Agenda Links: Precon/Day 1 | Day 3
AGENDA: DAY II
TUESDAY, MAY 16, 2017
7:30 am
Registration Commences
MORNING PLENARY SESSION
8:00 am
Welcome and Overview
Dante Beccaria
Senior Vice President, Global Head of Ethics and Business Integrity, Sanofi, Paris, France (Co-chair)
Senior Vice President, Global Head of Ethics and Business Integrity, Sanofi, Paris, France (Co-chair)
Mr. Dante Beccaria is the Global Compliance Officer and Senior Vice President of Sanofi. Mr. Beccaria began his career in 1985 in the field of Financing & Treasury and bank relationships first at Shell Italy and then Alcatel Italy. He has over 20 years’ experience within Sanofi, having covered both operational and Corporate responsibilities. In 1990, he joined the Sanofi Italian affiliate to implement a Treasury Platform, gathering all the Business activities in the country. Since 1992, he served as Controlling Director of the Italian Pharma affiliate. In 2001, he became Projects Director within the Mergers & Acquisitions Corporate department. In 2003, he joined the Corporate Internal Audit as Associate Vice President. He served as Vice President of Internal Audit after the acquisition of Aventis.
8:10 am
OECD Update
Nicola Bonucci, DEA, DESS, LLM
Director, Directorate for Legal Affairs, Organisation for Economic Co-operation and Development, Paris, France
Director, Directorate for Legal Affairs, Organisation for Economic Co-operation and Development, Paris, France
Nicola Bonucci is the Director for Legal Affairs and the coordinator for accession. He joined the OECD in 1993 as a Legal Counselor, served as Deputy Director from 2000 until becoming Director in 2005. He focuses on general public international law issues, participating in the negociation of international agreements, interpreting the basic texts of the Organisation, and providing legal opinions to the senior management (The Secretary-General and his Deputies), the Council (the governing body of the OECD), and its subsidiary bodies.
He plays an active role in the drafting and the negociation of the OECD legal instruments. He also deals with personnel matters, including litigation in front of the Administrative Tribunal of the OECD, budgetary issues and contracts. Since 1997 Mr. Bonucci has been closely involved in the monitoring and follow-up of the OECD Anti-Bribery Convention and is a regular speaker in international conferences on this subject.
He plays an active role in the drafting and the negociation of the OECD legal instruments. He also deals with personnel matters, including litigation in front of the Administrative Tribunal of the OECD, budgetary issues and contracts. Since 1997 Mr. Bonucci has been closely involved in the monitoring and follow-up of the OECD Anti-Bribery Convention and is a regular speaker in international conferences on this subject.
8:40 am
Pharmaceutical Compliance and Access to Medicine: Findings on Market Influence & Compliance in the 2016 Access to Medicine Index
Luca Genovese
Researcher, Access to Medicine Foundation, The Netherlands
Researcher, Access to Medicine Foundation, The Netherlands
Luca Genovese holds an Advanced Master in International Development from the Radboud University of Nijmegen, where amongst other topics he studied accountability frameworks for companies operating in development cooperation. After gaining experience as free-lance journalist in Italy, Luca worked in Africa on projects related to microcredit and rural development, prior to joining the UN World Food Programme in Burkina Faso.
He has also worked in logistics and business analysis for a commodity trading company in Rotterdam. Before joining the Access to Medicine Foundation, Luca built up expertise on Public-Private Partnerships and Base-of-the-Pyramid markets while working at the Global Alliance for Improved Nutrition. His academic background also includes an MA in International Relations from the University of Napoli “L’Orientale” and a BA in Communications and Journalism from the University of Salerno.
He has also worked in logistics and business analysis for a commodity trading company in Rotterdam. Before joining the Access to Medicine Foundation, Luca built up expertise on Public-Private Partnerships and Base-of-the-Pyramid markets while working at the Global Alliance for Improved Nutrition. His academic background also includes an MA in International Relations from the University of Napoli “L’Orientale” and a BA in Communications and Journalism from the University of Salerno.
9:10 am
The ISO Anti-Corruption Standard (ISO 37001)
Neill Stansbury, Esq.
Co-founder and Director of the Global Infrastructure Anti-Corruption Centre; Chair, International Organization for Standardization Anti-Bribery Project Committee; Vice Chair, Anti-corruption Standing Committee, World Federation of Engineering Organization, Buckinghamshire, UK
Co-founder and Director of the Global Infrastructure Anti-Corruption Centre; Chair, International Organization for Standardization Anti-Bribery Project Committee; Vice Chair, Anti-corruption Standing Committee, World Federation of Engineering Organization, Buckinghamshire, UK
Neill Stansbury is Co-founder and Director of the Global Infrastructure Anti-Corruption Centre (GIACC). He is a construction lawyer who has worked for over 30 years in the international infrastructure sector. He is Chairman of the International Organization for Standardization (ISO) Anti-Bribery Project Committee, Past Chairman of British Standards Institute Anti-Bribery Working Group, and Vice Chairman of the World Federation of Engineering Organisation’s Anti-Corruption Standing Committee. He was independent anti-corruption compliance monitor of Balfour Beatty, Parsons Brinckerhoff and Mabey Bridge. He is co-author of the GIACC Resource Centre. He has given anti-corruption presentations and workshops in over 25 countries.
9:40 am
Anti-Corruption Enforcement Panel
Peter Dieners, Esq.Partner and Head, Global Healthcare and Life Sciences Group, Clifford Chance, Co-chair, Legal Affairs Focus Group (LA FG), EUCOMED, Co-chair, Compliance Network (CN), EUCOMED, Düsseldorf, Germany
Dr. Peter Dieners is a Partner of Clifford Chance based in Düsseldorf, 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 Diener 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-à-vis government agencies in relation to legislative projects and amendments as well as for the elaboration of compliance related industry codes of conduct.
Ulf H. Grundmann, Esq.Partner, Life Sciences Practice Group, King & Spalding LLP, Frankfurt am Main, Germany
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 extrajudicial 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.
Michael K. Loucks, Esq.Partner, Skadden Arps LLP; Former Acting United States Attorney, District of Massachusetts, US Department of Justice, Washington, DC, USA
Paul J. Melling, Esq.Founding Partner, Baker & McKenzie – CIS, Limited, Moscow, Russia
Paul Melling is an English solicitor and the founding partner of Baker & McKenzie’s Moscow and Almaty offices. He has been a resident of Moscow since January 1989 and has spent over 28 years practicing law in the Russian Federation, Ukraine, Kazakhstan and other former Soviet republics. He founded and leads both Baker & McKenzie’s CIS Healthcare Industry Group and Compliance & Investigations Group and is a member of the Steering Committees for his firm’s Global and EMEA Healthcare Industry Groups. Mr. Melling has been the Honorary Legal Adviser to the British Ambassador to Russia since 1990 and is also Honorary Legal Adviser to Russia’s Association of International Pharmaceutical Manufacturers (AIPM). He is also a member of the Advisory Council of the Russo-British Chamber of Commerce.
Vivian Robinson, Esq.Queen’s Counsel, Partner, McGuire Woods; Former General Counsel of the UK Serious Fraud Office; Former Head, QEB Hollis Whiteman Chambers, Recorder of the Crown Court and Treasurer of Inner Temple, London, UK
Vivian Robinson QC became a barrister in 1967 and practised at the English criminal bar for over 40 years, acting for both prosecution and defence. He also sat as a part-time judge for over 30 years. He was appointed Queen’s Counsel in 1986, became Head of QEB Hollis Whiteman Chambers in 2006 and served as Treasurer of Inner Temple in 2009.
