Agenda Links: Precons/Day 1 | Day 3
AGENDA: DAY II
TUESDAY, APRIL 9, 2019
7:30 am
Registration Commences
MORNING PLENARY SESSION
8:30 am
Co-chair Welcome and Overview
8:45 am
Keynote on Anticorruption
Professor N. Craig Smith
Chaired Professor of Ethics and Social Responsibility, INSEAD; Academic Director, CSR & Ethics Research Group, INSEAD Social Innovation Centre, Fontainebleau, France
Chaired Professor of Ethics and Social Responsibility, INSEAD; Academic Director, CSR & Ethics Research Group, INSEAD Social Innovation Centre, Fontainebleau, France
Professor N. Craig Smith has been on the INSEAD faculty for the past ten years as the Chaired Professor of Ethics and Social Responsibility. He was previously on the faculties of London Business School, Georgetown University, and Harvard Business School. At INSEAD, Smith teaches and directs programs on business ethics and compliance and corporate social responsibility/sustainability. Smith directs the INSEAD Healthcare Compliance Implementation Leadership Programs in Fontainebleau and the INSEAD Ethics and Compliance Leadership Program in Singapore.
Smith’s research is at the intersection of business and society, encompassing business/marketing ethics, corporate social responsibility, and sustainability strategies. He is the author, coauthor or coeditor of eight books and forty articles in academic journals. Smith’s journal articles and case studies often address ethics, corporate responsibility and compliance in the healthcare industry, including topics such as pharmaceutical marketing practices, drug pricing, and access to essential medicines.
Smith’s research is at the intersection of business and society, encompassing business/marketing ethics, corporate social responsibility, and sustainability strategies. He is the author, coauthor or coeditor of eight books and forty articles in academic journals. Smith’s journal articles and case studies often address ethics, corporate responsibility and compliance in the healthcare industry, including topics such as pharmaceutical marketing practices, drug pricing, and access to essential medicines.
9:15 am
The Emerging Role of Technology Companies in the Life Science Marketplace and the Ethical and Compliance Implications of this Development
Abhiroop Gandhi, MS, MBA
Trust and Compliance Officer, Verily Life Sciences (an Alphabet company); Former Vice President, Corporate Compliance, Mallinckrodt, San Francisco, CA, USA
Trust and Compliance Officer, Verily Life Sciences (an Alphabet company); Former Vice President, Corporate Compliance, Mallinckrodt, San Francisco, CA, USA
Abhiroop Gandhi is the Trust & Compliance Officer at Verily (formerly Google Life Sciences), a company at the intersection of technology, data science and healthcare. He has over 15 years of experience in biopharmaceuticals and medical devices. He has played roles in corporate compliance, risk management and commercial strategy and operations. He was previously Vice President of Corporate Compliance at Mallinckrodt Pharmaceuticals, where he established the company’s Enterprise Risk Management (ERM) and international healthcare programs. Prior to the acquisition by Mallinckrodt, he helped build and manage Questcor’s healthcare compliance program. Before joining Questcor, Mr. Gandhi held positions at Actelion Pharmaceuticals, Genentech, Razorfish and GE Capital (General Electric).
9:45 am
Annual Anticorruption Roundtable
Andrew Butel
Partner, Kirkland & Ellis International LLP, London, UK
Partner, Kirkland & Ellis International LLP, London, UK
Andrew Butel is a partner in the London office of Kirkland & Ellis International LLP focusing on advising clients on a range of white collar and corporate crime matters.
Since joining Kirkland, Andrew’s representative matters have included:
Representing a global extractives company in respect of internal and governmental investigations into alleged bribery and corruption conducted by the SFO, the U.S. Department of Justice, the U.S. Securities & Exchange Commission, the Australian Securities and Investments Commission and the Australian Federal Police.
Representing a manufacturing company in an internal investigation concerning certain product specification claims. Advising on related potential criminal, civil and regulatory exposure in the UK and coordinating with local counsel in six other jurisdictions.
Defending an ultra high-net-worth individual in respect of bribery and money laundering investigations conducted by the UK National Crime Agency together with Swiss and African criminal investigation authorities.
Since joining Kirkland, Andrew’s representative matters have included:
Representing a global extractives company in respect of internal and governmental investigations into alleged bribery and corruption conducted by the SFO, the U.S. Department of Justice, the U.S. Securities & Exchange Commission, the Australian Securities and Investments Commission and the Australian Federal Police.
Representing a manufacturing company in an internal investigation concerning certain product specification claims. Advising on related potential criminal, civil and regulatory exposure in the UK and coordinating with local counsel in six other jurisdictions.
Defending an ultra high-net-worth individual in respect of bribery and money laundering investigations conducted by the UK National Crime Agency together with Swiss and African criminal investigation authorities.
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
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 Partner in the Düsseldorf office of Clifford Chance. He is the Regional Managing Partner for Germany and heads the Global Healthcare, Life Sciences and Chemicals industry group of Clifford Chance. Dr. Peter Dieners specializes in healthcare related regulations, healthcare fraud and abuse prevention, compliance and healthcare-related commercial and corporate transactions. He advises lading pharmaceutical, medical device, and chemical companies on all of their business-critical corporate, commercial, and compliance matters, including investigations and related prevention counseling. He also acts for trade associations and companies vis-à-vis government agencies in relation to legislative projects and amendments as well as for the elaboration for compliance-related industry codes of conduct.
Michael K. Loucks, JD
Partner, Skadden Arps LLP; Former Acting United States Attorney, District of Massachusetts, US Department of Justice, Washington, DC, USA
Partner, Skadden Arps LLP; Former Acting United States Attorney, District of Massachusetts, US Department of Justice, Washington, DC, USA
Michael Loucks is a Partner at Skadden Arps LLP. He is an experienced trial and appellate attorney whose practice focuses on internal investigations and government enforcement matters in the U.S. and abroad, and on false claims act litigation in federal and state courts. Prior to joining Skadden in 2010, Mr. Loucks served as acting U.S. attorneyand first assistant U.S. attorney for the District of Massachusetts. He repeatedly has been selected for inclusion in Chambers USA: and The Best Lawyers in America.
Paul J. Melling, Esq.
Founding Partner, Baker & McKenzie – CIS, Limited, Moscow, Russia
Founding Partner, Baker & McKenzie – CIS, Limited, Moscow, Russia
Paul Melling is an English solicitor and the founding partner of Baker McKenziie’s Moscow and Almaty offices, having now spent over 30 years living and working in Moscow and in the countries of the former USSR. He founded and leads both Baker McKenzie’s CIS Compliance & Investigations Group and also its CIS Healthcare industry Group and is a member of the Steering Committee for Baker McKenzie’s Global Heathcare industry Group and for its EMEA Compliance & Investigations Group. Paul Melling has been the Honorary Legal Adviser to the British Ambassador to the Russian Federation since 1990 and is a member of the Advisory Council of the Russo-British Chamber of Commerce. He has been Honorary Legal Adviser to Russia’s Association of International Pharmaceutical Manufacturers (AIPM) since its founding in 1994.
Tom Gregory, MBA
Partner, Forensic & Integrity Services, EY, Atlanta, GA, USA (Moderator)
Partner, Forensic & Integrity Services, EY, Atlanta, GA, USA (Moderator)
Tom Gregory is a Partner in Ernst & Young’s Forensic & Integrity Services practice where he serves as the Global Sector Leader for Health & Life Sciences. He has over 25 years of experience leading significant investigations in the sector and advising clients on complex litigation, compliance programs and government inquiries. His current work focuses on applying economic tools and data analysis to understand market behavior and model the financial impact to support resolution of matters arising under anti-bribery and corruption statutes. Mr. Gregory’s work covers the full spectrum of the health and life sciences sector including phamaceutical manufacturers, biotechs, medical devices and technology, hospitals, insurance providers, long term care, consumer health, supplies, wholesalers and distributors, health data and services, and medical equipment. He advises companies, their outside legal counsel and regulators and has led matters in over 40 countries including significant multi-national disputes.
