PROGRAM SCHEDULED for November 14-17, 2016 | Program will be held in Barcelona, Spain
Kathleen Boozang has been Dean of Seton Hall Law since July 2015. She has served in multiple administrative capacities during her tenure at Seton Hall, including Associate Dean for Academic Affairs for eight years and Vice Provost for two years.
Dean Boozang came to Seton Hall in 1990 as the founder of the Law School’s now top-ranked Center for Health & Pharmaceutical Law & Policy. Prior to becoming Dean, she also established the Law School’s graduate degrees, Division of Online Learning and global life sciences compliance training programs.
Dean Boozang teaches a variety of health law courses in person and online including the survey health law course, a course on health care fraud and corruption, and death and dying. In her scholarship, Dean Boozang has dedicated much of her career to nonprofit governance issues with a special focus on religiously sponsored hospitals. In the last several years, however, she has expanded her research and teaching to explore the legal and policy issues related to corporate compliance, with a particular focus on the global life sciences industry.
Throughout her legal career, Dean Boozang has been active in public service. She has served on numerous advisory boards and committees for healthcare providers and for the states of New Jersey and New York, including serving as an advisor to the New Jersey Attorney General Task Force on Physician Compensation by Pharmaceutical Companies, which resulted in the promulgation of proposed regulation. She is a former member of the New York State Task Force on Life and the Law, an interdisciplinary commission with a mandate to develop public policy on bioethical issues.
Dean Boozang currently serves on the Board of Trustees of the St. Joseph Healthcare System in New Jersey. In 2013, the ASLME conferred upon Dean Boozang the Jay Healy Health Law Teacher Award. She was named the Seton Hall University Woman of the Year in 2006 and the Washington University Law School’s Young Alum of the Year in 2004.
She received her B.S. from Boston College and her J.D. from Washington University School of Law in St. Louis, Missouri, where she was inducted into the Order of the Coif and served as the managing editor of Law Quarterly. She received her LL.M. from Yale Law School in 1990.
Anne-Sophie Bricca is Director Legal Affairs and Compliance EMEA, at Terumo BCT, a global leader in blood components and cellular technologies. With her team, she provides legal and compliance support to Terumo BCT sales entities in EMEA. She is a member of Terumo BCT Executive Leadership Team. She represents the Company at Eucomed Legal Affairs Focus Group, Compliance Group and Code Committee.
Before joining Terumo BCT in 2009, Anne-Sophie Bricca worked as in-house counsel for the IT industry during 10 years (HP, CPG International, Ingram Micro). She also worked as a general counsel for Franco Dragone Entertainment Group for the design and making of the Macao show “The House of Dancing Water”.
Anne-Sophie holds two post graduates degrees in European Laws from the University Robert Schuman (Strasbourg) and in International Laws from the Université Libre de Bruxelles (Brussels). She was the laureate of the international Rousseau Competition in International Laws chaired by Boutros Boutros-Ghali in 1997.
Annabelle joined Simmons & Simmons in 2013, after more than 14 years at another international law firm, where she headed the Pharmaceuticals & Healthcare group. She was admitted to the Brussels bar in 1998. She was educated at the Catholic University of Louvain and also spent a half year on an exchange program at the Rijksuniversiteit of Leiden. She was a part time lecturer at the Catholic University of Louvain from 1997 to 2003. She is a member of the Brussels Pharma Law Group, European Food Law Association and the Belgian Regulatory Affairs Society (BRAS) where she is also active in the Education Group organizing training sessions for BRAS members. She is frequently invited to speak at international conferences and has published numerous articles in legal and trade journals relating to regulatory matters. Since 2010, she is a regular lecturer of the European Healthcare Compliance Ethics & Regulation program organized by Sciences Po and Seton Hall Law. Annabelle speaks French, Dutch and English.
Ms. Bruyndonckx’s more recent publications include "Promoting Medical Devices in Belgium" in Promoting Medical Devices Globally, bilingual edition, May 2009; Promoting Medical Products in Europe & North America, second edition, June 2007; "New health rules", European Legal Development Bulletin, Baker & McKenzie, October 2005.
