15^th LEGAL AFFAIRS CONFERENCE
HOTEL OKURA, AMSTERDAM
26-27 MARCH 2019

Jules Fabre Senior Counsel, European IP & Regulatory Litigation - Teva Pharmaceuticals Jules is a Senior Counsel in the European IP and Regulatory Litigation team at Teva Pharmaceuticals. He has extensive experience in cross border IP litigation and previously worked in private practice as a patent litigator with Hogan Lovells and Linklaters, in Paris. Jules holds a Master’s degree in Business law from Sorbonne University, in Paris and an LL.M in Intellectual Property from the C.E.I.P.I (Centre d’Études Internationales de la Propriété Intellectuelle), in Starsbourg. He is an active member of Medicines for Europe’s Legal Affairs Committee.

Sjoerd Hoekstra Director Patent Examination - EPO In the European Patent Office Dr. Sjoerd Hoekstra is member of the management team in the Sector Health, Biotechnology and Chemistry (HBC). As director he is leading a directorate of 6 teams comprising 71 examiner and 12 formalities officers. This directorate is responsible for the patent grant procedure from search to grant in the fields of pure chemistry, second medical use of small organic molecules, in vivo diagnostics, conjugated and targeted medicines, galenics and chemical aspects of biomaterials. The directorate of Mr. Hoekstra in the European Patent Office produces about 3.500 searches with opinions, 3.500 final actions in examination and supports the opposition directorates. 18 of his examiners are responsible for about 140 oppositions annually. Educated as plant molecular biologist, he joined the European Patent Office in Munich in 1990 and developed himself to become an all-round examiner with tasks ranging from classification & documentation via substantive examination to opposition work. In the office Mr. Hoekstra was active in the Examiners Academy lecturing substantive patent law and was nominated director in 2003 in a Biotech department in The Hague. Mr. Hoekstra is chair of the EPO's Examination matters committee which organises and annual seminar for patent attorneys hosting 170 guests annually and has contributed on many occasions as speaker in Biotech patenting conferences throughout Europe.

Imre Gonda Head of IP Department - Chemical Works of Gedeon Richter Plc. Imre Gonda has been practicing national and international IP law for more than 17 years. Currently he is the head of IP Department one of the largest pharmaceutical company in the Central European region which is very active in both areas, research of originating pharmaceuticals and generic product development. Before he joined Gedeon Richter Plc., he filled different positions in the Hungarian Intellectual Property Office, for 10 years he was the deputy-head of Trademark, Model and Design Department. He was responsible for managing and supervising the operation of national and international trademark, geographical indication and design sectors. He was involved in norm setting procedures including the preparation of amendments of laws and the creation of new international legal instruments. He participates in different international forums on a regular basis at WIPO and EU institutions, he was the elected vice-chair for eight cycles of the WIPO Standing Committee on the laws of Trademarks, Designs and Geographical Indications which forum was chaired by him for two years. He was participating in different forums of EUIPO (e.g. Management Board and Budget Committee; Liaison Meeting) in his national capacity for a considerable time period. He is qualified as a lawyer in Pázmány Péter Catholic University (Budapest) and did post graduate studies in European Law (LLM). He has written and edited a number of publications and books.

Karin Pramberger Intellectual Property Director - Polpharma Group Karin joined the Polpharma Group as Intellectual Property Director in April 2018. She is responsible for all patent and trade mark related activities. Prior to joining the Polpharma Group, Karin was Head of IP of Medichem, Spain, and worked in various positions within the patent department of Teva, Barr and Pliva after having spent 7 years in a law firm in Vienna, Austria, where she became European and Austrian patent and trade mark attorney. She studied Biotechnology in Vienna, Austria, and at the Ecole Nationale Supérieure de Chemie de Paris, France. In 2017 she graduated with an LLB from the University of London. Since 2005 she is a tutor at CEIPI, University of Strasbourg, for the pre-exam and the C-part of the European Qualifying Exam, and since 2006 she is an active member of the Legal Affairs Committee of Medicines for Europe.

Adrian van den Hoven Director General - Medicines for Europe Adrian van den Hoven was appointed Director General of Medicines for Europe on 1 September 2013. Before this he was Deputy Director General of BUSINESSEUROPE with responsibility for the International Relations and Industry departments. He worked as an International Relations researcher and adjunct professor in Italy (EUI), France (Nice) and Canada (Windsor) prior to joining BUSINESSEUROPE in 2003. He received his doctorate in Political Science from the University of Nice, France in 2000.