10:45 am
Transition Break
MINI SUMMITS ROUND I: 11:15 am – 12:15 pm
Mini Summit 1: Annual Medical Device Ethics and Compliance Best Practices Roundtable
Join panelists as they address:
- Differences between MedTech and pharma, e.g. industries’ structure, legal framework, relationship with HCPs, transparency, ban of direct sponsorship of HCPs, conference vetting system, and patients organisations.
- Main challenges encountered by MedTech companies given the new codes in US and EU, specific to phase out of direct sponsorship practical challenges, product and procedure trainings, reaction of the stakeholders, i.e. PCOs and HCOs, and placement of equipment, loan, samples.
- Areas of convergence (e.g. digital, patient organization)?
11:15 am
Introductions, Panel Discussion and Q&A
Suzanne Durdevic, LLM
Associate General Counsel – International, Fortive | ASP; Member, Strategic Committee, International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France
Associate General Counsel – International, Fortive | ASP; Member, Strategic Committee, International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France
Aline Lautenberg
General Counsel and Director Legal & Compliance, MedTech Europe, Brussels, Belgium
General Counsel and Director Legal & Compliance, MedTech Europe, Brussels, Belgium
Aline Lautenberg is MedTech Europe’s General Counsel and Legal & Compliance Director. As such, she is advising on MedTech Europe’s contractual, regulatory and statutory obligations. She is also assisting the Chief Executive and the Board of Directors. Moreover, Aline leads the association’s working groups on legal matters, including data protection and compliance. The Legal & Compliance team’s goal is to provide a clear framework assessing the appropriateness and legality of any and all matters affecting both the association as well as the medical technology industry more broadly. Aline has more than 15-year experience in the MedTech industry. She’s a graduate of the university of Louvain-la-Neuve (Belgium) and speaks fluently French, English and German.
Chrystel Lanxade
Regional Compliance Officer, Europe Middle East Africa, Alcon; Former Head of Legal & Compliance Alcon France; Former Legal & Compliance Head Novartis Consumer Health France, Former Legal Counsel, Leem, Cointrin, Canton of Geneva, Switzerland
Regional Compliance Officer, Europe Middle East Africa, Alcon; Former Head of Legal & Compliance Alcon France; Former Legal & Compliance Head Novartis Consumer Health France, Former Legal Counsel, Leem, Cointrin, Canton of Geneva, Switzerland
Christopher L. White, JD
Chief Operating Officer and General Counsel, Advanced Medical Technology Association (AdvaMed), Washington, DC, USA
Chief Operating Officer and General Counsel, Advanced Medical Technology Association (AdvaMed), Washington, DC, USA
Mr. White is the Chief Operating Officer and General Counsel of Advanced Medical Technology Association (AdvaMed). Mr. White serves as the Association’s Chief Legal Officer and manages AdvaMed’s Legal Committee to develop and promote legal policy positions enhancing patient access to medical technology. Mr. White also leads the Association’s global working groups on legal policy and compliance, including over 1500 in-house medtech lawyers. He testified before state and federal legislative committees on priority legal policy issues; led the drafting team revising the AdvaMed Code; and led the multinational negotiating team to draft the Kuala Lumpur Principles, harmonizing industry Codes of Ethics in Asia. He is an Advisory Board Member to the GWU School of Medicine and Health Sciences. As Chief Operating Officer, he manages the Association’s HR, IT, Facilities, and, governance and provides counsel on contract, corporate, tax exemption, HR, and legislative and regulatory matters.
Ulf H. Grundmann
Partner, FDA and Life Sciences, King & Spalding LLP, Frankfurt am Main, Germany (Moderator)
Partner, FDA and Life Sciences, King & Spalding LLP, Frankfurt am Main, Germany (Moderator)
Ulf Grundmann is Partner of the Government Matters Practice Group, and he concentrates on regulations and compliance regarding the pharmaceutical, medical devices, cosmetic and food industries, and on litigation in the European Union. For more than 20 years, Ulf has advised clients through all stages of the product life cycle, including product development, trademark clearance, labeling, advertising and promotion, product launch, distribution, licensing and compliance in the EU. He also handles all kinds of litigation related to the products, the distribution, intellectual property rights, competition and advertising. This includes aspects related to parallel importation, protection against falsified products, recalls, and product end-of-life. He litigates matters before German and European courts, including the General Court and the Court of Justice of the EU.
Mini Summit 2: Compliance in the Light of Digitalization
With major transformation programs of companies towards digitalization, challenges for compliance organizations rises. Questions such as how digitalization impacts the future work of compliance and how to transform compliance to cope with new challenges will be discussed.
Risks are transforming to more technical risks and may require completely new competences within the compliance organization to understand and assess these risks. Furthermore the compliance organization itself needs to digitalize their programs and way of working. In light of this transformation, what does it mean for future talent management and program development?
11:15 am
Introductions, Panel Discussion and Q&A
Gérald Hucky
Head Group Compliance, Sonova Group; Former Compliance Audit Manager, NameZimmer Biomet, Zürich, Switzerland
Head Group Compliance, Sonova Group; Former Compliance Audit Manager, NameZimmer Biomet, Zürich, Switzerland
Gérald Hucky is Sonova’s Head of Group Compliance since November 2017. Gérald originally hails from France and has more than 12 years’ experience in the medical device sector both in-house and in consulting practices. From 2006 to 2016, Gérald worked at the orthopaedics company Zimmer Biomet in Switzerland and in the United States where he was a Manager Compliance Audit for Americas. Before joining Sonova, Gérald was a Manager Fraud, Investigation and Dispute Services for Ernst & Young in Zurich.
Marie-Claire Pickaert
Former Deputy Director General, Chief Financial Officer and Ambassador to the Medical Communities, European Federation of Pharmaceutical Industries and Associations (EFPIA), Brussels, Belgium
Former Deputy Director General, Chief Financial Officer and Ambassador to the Medical Communities, European Federation of Pharmaceutical Industries and Associations (EFPIA), Brussels, Belgium
Marie-Claire Pickaert is Managing Director of MCP Advice & Partnerships. She was previously the Deputy Director General at EFPIA. Her positions included CFO and CECO Board Member at DE POEL, an institution providing social inclusion support to adults with mental and physical disabilities. She is an active member of Ethics.
Niels Wohlwend, lic iur, MAES
Senior Director, Healthcare Compliance (HCC) Europe & Canada, Celgene; Member, WFPIA Ethics & Compliance Committee; Former Global Head of Compliance, ACINO; Former Head of Compliance APAC, LATAM and MEA, Mundipharma, Boudry, Canton of Neuchâtel, Switzerland
Senior Director, Healthcare Compliance (HCC) Europe & Canada, Celgene; Member, WFPIA Ethics & Compliance Committee; Former Global Head of Compliance, ACINO; Former Head of Compliance APAC, LATAM and MEA, Mundipharma, Boudry, Canton of Neuchâtel, Switzerland
Niels Wohlwend is the Senior Director HCC Europe & Canada, Global Compliance Group at Celgene and a Member of Ethics & Compliance Committee (E&CC) at EFPIA. He was previously the Global Head of Compliance at ACINO.