Frederick T. Davis is a litigation attorney whose practice focuses on international arbitration and criminal, regulatory and civil litigation and investigations involving US law. Mr. Davis has tried numerous cases in private practice and has represented clients in high profile matters in both French and English language tribunals. He has represented major US, French and multinational companies in international arbitrations administered by the ICC, AAA and other institutions, and has also served as an arbitrator in ICC arbitrations. The French government has named him a “Chevalier” of the National Order of Merit of France.
Mr. Davis’s recent matters include litigations and international arbitrations for General Electric, NBC and PdVSA. He represented five of the largest banks in France in litigations related to World War II assets; Citibank in many international proceedings including lawsuits in India, Gabon and Australia and Lloyd’s of London related litigation; and the heirs of W. Averell Harriman in a lawsuit against Pamela C. Harriman. In John Hancock Leasing Corp. v. Frank, he obtained a $28 million judgment for the plaintiffs in a RICO jury trial, and in 2006, in RMST v. State Bank of Long Island, he obtained a $44 million verdict in a jury fraud trial.
Mr. Davis is a past chair of the European Affairs Committee of the New York City Bar Association. He is also a member of the International Bar Association, American Bar Association, Federal Bar Council and American Law Institute. He is an elected fellow of the American College of Trial Lawyers and a frequent lecturer for the New York Law Journal seminars, Practicing Law Institute, American Bar Association, International Chamber of Commerce, and Federal Bar Council. He taught a full academic course on international litigation and arbitration as the Nomura Lecturer on International law at the Harvard Law School during the 2007 Winter Term. He also founded and led a series of a pro bono trial advocacy training seminars (in French and English) for the prosecutors of the International Criminal Tribunal for Rwanda.
Mr. Davis joined Debevoise as a partner in 2004. He served as an Assistant U.S. Attorney in the Southern District of New York from 1974 to 1979, where he was Chief of Appeals from 1977 to 1978. Mr. Davis served as a Law Clerk to the Honorable Henry J. Friendly, Chief Judge of the U.S. Court of Appeals, Second Circuit and to Justice Potter Stewart of the U.S. Supreme Court.
He received his B.A. from Harvard University in 1967 and his J.D. from Columbia Law School in 1972, where he was the Writing and Research Editor of the Columbia Law Review.
Alja Poler De Zwart is an associate in the Privacy and Data Security Group in Morrison & Foerster's Brussels office. Ms. Poler De Zwart's practice focuses on information technology law, with an emphasis on privacy and data security. She has advised on international data transfers, cloud computing, direct marketing, innovative data use (e.g. customer profiling), blacklisting, e-discovery, the use of email and the Internet in the workplace, employee monitoring and whistle blowing procedures, as well as assisting clients with their dealings with the regulators. She has drafted privacy policies, terms and conditions for online services, guidelines and notices, and data transfer and processing agreements. Her clients include Dutch, European and U.S. based corporations and organizations from a broad range of industry sectors, including technology, telecommunications, advertising, retail, consumer products, entertainment, pharmaceutical and financial industries.
Prior to joining Morrison & Foerster, Ms. Poler De Zwart was an associate in the Information, Communication & Technology team at a law firm De Brauw Blackstone Westbroek in Amsterdam. She also worked as a legal associate at the SOLVIT centre in The Hague, advising businesses on difficulties caused by failure to implement or correctly interpret EU law by public authorities.
Ms. Poler De Zwart is a native speaker of Slovenian, speaks fluent English and Dutch and has a working knowledge of Croatian, Serbian and German languages. She is a member of the Amsterdam and Brussels Bar. She graduated from the University of Maribor (LL.B.) in 2003 and the University of Leiden (LL.M.) in 2006.
Sue Egan offers the benefits of her thirty years of practical experience and pragmatic approach to organizations of all types and sizes needing to improve their performance in the key areas of Corporate Governance, Compliance, Risk Management, and Change Management.
Ms. Egan has an MBA from Cranfield University School of Management, a BSc in Math and Physics from Manchester University, is a Fellow of the Chartered Management Institute, and a member of the Non-Exec Directors’ Club. Sue Egan Associates Limited is also a member of the Thames Valley Chamber of Commerce Group.
Ms. Egan’s positive, practical approach and influencing skills have enabled her clients to achieve their business goals in a wide range of situations from single person projects to cross-functional teams across cultural and geographic boundaries and at all levels up to and including main board.
