, Network Steering Committee, Eucomed, Milan, Italy

    Speaker Bio

    Proven success in developing, implementing and sustaining robust local and international Compliance Programs in Life Sciences business (Pharma, Medical Devices, Animal Health).

    Experience in managing the European Compliance Program in a company with a Deferred Prosecution Agreement related to FCPA including a Federal Monitor.

    Experience in Privacy, Quality & Compliance, Enterprise Risk Management and Business Continuity Management.

    Specialties:
    • Extensive knowledge in business practices.
    • Compliance program management to prevent compliance, reputational, legal, and financial risks (anti-bribery, FCPA, Italian Law 231/2001, Privacy, Investigations, Safety, Health & Enviromental) also in merging and acquisition environment.
    • Continuos improvement mindset.
    • Champion in company cultural turnaround, while integrating Compliance in every day practices.
    • Excellent at team building.
    • Good communication and interpersonal skills.
    • Ability to manage multiple priorities and programs across a complex organization with multiple stakeholders.
Piergiorgio Pepe, LLM, EEMEA
Compliance Area Director, Office of Ethics and Compliance, AbbVie; Former Director, Compliance and Ethics, EMEA, Bristol-Myers Squibb, Paris, France
Ben Shoshan
Director/Owner, Consultant and Executive Coach, Open Water, London, UK

Presentation Material (Acrobat)
Christine Longawa, CPA, CFE
Associate Director, Healthcare and Life Sciences Disputes, Regulatory, Compliance and Investigations, Navigant Consulting, Inc., Chicago, IL, USA (Moderator)

    Speaker Bio

    Christine Longawa, CPA, CFE is an Associate Director in Navigant's Healthcare and Life Sciences Disputes, Regulatory, Compliance, and Investigations Practice. Christine began her career in public accounting, specializing in financial statement audits of life sciences organizations. Since joining Navigant in 2008, Christine has assisted numerous clients in developing, analyzing, monitoring and auditing their global compliance programs. Christine has expertise in serving as and managing the Independent Review Organization (IRO) and Pre-IRO for several life sciences companies. She has experience working on Corporate Integrity Agreement Board Advisor engagements and compliance effectiveness reviews. In addition, Christine has supported her clients with their field force monitoring and aggregate spend obligations.
5:45 p.m. Adjournment

MINI SUMMIT XIII: MEDICAL DEVICES: THE CHANGING ENFORCEMENT LANDSCAPE
4:30 p.m. Introductions, Panel Discussion and Q&A
Roeland Van Aelst
Regional Vice President, HCCO MD&D EMEA and Canada, Office of Health Care Compliance and Privacy, Johnson & Johnson; Co-chair, Strategic Committee, International Society of Healthcare, Ethics and Compliance Professionals (ETHICS); Chairman, MedTech Compliance Network, Brussels, Belgium (Co-chair)
Chris Holmes
Director, Navigant Consulting, Inc., London, UK

    Speaker Bio

    Navigant continues to expand its global Life Sciences practice and has recently recruited Chris Holmes to the Regulatory and Compliance team. Chris brings over twenty years of experience delivering strategic advice and implementation expertise including regulatory compliance, drug safety, risk management and operational performance programs. He has served clients extensively across Europe and the US and helped build global governance, organization and operating models which have had significant positive impact on compliance, quality, cost and patient safety.

    Prior to joining Navigant, Chris was Director at WCI Consulting where he implemented multiple assessment and risk mitigation programs, including Top 10 pharmaceutical, biotechnology and consumer health clients. Chris also set up and developed leading industry networks with over 60 subscribing companies sharing best practice, benchmarking and thought leadership in patient safety and regulatory affairs.
Maurits J.F. Lugard, MA, JD, LLM
Partner and Lead, EU Life Sciences Regulatory Team, Sidley Austin LLP; Former Member, European Commission's Legal Service, Brussels, Belgium (Moderator)

    Speaker Bio

    Maurits Lugard leads Sidley's EU Life Sciences Regulatory and Compliance team. He has an uncommon wealth of experience in EU law, drawing on his tenure within the European Commission and practicing in the regulatory capitals of Brussels and Washington, D.C. Maurits's practice focuses on helping clients navigate the complex web of EU and Member State rules and procedures with an emphasis on food, drugs, medical devices, cosmetics and biotechnology.
    Presentation Material (Acrobat)
5:45 p.m. Adjournment

MINI SUMMIT XIV: R&D COMPLIANCE -- CASE STUDY ON CLINICAL TRIAL DATA DISCLOSURES
4:30 p.m. Introductions, Panel Discussion and Q&A

Ima Parrondo
Health Care Compliance Officer EMEA-C, Janssen Pharmaceutical Companies of Johnson & Johnson, Madrid, Spain

    Speaker Bio

    Dr Ima Parrondo is the head of the EMEA Health Care Compliance organization for Janssen, Pharmaceutical company of Johnson and Johnson, since 2008.