Anita Kyung-Hee Kim-Reinartz
Partner, Forensic & Integrity Services, EY, Düsseldorf, Germany (Moderator)
Partner, Forensic & Integrity Services, EY, Düsseldorf, Germany (Moderator)
Mini Summit 3: Data Privacy, Consent Management and GDPR Update
While GDPR is already enforceable law, the new regulation is still top of mind for many data privacy and compliance officers, who are learning how best to comply with the law’s many complex requirements.
Join IQVIA’s Giuseppe Saporito, Attorney-at-Law, and panelists for a discussion and practical insights from GDPR’s first year of enforceability. Highlights will include:
- How can Life Sciences companies effectively manage “Consent”?
- What is the impact of data privacy on the transparency landscape?
- What is the current enforcement environment?
11:15 am
Introductions, Panel Discussion and Q&A
Irith Kist, LLM, CIP/M
Functionaris Gegevensbescherming/ Data Protection Officer, The Netherlands Cancer Institute, Amsterdam, The Netherlands
Functionaris Gegevensbescherming/ Data Protection Officer, The Netherlands Cancer Institute, Amsterdam, The Netherlands
Irith Kist holds the position of data protection officer at the Netherlands Cancer Institute in Amsterdam. In addition, she is a strategic consultant in international and European (privacy) law, and she is a certified court interpreter and sworn translator in the English language with the district courts and court of appeals in the Netherlands. Irith holds a triple master’s degree in political science, specialization international relations, international and European law, specialization privacy law and human rights law, and international and European tax law.
Nicola Orlandi
Head, Data Privacy Pharma, Global Privacy Office, Novartis International AG; Former Head of Legal and Compliance, Sandoz S.p.A., Basel, Switzerland
Head, Data Privacy Pharma, Global Privacy Office, Novartis International AG; Former Head of Legal and Compliance, Sandoz S.p.A., Basel, Switzerland
Nicola Orlandi is Head of Data Privacy Pharma and Oncology in Novartis International AG. In his current role he is partnering with divisional business to enable growth, productivity and innovation. He is also working in implementing privacy controls and considering data privacy requirements as well as business needs. His main areas of expertise are Digital Medicine, Real World Evidence, Big Data and AI, Data transparency, Data Anonymization and pseudonymization.
Eirini Tsotra, MS, CIPP/E, CIPM, CISA
Director, Privacy & Data Protection, Ferring International Centre SA, St-Prex, Switzerland
Director, Privacy & Data Protection, Ferring International Centre SA, St-Prex, Switzerland
Eirini Tsotra is the Privacy & Data Protection Director within the Global Privacy Office of Ferring International Centre S.A. Based in Switzerland, she is responsible to ensure Privacy Compliance requirements are globally implemented and maintained in accordance with the appropriate European Data Protection Regulation and respective national privacy laws. She has 10 years of previous Audit experience.
Giuseppe Saporito, LLM
Global Legal & Regulatory Expert, IQVIA, Milan, Italy (Moderator)
Global Legal & Regulatory Expert, IQVIA, Milan, Italy (Moderator)
Giuseppe Saporito is an Attorney-at-Law working in the Commercial Compliance department within IQVIA. Giuseppe is responsible for the legal monitoring and interpretation of the life science regulations that are impacting software products in the compliance area. Prior to joining IQVIA in November 2015, Giuseppe worked for an Italian Pharmaceutical Company where he was part of the corporate legal office advising on IP, Ethics and Compliance matters. Giuseppe was admitted to the Italian bar in 2013
Mini Summit 4: The Next Chapter — Improving the Future of Compliant HCP Engagements
Across the globe, regulations regarding HCP engagement are growing in number and in complexity. Life sciences companies are challenged not only by staying up to date, but by making the process more efficient. Leading companies are leveraging technology to streamline processes, reduce costs, increase efficiencies across the organization, and to garner new insights from data to help them make better decisions.
IQVIA Commercial Compliance’s Chris van Bronckhorst will lead a panel of industry professionals who will explore current challenges, emerging trends and best practices that life sciences companies are employing to stay ahead of the compliance game.
11:15 am
Introductions, Discussion and Q&A
Michael Bartke, PhD
Director Ethics & Compliance, Alexion, Former Director Compliance Management, Daiichi Sankyo Europe GmbH, Strategic Committee, ETHICS, Munich, Germany
Director Ethics & Compliance, Alexion, Former Director Compliance Management, Daiichi Sankyo Europe GmbH, Strategic Committee, ETHICS, Munich, Germany
Michael Bartke has more than 30 years’ experience at research-based companies e.g. Bristol Myers Squibb and Daiichi Sankyo – e.g. Head of Marketing involved in various national and international projects. 2008 Director Compliance Management at European Headquarter for Daiichi Sankyo Europe; experience in various areas of Compliance and risk management. Activities in associations re Compliance at FSA Berlin, Germany, EFPIA Brussels, Belgium ( Co-Chair Compliance Committee), and IFPMA Geneva, Switzerland ( Code Compliance Network); He is now the Director, Ethics and Compliance at Alexion Pharma Germany and since 2019 is a compliance consultant and a Member of Strategic Committee of ETHICS, Paris, France
Matthew Coombs
Director, Account & Services Offering Management, Commercial Compliance, IQVIA, Former Strategic Business Director, Qforma, London, UK
Director, Account & Services Offering Management, Commercial Compliance, IQVIA, Former Strategic Business Director, Qforma, London, UK
Matt Coombs is a Services Development Director with AHM- a technology and services company providing the Life Science industry with event management solutions to drive effective and compliant HCP engagements. Matt is responsible for developing IQVIA’s managed service offering for customers in Europe and Asia and has extensive experience in both service execution and system implementations for interactions with HCPs. Prior to joining IQVIA, Matt was involved in leading implementations of SaaS solutions including Key Opinion Leader Management, Brand Knowledgebase, Performance Management, Launch Management and Market Access with a wide range of multinational organizations.
Daniel T. Kessler, MA, JD
Founder & Principal, Givon Advisors; Former Chief Counsel, Int’l Trade Controls, Pfizer; Tel Aviv, Israel
Founder & Principal, Givon Advisors; Former Chief Counsel, Int’l Trade Controls, Pfizer; Tel Aviv, Israel
Daniel T. Kessler is a aeasoned international lawyer with over thirty years’ experience in governance, risk management and compliance, as well as in broad general corporate and commercial matters, as consultant, in-house counsel, with public companies, startups and international governmental organizations.
Chris van Bronckhorst
Global Compliance Director, IQVIA, The Hague, Netherlands (Moderator)
Global Compliance Director, IQVIA, The Hague, Netherlands (Moderator)
Chris van Bronckhorst leads the Go-To-Market teams in Europe & Asia in defining solutions for clients. Chris started as a program developer and designer. He evolved to a manager in the IT consultancy, services and project industry. He was a compliance director for the Public Sector when working for a global IT consulting firm. Managing risks, compliance and contract negotiations were one off his tasks.
Mini Summit 5: Annual Middle East Africa (MEA) Compliance Update
Panelists will engage in discussions on the following topics related to the region:
- Tour of country regulations and enforcement, including self-regulation and the impact of changes in IFPMA code.
- Access solution from compliance perspective
- Interaction with Patient Groups and Patients
- Trade Association work in the region and collaboration between the sectors.