Ms. Egan is a founder member of the organizing committee of the International Pharmaceutical Compliance Congress and Best Practices Forum conferences. She has a high reputation as a speaker and presenter of case studies at conferences, in the U.S., Europe, Asia Pacific, and Latin America. She also delivers presentations and training using web-based tools.
Ms. Egan began her career in IT, spending almost twenty years developing software, managing projects and teams, training people, and setting the technology strategy. From this background, and her Project Management qualification gained while studying for her MBA, she developed the Change Management techniques that she now uses in organizations of all types and sizes to help them to manage change.
During the last twelve years, Ms. Egan has also been a Compliance Officer at all levels from single marketing company to international VP. The experience she gained whilst performing these roles enabled her to develop the Corporate Governance and Compliance knowledge and techniques that she applies to her consultancy work. She has developed different aspects of her Risk Management knowledge and experience from both her IT roles and her Compliance Officer roles.
In November 2009, Ms. Egan attended the two-day Non-Executive Directors’ Seminar at Cranfield University School of Management to add the theory of Corporate Governance to her practical knowledge, to enable her to better understand her role as a school governor, and to prepare her for possible Non-Executive Director roles in the future.
Ms. Egan has worked for companies including GlaxoSmithKline, AstraZeneca, Wickes and Hoskyns (now part of Cap Gemini). She has excellent current contacts at senior levels within the global life science sector (including pharmaceuticals, biotechnology, and medical devices companies) based on her reputation for getting things done and her regular conference speaking and case studies engagements.
Cécile Gousset is Associate Vice President of Compliance Risk Assessment, Education & Monitoring, Global Compliance & Business Integrity at Sanofi. She has thirteen years of experience at Sanofi in its Regulatory Affairs (French affiliate) and Global Medical Operations, as Head of the Medical Information Compliance Department. She has been in the Global Ethics & Business Integrity department since 2013.
Prior to becoming affiliated with Sanofi, Ms. Gousset spent six years at Astra-Zeneca France in Regulatory Affaris and two years in Merieux UK as Product Manager.
As Assistant Dean, Ms. Handler-Hutchinson develops and oversees all aspects of Seton Hall Law’s Graduate and Professional education including the M.S.J. and LL.M. degree programs, Graduate Certificates, international compliance programming, and educational seminars for lawyers, compliance officers and other professionals working in highly regulated industries. Additionally, Simone oversees the Center for Health & Pharmaceutical Law & Policy, a think-tank where faculty and researchers produce scholarship, white papers and recommendations for policy on the varied and complex issues posed by health and pharmaceutical law.
Ms. Handler-Hutchinson joined Seton Hall Law School in the fall of 2007 as Director of the U.S. Healthcare Compliance Certification Program & Faculty Fellow and directed the growth and launch of the European and Asia-Pacific Healthcare Compliance Programs. In 2009, she was named Executive Director of the Center for Health & Pharmaceutical Law & Policy and in 2015 became Assistant Dean. Prior to joining Seton Hall Law, she practiced health care law with Schenck Price Smith & King, LLP, and served as in-house counsel to a large healthcare system. Prior to that, she served as the Executive Editor at Brownstone Publishers in New York, overseeing several healthcare newsletters and, earlier in her career, she represented hospitals and healthcare providers in transactional, fraud and abuse, and regulatory matters.
Ms. Handler-Hutchinson co-edited (with Dean Kathleen Boozang) the first edition of the PHARMACEUTICAL AND MEDICAL DEVICE COMPLIANCE MANUAL, published by the American Health Lawyers Association and Food and Drug Law Institute. She has numerous other publications to her credit, and in the past has been an adjunct professor at the Law School.
Ms. Handler-Hutchinson received her B.A. in Economics from Emory University and her J.D., cum laude, from Seton Hall University School of Law.
Dr. Holtorf is the founder of the Health Outcomes Strategies, ltd. Her areas of expertise are value of healthcare products and policy decisions on healthcare products for the in- and off-patent sector, reimbursement strategies, outcomes research and health economics, health technology assessment processes, payer interactions, product / device / service synergies. In addition, she has been involved with patient involvement initiatives.