In 2009 he left the practising bar to take up appointment as first General Counsel at the Serious Fraud Office. In this capacity he played a prominent role in the development of the SFO’s enforcement strategy on the UK Bribery Act and was its principal liaison with the business community on this subject.
In 2011 he joined US law firm McGuireWoods and leads its London Office Government Investigation and White Collar Litigation team. He advises clients on compliance, regulatory and white collar crime issues, both in the UK and internationally. He has travelled extensively on behalf of the firm in Europe, the US, India, South America, China and Africa.
He is a Vice-Chair of the American Bar Association Section of International Law Anti-Corruption Committee and a co-author of “The FCPA and UK Bribery Act – A Ready Reference for Business and Lawyers” published by the ABA.
In 2009 he left the practising bar to take up appointment as first General Counsel at the Serious Fraud Office. In this capacity he played a prominent role in the development of the SFO’s enforcement strategy on the UK Bribery Act and was its principal liaison with the business community on this subject.
In 2011 he joined US law firm McGuireWoods and leads its London Office Government Investigation and White Collar Litigation team. He advises clients on compliance, regulatory and white collar crime issues, both in the UK and internationally. He has travelled extensively on behalf of the firm in Europe, the US, India, South America, China and Africa.
He is a Vice-Chair of the American Bar Association Section of International Law Anti-Corruption Committee and a co-author of “The FCPA and UK Bribery Act – A Ready Reference for Business and Lawyers” published by the ABA.
Yuet Ming Tham, JDPartner, Sidley Austin LLP; Former Asia Pacific Regional Compliance Director, Pfizer; Former Deputy Public Prosecutor Singapore, Hong Kong
Yuet Ming Tham is a partner in Sidley’s Singapore/Hong Kong offices, and is the Head of Sidley’s Asia Pacific Compliance and Investigations Group. Ms. Tham is qualified in New York, the UK, Singapore and Hong Kong. Ms. Tham has extensive experience carrying out investigations and advising a large number of major U.S./European pharmaceutical and medical device companies on compliance, clinical trials, labeling, promotional and marketing regulations, as well as contractual and commercial matters such as distribution agreements. In November 2016 Ms. Tham was named the “Compliance & Investigation Lawyer of the Year 2016” and her team was named the “Compliance & Investigation Firm of the Year 2016”. She has been acknowledged as a “Leading Lawyer” by Chambers Asia Pacific in the Life Sciences, AntiCorruption, Dispute Resolution and Contentious Financial Regulatory categories.
Ted Acosta, Esq.Americas Vice Chair, Risk Management, EY; Former Senior Counsel, Office of Inspector General, US Department of Health and Human Services, New York, NY, USA and Paris, France (Moderator)
Ted Acosta is a senior executive with over 22 years of professional services experience. He began his career as a practicing white-collar and regulatory attorney both in private practice and with the US Federal government. He has spent the last 16 years at EY where he focused on assisting clients with internal investigations and compliance program structures for US regulatory obligations, as well as foreign standards. In that role, Ted served many public and private Fortune 500 companies on matters in over 50 countries, working significantly on the ground and with C-suites.
In 2014, Ted was named Vice Chair of Risk for EY’s Americas and US firms and appointed to their management boards. He leads the Risk Management organization, which covers internal risk assessments, compliance, ethics, privacy and independence, as well enterprise risk management, and client and engagement acceptance, among others.
In 2014, Ted was named Vice Chair of Risk for EY’s Americas and US firms and appointed to their management boards. He leads the Risk Management organization, which covers internal risk assessments, compliance, ethics, privacy and independence, as well enterprise risk management, and client and engagement acceptance, among others.
10:45 am
Networking Break
AFTERNOON MINI SUMMITS GROUP II: 11:15 am — 12:30 pm
MS 6: Practical Implications of Brexit on Life Science Companies
11:15 am
Introductions, Panel Discussion and Q&A
Fabien Roy, DESSSenior Associate, Hogan Lovells; Member, EFGCP-MedTech Europe Working Party, Brussels, Belgium
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 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 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.
Elisabethann Wright, Esq.Partner, Hogan Lovells International LLP, Brussels, Belgium (Moderator)
Listed as a “leading authority” on EU Life Sciences law by Who’s Who Legal: Life Sciences 2015 Elisabethann Wright has been practising in the Life Sciences sector for over 30 years in both private practice and international institutions. Her role includes assisting clients in the classification of their products, the establishment of a pathway to authorisation and marketing of their products in the EU (including related regulatory obligations), pharmacovigilance obligations, promotion and marketing of products, sales agreements, clinical trial agreements, adverse event reporting, product withdrawals, data privacy obligations, and conduct of compliance and anti-bribery investigations.
Elisabethann Wright also has experience in litigation before the European Court of Justice, the European Court of First Instance, and the European Free Trade Agreement (EFTA) Court. Elisabethann was a Référendaire (Law Clerk) at the Court of Justice of the European Communities for a number of years.
Elisabethann Wright also has experience in litigation before the European Court of Justice, the European Court of First Instance, and the European Free Trade Agreement (EFTA) Court. Elisabethann was a Référendaire (Law Clerk) at the Court of Justice of the European Communities for a number of years.
MS 7: The Interfaces Between the Roles of the Compliance and Quality Functions
11:15 am
Introductions, Panel Discussion and Q&A
Edoardo Lazzarini, PhDCompliance Initiatives Director EUCAN, Takeda Pharmaceuticals International, Former Compliance Officer EMEA (Europe, Middle East & Africa), Biomet, Milano, Italy
Edoardo Lazzarini is currently “Europe & Canada Compliance Initiatives Director” in Takeda, a multinational company, global leader in pharmaceutical sector.
Before joining TAKEDA, Edoardo was European Compliance Officer, in North American company leaders in medical devices orthopedic business. Edoardo worked with increasing compliance responsibility in several pharmaceutical companies (MSD, Schering-Plough) and in the electronic industry.
Edoardo has experience in pharma drug manufacturing and quality assurance being certified Qualified Person.
In 2015, Edoardo Lazzarini was honored with the “PwC Award for Leadership in the Advancement of Ethics in the Medical Device Industry”, presented at the eighth annual Global MedTech Compliance Conference in Athens, Greece.
Before joining TAKEDA, Edoardo was European Compliance Officer, in North American company leaders in medical devices orthopedic business. Edoardo worked with increasing compliance responsibility in several pharmaceutical companies (MSD, Schering-Plough) and in the electronic industry.
Edoardo has experience in pharma drug manufacturing and quality assurance being certified Qualified Person.
In 2015, Edoardo Lazzarini was honored with the “PwC Award for Leadership in the Advancement of Ethics in the Medical Device Industry”, presented at the eighth annual Global MedTech Compliance Conference in Athens, Greece.
David O’ShaughnessyVice President, Compliance, Emerging Markets, Quintiles; Board Member, ETHICS; Former Vice President Compliance, International Pharmaceuticals, GSK; Former Vice President, Global Compliance Strategy, AstraZeneca, Reading, UK
Dave O’Shaughnessy is the VP Compliance, R&D Solutions, in the Ethics and Compliance Office at QuintilesIMS since 2012. Dave reports to QuintilesIMS’ Chief Compliance Officer, and works with senior leaders to ensure R&D Solutions business units have effective compliance programs 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 roles 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.
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 roles 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.