- GDPR regulations compared to new regulations in the region
11:15 am
Introductions, Panel Discussion and Q&A
Maria Khoury, MBA, PharmD
Compliance Officer Levant, Roche; Chair, Lebanese Group of International Pharmaceutical Companies and Iraq LAWG (Local Area Working Group), Beirut, Lebanon
Compliance Officer Levant, Roche; Chair, Lebanese Group of International Pharmaceutical Companies and Iraq LAWG (Local Area Working Group), Beirut, Lebanon
Maria Khoury joined Roche in 2015 as Compliance Officer for Levant countries and is based in Beirut. She is also the lead of the compliance groups for Lebanon and Iraq trade associations. She worked for the last 15 years in the pharma industry and held various roles in sales and marketing before assuming compliance officer function in JnJ in 2011 and in Roche in 2015.
Minal Patel
Health Care Compliance Officer, Pharma and Consumer, Johnson & Johnson, Johannesburg Area, South Africa
Health Care Compliance Officer, Pharma and Consumer, Johnson & Johnson, Johannesburg Area, South Africa
Minal Patel is the health care compliance officer for the Johnson & Johnson Pharmaceutical and Consumer companies in Sub-Saharan Africa and South Africa for the last three years. She was a speaker at the Second Forum on Anti-Corruption Southern Africa on the topic of promoting and demonstrating an organizational commitment to a compliance culture from top to bottom. Her eight years of experience in the pharmaceutical industry cover various aspects of compliance including quality, safety and regulatory affairs. She enjoys travelling and being outdoors.
Rami A. Rajab
Chairman, Mecomed Medical Technology Association Middle East & Africa (MECOMED); Chairman, LIFE (LivaNova International Fellowship), International Corporate Social Responsibility; Former Vice President Market Access, Emerging Markets, LivaNova, Maidenhead, UK
Chairman, Mecomed Medical Technology Association Middle East & Africa (MECOMED); Chairman, LIFE (LivaNova International Fellowship), International Corporate Social Responsibility; Former Vice President Market Access, Emerging Markets, LivaNova, Maidenhead, UK
Rami Rajab is the Chairman of MECOMED, the Middle East & Africa Medical Device, Diagnostics and Imaging trade association. He is Also Chairman of LIFE, LivaNova’s International Fellowship (the International Corporate Social Responsibility) Over the last 33 years Rami covered roles in Sales, Distribution Management, Team and Regional Leadership, in various geographies covering the Middle East & Africa, Europe, Latin America, South and South-East Asia and China. He was actively engaged in the Cyberonics – Sorin Group Merger then Integration leading Sorin Group’s Intercontinental Sales Team. He has a solid understanding of the markets dynamics and particularities, engaging and cooperating with various stakeholders at various levels of the Healthcare Ecosystem including governments officials on matters related to health policy, legislation, ethics and compliance and financial reimbursement.
Laura Nassar, PharmD
Head of Compliance Middle East, Roche Pharmaceuticals; Chair, Compliance Committee, Pharmaceutical Research and Manufacturers Association, Gulf (PhRMAG); Former Regional Pharma HCC Officer Emerging Markets, Johnson & Johnson, Beirut, Lebanon (Moderator)
Head of Compliance Middle East, Roche Pharmaceuticals; Chair, Compliance Committee, Pharmaceutical Research and Manufacturers Association, Gulf (PhRMAG); Former Regional Pharma HCC Officer Emerging Markets, Johnson & Johnson, Beirut, Lebanon (Moderator)
Laura Nassar is the Head of Compliance for Middle East at Roche Pharmaceuticals, based in Dubai. She is the Lead for PhRMAG (PhRMA Gulf) Compliance and Legal Working Group and Chair of the Middle East Ethics Review Board (LERB), governing body of the MEA Code of Promotional Practices. She has over 18 years’ experience in the healthcare industry, across a wide range of disciplines such as Pharmacy, Sales and Marketing, Skills Training and Compliance. She worked closely with management teams in Turkey, Middle East, West Asia and Africa to build a strong compliance culture and support sustainable business growth. Laura holds a Pharm.D degree from St Joseph University in Beirut, Lebanon.
12:15 pm
Networking Luncheon
MINI SUMMITS ROUND II: 1:15 pm – 2:15 pm
Mini Summit 6: Whistleblower Updates: New EU-wide Standards to Protect Whistleblowers & US Qui Tam
Actions against Foreign Pharma and Device Companies doing Business in the US
Early this year, the EU Council adopted its position on a new directive to guarantee a high-level protection to whistleblowers across the Union. While there are similarities, the whistleblower regime is slightly different between the regions, and companies headquartered in the EU must be aware of the US regulatory environment which can lead to enforcement actions. Join Tom and Ulf as they walk the audience through an in-depth discussion.
1:15 pm
Introductions, Discussion and Q&A
Thomas W. Beimers, JD
Partner, Hogan Lovells; Former Senior Counsel for Administrative and Civil Remedies, Office of the Inspector General, Department of Health and Human Services, Minneapolis, MN, USA
Partner, Hogan Lovells; Former Senior Counsel for Administrative and Civil Remedies, Office of the Inspector General, Department of Health and Human Services, Minneapolis, MN, USA
Tom Beimers is a member of the health care practice group at Hogan Lovells US LLP, where he counsels clients on fraud and abuse, compliance, and risk management issues, and assists clients with False Claims Act and other health care fraud investigations. Tom focuses a significant portion of his practice on complex Anti-Kickback Statute matters. Tom was previously senior counsel with the Department of Health and Human Services’ Office of the Inspector General, where he was a member of the Pharma Team. In that capacity, Tom investigated False Claims Act and other fraud matters, and negotiated and monitored corporate integrity agreements with pharmaceutical manufacturers. Tom is a frequent national speaker and author on topics related to healthcare fraud and abuse, white collar criminal defense, and compliance matters.
Ulf H. Grundmann
Partner, FDA and Life Sciences, King & Spalding LLP, Frankfurt am Main, Germany
Partner, FDA and Life Sciences, King & Spalding LLP, Frankfurt am Main, Germany
Ulf Grundmann is Partner of the Government Matters Practice Group, and he concentrates on regulations and compliance regarding the pharmaceutical, medical devices, cosmetic and food industries, and on litigation in the European Union. For more than 20 years, Ulf has advised clients through all stages of the product life cycle, including product development, trademark clearance, labeling, advertising and promotion, product launch, distribution, licensing and compliance in the EU. He also handles all kinds of litigation related to the products, the distribution, intellectual property rights, competition and advertising. This includes aspects related to parallel importation, protection against falsified products, recalls, and product end-of-life. He litigates matters before German and European courts, including the General Court and the Court of Justice of the EU.
Mini Summit 7: The Evolution of Risk Assessment and Using Risk Assessment to Design Compliance Programs
Join panelists as they address:
- The elements of an effective compliance program and the DOJ guidance of 2017
- The Chicken and Egg question: who was first – RA or the CO program?
- The implementation of Compliance risk assessments in large and medium LS companies
- What is the difference to the ERM?
- Who is in charge of the risk assessments?
- Who is involved in those risk assessments?
- What is the impact of its results to the Compliance Program?
1:15 pm
Introductions, Discussion and Q&A
Karen Eryou
Head, Ethics & Compliance Programs, UCB Pharma; Former Co-chair, Asia Pacific Pharma Compliance Congress, Brussels, Belgium
Head, 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 Pharma. 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 policies, 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.
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.