Dr. Holtorf has served as visiting faculty at the University of Utah between 2006 and 2007, and remains adjunct faculty in the Pharmacotherapy Outcomes Research Center at the University of Utah College of Pharmacy, where, in addition to her academic contributions, participated as investigator in a variety of outcomes studies. She has published broadly, among others on subjects of evidence based decision making and quality control in healthcare. As member of the Health Technology Assessment international Association (HTAi) and the International Society of Pharmacoeconomics and Outcomes Research (ISPOR), she is engaged in the Health Technology Assessment working groups for pharmaceuticals, medical devices and diagnostics, the workgroups for Patients in Research and for Personalized Medicines. Dr. Holtorf has also been appointed as evaluator at the EU-commission on multiple occasions and serves on University accreditation boards in Germany.
Dr. Holtorf obtained her Ph.D. in natural sciences (Dr.rer.nat) from the University of Marburg (Germany) and her MBA from the University of Birmingham (United Kingdom). She looks back on over 25 years of experience in the pharmaceutical and chemical industry in research and marketing with global responsibilities. Among others, she was responsible for the global Disease Management strategy and activities of Novartis Pharma, AG. Between 2000 and 2004, Dr. Holtorf managed the biotech business unit of a midsized Swiss chemical company and held a seat in the executive committee. Previously, she was responsible for technical development in the field of products of biologics in mammalian cell culture in the pharmaceutical industry.
Dominique Laymand is Senior Vice President, Chief Ethics and Compliance Officer. In this role, she is responsible for maintaining, monitoring, and controlling a compliance and ethics model that proactively addresses key compliance matters for EMEA. She works closely with the EMEA Business leadership teams to establish policy oversight and governance of these areas. She has a particular focus on Business Practices and is a member of the Bristol-Myers Squibb Corporate Compliance Council and Anti-Bribery Committee.
Ms. Laymand was previously Vice President Compliance and Ethics of Bristol-Myers Squibb (BMS). As such, and since 2004, she set up and managed the compliance and ethics program at BMS for Europe, Middle East, Africa, Turkey, and Russia. This program is based on an integrated approach for supporting operational risks prevention and mitigation, as well as on high standards of Business Integrity. Ms. Laymand has a broad experience at BMS, having started with the company in 1983 as Legal Counsel. Since then, she has held increasingly responsible legal positions which have given her experience in various functions and units including Marketing, Medical, Pricing & Reimbursement, Human Resources, and all the matters related to pharmaceutical laws.
Ms. Laymand received her Business Law Degree from Montpellier University in 1983 and her Health Law Degree in Sceaux University in 1996.
Abdul Luheshi is the Director of Life Sciences and Regulatory Compliance within KPMG’s UK practice and is a specialist in anti-bribery/anti-corruption (ABAC) regulatory compliance. Mr. Luheshi brings more than twenty years’ experience in the life sciences industry, covering broad commercial responsibilities, and focusing in the area of regulatory compliance transformations. In addition to designing and building compliance programs and organizations, he has led specific efforts in response to changing regulatory parameters, including responding to enforcement actions.
Mr. Luheshi is a specialist in proactive and reactive ABAC programs within the pharmaceutical, medical device, and consumer health industries. His experience combines subject matter expertise with industry multi-functional experience. He has done a significant amount of work across Europe (primarily Germany, Greece, Russia and France), the Middle East Africa (UAE, Saudi Arabia) and Asia Pacific (China, India, South East Asia and Japan).
Mr. Luheshi developed regional (EMEA and Asia Pacific) compliance organizations encompassing organizational design, recruitment and operational management, management of sales and marketing risk, third party risk, and management oversight and governance. He designed and implemented an enhanced compliance program for a leading international healthcare company in China, which included progressive approaches to training and communication, utilizing data analytics to improve senior management oversight, ongoing risk assessment, and a monitoring program overseeing selected value transactions with customers, vendors, and partners. He deployed a data privacy program for the UK/Ireland affiliate of an international medical device company, which covered the localization of the Corporate Policy, established “Safe Harbor” certification in the U.S., and implemented a review and approval process for on-line marketing.
