Agenda – Day II

Dave O’Shaughnessy is the Health Care Compliance Officer for EMEA Pharmaceuticals R&D, within the Johnson & Johnson Health Care Compliance & Privacy organization, based in the UK. Prior to this, Dave spent 5½ years at IQVIA (formerly Quintiles) as the VP Compliance, R&D Solutions, in the Ethics and Compliance Office. Dave also 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 (QA) in R&D. Dave was also the VP, Global Compliance Strategy and Implementation at AstraZeneca Headquarters in London and managed a central, global team with responsibility for the definition and deployment of the Global Compliance Program. Dave has been an active member of the International Society for Healthcare Ethics and Compliance Professionals (ETHICS) and continues to serve on its Strategic Committee.

Michele Tagliaferri is a partner at Sidley and leads the investigations and compliance team in Sidley’s Brussels office. He has significant experience conducting internal investigations and advising life sciences clients in international enforcement matters, including matters arising under the FCPA and other anti-bribery legislations. Michele also assists clients in developing, auditing and enhancing compliance programs, as well as conducting anti-corruption compliance training courses for employees and senior management. He routinely conducts compliance reviews, training sessions, risk assessments, and due diligence in connection with mergers and acquisitions, joint ventures, and third-party engagements. He also has experience with EU data privacy and cross-border discovery and counsels clients on how to effectively manage data privacy risks, particularly in EU-U.S. cross-border investigations. Michele is licensed to practice law in New York, Washington, D.C., Italy and Belgium. Prior to joining the Brussels office, Michele practiced for several years in Sidley’s Washington, D.C. office.

Ann Beasley is a Director at Navigant Consulting, Inc., in the Healthcare and Life Sciences Disputes, Regulatory, Compliance and Investigations practice. She has over 17 years of in-house healthcare and life sciences experience for companies in pharmaceutical, biologics, vaccine, device and genetic testing. 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.

She has built and managed local and global corporate compliance programs and initiated specific projects including performing complex investigations, building investigation protocols, Codes of Conduct and other structural elements of a Corporate Compliance Program.

Ann’s legal and regulatory expertise includes advertising and promotion, kick-backs, anti-bribery and anti-corruption, grants and charitable contributions.

Nicola Orlandi is Head Data Privacy Pharma. In that role, he partners with divisional business to enable growth, productivity and innovation, implementing privacy controls and considering data privacy requirements as well as business needs. His major accountabilities are to build scientific and business expertise in area of division in order to fully understand data privacy related business needs, to assess business strategy and projects as well as project proposals with regard to arising data privacy challenges and provide associated legal counselling.

Hubertus Stockmann has been working for 20 years in the healthcare industry (Philips Medical Systems, Smith & Nephew, ConvaTec, Mölnlycke Healthcare, Merck KGaA, Getinge) in the broad field of Quality and Compliance Management with a focus on risk management and process improvements. Having worked in various parts of the world and being responsible for local, regional and global Compliance he has wide ranging expertise regarding laws, regulations, standards and risk management. In his current position as Regional Compliance Officer EMEA, Getinge AB, he is responsible for the development, implementation and monitoring of the corporate compliance programs and serves as the Group Data Protection Manager.

Mario Prohasky is Principal, Polaris Management Partners where he oversees Polaris’ EMEA consulting services and has global responsibility for our FMV and data analytics practice. His areas of expertise include the full breadth of Polaris’s global offerings including compliance program design and implementation, FMV and data analytics and transparency. His work focuses strongly on helping clients to drive business value through compliance while maintaining effective risk management programs.

He brings extensive experience in designing and implementing effective FMV solutions globally, with a focus on interactions with Healthcare Professionals as well as Healthcare Organizations. He has also managed numerous compliance risk and needs assessment projects and actively supports clients in the ongoing implementation of their compliance programs.

Prior to joining the firm, Mario spent 3 years as a financial analyst and consultant in the Asset Management industry in London, focusing on clients in the US and Europe.