Thomas K. Hauser, MA HSG, MSJ
Director, Life Sciences Governance, Risk Management, and Compliance Practice, Navigant; Former Global Chief Compliance Officer, Siemens Healthcare; Treasurer, International Society of Healthcare, Ethics and Compliance Professionals (ETHICS), London, UK (Moderator)
Director, Life Sciences Governance, Risk Management, and Compliance Practice, Navigant; Former Global Chief Compliance Officer, Siemens Healthcare; Treasurer, International Society of Healthcare, Ethics and Compliance Professionals (ETHICS), London, UK (Moderator)
Thomas K. Hauser is a director and the European practice leader of the Life Sciences Governance, Risk Management and Compliance practice. This includes a deep understanding of anti-bribery and anti-corruption (domestic and international), conflicts of interest, and regulatory matters as they manifest in daily operations and which require practical risk management controls. Thomas has more than two decades of operational business experience, in management roles as CEO and in operational compliance and consulting. Thomas has significant international experience in medical device and pharmaceutical companies; focusing on the U.S., Europe, Russia/CIS, Middle East and China. Thomas served for more than six years as the global Chief Compliance Officer for a $16B Life Sciences company (covering MedTech and Pharma) with over 100 world-wide locations.
Mini Summit 8: Analytics with Reference to Transparency and/or Monitoring
In this new era of transparency and access to publicly available data, which functions as a resource for consumers, HCPs, and Pharma/Device industries, there is increased focus on HCP Interactions. Engage with panelists as they discuss how data can be leveraged to:
- Identify and mitigate risk,
- Drive compliance monitoring activities, and
- Proactively inform critical business decisions
1:15 pm
Introductions, Discussion and Q&A
Michaeline Daboul
Chief Executive Officer and Co-Founder, Medispend, New York, New York
Chief Executive Officer and Co-Founder, Medispend, New York, New York
Michaeline Daboul is the Co-founder and CEO of MMIS. She introduced MediSpend, the first open source Softwareas-a-Service, compliance cloud solution to the life sciences industry in 2011. Since 1985 Michaeline has been introducing disruptive technologies in the pharmaceutical industry for drug development, genomics research, and now compliance cloud solutions. Michaeline works with compliance leaders from some of the world’s most innovative and emerging life science companies to reduce compliance risk while modernizing compliance programs. Her latest initiative, MediSpend, is now recognized as the compliance system of record for some of the world’s largest Life Sciences companies. In addition to leading MMIS, Michaeline mentors’ women in their tech careers and writes a blog for entrepreneurs and life science executives.
Monique Fonfara-Weinberg
Compliance Manager, Boehringer Ingelheim Corporate Center GmbH, Ingelheim am Rhein, Germany
Compliance Manager, Boehringer Ingelheim Corporate Center GmbH, Ingelheim am Rhein, Germany
Monique Fonfara-Weinberg has over 16 years of international work experience in the pharmaceutical industry. Currently she is serving as Compliance Manager, Global Healthcare Compliance at Boehringer Ingelheim Corporate Center GmbH. Previous experiences at BI include Sales, Marketing and Legal in national and international roles. For the past five years, she has concentrated on ensuring BI’s readiness for the EFPIA HCP/HCO Disclosure Code globally and at headquarters by supporting various international affiliates, corporate-based functions and Global Healthcare Compliance Officer. In her compliance role, she provides support to activities and initiatives planned and executed across different Therapeutic Areas including Compliance Trainings, Risk Assessment, Monitoring and Analytics.
Arielle Hung
Compliance Counsel, Merck KGaA, Darmstadt, Germany
Compliance Counsel, Merck KGaA, Darmstadt, Germany
Arielle Hung is currently the Compliance Counsel specializing in Healthcare compliance at Merck KGaA, Darmstadt, Germany. With her legal background, her primary responsibility is to establish and manage global compliance policies, procedures and agreement templates for the Healthcare business. She joined Merck in 2014, starting as the Compliance Officer for Taiwan and China (Chemical business). Prior to this, she had several years of professional working experience in banking compliance and government affairs in two international banks headquartered in the UK and the US.
Laetitia Ducroquet Minel
Senior Director, Ethics & Compliance, Ipsen, Boulogne-Billancourt, France
Senior Director, Ethics & Compliance, Ipsen, Boulogne-Billancourt, France
Laetitia Minel joined the Ipsen Global Ethics & Compliance department in May 2015, as Global Transparency Manager. Laetitia is a pharmacist and a graduate of the EM Lyon Business School. She began her career as a medical representative, before turning to market research, and then joined the consulting field where she has supported pharmaceutical companies in the implementation of their E&C program.
After several E&C roles at Ipsen, Laetitia is now in charge of the Ipsen E&C Third-Party program, of the E&C support provided to Global Consumer HealthCare, and of the E&C support provided to Northern and Central Europe.
After several E&C roles at Ipsen, Laetitia is now in charge of the Ipsen E&C Third-Party program, of the E&C support provided to Global Consumer HealthCare, and of the E&C support provided to Northern and Central Europe.
Carl Judge
Partner, Forensic & Integrity Services, EY, London, UK (Moderator)
Partner, Forensic & Integrity Services, EY, London, UK (Moderator)
Mini Summit 9: Ethics and Compliance Issues in Patient Relationships, Including Patient Access and Support
Programs
This session explores an analytical approach to helping manufacturers create effective patient support programs by taking into account the various stakeholder’s perspectives, strengths, and appropriate level of engagement. Manufacturer’s face very specific risks in their involvement in, and support of, patient support activities. Industry Codes are slowly starting to provide some direction for manufacturers.
Join the panel as they address what questions should be asked as company’s move from reactive responses to internally designed programs to pro-active design of programs created and run by multiple stakeholders.
1:15 pm
Introductions, Panel Discussion and Q&A
Stephen Nguyen Duc
Vice-President, Global Head of Human Resources and Ethics & Compliance, Medday Pharmaceuticals; Board Member, Strategic Committee International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France
Vice-President, Global Head of Human Resources and Ethics & Compliance, Medday Pharmaceuticals; Board Member, Strategic Committee International Society of Healthcare Ethics and Compliance Professionals (ETHICS), Paris, France
Stephen Nguyen-Duc joined Medday in November 2018 as VP, Global Head of Ethics & Compliance. As part of his career, he has held several senior positions in Clinical Operations, Human Resources and Compliance in multinational companies. In his last position before Medday, he was the Compliance Officer for Europe and Canada at Abbvie Pharmaceuticals. Stephen is an active member of various associations promoting Trust and Integrity in Healthcare. He is Board member and Co-Chair of the Strategic Committee of Ethics, the International association of Healthcare Compliance Officers
Ariadna Quesada, MSJ
Law, Ethics and Compliance Officer, The Netherlands, AbbVie; Former Compliance Manager International, MicroPort Orthopedics Inc., Amsterdam, Netherlands
Law, Ethics and Compliance Officer, The Netherlands, AbbVie; Former Compliance Manager International, MicroPort Orthopedics Inc., Amsterdam, Netherlands
Ariadna Quesada is the responsible for the Office of Ethics and Compliance for AbbVie Inc in The Netherlands. She is a Certified Fraud Examiner (CFE) and has attended the Healthcare Compliance Certification Programs from Seton Hall University in Europe and US. Before joining AbbVie Inc., Ariadna worked for MicroPort Orthopedics and DaVita as the compliance officer for the International regions. Ariadna started her career working for Royal Dutch Shell where she held different positions in finance, controls and compliance both in South America and in Europe.