Mr. Luheshi facilitated the design and deployment of a Europe-wide distributor management system to protect supply routes, optimize inventories, and track international product flows. It also studied the supply chain, including analysis of transaction data, contracts, and financials to establish anomalies, control gaps, and opportunities for improved profitability. The analysis of the supply chain processes included price waterfall analysis and margins and profitability as part of a Europe-wide reorganization of the supply chain for a major industrial products supplier to the pharmaceutical industry.
Mr. Luheshi implemented a strategic multi-year investment plan designed to create a step change in business performance and market position. The plan also facilitated the leadership of multi-functional teams/organisations to bring about rapid, controlled, and measurable business outcomes.
Mr. Luheshi has a B.S. in Chemistry and Biochemistry, a Ph.D. in Organic Chemistry, and a MBA in Finance and Strategic Management.
Geneviève Michaux is a Belgian- and French-qualified lawyer who focuses on issues surrounding the regulation of drugs, biologicals, medical devices, cosmetics and food in Europe, both at the Union and national level.
Ms. Michaux focuses on European, French, and Belgian food and drug law, with particular emphasis on pharmaceuticals and medical devices. Her work covers a wide range of issues, including regulatory status of borderline products, clinical trials, life cycle management, labeling and promotions, and issues raised by specific categories of medicinal products, such as orphan or advance therapy medicinal products. Geneviève provides assistance to pharmaceutical companies on important new legislative projects and policy developments in the EU and has, among other matters, helped shape the new EC Paediatric Regulation. She regularly instructs and supervises local counsels for pan-European or worldwide projects. She also has broad litigation experience in life science matters, including product liability, advertising and promotional activities, and generic approvals.
Ms. Michaux is recognized as a leading regulatory lawyer in legal directories and by many organizations, such as Who's Who Legal, Life Sciences, 2012. She has published many articles on food and drug law and regularly speaks at legal and regulatory conferences on pharmaceuticals and medical devices.
Ms. Michaux is a member of both Brussels and Paris bars. She speaks three languages, including Dutch, English and French. She is also a member of the editorial board of SCRIP Regulatory Affairs Journal Mediator with the Brussels Business Mediation Center. Additionally, Geneviève was awarded the “Who’s Who Legal” for Life Sciences for 2011-2012, and the de Harzen Prize (ULB) for excellence in Case Resolution over all five years of study in 1988.
Ms. Michaux holds her J.D. from Université Libre de Bruxelles (ULB), magna cum laud, and her L.L.M. from Harvard Law School.
Edward specializes in international transactional work and U.K. and European competition and anti-trust regulation.
Mr. Miller has particular experience in advising French, U.S. and U.K. based quoted international joint ventures, mergers and acquisitions, and cross border commercial agreements (including distribution and licensing arrangements, outsourcing, public authority contracting and others) in a range of industries including pharma/biotech, life sciences and health care, food and agriculture, and the rail industry.
He also focuses on competition and anti-trust law and has successfully represented clients in investigations conducted by the European and UK authorities, in the conception and implementation of international pricing and distribution structures, and in obtaining multi-jurisdictional merger clearances.
He is listed as a notable practitioner in anti-trust in Chambers Guide to the U.K. Legal Profession 2005 and 2006. Mr. Miller is the Honorary legal adviser to the Council of the UK Manufacturers’ Agents’ Association, Honorary Legal Adviser to the European Sales and Marketing Association, U.K. Delegate to the International Union of Commercial Agents and Brokers Legal Working Group, and U.K. Expert at the International Distribution Institute.
Mr. Miller holds his J.D. from the University of Oxford, Oriel College (1982); attended the Free University of Brussels for his Licence Spéciale en Droit Européen; holds an L.L.M. International Law from the Hebrew University of Jerusalem (1985); and his Solicitors Finals from Manchester Polytechnic (1986).
Arthur Muratyan is a lawyer with long standing experience in Pharma Industry. In 2011, he retired from Sanofi where he was VP-Head of Legal Corporate and Global Compliance Officer.
Mr. Muratyan is Secretary General of ETHICS. He was recently appointed as a new member of the EUCOMED Independent Compliance Panel. He is also member of the Board of ICC-France (International Chamber of Commerce-France).
Stephen Nguyen-Duc is currently Area Director of the Office of Ethics & Compliance, International Operations, for Abbvie Pharmaceuticals in Europe & Canada. Before that, he was also in charge of Ethics & Compliance operations for Eastern Europe, Middle East, and Africa.