Chrisoula Nikidis is the Canadian Head of Compliance and Ethics Solutions at IQVIA. A dedicated leader in the field of compliance, ethics, governance and stakeholder relations in the innovative medicines and life science sectors, Chrisoula’s successful career is highlighted by creative citizen mobilization, coalition-building and the development of ethical practices on a provincial, national and international level.

She has built a reputation as a trusted and respected leader of issues involving ethics and integrity both in the private and public sectors. She was previously the Executive Director, Ethics and Compliance for Innovative Medicines Canada.

Chrisoula has played a pivotal role in the advancement of compliance and ethics on the provincial, national and international level through her leadership in the Code of Ethical Practices as well as with her work with IFPMA and the APEC Biopharmaceutical Ethics Initiative.

Nicola Bedlington is Secretary General of the European Patients’ Forum and joined as its first Executive Director. She was the founding Director of the European Disability Forum, an umbrella organization uniting over 70 European disability NGOs to advocate for the human rights and inclusion of disabled citizens in Europe, and prior to this she worked as an external expert for the European Commission, heading the NGO unit within the HELIOS Program.

Previously, she worked for the Swiss Government, leading the Environment and Schools Initiatives Secretariat (ENSI), an international government-based network set up by OECD focusing on innovation, action research and policy development in the field of Education for Sustainable Development.

Whilst in Switzerland, she has also worked as an independent consultant/evaluator, specializing in European social and development policy and health advocacy.

Cécile has 18 years of experience with Sanofi, in Regulatory Affairs (French affiliate) and Global Medical Operations (Head of Medical Information Compliance Department). She joined the Global Ethics & Business Integrity Department in 2013.

Previously, she spent 6 years in AstraZeneca (Regulatory Affairs) and 2 years in Merieux UK (Marketing/Product Manager). Cécile represents Sanofi at the IFPMA Ethics & Business Integrity Committee and at the EFPIA Ethics & Compliance Committee. Cécile is also a member of the ETHICS association.

Stephen is currently Director for Ethics & Compliance Operations in Western Europe, Canada & Israel for Abbvie Pharmaceuticals. He also covered for a period of time Ethics & Compliance operations for Eastern Europe, Middle East & Africa.

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

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

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

Stephen is graduated from the Pharmacy School of Paris with a major in industrial pharmacy and pharmacology and from the YMP of INSEAD Business School.

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 life sciences companies. His practice focuses on performing compliance assessments and investigations, reviewing and optimizing organizational processes and implementing effective and sustainable compliance solutions.

Casey is a Director in Navigant’s Global Life Sciences Regulatory & Compliance (“LS R&C”) practice. Casey’s experience includes developing and implementing global compliance programs, assisting client in the development and optimization of organizational processes, supporting clients through settlement and implementation of CIAs, preparing for Independent Review Organization (“IRO”) reviews, and providing IRO services. 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.

Maria Khoury is the Compliance Officer for Levant Countries in Hoffmann La Roche, based in Beirut Lebanon.She is the lead of the compliance committees in the Group of International Pharmaceutical Companies – Lebanon and Iraq Local Area Working Group.Maria worked in the pharmaceutical industry for the last 18 years and held various roles in sales and marketing before assuming Compliance Officer function at JnJ in 2011 and at Hoffmann La Roche starting 2015.She obtained her Doctorate in Pharmacy from “Universite Saint Joseph”-Beirut and her MBA from “Ecole Superieure des Affaires”-Beirut.

Laura Nassar is the Head of Compliance for Middle East at Hoffmann La Roche, based in Dubai. She has over 17 years’ experience in the healthcare industry in MEA region, across a wide range of disciplines such as Pharmacy, Sales and Marketing, Skills Training and Compliance. Laura is a long-standing member of the Middle East Ethics Review Board (LERB), governing body of the MEA Code of Promotional Practices and Chair of PhRMAG Compliance and Legal Working Group.