    Before joining Compliance, she served as Area Medical Director for Europe South in Janssen, and previously had Marketing and Sales responsibilities, in national and international roles.

    She currently leads the HCPs/HCOs Disclosure of Transfer of Value project within Janssen.

    She is an active member of the Efpia Ethics and Compliance Committee and currently leads the Working Group on "Interactions between industry and all the stakeholders: collaborative approach in deepening ethical standards and improvement of the governance".

    She served on the Efpia Compliance Committee Steering Group and led the Working Group on Medical Education who prepared the Efpia Position Paper on Medical Education and collaborated with the Biomed Alliance in the development of their Code.
    Presentation Material (Acrobat)
Daniela Fabian Masoch, Esq.
Founder and Managing Director, Fabian Privacy Legal GmbH, Member and Chapter Co-Chair, International Privacy Professionals Association (IAPP), Former Global Head Data Privacy, Novartis International AG, Basel, Switzerland

    Speaker Bio

    Daniela is the founder and managing director of FABIAN PRIVACY LEGAL GmbH.
    • In depth knowledge of applicable practices and laws relating to global and Swiss data privacy and related matters, privacy governance, compliance and risk management, Human Resources, Information Technology, Health, Safety and Environment as well as contracts and contract negotiations
    • Designing strategy, building, implementing and managing a global data privacy compliance function and program as well as Binding Corporate Rules (BCR) in a multinational pharmaceutical company
    • Conceptualizing global and local training programs and awareness campaigns tailored to different organizational levels and business functions
    • Designing and implementing effective risk management and privacy controls, including assessment tools and audit frameworks
    Presentation Material (Acrobat)
Fabien Roy, DESS, European Law
Senior Associate, Hogan Lovells, Brussels, Belgium (Moderator)

Presentation Material (Acrobat)
5:45 p.m. Adjournment

MINI SUMMIT XV: ADVANCED ISSUES IN APPLYING ANALYTICS -- USING THE DATA TO PROVIDE VALUE AND PARTNER WITH THE BUSINESS
4:30 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 been a Compliance Officer at all levels from single marketing company and European Compliance Officer for GlaxoSmithKline (GSK) to international VP for AstraZeneca (AZ). As VP Compliance for AZ's International Sales and Marketing Organisation, Sue had responsibility for ensuring compliance in every country in which AZ had commercial operations except the USA and Canada. During her time at both GSK and AZ, Sue helped senior leaders find innovative ways to conduct business ethically and in a compliant manner without jeopardising the bottom line.

    In early 2010, Sue established the management consultancy Sue Egan Associates Limited, specialising in Corporate Governance, Risk Management, Compliance and Change Management. Clients include life science companies, charities, a European Agency, and companies in other industry sectors who have all used Sue's unique experience and approach to help them achieve their goals ethically and sustainably.

    In addition to her compliance and ethics experience, Sue has over 20 years' experience in Information Technology and related fields, including Project Management and Computer Systems Validation. She has an MBA from Cranfield University School of Management, UK and a BSc degree in Mathematics and Physics from Manchester University, UK. Sue is a Fellow of the Chartered Management Institute.
Anita K. Kim-Reinartz
Partner, Fraud Investigation and Dispute Services, EY, Düsseldorf, Germany

    Speaker Bio

    Anita Kim-Reinartz is a Forensic partner with more than 14 years of experience in fraud detection, compliance management and forensic data analytics. Since 2012 she is heading the life sciences sector for forensic services and from 2013 she additionally heads the forensic data analytics team in Germany. She has extensive experience implementing global data analytics projects e.g. she led a global continuous controls monitoring project for one of the leading technology companies in Germany. Anita has led the design of a then market leading fraud analytics detection method which was trademarked in Germany and won the German Prize for Innovation.
Tamara Tubin
Compliance Director, Business Support EUCAN, Takeda Pharmaceuticals International AG, Switzerland
John Patrick Oroho, Esq.
Executive Vice President and Chief Strategy Officer, Porzio Life Sciences, LLC, Principal, Porzio, Bromberg & Newman PC, Morristown, NJ, USA (Moderator)

    Speaker Bio

    JOHN PATRICK OROHO, Executive Vice President and Chief Strategy Officer of Porzio Life Sciences, LLC, meets regularly with companies to identify sales and marketing issues and to propose solutions that streamline their practices in meeting compliance requirements of all 50 states and the District of Columbia.

    Mr. Oroho is also a principal of the law firm, Porzio, Bromberg & Newman P.C., and practices in the Life Sciences Compliance and Commercialization Department. He concentrates his law practice in regulatory compliance with respect to the Prescription Drug Marketing Act (PDMA), Antikickback statute, False Claim Act, and Medicare and Medicaid fraud and abuse.

    Mr. Oroho has an extensive pharmaceutical regulatory and compliance background. He spent three years as General Counsel for Integrated Pharma Technologies and Computer Systems Services & Consulting, Inc.
5:45 p.m. Adjournment



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