Ann Beasley, JD
Director, Navigant Consulting; Former Senior Vice President, Chief Compliance Officer, Biogen; Former Co-chair, International Pharmaceutical and Medical Device Compliance Congress, Boston, MA, USA (Moderator)
Director, Navigant Consulting; Former Senior Vice President, Chief Compliance Officer, Biogen; Former Co-chair, International Pharmaceutical and Medical Device Compliance Congress, Boston, MA, USA (Moderator)
Ann Beasley is a Director with over 18 years’ experience as an in-house Compliance Officer and lawyer in building, managing and optimizing corporate compliance programs in life sciences companies. Ann brings an understanding of the issues clients’ face in implementing all the elements of an effective compliance program across global biotech, pharmaceutical, and device companies’ international operations. This includes a deep understanding of anti-bribery and anti-corruption (domestic and international), conflicts of interest, and regulatory matters as they manifest in daily operations and which require practical risk management controls. She has practiced in both legal and compliance departments and just prior to joining Navigant, was the Chief Compliance Officer and Senior Vice President at Biogen. Ann has significant international experience having built and led global compliance programs for major pharmaceutical and biotechnology companies, including developing the organizational infrastructure of the function and the individual skill development of compliance professionals.
Mini Summit 10: Annual Central and Eastern Europe (CEE) Compliance Best Practices Update
Review regulatory and enforcement actions in the region, including discussions related to:
- Interactions with Third Parties
- Investigations in anticompetitive and antibribery activities
- Anti-money laundering activities
- Tax Evasion
- New cases of Antitrust Issues
- Amendments to local code on disclosure of corporations with patient organizations
- Data Privacy Regulations
1:15 pm
Introductions, Discussion and Q&A
Martina Leposa
Healthcare Compliance Officer, Janssen-Cilag Ltd. (a Johnson & Johnson company); Chair, Compliance Committee, Association of Innovative Pharmaceutical Manufacturers, Budapest, Hungary
Healthcare Compliance Officer, Janssen-Cilag Ltd. (a Johnson & Johnson company); Chair, Compliance Committee, Association of Innovative Pharmaceutical Manufacturers, Budapest, Hungary
As a Healthcare Compliance Officer, Ms. Leposa supports both Janssen’s and J&J Consumer’s business to increase their competitive market position by leading, developing and implementing our compliance and monitoring program. In the last few years from an EU lawyer she became a compliance professional who is enthusiastic about new approaches, projects and tools not only within her company but on a broader scope, in her country and region. She has the honor of leading the Compliance Working Group of the Association of Innovative Pharmaceutical Manufacturers which creates the opportunity to make a difference in the field of integrity.
Paul J. Melling, Esq.
Founding Partner, Baker & McKenzie – CIS, Limited, Moscow, Russian Federation
Founding Partner, Baker & McKenzie – CIS, Limited, Moscow, Russian Federation
Paul Melling is an English solicitor and the founding partner of Baker McKenziie’s Moscow and Almaty offices, having now spent over 30 years living and working in Moscow and in the countries of the former USSR. He founded and leads both Baker McKenzie’s CIS Compliance & Investigations Group and also its CIS Healthcare industry Group and is a member of the Steering Committee for Baker McKenzie’s Global Heathcare industry Group and for its EMEA Compliance & Investigations Group. Paul Melling has been the Honorary Legal Adviser to the British Ambassador to the Russian Federation since 1990 and is a member of the Advisory Council of the Russo-British Chamber of Commerce. He has been Honorary Legal Adviser to Russia’s Association of International Pharmaceutical Manufacturers (AIPM) since its founding in 1994.
Madina Plieva, PhD
Legal and Compliance Head, Russia, Bristol-Myers Squibb; Legal Director, Association of International Pharmaceutical Manufacturers (AIPM); Former Head of Legal Department, Kutafin Moscow State Law Academy, Moscow, Russian Federation
Legal and Compliance Head, Russia, Bristol-Myers Squibb; Legal Director, Association of International Pharmaceutical Manufacturers (AIPM); Former Head of Legal Department, Kutafin Moscow State Law Academy, Moscow, Russian Federation
Dr. Plieva is Legal and Compliance Lead, responsible for Russia and Israel, at Bristol-Myers Squibb (BMS). Before joining BMS worked in Association of International Pharmaceutical Manufacturers (AIPM) in position of Legal Director, supervised Legal, Compliance and Medical Committees, represented Russian Member Association in Compliance Committes of IFPMA and EFPIA.
Mariusz Witalis
Partner, Forensic & Integrity Services, EY, Warsaw, Poland (Moderator)
Partner, Forensic & Integrity Services, EY, Warsaw, Poland (Moderator)
Mariusz Witalis is a Partner leading the EY Forensic & Integrity Services practice in Central, Eastern and South Eastern Europe & Central Asia (CESA). He is also a member of EY Forensics health sciences management team for Europe, Middle East, India & Africa (EMEIA).
Mariusz specializes in assisting medical device companies, pharmaceutical manufactures and biotechnology companies with internal and government investigations and compliance-related matters.
He has 20 years of 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 medical device, pharmaceutical and biotechnology companies on compliance-related topics in over 40 countries in EMEIA.
Mariusz is a member of the Compliance Committee at the Warsaw Stock Exchange and teaches on compliance and forensic audit at Warsaw universities.
Mariusz specializes in assisting medical device companies, pharmaceutical manufactures and biotechnology companies with internal and government investigations and compliance-related matters.
He has 20 years of 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 medical device, pharmaceutical and biotechnology companies on compliance-related topics in over 40 countries in EMEIA.
Mariusz is a member of the Compliance Committee at the Warsaw Stock Exchange and teaches on compliance and forensic audit at Warsaw universities.
2:15 pm
Transition Break
AFTERNOON MINI SUMMITS ROUND III: 2:30 pm – 3:30 pm
Mini Summit 11: Reducing FCPA Exposure through Better Use of Data
Regulators expect companies are leveraging data in meaningful ways to ensure operations are in line with regulations. The panelists will share fact situations, such as payments made to high-risk individuals, and describe how data can be leveraged to be more compliant to reduce FCPA exposure.
2:30 pm
Introductions, Panel Discussion and Q&A
Michael K. Loucks, JD
Partner, Skadden Arps LLP; Former Acting United States Attorney, District of Massachusetts, US Department of Justice, Washington, DC, USA
Partner, Skadden Arps LLP; Former Acting United States Attorney, District of Massachusetts, US Department of Justice, Washington, DC, USA
Michael Loucks is a Partner at Skadden Arps LLP. He is an experienced trial and appellate attorney whose practice focuses on internal investigations and government enforcement matters in the U.S. and abroad, and on false claims act litigation in federal and state courts. Prior to joining Skadden in 2010, Mr. Loucks served as acting U.S. attorneyand first assistant U.S. attorney for the District of Massachusetts. He repeatedly has been selected for inclusion in Chambers USA: and The Best Lawyers in America.
Michael O’Connor, MS
Vice President of Compliance Technology, Porzio Life Sciences, LLC; Former Global Head Compliance and Ethics Operations, Alexion; Former Executive Director, Global Head, IS Business Consulting, Boehringer Ingelheim, New York, NY, USA (Moderator)
Vice President of Compliance Technology, Porzio Life Sciences, LLC; Former Global Head Compliance and Ethics Operations, Alexion; Former Executive Director, Global Head, IS Business Consulting, Boehringer Ingelheim, New York, NY, USA (Moderator)
Michael O’Connor is Vice President of Compliance Technology for Porzio Life Sciences, LLC. In this role, Michael advises life sciences companies on the strategic use of data analytics and technology to drive compliance with governing laws, codes, and industry standards and also leads the development of the Porzio Life Sciences technology solution offerings. Prior to joining PorzioLS, Mr. O’Connor held executive leadership positions as the global head of compliance and ethics operations at Alexion and as an executive director, global head, IT business consulting at Boehringer Ingelheim. Most recently, Mr. O’Connor was a Principal/Owner at 3rd Wave Compliance, a technology focused consulting company geared toward life sciences companies.