Andreas Schillack Head Legal Europe, Attorney at Law - Sandoz International GmbH Andreas Schillack, Head Legal Europe, Sandoz, has a long-term track record of legal leadership roles in the pharmaceutical industry. This is also including Novartis Pharma, MSD, Eli Lilly, as well as outside counseling at CliffordChance. He was involved in several legal headline cases and proceedings throughout his career so far. Currently, Andreas leads at Sandoz in Europe an approach of legal business partnering, regional initiatives, knowledge sharing and cultural transformation for and with his team of 50+ in-house counsels.

Kees Schillemans Partner - Allen & Overy LLP Kees specialises in EU and competition law. He regularly represents clients in proceedings before competition and regulatory authorities and courts. Kees has extensive experience in cartel and merger control proceedings before the Dutch Competition Authority and the European Commission. He also advises and litigates on matters of EU law and private enforcement of competition law including cartel damages cases. Kees regularly publishes on competition law and is the chairman of the Dutch Association for competition law. Chambers Europe (2018) describes Kees as an "excellent adviser who brings a lot of added value to the table in a complex transaction" and notes that he is "renowned for cartel and merger control cases before the European Commission and the ACM". WWL says: ""Rising star" Kees Schillemans is already regarded as a "very influential" name in the Dutch competition field, active in both antitrust and merger control matters." Legal qualifications - Admitted as advocaat, Netherlands, 2000 - Exempt european lawyer, England and Wales, 2009 Languages - Dutch, (Level 1 - Fluent/Bilingual) - English, (Level 1 - Fluent/Bilingual)

Agnieszka Deeg-Tyburska Legal Director - Polpharma Group Agnieszka Deeg-Tyburska, works as the Legal Director of the Polpharma Group. Currently she manages the team of lawyers in Poland (3 locations), Russia, Kazakhstan, Barcelona and IP teams, on direct reporting or doted line basis. Before that she was a General Counsel, director of the Legal Department of nc+, a Polish premium pay television, where she managed the team of 14 lawyers, half coming from Canal + Cyfrowy S.A. and half from ITI Neovision S.A. In her so far career she also handled a number of large and sophisticated transactions, with a particular emphasis on the acquisitions of public companies, investment transactions of venture capital funds, representation of international financial institutions on the acquisitions of Polish bans and leasing companies, as well as in MBO and LBO structures. She represented a number of financial institutions and borrowers in the lending, debt securities issuance programs, and finance lease transactions.

Tomos Shillingford Associate General Counsel IP - Insud Pharma Tom is Associate General Counsel IP at Insud Pharma, a diversified biopharmaceutical business based in Madrid, Spain. Tom’s previous position was Director IP Litigation at Allergan, which at that time incorporated the Actavis Group of companies. Tom is a dual qualified lawyer (England and Wales, Australia) whom previously worked in private practice in London with Bird & Bird and in Melbourne with Herbert Smith Freehills. Tom has been working in the pharmaceutical industry for over 9 years and has a wealth of experience in patent litigation across the globe. He advises on a range of IP and regulatory issues as well as providing contractual and M&A support. Tom has managed many prominent patent actions, including Actavis v Sanofi (Irbesartan HCT), Actavis v Boehringer Ingleheim (Telmisartan HCT), Actavis v Warner Lambert (Pregabalin) and Actavis v Eli Lilly (Pemetrexed).

George Moore Assistant General Counsel - Europe, Australia and Asia - IP and IP Litigation - Mylan George Moore is Assistant General Counsel - Europe, Australia and Asia - IP and IP Litigation, at Mylan. He currently leads the IP team at Mylan for Europe, Australia and Asia, and also the IP Litigation function for all ROW matters. He is a qualified solicitor (England & Wales) with a masters’ degree in chemistry. He has over 10 years in house pharmaceutical experience, having worked at Apotex in Canada and Sandoz in Germany. He previously worked in private practice in the UK, training and qualifying at Bristows, before then working at Allen & Overy.