Debolina Partap, BCOM, LLMGeneral Counsel, Wockhardt, Mumbai, India
Debolina Partap is Vice President Legal and General Counsel, Wockhardt Limited. She is with the company for 11 years and is responsible for legal and compliance work of Wockhardt Group spread over 50 countries. Her role involves overseeing compliance, litigation management, contract management, intellectual property management, financial documentation, mergers and acquisitions, corporate advisory services, special advice to board and development of legal compliant systems within the organisation. She has over 20 years of experience. Wockhardt is a global pharmaceutical and Healthcare company and the only one company in India with businesses in both these verticals. Debolina is an avid speaker. She has participated in global conferences of Bio Asia, Terrapin , IBCAsia, all in Singapore In house community Hong Kong and ILO Hong Kong. She and her team has atleast 15 awards to their credit in the field of legal and compliance.
Rajiv Joshi, ICAI, ISACA, CIA, CFEPartner, Fraud Investigation & Dispute Services, EY, Mumbai, India (Moderator)
Rajiv Joshi is a Partner with Fraud Investigation Dispute Services of EY India He has previously worked with KPMG Forensic, Reliance Retail and ICICI Prudential Life Co. He has gathered more than 14 years of professional experience. He has gained extensive forensic experience in sectors like Life Science, Retail, Insurance, IT/ITES etc. Rajiv is a Chartered Accountant , CISA, CFE and CIA. He has done his post graduation in Commerce from Mumbai University. *Skills Investigations, enterprise risk management, revenue assurance program and internal audit Risk management, business development, channel reviews, supply chain management, internal audit and compliance Experience in Investigation: Rajiv has led various investigations across Life Science, Retail and Insurance industry He was instrumental in framing the risk management framework around supply chain management, various store formats and categories in Reliance Retail He was instrumental in framing the internal audit program and the risk management framework in ICICI Prudential Life Insurance Co.
MS 8: Risk Assessments and Monitoring Plans, Part I
11:15 am
Introductions, Panel Discussion and Q&A
Michael Alan GleaveCompliance Officer, Corporate Compliance and CSR, H. Lundbeck A/S, Copenhagen, Denmark
Currently employed as a global compliance officer with Lundbeck. Main accountabilities are managing global investigations, compliance audits and compliance risk management. I have a background in compliance, risk and quality management in a number of senior management and advisory positions. Was previously at Novo Nordisk as a Senior Risk Advisor, for the company’s enterprise risk management programme. Prior to that, was employed in various global compliance and quality management positions at Intetek, one of the largest product and systems certification companies in the world.
Anita K. Kim-ReinartzPartner, Fraud Investigation & Dispute Services, EY, Düsseldorf, Germany
Anita K. Kim-Reinartz is Partner within Business Integrity & Corporate Compliance of EY and focusing on Compliance Auditing and Consulting, Investigations
Since 2013 Anita ist the Head of FIDS Life Science, Healthcare & Chemicals Compliance
She has more than 15 years consulting experience within the areas of Fraud Prevention, Detection, Investigation and Compliance
Since 2013 Anita ist the Head of FIDS Life Science, Healthcare & Chemicals Compliance
She has more than 15 years consulting experience within the areas of Fraud Prevention, Detection, Investigation and Compliance
Jose RamosCompliance Officer for Italy, Portugal, and Spain, Biogen, Madrid, Spain
Dr. Ramos started in the Pharmaceutical Industry in Eli Lilly, with relevant responsibilities such as Medical Advisor, Managing Clinical Research Operations Unit in Spain — and supporting the set up for the EU Regional Data Management Center.
He is a Global Leader for the implementation of Clinical Financial Planning processes and systems and a Transformation Champion for Italy, Spain and the Medical Function. Dr. Ramos is the Compliance Officer for the Spain, Portugal and Greece — supporting the Medical Function for the Europe, and Since Jan, 2015, the Compliance Officer in Biogen, for Italy, Portugal and Spain. Supporting the Medical Function for Europe, and key single contact for the Standards and Governance Team for Europe. At the present he is acting as Interim, Compliance Officer for France, Belgium and Netherlands.
He is a Global Leader for the implementation of Clinical Financial Planning processes and systems and a Transformation Champion for Italy, Spain and the Medical Function. Dr. Ramos is the Compliance Officer for the Spain, Portugal and Greece — supporting the Medical Function for the Europe, and Since Jan, 2015, the Compliance Officer in Biogen, for Italy, Portugal and Spain. Supporting the Medical Function for Europe, and key single contact for the Standards and Governance Team for Europe. At the present he is acting as Interim, Compliance Officer for France, Belgium and Netherlands.
Abdul Luheshi, MBAExecutive Director, Global Operations, Ethics & Compliance, Astellas Pharma EMEA; Former Vice President, Health Care Compliance, Johnson & Johnson; Former Co-chair, Asia Pacific Pharma Compliance Congress, Chertsey, UK (Moderator)
Abdul has almost 20 years of experience in ethics and compliance. During this time he has led the compliance organization for Johnson & Johnson in the Asia Pacific region followed by a spell as a consultant and is currently leading the Group Operations team of the E&C organization of Astellas.
Originally an organic chemist, post-MBA has held posts in operations management and finance across the chemical, agrichemical and healthcare industries.
Originally an organic chemist, post-MBA has held posts in operations management and finance across the chemical, agrichemical and healthcare industries.
MS 9: Patient Programs and Interactions with Patient Organizations—Managing the Risks of Getting Closer to the Patient
11:15 am
Introductions, Panel Discussion and Q&A
Karen EryouHead, Ethics & Compliance Programs, UCB Pharma, Former Co-chair, Asia Pacific Pharma Compliance Congress, Brussels, Belgium
Karen Eryou is currently the Head of Ethics & Compliance Programs for UCB. In this role she is responsible for the development of UCB’s program on ethical decision making as well as leading the global compliance operations group. This group includes transparency, third party management, investigations, monitoring & analytics as well as a frameworks programs which encompasses polices, procedures, training, and communication. From 2010 – 2016, Karen was based in Shanghai, China where she built the compliance function for UCB, initially for China and later for the Asia-Pacific region. Originally from Vancouver, Canada Karen has over 18 years of international work experience in the pharmaceutical industry including clinical operations, quality assurance, auditing & inspections, medical affairs, and business practice compliance. She has focused on business practices, ethics, and compliance topics for the past 10 years.
Dominik GellerHead Pharma Healthcare Compliance Office, Roche, Basel, Switzerland
Dominik Geller is the head of the Global Pharma Healthcare Compliance Office at Roche in Basel. In this role he develops and maintains the compliance management system for interactions with healthcare professionals and entities across the division globally. Before his current compliance role, he gained several years experience as Audit Director R&D. Before that he established and headed Group Risk Management and as such was coordinating diligent risk management decisions and risk consolidation across the whole Group. He originally joined Roche in ’97 as Head of Group Controlling Finance and Treasury and had developed this function, including financial reporting, planning, risk control, accounting governance and also global treasury and risk system responsibilities. He was also in charge of the Treasury Middle-Office Operations. Prior to Roche Dominik worked at a bank now part of UBS and held various positions and led projects in IT, derivatives sales and risk control in Basel, Zürich and London.
Chris J. HolmesDirector, Healthcare and Life Sciences Disputes, Regulatory, Compliance and Investigations, Navigant, London, UK
Chris Holmes is a Life Sciences consulting expert with over 20 years experience in delivering strategic advice and implementation. His expertise includes regulatory affairs and compliance, drug safety, risk management and operational performance programs for pharmaceutical, biotechnology, medical device and consumer health companies. Chris has worked extensively in Europe, as well as the US and Japan helping his clients to build global governance, organization, and operating models that will have significant positive impact on compliance, quality, cost, and patient safety. Prior to joining Navigant, Chris was Director at WCI Consulting, where he implemented assessment and risk mitigation programs for numerous clients. Chris has established himself as a true leader in drug safety and pharmacovigilance through his development and implementation of subscription-based networks for benchmarking, best practice, and thought leadership in safety and regulatory governance.