Mini Summit 12: Behavioral Science to Enhance Effectiveness of Compliance Programs
Following its popularity in the public sector, corporate leaders especially in the field of compliance are flocking around the behavioral sciences in search of answers for understanding behavior, decision-making, and building cultures of compliance and integrity. Building on their personal journey, panelists will:
- Highlight the relevance and practical applications of behavioral sciences
- Share basic principles with immediate and simple ideas for the audience to take away
- Explore how the evolution of the compliance role (and GRC/I&C functions) opens up new opportunities for fresh approaches
2:30 pm
Introductions, Panel Discussion and Q&A
Sue Egan
Director and Principal Consultant, Sue Egan Associates, Great Missenden, Buckinghamshire, UK
Director and Principal Consultant, Sue Egan Associates, Great Missenden, Buckinghamshire, UK
Director, SEAL Compliance (a trading name of Sue Egan Associates Limited) Sue established her consultancy in January 2010 to provide practical assistance for small to medium sized companies trying to establish their compliance programs from nothing, improve on existing programs, and / or enable compliance team members to achieve their full potential. She has been a Compliance Officer at all levels from single marketing company and region for GlaxoSmithKline to international VP for AstraZeneca. As a founder member of the organizing committee of the International Pharmaceutical and Medical Device Compliance Congress, she has a high reputation as a speaker and presenter of case studies and practical guidance at conferences in the USA, Europe, Asia Pacific, and Latin America. Sue Egan Associates is also a member of the Thames Valley Chamber of Commerce Group. In addition to her consultancy work, Sue also provides membership assistance to ETHICS Society.
Brett Hudson, MBIM
Head, Group Integrity & Compliance, Novartis; Former Global Program Director – Integrity & Compliance, Sandoz, Basel, Switzerland
Head, Group Integrity & Compliance, Novartis; Former Global Program Director – Integrity & Compliance, Sandoz, Basel, Switzerland
Brett Hudson has been Head of Group Integrity and Compliance, since Feb 1, 2017. Brett joined Novartis in 2007 and worked in various commercial roles within Sandoz, Australia before being appointed the Country Head for Sandoz Thailand in 2012. In 2015, Brett moved to Germany and became the Global Step Change Program Lead for Sandoz. Prior to joining Sandoz, Brett worked in various commercial roles across a variety of industries and markets.
Katharina Kneisel, MBA
Senior Manager Corporate Compliance, Fresenius SE & Co. KGaA, Bad Homburg vor der Höhe, Hessen, Germany
Senior Manager Corporate Compliance, Fresenius SE & Co. KGaA, Bad Homburg vor der Höhe, Hessen, Germany
Antje Petersen Schmalnauer
Group General Counsel, Sonova Group; Former Interim Vice President Legal and General Counsel, Kautex Textron; Former Global Compliance Officer and Data Protection Officer, Biomet. Zurich, Switzerland
Group General Counsel, Sonova Group; Former Interim Vice President Legal and General Counsel, Kautex Textron; Former Global Compliance Officer and Data Protection Officer, Biomet. Zurich, Switzerland
Mr. Schmalnauer is Group General Counsel for the Sonova Group whose global legal department also houses the functions of Data Protection as well as Compliance. Both topics have been near and dear to him for the last almost twenty years of his in-house career, most of which were spent in the Medical Device industry. His early law experiences were as an associate and then partner at a regional law firm in the Midwest of the United States, where he specialized in international law matters.
Katharina Weghmann
Associate Partner, Forensic & Integrity Services, EY, Düsseldorf, Germany (Moderator)
Associate Partner, Forensic & Integrity Services, EY, Düsseldorf, Germany (Moderator)
Mini Summit 13: Third Party Due Diligence and Management
Life Science companies continue to work with a large number of third parties including HCPs, HCOs, Sales and Distribution third parties and other vendors. Working with third parties brings significant opportunity and scale, but also substantial legal, compliance and reputational risks.
IQVIA Commercial Compliance’s Mario Prohasky will lead this panel of experts to discuss the complexity of third party ecosystems and the importance of a structured methodology to assess and act upon risks associated with third party interactions making third party risk management a critical aspect of any compliance program.
2:30 pm
Introductions, Panel Discussion and Q&A
Edoardo Lazzarini, PhD
Healthcare Compliance Consultant; Former EuCan Ethics & Compliance Initiatives Director, Takeda Pharmaceuticals; Former Compliance Officer EMEA (Europe, Middle East & Africa), Zimmer Biomet, Milan, Italy
Healthcare Compliance Consultant; Former EuCan Ethics & Compliance Initiatives Director, Takeda Pharmaceuticals; Former Compliance Officer EMEA (Europe, Middle East & Africa), Zimmer Biomet, Milan, Italy
Edoardo Lazzarini has over 20 years of compliance experience gained both at European and country levels in pharmaceutical and medical devices multinational companies. He has been directly responsible for overseeing and implementing business ethical Compliance programs at international level (EMEA and Canada) and he gained invaluable experience in managing the European Compliance Program in a company with a Deferred Prosecution Agreement related to FCPA including a Federal Monitorship. He has been Chairman and Member of Organismo di Vigilanza 231 in several legal entities. He has lecturer at graduate level, is a frequent speaker at Compliance conferences, and regularly publish and post on Compliance/ Anticorruption issues. In the last years Edoardo has been awarded by the International Compliance community of the “Leadership in the Advancement of Ethics in the Medical Device and Diagnostic Industry” award, and by the Italian Anticorruption Leaders community of the Italian Compliance “Award 231”.
Carlos Romero Lopez, LLB, MBA
Head of Compliance Healthcare South Europe, Merck Group, Madrid, Spain
Head of Compliance Healthcare South Europe, Merck Group, Madrid, Spain
Carlos Romero Lopez is an internationally Certified Compliance Professional by the IFCA and is currently Head of Healthcare Compliance for South Europe at Merck and a Compliance Officer of the subsidiary of Merck in Spain. On top of his compliance expertise, Carlos also has deep knowledge both in internal and external auditing, as he is former Global Internal Audit Manager at Merck and, prior to that, senior financial auditor at PwC.
Tamara Tubin
International Compliance Director, Corporate Compliance, Wright Medical Group N.V.; Vice Chair, Ethics & Compliance Committee, MedTech Europe, Member, Strategic Committee, International Society of Healthcare, Ethics and Compliance Professionals (ETHICS), Zürich, Switzerland
International Compliance Director, Corporate Compliance, Wright Medical Group N.V.; Vice Chair, Ethics & Compliance Committee, MedTech Europe, Member, Strategic Committee, International Society of Healthcare, Ethics and Compliance Professionals (ETHICS), Zürich, Switzerland
Ms. Tubin is International Compliance Director, Wright Medical Group N.V. In this capacity she leads the company’s strategic efforts of the company’s corporate compliance program for International. Furthermore Ms. Tubin is representing Wright Medical in Brussels, Belgium, at MedTech Europe’s Trade Association as Vice-Chair of the Ethics and Compliance Committee. In her capacity as an individual, independent person she is non-executive member of the board and strategic committee member of ETHICS – the non-profit society of International HealthCare Ethics and Compliance Professionals in Paris, France.