Jeffrey Francer Senior VP & General Counsel - Association for Accessible Medicines (aam) Jeff Francer is Senior Vice President and General Counsel of the Association for Accessible Medicines, where he leads legal and international trade advocacy. Jeff served as Associate Chief Counsel of the Food and Drug Administration from 2003 to 2005, where he advised agency leaders on issues involving the regulation of drugs and biologics including clinical investigation, manufacturing, promotion, enforcement and legislative matters. After leaving the FDA, Jeff served as Associate General Counsel, U.S. Compliance Officer, and Chief Privacy Officer of Biogen Idec, Inc. At Biogen Idec, he was the primary in-house counsel on FDA issues, fraud and abuse prevention and patient privacy. Jeff was also responsible for overseeing the U.S. corporate compliance program. Immediately prior to joining AAM, Jeff served as Vice President and Senior Counsel of the Pharmaceutical Research and Manufacturers of America (PhRMA) where he was the principal counsel to the association on issues relating to the research, development and regulation of medicines in the U.S. and globally. Mr. Francer received his A.B. in Public Policy and Economics from Brown University, his M.P.P. from Harvard University, and his J.D. from the University of Virginia.

Kenneth V. Phelps President and CEO - Camargo Pharmaceutical Services In 2003, Ken Phelps applied more than three decades of industry experience to found Camargo Pharmaceutical Services in Cincinnati with Dr. Ruth Stevens (chief scientific officer and executive vice president). It is no coincidence that 2003 was also the year the US FDA introduced guidelines governing the 505(b)(2) approval pathway. From the beginning, Camargo has focused solely on being the industry's 505(b)(2) development partner of choice. In 2011, Camargo opened a second location in Durham, N.C., in the Research Triangle Park. Today, Camargo partners with companies in more than 25 countries worldwide and has led the largest percentage of 505(b)(2) submissions of any team submitting to the FDA — Camargo has led more than 1100 Agency meetings and is the industry authority in 505(b)(2). Before founding Camargo, Phelps' diverse background in drug development had led to a number of executive-level assignments in the areas of quality control, project management and regulatory, clinical and medical affairs at Duramed Pharmaceuticals. Phelps also held a number of positions at Merrell-National Labs (which merged to become Merrell Dow and later evolved into Aventis), where he was responsible for global quality assurance, quality control, and processing technology, with an assignment based in Milan, Italy. Today, as a thought leader in the shifting landscape of drug development and emergent pathways around the globe, Phelps addresses the financial challenges of pharmaceutical companies caused by the generics cliff and routinely presents on the topic at events worldwide. He has recently been invited to speak on the topic at DCAT and other international conferences on how companies can realize the opportunities of 505(b)(2) and expanded marketability. Phelps is also a founding member of the 505(b)(2) Forum, an assembly of product developers and service providers interested in improving best practices across the 505(b)(2) development process. He publishes articles frequently and is a featured interviewee in publications, videos and podcasts concerning new, repositioned, and differentiated product development around the globe. You can access these resources by following the Camargo Blog where Phelps and his team elaborate on current market trends.

Ignace Vernimme Partner - Stibbe Ignace Vernimme has special expertise in IP law and related areas within the pharmaceutical, food and beverage, metallurgic, comic strip and fashion industry. His activities encompass in particular patents, trademarks and copyright, designs, know-how protection, technology transfer and the specific rules applicable to pharmaceutical products. Ignace is member and president of the Commission for admission of Belgian patent attorneys (Ministry of Economic Affairs). He is arbitrator and member of CEPANI (Belgian Center for Arbitration and Mediation - Intellectual Property Litigation), arbitrator and mediator of WIPO (World Intellectual Property Organisation). He is also panellist of CEPANI (Alternative Dispute Resolution) and panellist at the Czech Arbitration Court (CAC).

Gyorgy Thaler Chair Legal Affairs Committee - Medicines for Europe Dr. György Thaler joined Gedeon Richter PLC in 1983 as a chemical engineer. After spending some years as a medicinal chemist he completed his Ph.D. at the Technical University of Budapest in synthetic organic chemistry. After holding different management positions he is development director of the Richter Group since 1992. His current responsibilities are product development and regulatory affairs. He is the chairman of the Legal Affairs Committee of Medicines for Europe, since its establishment in 2002. He is also serving as Executive Board member of Medicines for Europe.