Mr. Nguyen-Duc graduated from the Pharmacy School of Paris with a major in industrial pharmacy and pharmacology. He is also an alumni of INSEAD business school. He also previously held multiple roles in Human Resources, Sales training, Six Sigma and Clinical research in different companies prior to Abbvie.
Mr. Nguyen-Duc is currently Vice-Chair of the EFPIA Compliance Steering Committee. He is also a Strategic Committee member of Ethics (International Society of Healthcare Ethics & Compliance professionals).
Kirk Ogrosky is a Partner at Arnold & Porter LLP in Washington, D.C. He represents corporations and executives in civil and criminal investigations, Foreign Corrupt Practices Act (FCPA) matters, False Claims Act (FCA) litigation, and trials. Having a track record of successful resolutions and an ability to achieve timely results has been the hallmark of his practice. If unable to resolve a matter, he is an experienced trial attorney and litigator having first-chaired numerous high profile cases.
Whether originating from the receipt of a subpoena or an internal process, Mr. Ogrosky regularly leads internal investigations for public and private companies that are targeted to identify issues, isolate problem areas, and initiate corrective action plans. Over the last twenty years, he has taken almost forty defendants through trial to verdict, and juries have returned verdicts in his favor in every trial he has first-chaired in the last ten years. In addition, he has successfully litigated a number of FCA cases where court decisions have alleviated the need for trial.
Prior to joining the firm, Mr. Ogrosky served as the Deputy Chief of the Fraud Section in the Criminal Division of DOJ from 2006 to 2010, and as an Assistant U.S. Attorney in the Southern District of Florida from 1999 to 2004. Based on his government service, he has been recognized as the key architect behind modern criminal healthcare enforcement programs. While at DOJ, he managed prosecutors and agents handling national criminal investigations, FCA parallel proceedings, FCPA investigations, and securities fraud matters. In addition, he served on committees of the joint DOJ-HHS Healthcare Fraud Prevention and Enforcement Action Team (HEAT). He frequently speaks as a faculty member, panelist, and keynote on topics involving fraud, foreign bribery, and trial. He serves as an Adjunct Professor of Law at Georgetown, where he teaches courses on the use of experts and healthcare fraud.
Ranked as a leading lawyer by Chambers USA, clients praised Mr. Ogrosky’s “exceptional work” and “great judgment.” He is ranked by Super Lawyers for white collar defense and as one of the Top 100 Lawyers in DC, 2014-16; The Legal 500 for white collar defense, 2014-2016; and is Martindale AV-rated. For his work handling fraud cases, he received the U.S. Attorney General's Award for Distinguished Service, 2008; U.S. Assistant Attorney General's Award for Special Initiative, 2007; HHS OIG's Exceptional Achievement Award, 2010; and the Director's Award for Superior Performance as an AUSA, 2003.
Mr. Gerald Orlik is Global Business Unit General Medicines & Emerging Markets (GEM) Compliance Business Partner at Sanofi since January 2016. Until this date, he was Regional Compliance Officer Europe at Sanofi. In his new role, he provides strategic compliance leadership and support to the GEM projects and initiatives and acts as primary point of contact for GEM for implementing, promoting, and enforcing compliance standards. He also supports Global Compliance in addressing strategic priorities and serves as the liaison between GEM and the Global Compliance organization.
Prior to joining Sanofi, Gerald Orlik served as VP & EMEA Chief Compliance Officer at Mylan. He created the function, designed and implemented the compliance program for EMEA region. Before Mylan, Mr Orlik served as Schering-Plough Director of Compliance and Business Practices, a member of the executive committee for the French subsidiaries, overseeing all compliance-related matters for both human and animal health operations, primarily focused on Sales & marketing activities also covering clinical trials, medical affairs and manufacturing. Prior to Schering-Plough, he had varied industry experiences in the field of global risk management services with the audit and advisory services firm PricewaterhouseCoopers.
Mr. Orlik has a strong project management practice and an extensive experience in governance, internal control and risk management.