Joe Henein is President and CEO of NewBridge, a specialty pharma positioned to be first-in-class licensing only platform for innovative therapeutics and bridge the access gap between innovation and patients by licensing innovative products from global pharmaceutical companies to Middle east to Africa Region. He has over 30 years in the pharmaceutical industry covering the USA, (Global), Europe and Middle East/Africa. Previoiusly, Joe worked in Big Pharma, mostly Wyeth Pharmaceuticals which is now a part of Pfizer. He was Vice President and Global Commercial Chair for number of therapeutic areas, like Infectious Diseases and Women’s Health Care. He was also VP & Regional Managing Director for Wyeth in MEA. Joe served in various Wyaeth executive committees during his tenure as: Global Development Council, Global Development Strategy Board, and European Operation Council. He also served as the Vice Chair for the PhRMA MEA Committee and the Chair for PHRMA MEA Ethics Review Board.

Nicolas Honhon is the Head of Ethics & Compliance EMEA at UCB. He has over 10 years of experience within healthcare compliance, having covered both operational and corporate responsibilities. With a nursing and psychology education, he has hands on healthcare experience within hospital care. Moving within the pharmaceutical industry, he started within R&D departments working for major CROs such as PPD and SynteractHCR. Transitioning into quality and audit function, he moved to Amgen prior to joining UCB Ethics & Compliance department where he was appointed Head of EMEA in 2016.

Mr. Huber is the secretary general of Pharmig in Vienna. Pharmig – the Association of the Pharmaceutical Industry in Austria – is a voluntary and party-politically independent representation of interests of the pharmaceutical industry in Austria. Previously, he served the petrochemical company BP Austria in Vienna where he held a series of different leading positions with increasing responsibility in Austria as well as abroad. In 2000 Mr Huber moved to LAFARGE Zement in Oberursel in Germany. Mr. Huber is a member in different boards and committees of the international and the european pharmaceutical associations as well as Vice President of Pharmig Academy (Education Center in Pharma and Health Care) and chairman of the board of AMVO – Austrian Medicines Verification Organization.

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

Ceren Aral Desnos is a life sciences lawyer with over 9 years of experience in advising medtech and pharma multinationals on a wide range of topics with an emphasize on compliance and anti-corruption practice areas. Representing trade associations at both national and EU level, she has been involved in policy discussions with MedTech Europe, EFPIA and Business Europe over the past years. She is currently acting as MedTech Europe’s Interim Director of Legal and Compliance.

Ceren is the regional representative of the International Bar Association’s (IBA) Anti-Corruption Committee and a member of International Society of Healthcare Ethics and Compliance Professionals (ETHICS).

Christine M. Sainvil is a freelance consultant in program management.

She cumulates 20 years of experience in program management in profit and not-for-profit organisations at international level, particularly in the healthcare sector.

Christine started her career with MCI Group, an association management consultancy, during which she assisted various US-based professional and trade associations in developing their activities in Europe, Middle East and Africa. She also worked as Project and Grant Manager with Soros Foundation in DR Congo.

She took on the development, implementation and management of MedTech Europe’s initiative on ethics and compliance: the Conference Vetting System, in February 2012. In 2015, she was appointed Project Director of a three year project funded by the Siemens Integrity Initiative and the World Bank to develop the Medical Devices’ industry compliance standards in the Middle East and North Africa region.

Roeland joined Johnson & Johnson in 1987 as a Medical Representative for Janssen Pharmaceutica. Currently, he is the Regional Vice President – HCCO MD EMEA and also fulfills the Chairman role of the MedTech Europe Ethics and Compliance Committee.

He has 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. 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 / Sciences Po- and the INSEAD training programs for Compliance professionals and is co-chairman for the International Pharmaceutical and Medical Device Compliance Congress.

Lee Betteridge has over 13 years’ experience in the Pharmaceutical and Life Science industry having started his career in R&D. He is a Director in PwC’s Global Pharmaceutical and Life Sciences GRC practice and has a deep understanding of the pharmaceutical and medical device value chains. He has helped companies to mitigate risks associated with healthcare compliance, bribery and corruption and fraud around the world. Lee’s experience includes the design and implementation of ethics and compliance frameworks, including mitigating risk posed by third parties. M&A due diligence, market access and clinical trial compliance and Forensic investigations (FCPA, UK BA etc).