Johan Verhaeghe National Policy Liaison - Medicines for Europe Johan Verhaeghe joined Medicines for Europe (formerly EGA) in January 2015 as Falsified Medicines Directive Project Manager. In February 2017 he took on additional responsibilities as National Policy Liaison. As coordinator of the National Associations Committee, Johan’s task is to manage the platform where different national associations not only share their ‘best practices and lessons learned’ but also discuss a broad variety of topics that are related to the industry. To operate in a more harmonised environment, it is crucial for our member associations to understand the different markets in order to better serve the interests of their own country. This objective is pursued in line with Medicines for Europe’s commitment to strive for increased access to medicines for all European citizens. Johan also continues to support all members of Medicines for Europe with regard to the implementation process of complying with the Falsified Medicines Directive. With an educational background in philosophy, Johan approaches projects with pragmatism and focuses on the goals to be achieved. Medicines for Europe, as the voice of the generic, biosimilar and value added medicines industries, aims to increase the health and wellbeing of all Europeans through better access to high quality medicines.

Harald Mische Official DG Competition - European Commission Harald Mische is an official at the European Commission’s Directorate General for Competition, where he currently forms part of the team in charge with antitrust enforcement in the pharma and health services sectors in Directorate E. He joined DG Competition in 2002, first working in the Cartel Unit and then in the Pharmaceuticals, chemicals and basic industries Unit (moving to the newly created Pharma Sector Inquiry Task Force in 2008, which is now as unit responsible for the health sector as part of Directorate E). Prior to joining the Commission, and after qualifying as a lawyer in Germany, Mr. Mische practiced EC and German competition law in the Brussels office of a leading American law firm. Before that, he worked as an intern in DG Competition’s Merger Task Force. Mr. Mische obtained a Ph.D. in EC merger control from the Eberhard-Karls-University of Tübingen. He is a regular speaker on antitrust issues, has written various articles on EC competition law and authored “Nicht-wettbewerbliche Faktoren in der Europäischen Fusionskontrolle – Wettbewerbspolitik zwischen Schutzpolitik und Gestaltung” (“Non-competition issues in European merger control”), Wirtschaftsrecht und Wirtschaftspolitik Bd. 175, Nomos, Baden-Baden, 2002.

Vincenzo Salvatore Of Counsel - BonelliErede Expertise - EU life sciences regulatory and compliance matters with a focus on: - clinical trials - marketing authorisation procedures - pharmacovigilance - personal data protection - promotion and marketing of medical devices - inspections and enforcement - Foreign Languages: English, French, Spanish Background - Team Leader of the Healthcare and Life sciences Focus Team - Joined as Of counsel in 2015 - Former Head of the Legal Service at the European Medicines Agency - Speaker at various EU regulatory conferences in Italy and abroad Ranking and Awards Who's Who Legal lists Vincenzo Salvatore as one of Italy’s most highly regarded practitioner on life science law. Testimonials “He really stands out in the market. He is an extensive experienced practitioner boasting expertise across a range of matters including clinical trials, marketing authorization and data protection” (Who's Who Legal) Qualifications and Academia - Full Professor of European Union Law at the University of Insubria, Varese - Member of the Italian Bar, admitted to practice before the Italian Supreme Courts (Corte di Cassazione and Consiglio di Stato) - PhD in European Law from the European University Institute - Law degrees from the University of Pavia

Miguel Vidal-Quadras Trias de Bes Lawyer - Vidal Quadras & Ramon PhD in Law and professor in the University in Barcelona, Miguel has written several books and articles on patent, pharmaceutical law and technology transfer. He is a founding partner of VIDAL-QUADRAS & RAMON, law firm specialised in IP Law, and has assessed AESEG since it was set up in 1998, especially in relation to the implementation in Spain of several regulations.

Sascha Stolzenberger Director of Biotech Intellectual Property - Gedeon Richter Pharma GmbH Dr. Stolzenberger is a European Patent Attorney currently working as Director of Biotech Intellectual Property (IP) at Gedeon Richter Pharma GmbH, Germany. Within Gedeon Richter Corporation, the IP division in Germany is responsible for patent clearance, portfolio management, prosecution, and litigation that relate to the company's biosimilar developments. Dr. Stolzenberger joined Gedeon Richter in 2009. Prior to this he held the position as Senior IP manager at BioGeneriX AG / ratiopharm GmbH for almost 10 years. In the latter, he was responsible for the global patent management of multiple biosimilar products from candidate selection to product launch, including post-launch litigation. Furthermore, Dr. Stolzenberger contributed to the technical development for several projects, in particular to the development of new pharmaceutical compositions. Dr. Stolzenberger is Biologist and graduated in Biochemistry and Molecular Biology. He received his doctorate from the University of Würzburg.