Graduated with management controlling from one of the top French universities in finance and economics (Universite Paris-Dauphine), Mr Orlik completed a master’s degree in computer sciences. Senior officer in the Military Reserve, he is Knight of the National Order of Merit (France) and is graduated from the French higher staff college for reserve officers (ESORSEM).
Ms. Pickaert is the Deputy Director General of EFPIA, member of EFPIA’s General Management. Since 2008, Ms. Pickaert has coordinated EFPIA’s ethics and compliance activities. Following the adoption of the 2010 Leadership Statement calling for greater transparency, accountability, and ethical behaviour within and industry framework of self-regulation, she took the lead of activities, including the creation of the EFPIA ethics platform and the development of the EFPIA Disclosure Code. She is acting as the Chief Ethics & Compliance Officer at EFPIA.
In 2015, Ms. Pickaert was asked to take the role of Ambassador to the Medical Communities, coordinating EFPIA’s relationships with medical & scientific societies, including learned societies, also through professional communities within the pharmaceutical companies that interact with medical communities.
Ms. Pickaert has her masters with honors in Economic Science from the Vrije Universiteit te Brussel (Belgium) – with honours. Her thesis is titled: Economic and Social Impact of Education and the Value of Human Capital – first class honours. She also has continued education and specialization – postgraduate/executive training in Applied Psychology in Economics (two years), Auditing and Valuation of Enterprises (two years), and Hospital Management (one year).
Alexandre Regniault is a Partner at Simmons & Simmons in Paris. He joined the firm in 2002, after graduating from the University of Oxford and Université Panthéon-Assas Paris II, then spending four years with another international law firm. He specialises in regulatory advice and dispute resolution principally on behalf of Life Sciences (pharmaceutical, medical devices and biotech) companies and significant players in highly regulated industries. He is also a member of the firm's Crime, Fraud and Investigations Group.
He has significant expertise in transactional negotiations, compliance audits and advice on regulatory matters, advising notably sponsors of clinical trials, and major companies in the sector on pricing, reimbursement, advertising, anti-corruption and commercial practices. He is experienced in crisis management and frequently liaises with the French regulatory authorities on behalf of industry players.
Mr. Regniault advises insurers and reinsurers, especially in the fields of professional and product liability. He coordinates the activities of the Intellectual Property team in the Paris office of Simmons & Simmons LLP. He is a Vice-President of France Biotech and a Board member of the Association of Executives in the European Medical Device Industry (ACIDIM).
Brian Sharkey is Counsel to Porzio, Bromberg & Newman. He is a member of the firm's Life Sciences Practice Group and concentrates his practice in the area of product liability and mass torts. He is also a Manager of Regulatory and Compliance Services of Porzio Life Sciences, a subsidiary of the firm. In that role, he counsels life sciences companies on a variety of compliance-related issues, most significantly those relating to ex-U.S. marketing disclosure and gift limitation laws and industry codes.
In particular, Mr. Sharkey focuses on helping companies understand and comply with global reporting requirements for transfers of value to healthcare professionals, healthcare organizations, and patient organizations. He has written and spoken extensively on the evolving global transparency landscape for disclosure requirements, including with respect to data privacy obligations. He also has experience performing internal company investigations. In addition to his Life Sciences roles, Mr. Sharkey serves as Director of Compliance and Legal Affairs of Porzio Governmental Affairs, LLC, another subsidiary of the firm. In this capacity, he counsels clients on campaign finance laws and regulations.
Prior to joining Porzio, Mr. Sharkey was a clerk for the Honorable Justice Peter G. Verniero, New Jersey Supreme Court, and a summer associate at Porzio, Bromberg & Newman. He has been recognized on the New Jersey Super Lawyers “Rising Stars” List, Personal Injury Products, Defense in 2007, and 2009 to 2014. He is a member of the New Jersey State Bar Association, New Jersey Supreme Court Committee on the Unauthorized Practice of Law, and New York State Bar Association.
Mr. Sharkey has written several publications, the most recent being "Getting the Deal Through - Life Sciences 2014," United States Chapter, published by Getting the Deal Through, 2014; "Sunshine Spreading Across the Atlantic and Over Europe," European Medical Writers Association, Vol. 22, Iss. 4, December 2013; "Holland. The Original Cool," Sunshine Abroad: International Transparency, October 2013.