Casey HortonDirector, Healthcare and Life Sciences Disputes, Regulatory Compliance and Investigations, Navigant, Chicago, IL, USA
Casey J. Horton has over fifteen years of experience leading numerous risk, compliance and operational improvement projects, both in the US and across the globe. Casey brings Navigant clients a unique perspective and understanding of the regulatory and legal challenges facing both healthcare and life sciences companies. His practice focuses on performing compliance assessments and investigations and implementing effective and sustainable compliance solutions. Casey is a Director in Navigant’s Global Healthcare and Life Sciences Disputes, Regulatory, Compliance & Investigations (“HLS DRCI”) practice, where he brings deep experience and knowledge of compliance program development, Corporate Integrity Agreements (“CIAs”), compliance and enterprise risk assessment execution, global monitoring initiatives, antibribery / anti-corruption issues, third-party due diligence review programs, patient services and assistance program reviews and financial and economic damage calculations. Prior to joining Navigant, Casey worked internally within a Top 10 pharmaceutical manufacturer’s Office of Ethics and Compliance (“OEC”) during CIA implementation and execution.
Tamara Tubin, lic. iur.Compliance Director EUCAN, Takeda Pharmaceuticals International AG; Strategic Committee, International Society of Healthcare Ethics and Compliance Professionals (ETHICS); Former Corporate Compliance Director, Biogen International; Former Ethics and Compliance Director International, Carefusion, Zurich, Switzerland (Moderator)
Ms. Tamara Tubin is a senior executive with more than ten years of experience and a proven track record of successfully developing, implementing and sustaining international effective ethics & compliance corporate programs for healthcare industry corporate companies in the biotech/rare diseases, biosimilars, pharmaceutical and medtech sector. In her current regional role, Ms. Tamara Tubin is Compliance Director, Europe Canada and Israel (EUCAN). She works closely with the global compliance function on the development and implementation of a comprehensive compliance program within EUCAN in order to operationalize Takeda’s compliance program across the company. Furthermore she is advising the business to manage risks and to conduct business in a compliant and ethical manner. In addition and in her personal capacity – she is a member of the strategic committee of ETHICS – the international society of healthcare ethics and compliance professionals in Paris, France.
MS 10: Global Transparency Data Analytics: What They Mean for Your Company
11:15 am
Introductions, Panel Discussion and Q&A
Chrissy Bradshaw, JDVice President, Porzio Life Sciences, LLC, Morristown, NJ, USA
Chrissy Bradshaw is a Vice President for Porzio Life Sciences, LLC. In her role, Ms. Bradshaw oversees the development, implementation and support of Porzio AggregateSpendID, the company’s automated tool for the collection and reporting of payments to healthcare professionals (HCPs) and healthcare organizations (HCOs).
She serves as a primary point of contact for new customers, analyzes customer reporting requirements, and directs system design and implementations. Further, in collaboration with the other Regulatory and Compliance Services Managers and Directors, Ms. Bradshaw is responsible for ensuring that all products are accurate, current and relevant to the needs of the industry.
Ms. Bradshaw is also a principal with Porzio, Bromberg & Newman P.C. and a member of the firm’s Life Sciences Compliance and Regulatory Counseling Department. She served as a judicial clerk for the Honorable Gail L. Menyuk of the New Jersey Tax Court during the 2006-2007 term.
She serves as a primary point of contact for new customers, analyzes customer reporting requirements, and directs system design and implementations. Further, in collaboration with the other Regulatory and Compliance Services Managers and Directors, Ms. Bradshaw is responsible for ensuring that all products are accurate, current and relevant to the needs of the industry.
Ms. Bradshaw is also a principal with Porzio, Bromberg & Newman P.C. and a member of the firm’s Life Sciences Compliance and Regulatory Counseling Department. She served as a judicial clerk for the Honorable Gail L. Menyuk of the New Jersey Tax Court during the 2006-2007 term.
Kirtis Kraeuter, MGAHead, Worldwide Compliance Committee and Monitoring Center of Expertise, Bristol-Myers Squibb, Princeton, NJ, USA
Marcel Maderitsch, LLMSenior Compliance Officer, Vifor Pharma, Zürich, Switzerland
Mr. Marcel Maderitsch, Senior Compliance Officer Vifor Pharma (Ltd.) Marcel is Austrian Citizen and graduated in International Law and International Relations from Lancaster University (United Kingdom) and Business Management (Diplom Betriebswirt FH) from Kempten University of Applied Sciences (Germany), and is a state certified training instructor (Germany). Prior to joining Vifor Pharma’s global headquarters in Glattbrugg/ Switzerland as Compliance Officer in April 2016, Marcel has gained over ten years of experience in providing Compliance trainings in English, French and German throughout Europe and North Africa in the Medical Devices industry (Zimmer Biomet) and Banking sector (UBS Investment Bank). At Vifor Pharma Marcel is primary responsible for Vifor Pharma’s transparency and disclosure obligations and the compliance training program. Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions.
Mr. Marcel Maderitsch, LL.M., Senior Compliance Officer Vifor Pharma (Ltd.)
Marcel is Austrian Citizen and graduated in International Law and International Relations from Lancaster University (United Kingdom) and Business Management (Diplom Betriebswirt FH) from Kempten University of Applied Sciences (Germany), and is a state certified training instructor (Germany).
Prior to joining Vifor Pharma’s global headquarters in Glattbrugg/Switzerland as Compliance Officer in April 2016, Marcel has gained over ten years of experience in providing Compliance trainings in English, French and German throughout Europe and North Africa in the Medical Devices industry (Zimmer Biomet) and Banking sector (UBS Investment Bank).
At Vifor Pharma Marcel is primary responsible for Vifor Pharma’s transparency and disclosure obligations and the compliance training program. Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions.
Mr. Marcel Maderitsch, LL.M., Senior Compliance Officer Vifor Pharma (Ltd.)
Marcel is Austrian Citizen and graduated in International Law and International Relations from Lancaster University (United Kingdom) and Business Management (Diplom Betriebswirt FH) from Kempten University of Applied Sciences (Germany), and is a state certified training instructor (Germany).
Prior to joining Vifor Pharma’s global headquarters in Glattbrugg/Switzerland as Compliance Officer in April 2016, Marcel has gained over ten years of experience in providing Compliance trainings in English, French and German throughout Europe and North Africa in the Medical Devices industry (Zimmer Biomet) and Banking sector (UBS Investment Bank).
At Vifor Pharma Marcel is primary responsible for Vifor Pharma’s transparency and disclosure obligations and the compliance training program. Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions.
Jeffrey Campbell, JDPresident and Chief Executive Officer, Porzio Life Sciences, LLC, Morristown, NJ, USA (Moderator)
Jeffrey Campbell is the President and CEO of Porzio Life Sciences, LLC. Mr. Campbell sets the strategic goals of the company and is primarily responsible for evaluating business opportunities such as geographic expansion, joint ventures, partnerships and acquisitions. Mr. Campbell is integrally involved in development decisions concerning Porzio GST , PorzioLS’s third generation international spend aggregation and reporting solution. He also works closely with personnel to ensure the continuous improvement of the company’s products and services and to maintain the organization’s leadership in the field of life sciences sales and marketing compliance consulting.