Benjamin May Partner, Head of IP - ARAMIS Société d'Avocats One of the founders of Aramis law firm in Paris, Benjamin May was admitted to practice law in 2000. Benjamin specializes in international patent litigation with a focus on pharmaceuticals and biotech. He is a true litigator and at his best in technically complex proceedings, in particular in the context of cross-border litigation. Benjamin is praised by his clients for his litigation skills and understanding of complex technology. A regular speaker in various IP & life sciences forums, Benjamin is the author of several publications on patent law, e.g. in 2019 “patent litigation in France”, “Second medical use patents: where do we stand?”, “preliminary injunction in the pharma sector”. Aramis law firm focuses on patent and SPCs expiry strategies, IP litigation & trade secrets, regulatory matters, distribution and licensing agreements, marketing matters and anti-trust. Aramis acts for pharma companies, medical devices manufacturers as well as several cosmetics and biotech companies. Aramis was recorded in 2018 as the highest turnover increase amongst business law firms in Paris. Contact: may@aramis-law.com

Kristof Roox Partner - Crowell & Moring Kristof Roox serves as co-managing partner of the firm's Brussels office. He specializes in intellectual property (IP) litigation in a variety of technological and commercial fields, with a particular focus on complex patent litigation in the pharmaceutical and life sciences sector. He has been involved in a number of cases concerning parallel litigation in several jurisdictions and European cross-border issues. He further advises on many aspects of intellectual property portfolio management, including licensing, protection of trade and domain names, trade secrets, combating counterfeiting and piracy, broadcasting and cable retransmission, technology transfer and strategic IP planning. He has also extensive experience in a wide variety of media law issues. In addition to traditional IP litigation and counseling, Kristof is widely recognized for his thought leadership in the regulatory aspects of life sciences. He advises clients on regulatory, IP and commercial issues, including launch and marketing strategies, food supplements, pharmaceutical marketing practices, pricing and reimbursement, distribution models, OTC-products, competition law aspects, etc. Kristof also litigated several high profile cases before the Belgian's highest Administrative Court (Raad van State) challenging/defending Government reforms of the healthcare system, parallel import authorizations, marketing authorizations, etc. He also assists clients in procedures before the European Agency for the Evaluation of Medicinal Products (EMEA), the Ethical Healthplatform Mdeon and the Deontological and Pharmaceutical Ethics Committee. Kristof has also experience with (referrals to) Co-ordination Group for Mutual Recognition and Decentralized Procedures, autogeneric immunological veterinary medicinal product, etc. Furthermore, he advises and represents leading trade associations in the life sciences sector. Kristof is a very experienced litigator in general commercial and civil matters, covering all aspects of dispute resolution including arbitration. As a specialist in private international law issues, he often deals with complex multi-jurisdictional questions. He is reputed for his knowledge of judicial and procedural law issues. Kristof is a qualified lawyer in Belgium and received a law degree cum laude at the Free University of Brussels in 1994. He also obtained a master of laws (LL.M) in intellectual property law at the University of London (Queen Mary and Westfield College) in 1996. Kristof is admitted at the Brussels bar since 1994. In 1998 he became an assistant professor private international law at the University of Gent. He also lectures on various IP topics in several educational institutions, such as patent law at the University of Liège (LL.M in European competition and IP law). He is a frequent speaker at professional and academic conferences and published several articles on intellectual property and private international law matters. He is on the editorial board of IRDI, a leading Belgian journal on intellectual property matters. He is also an active member of various national and international intellectual property associations.

Alfonso Calles-Sánchez Administrator - DG Grow, European Commission Alfonso CALLES SANCHEZ works as an Administrator in the intellectual property and fight against counterfeiting of the Directorate General for Internal Market, Industry, Entrepreneurship and SMEs of the European Commission. He deals with IP international affairs and patent policy, especially EU pharmaceutical patent policy (SPC regulations, paediatric extensions and the SPC waiver). He has been a consultant on IPR for the United Nations Development Programme, and as a visiting scholar at Duke University he researched on policy instruments for the development of medicines for neglected diseases. He started his career in the IP field as a patent examiner in the Spanish Patent and Trademark Office in 2000. Alfonso is an industrial engineer from Universidad Politécnica de Madrid and holds a diploma on public administration from IESE Business School.