Dante Beccaria is the Senior Vice-President and Global Compliance Officer at Sanofi. He has over 25 years of experience within Sanofi, having covered both operational and corporate responsibilities. In 1990, he joined the Sanofi Italian affiliate to implement a Treasury Platform, covering all the business activities in the country. In 1992, he was appointed Controlling Director of the Italian Pharma affiliate. In 1997, he moved to Paris to take global responsibilities as Pharma Controller at Sanofi Corporate, then as CFO of the OTC & Generics Division. In 2001, he became Project Director within the Mergers & Acquisitions Corporate department. In 2003, he joined Corporate Internal Audit as Associate Vice President. He was then appointed Vice President Internal Audit after the acquisition of Aventis (2004) and remained in this position until April 2012. He was appointed Global Compliance Officer in May 2012.

Dominique Laymand is Executive Vice-President, Chief Ethics and Compliance Officer at Ipsen. She leads the Ethics and Compliance team and program, based on a Business Integrity vision.

In a former role, Dominique acted as EMEA Vice-President Compliance & Ethics at Bristol Myers Squibb.

Dominique Laymand is Honorary President of ETHICS, International Society of Healthcare Ethics and Compliance Professionals, whose mission is to be recognized as an independent international association of professionals, which sets standards of Ethics and Compliance, and shapes and influences strategies in the changing Healthcare environment for the ultimate benefit of Patients and Society at large, contributing to the development of Ethics and Compliance professionals.

Dominique is an active member of various Pharmaceutical Industry Associations and committees, proactively addressing Trust, Reputation and Compliance and Ethics matters. She also plays a key role in various industry associations and provides ethics and compliance education in many different arenas.

Mr. Rasmussen is Chief Compliance Officer at Lundbeck. Since 2009, he has been responsible for the global development of Lundbeck’s Compliance Structure, including governance, Code of Conduct and related global procedures and processes. He leads Lundbeck’s Sustainability Strategy and related projects, including Lundbeck’s commitment to the UN Global Compact Principles. Mr. Rasmussen has more than 15 years of leadership experience in the pharmaceutical industry within the fields of compliance & sustainability, strategy development and implementation, project management, auditing, communication and reporting. He has reported about Sustainability as a statutory requirement in Danish legislation since December 2008.

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.

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.

Abdul Luheshi 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.

George Fife is a Partner at EY, Fraud Investigation & Dispute Services. George specializes in assisting companies with global risk and compliance assessments and investigations. George works closely with management teams, chief compliance officers, general counsels and chief audit executives to identify enforcement risks, determine potential vulnerabilities and recommend solutions from business and operational perspectives to prevent, detect and respond to compliance risks. He has first-hand international experience in building, managing and assessing effectiveness of compliance programs, in the area of anti-corruption and anti-bribery, anti-trust and competition, Off-label and disguised promotion, Pharmaceutical and Medical Device Self-regulation and codes. Prior EY, George worked at Bristol-Myers Squibb where he served as EMEA Executive Director Compliance & Ethics and globally anticorruption and third-parties. Prior to BMS, George worked at GE Healthcare in a regional EMEA Compliance and Third-Parties Manager role as well as at GE Capital, starting as an FMP and working on several new acquisitions integration.

Madina Plieva is the Legal and Compliance Lead for Russia and Israel for Bristol-Myers Squibb.

Evgeny Tilezhinsky Evgeny has over 15 years of experience as a legal and compliance professional with the last 7 years in pharma. He is currently the Law and Compliance Lead for the central and Eastern Europe for Bristol-Myers Squibb. Previously, he was Senior Counsel for General Motors and was a lawyer (Russia & CIS) for GM.