Mr. Campbell also chairs the Life Sciences Practice Group of Porzio, Bromberg & Newman P.C., where he served as Managing Principal for 20 years. Mr. Campbell is a member of the International Association of Defense Counsel and is active in its Drug, Device and Biotech Committee.
Mr. Campbell received a J.D. from Stanford Law School in 1985 and a B.A. from Dickinson College, where he graduated summa cum laude in 1982.
Mr. Campbell also chairs the Life Sciences Practice Group of Porzio, Bromberg & Newman P.C., where he served as Managing Principal for 20 years. Mr. Campbell is a member of the International Association of Defense Counsel and is active in its Drug, Device and Biotech Committee.
Mr. Campbell received a J.D. from Stanford Law School in 1985 and a B.A. from Dickinson College, where he graduated summa cum laude in 1982.
12:30 pm
Networking Luncheon
AFTERNOON PLENARY SESSION
2:00 pm
Welcome and Overview
Stephen Nguyen-DucFormer Area Director Ethics & Compliance Western, Europe-Israel and Canada, AbbVie; Former Director, Ethics & Compliance Officer, Eli Lilly and Company, Paris, France (Co-chair)
Stephen Nguyen Duc 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.
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.
2:05 pm
Safeguarding Against Bribery and Corruption: Outreach from the Investigating Agencies
George “Ren” McEachern, CFE, CAMSSupervisory Special Agent, International Corruption Squad, US Federal Bureau of Investigation, Washington, DC, USA
Supervisory Special Agent George McEachern has worked in law enforcement since 1995 and entered on duty with the FBI in 2005. Supervisory Special Agent McEachern is an FBI certified subject matter expert in international corruption and has served in Tampa, Boston, and the Washington Field Office.
In 2013, he was selected to the FBI’s International Corruption Unit where he managed the FBI’s Foreign Corrupt Practices Act (FCPA) global investigations program and helped architect the FBI International Corruption Squads based in Washington, Los Angeles, New York, Miami, Houston, San Francisco, Boston and New Orleans.
Currently, Supervisory Special Agent McEachern supervises the Washington Field Office International Corruption Squad with a focus on FCPA, International Money Laundering, Kleptocracy and Antitrust investigations. Supervisory Special Agent McEachern is a Certified Fraud Examiner (CFE) and a Certified Anti-Money Laundering Specialist (CAMS).
In 2013, he was selected to the FBI’s International Corruption Unit where he managed the FBI’s Foreign Corrupt Practices Act (FCPA) global investigations program and helped architect the FBI International Corruption Squads based in Washington, Los Angeles, New York, Miami, Houston, San Francisco, Boston and New Orleans.
Currently, Supervisory Special Agent McEachern supervises the Washington Field Office International Corruption Squad with a focus on FCPA, International Money Laundering, Kleptocracy and Antitrust investigations. Supervisory Special Agent McEachern is a Certified Fraud Examiner (CFE) and a Certified Anti-Money Laundering Specialist (CAMS).
2:35 pm
Overview of the New Marketplace in 2017 and Beyond
Frank Wartenberg, PhDPresident, Central Europe, IMS Health, Frankfurt/Main, Germany
Frank Wartenberg was appointed President, Central Europe for QuintilesIMS in January 2011. He is responsible for the P&L of Germany, Austria, Czech & Slovak Republic, Hungary & five Adriatic Countries.
He has joined the company in May 2004 following the acquisition of scicon by IMS. He has a deep pharmaceutical market expertise and understanding of organisational implications within the marketing and sales frame. Before that he has been general manager in Germany since January 2010, headed the Commercial Effectiveness practice in EMEA from 2007 – 2009 and has built the German consulting team as country principal from 2004 – 2007.
Frank regularly shares his opinions with board members and senior management of the pharmaceutical industry in invited presentations, workshops and private discussions. He is a regular speaker at industry conferences and regularly publishes in international and national journals on marketing and sales strategy.
He has joined the company in May 2004 following the acquisition of scicon by IMS. He has a deep pharmaceutical market expertise and understanding of organisational implications within the marketing and sales frame. Before that he has been general manager in Germany since January 2010, headed the Commercial Effectiveness practice in EMEA from 2007 – 2009 and has built the German consulting team as country principal from 2004 – 2007.
Frank regularly shares his opinions with board members and senior management of the pharmaceutical industry in invited presentations, workshops and private discussions. He is a regular speaker at industry conferences and regularly publishes in international and national journals on marketing and sales strategy.
3:15 pm
Panel Discussion of the Challenges of the New Marketplace
- — Market Access
- — Demonstrating the Value of Innovation and Value-Based Payment Structures
- — The Future of Biosimilars
- — Targeting Treatment with Companion Diagnostics
- — Health Technology Assessments
- — Role of the Compliance Function
Keith M. Korenchuk, JD, MPHPartner, Arnold & Porter LLP, Washington, DC, USA
Keith Korenchuk counsels and advises global companies on regulatory and compliance matters worldwide, with a focus on compliance program effectiveness, compliance program implementation, operations and evaluation, and related regulatory counseling and advice. He works in a wide variety of industries and sectors including consumer products, electronics, energy, financial services, life sciences, medical device, pharmaceutical, and technology.
Since 2001, Mr. Korenchuk has been included in The Best Lawyers in America. He has developed, led, and implemented “hands-on” educational and healthcare programs that provide pharmaceuticals and healthcare services, teachers, school supplies, library resources, and computers to indigenous communities in South America for the past 12 years.
Since 2001, Mr. Korenchuk has been included in The Best Lawyers in America. He has developed, led, and implemented “hands-on” educational and healthcare programs that provide pharmaceuticals and healthcare services, teachers, school supplies, library resources, and computers to indigenous communities in South America for the past 12 years.
Roeland Van AelstRegional Vice President – HCCO MD&D EMEA & Canada, Office Health Care Compliance and Privacy, Johnson and Johnson; Board Member, International Society of Healthcare, Ethics and Compliance Professionals (ETHICS); Chairman, MedTech Compliance Network, Brussels, Belgium
Roeland Van Aelst joined Johnson & Johnson in 1987 as a Medical Representative for Janssen Pharmaceutica. He held various positions of increasing responsibility in both sales and marketing and joined the Corporate Office of Health Care Compliance in May 2005 for the EMEA region with extension to Asia, Latin-America and Canada in 2008. In 2010 Roeland became responsible for EMEA & Canada cross sector. Since October 2012 he is the Regional Vice President – HCCO MD EMEA. Today he also fulfills the Chairman role of the MedTech Europe Ethics and Compliance Committee. He is a member of the board and a founding member of ETHICS, an association for Compliance professionals in the Health Care industry. Roeland is an active contributor to the Seton Hall/ Sience Poand the INSEAD training programs for Compliance professionals and is co-chairman for the International Pharmaceutical and Medical Device Compliance Congress.
Dominik GellerHead Pharma Healthcare Compliance Office, Roche, Basel, Switzerland
Dominik Geller is the head of the Global Pharma Healthcare Compliance Office at Roche in Basel. In this role he develops and maintains the compliance management system for interactions with healthcare professionals and entities across the division globally. Before his current compliance role, he gained several years experience as Audit Director R&D. Before that he established and headed Group Risk Management and as such was coordinating diligent risk management decisions and risk consolidation across the whole Group. He originally joined Roche in ’97 as Head of Group Controlling Finance and Treasury and had developed this function, including financial reporting, planning, risk control, accounting governance and also global treasury and risk system responsibilities. He was also in charge of the Treasury Middle-Office Operations. Prior to Roche Dominik worked at a bank now part of UBS and held various positions and led projects in IT, derivatives sales and risk control in Basel, Zürich and London.