Mr. Sharkey holds his B.A. from The College of New Jersey (1997), and his J.D., magna cum laude, from Seton Hall University School of Law (2000).
Robert Skinner is Deputy Compliance Officer, Emerging Markets, Asia Pacific & Japan at GlaxoSmithKline. He has 24 years of experience within the pharmaceutical industry, mainly in Clinical Research and Compliance. His current position is Deputy Compliance Officer, Emerging Markets, Asia Pacific & Japan within GlaxoSmithKline. His main responsibility is working with business teams to identify and mitigate risks, including those related to anti-bribery & corruption, third party oversight, patient safety, commercial practices, scientific engagement and merger & acquisition activities. His previous role was Head of Medical Operations at GSK for the same region.
Dr. Skinner is a certified ‘Leading Professional in Ethics & Compliance’ (LPEC), an honorary member of the UK Royal College of Physicians’ Faculty of Pharmaceutical Medicine and a Visiting Lecturer at the University of Surrey and King’s College London. He obtained his Ph.D. from King’s College, University of London.
David Smith is a Partner in EY’s Fraud Investigation & Dispute Services (FIDS) practice in Russia. He has extensive experience in the areas of leading multi-national compliance projects, conducting fraud investigations, and quantification of loss and damage in legal disputes.
Since first joining EY and FIDS in 1998, Mr. Smith has worked in EY’s practices in England, Ireland, Australia, Czech Republic, Romania, and now Russia. In addition, he has also worked in the United Kingdom Serious Fraud Office and in public accounting practice in Australia. He has been the main content developer for global FIDS training courses and is a regular presenter for the company’s European practice. Mr. Smith has coordinated global and regional Foreign Corrupt Practices Act and sales and marketing compliance reviews both as team lead and project manager across a broad range of industries and locations.
Mr. Smith’s engagements within the life sciences industry include global coordinator for a European-based global pharmaceutical company conducting compliance reviews in smaller markets. His role included preparation of work plans, remote management of reviews in various countries, and managing the client relationship. In addition, he coordinated provision of local resources to assist the clients internal audit teams on compliance reviews globally. He has led post-acquisition investigation on behalf of global pharmaceutical company covering four European countries, conducted detailed assessments of sales model, accounting records, and interaction with health care professionals, and worked extensively with external counsel in preparation for reporting to regulators. He also led various local sales and marketing compliance reviews for pharmaceutical and medical device companies as part of global engagements in Russia, Ukraine, Czech Republic, and Romania, and led teams in six Asia–Pacific markets conducting sales and marketing compliance reviews for a global pharmaceutical company.
Andrew Thornton-Dibb helps clients with multi-jurisdictional corporate crime and contentious regulatory issues, with a focus on assisting clients both with internal investigations, and with regulatory and enforcement authority’s investigations and prosecutions. He has recently been, and is currently engaged in, a number of investigations in the UK and the U.S. involving a variety of enforcement authorities and regulators, including assisting clients with several current investigations into offences under the Bribery Act.
Mr. Thornton-Dibb also advises on compliance issues, including anti-bribery, anti-money laundering, and trade and economic sanctions, and has experience with designing and implementing compliance and dawn raid programs, and conducting training. This includes recently assisting a multi-national pharmaceutical company with its global anti-bribery and corruption program.
In addition to his private practice, Mr. Thornton-Dibb has experience as Assistant General Counsel for a Fortune Global 500 company focusing on global regulatory issues, which has given him an intimate understanding of how regulatory and corporate crimes issues impact a business. His front-line exposure to crisis management, and real experience with investigations and dealing and negotiating with authorities, puts him in an ideal position to help clients put in place compliance programs and deal with sensitive matters should they arise.
Mr. Thornton-Dibb’s background has also exposed him to advising on matters peripheral to regulatory issues and crisis scenarios, including settlement arrangements, judicial reviews, and parliamentary committee hearings.
After having studied Political sciences at Sciences Po, she studied in Virginia to get a BA in International Studies. Then after graduated at Bruges, College of Europe, specialising in European public affairs, she has been working at the European Commission, the French Chambers of commerce and in pharma industry as a lobbyist.
She is now working since 5 years at Sciences Po Executive Education in charge of international programs in public affairs.