Dr. Uta is the Director, Ethics and Compliance, South-East Europe for Eli Lilly and Company. He is an experienced Corporate Compliance and Ethics professional, with 25+ years in various roles in pharmaceutical industry (sales, regulatory, medical affairs and clinical research). Dr. Uta is also a Certified Corporate Compliance and Ethics Professional with SCCE since 2012.

Pawel Wajszczyk is a Regional Health Care Compliance Director for Johnson & Johnson Medical Devices in Eastern Europe. Pawel oversees activities of a regional team of HCC Officers and execution of compliance program in all JJ Operating Companies from Poland through Czech Republic, Hungary, Croatia, Russia and CIS. Pawel focuses on enterprise risk management, investigations and incident management. In addition, Pawel’s interests relate to soft cultural aspects of compliance management including shaping organizational culture, ownership and accountability. Prior to joining Johnson & Johnson, Pawel was working with PwC Poland Forensics Team where he managed multiple forensic projects for multinational companies on asset misappropriation and bribery. Pawel graduated from Marketing and Management Faculty at the University of Lodz, Poland. He later on expanded his scientific interests by undertaking postgraduate studies in Social Psychology and by obtaining Certified Fraud Examiner credentials in 2013.

Liesbeth Bergmans was previously employed as attorney-in-law at Loyens & Loeff N.V., a Benelux law firm, where she specialized in private equity transactions, banking & finance, and insolvency & restructuring. After 5 years, Ms. Bergmans changed jobs to become in-house legal counsel. First on a consultancy basis, working for various companies in temporary positions. In that context she started working at Teva Pharmaceuticals Europe B.V., where she ended up staying after a year. In her current position as EU Associate Director Senior Legal Counsel, she support the EU Commercial business from Amsterdam, the Netherlands.

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 an independent 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 programs.

Sue is a Fellow of the Chartered Management Institute and her consultancy is a member of Thames Valley Chamber of Commerce Group.

Ms. Sanz Escudero is currently Compliance Advisor at Merck Spain, ensuring compliance with company Policies, applicable self-regulation Codes and national laws and regulations. Her prior experience includes five years in Farmaindustria, the National Association of the Pharmaceutical Industry in Spain, as Codes Compliance Officer Advisor for the Self-Regulation System of the Pharmaceutical Industry. Through a collaboration agreement between Farmaindustria and EFPIA, the European Federation of Pharmaceutical Industries and Associations, Project Manager of the European e4thics platform since its launch in 2011, supporting monitoring of multinational events in Europe, by pre-assessing events with regard to the EFPIA HCP Code.

Oscar Perdomo is a Director in PwC’s Pharmaceutical and Life Sciences practice with over 10 years of experience in the pharmaceutical and life sciences industry. Throughout his career Oscar has partnered with clients to deliver services related to strategy and business planning, business analytics, risk management, and project management.

Oscar has worked with many global pharmaceutical and life sciences companies to build and enhance their global compliance programs and to mitigate risks associated with interactions with healthcare professionals, anti-kickback laws, and anti-bribery / anti-corruption laws. In addition, Oscar has worked with clients to audit and monitor business activities, develop corrective action plans, draft and update policies and procedures, and train employees on global compliance issues and standards.

Abdul Luheshi 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.

Pascale Paimbault is CEO, Consulting Alley and a member of ETHICS Board and Strategic Committee, former Treasurer.

She is the former Executive Director Ethics & Compliance EMEA, Astellas Pharma -Former Compliance Officer France -Benelux,Biogen and former Compliance Officer EMEA Wright Medical, Former Senior Director EMEA Compliance & ETHICS Bristol-Myers Squibb.

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

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. He 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 and is 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 (ETHICS).

Mr. Huber is the secretary general of Pharmig in Vienna. Pharmig – the Association of the Pharmaceutical Industry in Austria – is a voluntary and party-politically independent representation of interests of the pharmaceutical industry in Austria. Previously, he served the petrochemical company BP Austria in Vienna where he held a series of different leading positions with increasing responsibility in Austria as well as abroad. In 2000 Mr Huber moved to LAFARGE Zement in Oberursel in Germany. Mr. Huber is a member in different boards and committees of the international and the european pharmaceutical associations as well as Vice President of Pharmig Academy (Education Center in Pharma and Health Care) and chairman of the board of AMVO – Austrian Medicines Verification Organization.