Frank Wartenberg, PhDPresident, Central Europe, IMS Health, Frankfurt/Main, Germany
Frank Wartenberg was appointed President, Central Europe for QuintilesIMS in January 2011. He is responsible for the P&L of Germany, Austria, Czech & Slovak Republic, Hungary & five Adriatic Countries.
He has joined the company in May 2004 following the acquisition of scicon by IMS. He has a deep pharmaceutical market expertise and understanding of organisational implications within the marketing and sales frame. Before that he has been general manager in Germany since January 2010, headed the Commercial Effectiveness practice in EMEA from 2007 – 2009 and has built the German consulting team as country principal from 2004 – 2007.
Frank regularly shares his opinions with board members and senior management of the pharmaceutical industry in invited presentations, workshops and private discussions. He is a regular speaker at industry conferences and regularly publishes in international and national journals on marketing and sales strategy.
He has joined the company in May 2004 following the acquisition of scicon by IMS. He has a deep pharmaceutical market expertise and understanding of organisational implications within the marketing and sales frame. Before that he has been general manager in Germany since January 2010, headed the Commercial Effectiveness practice in EMEA from 2007 – 2009 and has built the German consulting team as country principal from 2004 – 2007.
Frank regularly shares his opinions with board members and senior management of the pharmaceutical industry in invited presentations, workshops and private discussions. He is a regular speaker at industry conferences and regularly publishes in international and national journals on marketing and sales strategy.
Michael Bartke, PhDFormer Director Compliance Management, DAIICHI SANKYO EUROPE GmbH, Strategic Committee, International Society of Healthcare, Ethics, and Compliance Professionals (ETHICS), Munich, Germany (Moderator)
Michael Bartke is a chemist by training and holds an PhD in organic chemistry from the university of Konstanz. He has almost more than 30 years of experience working in various positions and national / international projects the pharmaceutical industry e.g. ICI ( today Astra Zeneca), Bristol Myers Squibb and Daiichi Sankyo Europe. He moved 2001 to Daiichi Sankyo as Head of Marketing Germany and later on as Director New Product Planning responsible for the development of the cardiovascular drugs in Europe. Since 2008 he has been assigned as Director Compliance Management within the European Headquarter at Daiichi Sankyo Europe. He has experience in various areas of Compliance and risk management. He represented the Company at IFPMA, Code Compliance Network, Geneva and EFPIA, Compliance Committee, Brussels until 2015. He is member of the German Cardiac Society and the International Society of Healthcare Ethics and Compliance Professionals, Ethics, Paris.
4:00 pm
Networking Break
AFTERNOON MINI SUMMITS GROUP III: 4:30 pm — 5:30 pm
MS 11: Next Generation Compliance: Fostering Decision-Making in a Principle-Based Compliance Program
4:30 pm
Introductions, Panel Discussion and Q&A
Timothy Ayers, JD, MPHVice President, Chief Compliance Officer, Horizon Pharma PLC; Former Vice President, Chief Compliance Officer, Dendreon; Former Associate General Counsel, Executive Director of Compliance, Seattle Genetics Chicago, IL, USA
Tim Ayers is the VP, CCO of Horizon Pharma, plc. Prior to that he was the CCO of various oncology biotechs. Prior to that he was an attorney at Winston & Strawn LLP in Washington, DC.
Karen EryouHead, Ethics & Compliance Programs, UCB Pharma, Former Co-chair, Asia Pacific Pharma Compliance Congress, Brussels, Belgium
Karen Eryou is currently the Head of Ethics & Compliance Programs for UCB. In this role she is responsible for the development of UCB’s program on ethical decision making as well as leading the global compliance operations group. This group includes transparency, third party management, investigations, monitoring & analytics as well as a frameworks programs which encompasses polices, procedures, training, and communication. From 2010 – 2016, Karen was based in Shanghai, China where she built the compliance function for UCB, initially for China and later for the Asia-Pacific region. Originally from Vancouver, Canada Karen has over 18 years of international work experience in the pharmaceutical industry including clinical operations, quality assurance, auditing & inspections, medical affairs, and business practice compliance. She has focused on business practices, ethics, and compliance topics for the past 10 years.
Maureen McGirr, JDVice President, Office of Ethics, Global Compliance Organization, Merck, Sharp, and Dohme, Kenilworth, NJ, USA
Maureen McGirr is an experienced legal and compliance leader responsible for managing a wide range of issues in the pharmaceutical industry for more than twenty years at Merck & Co., Inc., Kenilworth, N.J. Maureen currently is Vice President, Global Compliance at Merck. In this role, she is responsible for the code of conduct, anti-bribery and corruption compliance program, investigations, training, code of conduct and corporate policies. Previously, Maureen held a number of positions in the Office of General Counsel based in the U.S. headquarters of Merck & Co. and also had an international assignment based in Japan.
Prior to joining Merck, Maureen was an associate at the law firms of Arnold & Porter and Hughes, Hubbard & Reed handling a broad range of litigation and regulatory counseling matters. Maureen has spoken at a number of legal, ethics and compliance conferences worldwide.
Prior to joining Merck, Maureen was an associate at the law firms of Arnold & Porter and Hughes, Hubbard & Reed handling a broad range of litigation and regulatory counseling matters. Maureen has spoken at a number of legal, ethics and compliance conferences worldwide.
Uffe Kåre Rasmussen, M.Sc.Senior Director and Chief Compliance Officer, H. Lundbeck A/S; Former Principal Scientist, Novo Nordisk A/S, Copenhagen, Denmark
Uffe Kåre Rasmussen, M.Sc
Chief Compliance Officer at Lundbeck. Since 2009, responsible for the global development of Lundbeck’s Compliance Structure, including governance, Code of Conduct and related global procedures and processes. Leading Lundbeck’s Sustainability Strategy and related projects, including Lundbeck’s commitment to the UN Global Compact Principles. More than 15 years of leadership experience in the pharmaceutical industry within the fields of compliance & sustainability, strategy development and implementation, project management, communication and auditing.
Chief Compliance Officer at Lundbeck. Since 2009, responsible for the global development of Lundbeck’s Compliance Structure, including governance, Code of Conduct and related global procedures and processes. Leading Lundbeck’s Sustainability Strategy and related projects, including Lundbeck’s commitment to the UN Global Compact Principles. More than 15 years of leadership experience in the pharmaceutical industry within the fields of compliance & sustainability, strategy development and implementation, project management, communication and auditing.
Kirtis Kraeuter, MGAHead, Worldwide Compliance Committee and Monitoring Center of Expertise, Bristol-Myers Squibb, Princeton, NJ, USA (Moderator)
MS 12: Risk Assessment and Monitoring Plans, Part II
4:30 pm
Introductions, Panel Discussion and Q&A
Sue EganDirector and Principal Consultant, Sue Egan Associates; Former Vice President Compliance, AstraZeneca, Great Missenden, Buckinghamshire, UK
Sue Egan has been a Compliance Officer at all levels from a single marketing company and region for GlaxoSmithKline to international VP for AstraZeneca. She has more than 30 years of practical experience in various corporate roles and is now a consultant.
Sue uses her insights and skills from having been a compliance officer to help her global clients to improve their personal impact and the effectiveness of their compliance programmes.
Sue has an MBA, is a Fellow of the Chartered Management Institute and her consultancy is a member of Thames Valley Chamber of Commerce Group.