Mario Prohasky, MBA
Principal, EMEA Compliance Consulting Practice Leader, IQVIA, London, UK (Moderator)
Principal, EMEA Compliance Consulting Practice Leader, IQVIA, London, UK (Moderator)
Mario Prohasky is a Principal with IQVIA Commercial Compliance. Mario is responsible for leading the compliance consulting team’s work in EMEA and also helps to lead its global FMV practice. He has extensive experience in implementing FMV methodologies for interactions with both HCPs and third parties. In addition, Mario has conducted numerous projects focused on setting up appropriate compliance processes in key areas such as grants management, interactions with HCPs/HCO, transparency, and more. He has worked with a wide range of clients within the commercial, compliance, medical and philanthropic arms of the Life Sciences industry. Prior to joining IQVIA Commercial Compliance, Mario spent 4 years as a financial analyst and consultant in the Asset Management industry in London, focusing on clients in US and Europe.
Mini Summit 14: Structuring an Efficient Digital Compliance Framework: Overcome Cross-jurisdictional
Boundaries, Process Complexity and Dispersed Resources
Due to ever increasing complexity and regulatory requirements, Compliance resources need to handle and process an increasing volume of information and face the challenge of recognizing and act upon the most important.
The workshop will introduce a structured approach, based on practical experience, to support Compliance Managers in simplifying global processes and improving their digital capabilities to counteract complexity.
caweco Practice Leader’s Carlo Geninazza will moderate an interactive discussion to explore best practices, success stories and examples of digitalization.
2:30 pm
Introductions, Panel Discussion and Q&A
Ioannis Talaslis
Compliance Excellence Manager, Merck Serono GmbH, Darmstadt, Germany
Compliance Excellence Manager, Merck Serono GmbH, Darmstadt, Germany
Carlo Geninazza
Senior Manager, CAWECO GmbH, Munich, Germany (Moderator)
Senior Manager, CAWECO GmbH, Munich, Germany (Moderator)
Carlo Geninazza is Senior Manager Ethics and Compliance and Practice Leader Business Development Pharma for caweco Business Consulting. For over 15 years, Carlo has been executing global digital, process reengineering and technical projects across regulated industries, supporting international organizations in successfully driving their digitalization initiative. He collaborates as speaker with MIB Business School as well as with different industry networks.
3:30 pm
Transition Break
AFTERNOON PLENARY SESSION
4:00 pm
Update on the New French Sapin II Law: Responding to the French Anticorruption Questionnaire, Inspections and Prosecutions
Emmanuel Farhat
Agence Française Anticorruption (AFA), France, Paris, France
Agence Française Anticorruption (AFA), France, Paris, France
George Fife
Partner, Forensic & Integrity Services, EY; Former Executive Director, Compliance & Ethics, Bristol-Myers Squibb, Paris, France (Moderator)
Partner, Forensic & Integrity Services, EY; Former Executive Director, Compliance & Ethics, Bristol-Myers Squibb, Paris, France (Moderator)
4:30 pm
Annual FCPA Update Roundtable
Robert I. Dodge, JD
Assistant Director, FCPA Unit, US Securities & Exchange Commission; Former Assistant U.S. Attorney, US Attorney’s Office, Western District of Michigan; Former Assistant Section Chief, Environmental Defense Section, US Department of Justice, Washington DC
Assistant Director, FCPA Unit, US Securities & Exchange Commission; Former Assistant U.S. Attorney, US Attorney’s Office, Western District of Michigan; Former Assistant Section Chief, Environmental Defense Section, US Department of Justice, Washington DC
Robert Dodge is an Assistant Director in the Securities and Exchange Commission’s FCPA Unit in Washington, DC. Bob has been at the Commission for fifteen years. Prior to his current position, he served as Assistant Chief Litigation Counsel, focusing primarily on FCPA enforcement actions. In that role, Bob was lead trial counsel in the SEC v. Straub and SEC v. Sharef cases. Before joining the SEC, Bob held several positions at the Department of Justice, including as an Assistant U.S. Attorney and Assistant Section Chief in the Environmental Defense Section.
Gary F. Giampetruzzi, Esq.
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc., New York, NY, USA (Moderator)
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc., New York, NY, USA (Moderator)
5:00 pm
Collaboration and Cooperation in Multi-jurisdictional Anticorruption Investigations and Prosecutions
Andrew Butel
Partner, Kirkland & Ellis International LLP, London, UK
Partner, Kirkland & Ellis International LLP, London, UK
Andrew Butel is a partner in the London office of Kirkland & Ellis International LLP focusing on advising clients on a range of white collar and corporate crime matters.
Since joining Kirkland, Andrew’s representative matters have included:
Representing a global extractives company in respect of internal and governmental investigations into alleged bribery and corruption conducted by the SFO, the U.S. Department of Justice, the U.S. Securities & Exchange Commission, the Australian Securities and Investments Commission and the Australian Federal Police.
Representing a manufacturing company in an internal investigation concerning certain product specification claims. Advising on related potential criminal, civil and regulatory exposure in the UK and coordinating with local counsel in six other jurisdictions.
Defending an ultra high-net-worth individual in respect of bribery and money laundering investigations conducted by the UK National Crime Agency together with Swiss and African criminal investigation authorities.
Since joining Kirkland, Andrew’s representative matters have included:
Representing a global extractives company in respect of internal and governmental investigations into alleged bribery and corruption conducted by the SFO, the U.S. Department of Justice, the U.S. Securities & Exchange Commission, the Australian Securities and Investments Commission and the Australian Federal Police.
Representing a manufacturing company in an internal investigation concerning certain product specification claims. Advising on related potential criminal, civil and regulatory exposure in the UK and coordinating with local counsel in six other jurisdictions.
Defending an ultra high-net-worth individual in respect of bribery and money laundering investigations conducted by the UK National Crime Agency together with Swiss and African criminal investigation authorities.
Robert I. Dodge, JD
Assistant Director, FCPA Unit, US Securities & Exchange Commission; Former Assistant U.S. Attorney, US Attorney’s Office, Western District of Michigan; Former Assistant Section Chief, Environmental Defense Section, US Department of Justice, Washington, DC
Assistant Director, FCPA Unit, US Securities & Exchange Commission; Former Assistant U.S. Attorney, US Attorney’s Office, Western District of Michigan; Former Assistant Section Chief, Environmental Defense Section, US Department of Justice, Washington, DC
Robert Dodge is an Assistant Director in the Securities and Exchange Commission’s FCPA Unit in Washington, DC. Bob has been at the Commission for fifteen years. Prior to his current position, he served as Assistant Chief Litigation Counsel, focusing primarily on FCPA enforcement actions. In that role, Bob was lead trial counsel in the SEC v. Straub and SEC v. Sharef cases. Before joining the SEC, Bob held several positions at the Department of Justice, including as an Assistant U.S. Attorney and Assistant Section Chief in the Environmental Defense Section.
Emmanuel Farhat
Agence Française Anticorruption (AFA), France, Paris, France
Agence Française Anticorruption (AFA), France, Paris, France
George Fife
Partner, Forensic & Integrity Services, EY; Former Executive Director, Compliance & Ethics, Bristol-Myers Squibb, Paris, France (Co-moderator)
Partner, Forensic & Integrity Services, EY; Former Executive Director, Compliance & Ethics, Bristol-Myers Squibb, Paris, France (Co-moderator)
Gary F. Giampetruzzi, Esq.
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc., New York, NY, USA (Co-moderator)
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc., New York, NY, USA (Co-moderator)
5:30 pm
Adjournment
Agenda Links: Precons/Day 1 | Day 3