Mr. Sharkey focuses on global transparency laws, codes, and regulations affecting the life sciences industry, as well as data privacy laws. Mr. Sharkey analyzes the reporting obligations that companies have under governmental regulatory schemes and industry self-regulation, and how those obligations are impacted by data privacy laws. Mr. Sharkey is also an attorney and Principal of Porzio, Bromberg and Newman.

Enno Behrendt is a German Attorney currently working for Siemens Healthineers as a Compliance Officer. He joined Siemens Corporate Compliance in 2007.

In his work, Enno focuses on “workplace vinegar” responsibility management, combining conventional compliance and risk system approaches with scientific insights and methods from psychology and behavioral economics.

He is a regular guest lecturer at the Hochschule Würzburg and has been a speaker at regional and international ethics associations.

Tjerk Schlufter is the Senior Vice President, Compliance at Fresenius SE. Previously, he was Senior Vice President Compliance at Fresenius Kabi, General Counsel with Siemens Healthcare, Imaging Division and General Counsel at OSRAM.

Hubertus Stockmann has been working for 20 years in the healthcare industry (Philips Medical Systems, Smith & Nephew, ConvaTec, Mölnlycke Healthcare, Merck KGaA, Getinge) in the broad field of Quality and Compliance Management with a focus on risk management and process improvements. Having worked in various parts of the world and being responsible for local, regional and global Compliance he has wide ranging expertise regarding laws, regulations, standards and risk management. In his current position as Regional Compliance Officer EMEA, Getinge AB, he is responsible for the development, implementation and monitoring of the corporate compliance programs and serves as the Group Data Protection Manager.

Anita Kim-Reinartz is a partner in Business Integrity and Corporate Compliance (BICC) at EY. She has over 16 years of experience in Compliance and Investigations. Currently, she is heads the Life Sciences Sector at BICC in Germany and is a Talent Leader of BICC in GSA. She has extensive experience in the area of compliance, such as implementing rule-based and newer value based approaches, compliance monitoring or compliance audits. Ms. Kim-Reinartz also led various investigations for multinational pharma- and medical device companies.

Stephen is currently Director for Ethics & Compliance Operations in Western Europe, Canada & Israel for Abbvie Pharmaceuticals. He also covered for a period of time Ethics & Compliance operations for Eastern Europe, Middle East & Africa.

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

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

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

Stephen is graduated from the Pharmacy School of Paris with a major in industrial pharmacy and pharmacology and from the YMP of INSEAD Business School.

Bernhard Fischer is the Healthcare Compliance Officer of Johnson & Johnson’s medical devices branch in Germany. Over the past 16 years he has held various Sales & Marketing as well as Healthcare Compliance positions in Germany, Austria and Switzerland. His focus is both on the strategic framework of building compliant organizations as well as its implementation on a tactical level. He is a frequent speaker at healthcare compliance trainings and a member of the healthcare compliance committee of the German medical devices trade association BVMed.

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

Dr. Reese is Partner and Co-Head at Global Healthcare, Life Sciences and Chemicals Group, Clifford Chance. He is also the Chair of the Pharmaceutical Law Committee of the Association for Intellectual Property and Copyright Law (GRUR), the Visiting Lecturer for Pharmaceutical Law at the University of Marburg, and a Member of the Legal Committee of the Federal Association of Pharma Companies (BAH).

Dr. Bartke has held various marketing, business development and compliance positions in the pharmaceutical industry over the past 30 years. Most recently, he was the Director Compliance Management in the European Headquarter of Daiichi sankyo Europe.

He has worked in the trade associations like (German) FSA, EFPIA (Co-Chair) and IFPMA and is a Member of the Strategic Committee, International Society of Healthcare, E.thics, and Compliance Professionals (Ethics), Paris, France

Member of the German Cardiac Society (DGK)