Sue uses her insights and skills from having been a compliance officer to help her global clients to improve their personal impact and the effectiveness of their compliance programmes.
Sue has an MBA, is a Fellow of the Chartered Management Institute and her consultancy is a member of Thames Valley Chamber of Commerce Group.
Carl JudgePartner, Fraud Investigation & Dispute Services, EY, London, UK
Carl Judge 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
Jolanta WyszynskaVice President, Compliance Europe, AstraZeneca, Warsaw, Poland
Jolanta Wyszynska is the VP Compliance Europe AstraZeneca. She oversees 33 European Markets and support Global Compliance Leadership Team and European Comercial Leadership Team in developing and delivering the right strategy. Prior to her current role, Jolanta was overseeing a number of small European Countries and was awarded with highly Commended Team of 2014 by an external independent body. Throughout the last 17 years, Jolanta has been working for AstraZeneca holding several senior positions in finance, procurement & compliance. Prior to joining AstraZeneca, Jolanta worked for SmithKline Beecham as a tax officer and prepared the company for the merger with Glaxo. Jolanta received her Master’s in Science (mathematic) from the University of Warsaw and completed Harvard and INSEAD Executive Leadership courses as a part of IWF program for talented women. She is actively working as a mentor and support young talented women.
Abdul Luheshi, MBAExecutive Director, Global Operations, Ethics & Compliance, Astellas Pharma EMEA; Former Vice President, Health Care Compliance, Johnson & Johnson; Former Co-chair, Asia Pacific Pharma Compliance Congress, Chertsey, UK (Moderator)
Abdul has almost 20 years of experience in ethics and compliance. During this time he has led the compliance organization for Johnson & Johnson in the Asia Pacific region followed by a spell as a consultant and is currently leading the Group Operations team of the E&C organization of Astellas.
Originally an organic chemist, post-MBA has held posts in operations management and finance across the chemical, agrichemical and healthcare industries.
Originally an organic chemist, post-MBA has held posts in operations management and finance across the chemical, agrichemical and healthcare industries.
MS 13: The Challenges of New Channels: Digital Communications, Social Media, and Other New Technologies
4:30 pm
Introductions, Panel Discussion and Q&A
Grant Castle, Esq.Partner, Covington & Burling LLP, London, UK
Grant Castle is a Partner in the London office of Covington & Burling practicing in the areas of life sciences regulatory law, with an emphasis on pharmaceutical and medical device regulation and associated compliance issues.
He has assisted clients with a wide range of regulatory and compliance issues and has participated in formal and informal advertising, commercial practices, good manufacturing practices (GMP), good clinical practices (GCP), drug safety and pharmacovigilance proceedings before the European Medicines Agency (EMA), the European Commission, national authorities, courts and self-regulatory bodies. He has handled a number of important judicial review cases before the EU and UK courts.
He has published extensively in the legal literature and has made several contributions to the technical literature in chemistry. He speaks and lectures frequently on compliance issues in both the pharmaceutical and medical device areas.
He has assisted clients with a wide range of regulatory and compliance issues and has participated in formal and informal advertising, commercial practices, good manufacturing practices (GMP), good clinical practices (GCP), drug safety and pharmacovigilance proceedings before the European Medicines Agency (EMA), the European Commission, national authorities, courts and self-regulatory bodies. He has handled a number of important judicial review cases before the EU and UK courts.
He has published extensively in the legal literature and has made several contributions to the technical literature in chemistry. He speaks and lectures frequently on compliance issues in both the pharmaceutical and medical device areas.
Giota PapamarkouGlobal Ethics & Compliance Director, Ipsen; Former EMEA Compliance and Ethics Manager, Bristol-Myers Squibb, Paris, France
Giota Papamarkou is a senior professional with over nine years of experience in Ethics & Compliance and Internal Controls in multinational pharmaceutical companies.
In March 2015, Giota joined Ipsen and since then she has been responsible for the development and enhancement of the Global Internal Ethics & Compliance Program and she has been the Ethics & Compliance Officer for the Global Teams reporting to the Ipsen’s Chief Ethics & Compliance Officer. In February 2016, in addition to her global responsibilities, Giota also took over the oversight of the Ipsen China Ethics & Compliance Program’s evolution.
Previously, Giota was Country Compliance & Ethics Officer for various European countries and Contributor to the European Compliance & Ethics Program in Bristol-Myers Squibb based in Paris and Athens and earlier, she held various positions in Business Controls in the same company based in Athens.
She received a university degree on Management Science & Technology from the Athens University of Economics and Business and completed the Sciences Po European Healthcare Compliance, Ethics and Regulation Programme and the Insead Healthcare Compliance Implementation Leadership Programme – Part II.
Giota speaks Greek, English and French and she is member of the ETHICS Association.
In March 2015, Giota joined Ipsen and since then she has been responsible for the development and enhancement of the Global Internal Ethics & Compliance Program and she has been the Ethics & Compliance Officer for the Global Teams reporting to the Ipsen’s Chief Ethics & Compliance Officer. In February 2016, in addition to her global responsibilities, Giota also took over the oversight of the Ipsen China Ethics & Compliance Program’s evolution.
Previously, Giota was Country Compliance & Ethics Officer for various European countries and Contributor to the European Compliance & Ethics Program in Bristol-Myers Squibb based in Paris and Athens and earlier, she held various positions in Business Controls in the same company based in Athens.
She received a university degree on Management Science & Technology from the Athens University of Economics and Business and completed the Sciences Po European Healthcare Compliance, Ethics and Regulation Programme and the Insead Healthcare Compliance Implementation Leadership Programme – Part II.
Giota speaks Greek, English and French and she is member of the ETHICS Association.
Jessica Pfennig, EMBA, MLSGlobal Commercial Operations, Global Digital Governance Director, AstraZeneca, Wilmington, Delaware, USA
Jessica Pfennig is Director of Global Digital Governance at AstraZeneca and is a digital innovator with over 20 years of strategy and management experience within large pharmaceutical organizations. Jessica has advanced degrees in chemistry, information science and an EMBA. Jessica is in charge of managing and monitoring AZ’s digital asset estate. In this role she influences the future regulations for digital interactions with patients, physicians and payers. She is recognized for integrating risk avoidance and commercial compliance standards to introduce innovative technology and services. Jessica is also the Senior Global Chair for the Digital Innovators within the Healthcare Businesswomen’s Association.
Melda Tanyeri, MS, MBADirector, Fraud Investigation & Dispute Services, EY, London, UK (Moderator)
Melda Tanyeri is a Director with EY’s Fraud Investigations & Dispute Services department in the UK, where she focuses on the Life Sciences Sector. Originally from Turkey, she was previously based in New York and Paris during her 15-year career with EY, prior to relocating to London. 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.
MS 14: Advanced Topics in Anti-Corruption Compliance Programs
4:30 pm
Introductions, Panel Discussion and Q&A
Keith M. Korenchuk, JD, MPHPartner, Arnold & Porter LLP, Washington, DC, USA
Keith Korenchuk counsels and advises global companies on regulatory and compliance matters worldwide, with a focus on compliance program effectiveness, compliance program implementation, operations and evaluation, and related regulatory counseling and advice. He works in a wide variety of industries and sectors including consumer products, electronics, energy, financial services, life sciences, medical device, pharmaceutical, and technology.
Since 2001, Mr. Korenchuk has been included in The Best Lawyers in America. He has developed, led, and implemented “hands-on” educational and healthcare programs that provide pharmaceuticals and healthcare services, teachers, school supplies, library resources, and computers to indigenous communities in South America for the past 12 years.
Since 2001, Mr. Korenchuk has been included in The Best Lawyers in America. He has developed, led, and implemented “hands-on” educational and healthcare programs that provide pharmaceuticals and healthcare services, teachers, school supplies, library resources, and computers to indigenous communities in South America for the past 12 years.
Daniel SchafaghiGlobal Compliance Operating Officer, Head of Compliance Emerging Markets, Boehringer Ingelheim GmbH, Ingelheim, Germany
Daniel Schafaghi has worked as an External Auditor for Ernst & Young in Frankfurt and as an Internal Auditor for Clariant in Basel, the Rewe Group in Cologne and for Boehringer Ingelheim in Ingelheim. He participated and led several audits and special investigations all around the world. Currently, Daniel works as the Global Compliance Operating Officer and Head of Compliance Emerging Markets at Boehringer Ingelheim’s Corp. Ethics & Compliance department. His responsibility includes amongst others the implementation of Antibribery/Anticorruption (ABAC) program elements with a focus on the worldwide implementation of an ABAC Third Party Due Diligence process and system.
Geert van GansewinkelManaging Partner, Europe and Asia Pacific, Polaris, Amsterdam, Netherlands (Moderator)
Geert van Gansewinkel is managing partner EMEA and AsiaPac for Polaris. He is Dutch, and based out of Amsterdam. He is responsible for Polaris’ business activities in Europe and Asia. Before joining Polaris, Geert worked at The Boston Consulting Group and Accenture.
MS 15: Impact of Self-Regulation Schemes on Industry Relationships with HCPs, HCOs and Patient Organizations
4:30 pm
Introductions, Panel Discussion and Q&A
Holger Diener, PhDManaging Director, Association of Voluntary Self-Regulation for the Pharmaceutical Industry; Vice-Chair, Ethics and Business Integrity Committee (eBIC), International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Berlin, Germany
Holger Diener has been Managing Director of the Association of Voluntary Self-Regulation for the Pharma-ceutical Industry (Freiwillige Selbstkontrolle für die Arzneimittelindustrie e.V. — FSA) since January 2012. Holger previously worked in the legal department of the German Association of Research-based Pharmaceutical Companies (Verband der forschenden Arzneimittelindustrie e.V. — vfa. He is Vice Chair of the Codes Committee and member of the Ethics and Compliance Committee at EFPIA. Holger is also a Vice Chair of the IFPMA Ethics and Business Integrity Committee (eBIC). Moreover, he is a Member of the International Society of Healthcare Ethics and Compliance Professionals (ETH-ICS). He is a renowned speaker at national and international congresses and symposia regarding compliance and compliance-related topics.
Jose F. Zamarriego Izquierdo, PhDDirector Unidad de Supervision Deontologica, Farmainidustria, Madrid, Spain
Mr. José F. Zamarriego is Director of Farmaindustria’s Code of Practice Surveillance Unit, Chair of the Codes Committee and Vice-Chair of EFPIA’s Compliance Committee, Member of EFPIA’s Steering Committee and Coordinator of the EFPIA e4ethics Initiative. He is also Chairman of IFPMA’s Code Complaint Procedure Adjudication Group and Member of the Code Compliance Network (CNN). He has participated in several modifications of the EFPIA, IFPMA and Farmaindustria Codes.
Previously he was standing professor in Universidad Europea de Madrid (UEM), and Dean of the Faculty of Economics and Business Administration and of Executive Director of the UEM General Foundation. These positions were held alongside that of General Secretary and General Director of the Spanish Generic Pharmaceutical Manufacturers Association (AESEG).
He is the author of publications and articles on the Spanish self-regulation system, the Code Surveillance Unit and the Code of Good Practices for the Promotion of Medicines and Interaction with Healthcare Professionals, marketing and generic medicines.
Previously he was standing professor in Universidad Europea de Madrid (UEM), and Dean of the Faculty of Economics and Business Administration and of Executive Director of the UEM General Foundation. These positions were held alongside that of General Secretary and General Director of the Spanish Generic Pharmaceutical Manufacturers Association (AESEG).
He is the author of publications and articles on the Spanish self-regulation system, the Code Surveillance Unit and the Code of Good Practices for the Promotion of Medicines and Interaction with Healthcare Professionals, marketing and generic medicines.
Jose Ramos, MD, MBACompliance Officer for Italy, Portugal, and Spain, Biogen, Madrid, Spain
Dr. Ramos started in the Pharmaceutical Industry in Eli Lilly, with relevant responsibilities such as Medical Advisor, Managing Clinical Research Operations Unit in Spain — and supporting the set up for the EU Regional Data Management Center.
He is a Global Leader for the implementation of Clinical Financial Planning processes and systems and a Transformation Champion for Italy, Spain and the Medical Function. Dr. Ramos is the Compliance Officer for the Spain, Portugal and Greece — supporting the Medical Function for the Europe, and Since Jan, 2015, the Compliance Officer in Biogen, for Italy, Portugal and Spain. Supporting the Medical Function for Europe, and key single contact for the Standards and Governance Team for Europe. At the present he is acting as Interim, Compliance Officer for France, Belgium and Netherlands.
He is a Global Leader for the implementation of Clinical Financial Planning processes and systems and a Transformation Champion for Italy, Spain and the Medical Function. Dr. Ramos is the Compliance Officer for the Spain, Portugal and Greece — supporting the Medical Function for the Europe, and Since Jan, 2015, the Compliance Officer in Biogen, for Italy, Portugal and Spain. Supporting the Medical Function for Europe, and key single contact for the Standards and Governance Team for Europe. At the present he is acting as Interim, Compliance Officer for France, Belgium and Netherlands.
Heather SimmondsDirector, Prescription Medicines Code of Practice Authority, London, UK
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.
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.
Brian Sharkey, JDVice President, Porzio Life Sciences, LLC, Morristown, NJ, USA (Moderator)
Brian Sharkey is a Vice President with Porzio Life Sciences, LLC. Mr. Sharkey collaborates with company directors, managers, and regulatory professionals to maintain the content of our products and services.
Mr. Sharkey focuses on international transparency laws, codes, and regulations affecting the life sciences industry. Specifically, he analyzes the reporting obligations that companies have under governmental regulatory schemes or industry self-regulation in countries outside the United States and counsels clients on how to comply with them. Mr. Sharkey has also been involved in the development of Porzio’s International Life Sciences Transparency Database, and has written and spoken extensively on the topic of international transparency.
Mr. Sharkey is also a Principal of Porzio, Bromberg & Newman PC and a member of the firm’s Life Sciences Compliance and Regulatory Counseling Department.
Mr. Sharkey is recognized on the New Jersey Super Lawyers “Rising Stars” List, 2007, 2009 – 2015.
Mr. Sharkey focuses on international transparency laws, codes, and regulations affecting the life sciences industry. Specifically, he analyzes the reporting obligations that companies have under governmental regulatory schemes or industry self-regulation in countries outside the United States and counsels clients on how to comply with them. Mr. Sharkey has also been involved in the development of Porzio’s International Life Sciences Transparency Database, and has written and spoken extensively on the topic of international transparency.
Mr. Sharkey is also a Principal of Porzio, Bromberg & Newman PC and a member of the firm’s Life Sciences Compliance and Regulatory Counseling Department.
Mr. Sharkey is recognized on the New Jersey Super Lawyers “Rising Stars” List, 2007, 2009 – 2015.
5:45 pm
Adjournment
Agenda Links: Precon/Day 1 | Day 3