Beatriz Diaz de Escauriaza Senior IP Counsel - Insud Pharma Beatriz is currently Senior IP Counsel at Insud Pharma Group, a diversified biopharmaceutical business based in Madrid, Spain. Beatriz holds a degree in Law and a Mater Degree in Intellectual Property. Before joining Insud Pharma, Beatriz worked in private practice as a patent litigator in Madrid with Bird & Bird where she specialized on pharma patent litigation (pleading, amongst others, in the finasteride and venlafaxine cases in Spain). She advises on a wide range of IP matters.

Corinna Sundermann Senior Vice President Intellectual Property - Fresenius Kabi Corinna Sundermann is heading the IP department of the Pharma Division at Fresenius Kabi. She joined Fresenius Kabi in 2008 as a Manager and built the IP department from 1 to 30 FTE since then. She is Senior Vice President since 2012. Focus is on generics, branded products, clinical nutrition and medical devices. Characteristic for the department is, to a certain extent, internal handling of litigation. Before joining Fresenius Kabi, she worked 10 years for an originator company, 5 years as a Head of Combinatorial Chemistry, 5 years in the IP department and is European Patent Attorney since 2006. She holds a Dr. rer. nat. from the University of Jena and a diploma in chemistry from the University of Frankfurt.

Roberto Romandini Max Planck Institute Roberto Romandini obtained his law degree from the University of Pisa and his LL.M. degree from the University of Munich, where he specialized in patent law. He completed his Ph.D. thesis on the patentability of human stem cells at the Max Planck Institute for Intellectual Property and Competition Law in Munich before practicing IP law at a leading IP law firm in Milan for 5 years. Since 2013 he has been a Senior Research Fellow at the Max Planck Institute for Innovation and Competition in Munich. His areas of interest are European and international patent law, biotechnological inventions, SPCs and regulatory exclusivities, plant variety rights and trade secrets. From November 2016 to May 2018 he led and coordinated the MPI Study on SPCs for the European Commission.

Sven Bostyn Associate Professor - University of Copenhagen Dr. Sven J.R. Bostyn (LLB, Lic. Jur., LLM law, PhD law) is Associate Professor of Biomedical Innovation Law at the Centre for Advanced Studies in Biomedical Innovation Law (CeBIL http://cebil.dk), Faculty of Law, University of Copenhagen. He also lectures at the Institute for Information Law (IVIR) of the University of Amsterdam. He is also a regular guest professor at CEIPI in Strasbourg. He is specialized in all areas of IP law, with special emphasis on patent law relating to pharmaceuticals, biotechnology, medical devices, software, Artificial Intelligence and SPC's. Sven is one of the most prominent authorities in Europe in the area of patent law. He is also specialised in regulatory exclusivities (data and market exclusivity, orphan drug designation etc.), and researches more generally also innovation incentivising mechanisms. He has written extensively on most areas of patent law, and apart from those subjects already mentioned, he has also published in the field of plant patent protection, plant variety rights, software related inventions, European and international harmonization of patent law and the Unitary Patent system. Sven has also been in private practice for the last 14 years where he advised and advises clients on most aspects of patent law, competition law, licensing and regulatory exclusivities. He also acted and acts as an expert witness in court cases. He was from 2013-2016 the Chair of the Expert Committee at the European Commission on the development and implications of patent law in the field of biotechnology and genetic engineering. Sven is the single author of more than 60 scientific publications in the aforementioned areas, and is a regular speaker on international conferences, where he speaks on a wide variety of topics, including IP protection in life sciences, pharma patents, SPC's, regulatory exclusivities in life science, IP issues relating to software and artificial intelligence, patent protection for plants and plant variety rights systems.

Marcel van Raaij Director Pharmaceutical Affairs & Medical Technology - Dutch Ministry of Health, Welfare and Sports Since October 2014 Marcel van Raaij is the Director of Pharmaceutical Affairs and Medical Technology at the Ministry of Health in the Netherlands. The Directorate is responsible for the policy making on pharmaceuticals (from innovation, market access, safe use to pricing and reimbursement), medical devices and technology and tibessues and cells including organ donation policy. Marcel van Raaij studied Medical Biology at the State University of Leiden (The Netherlands) and received his PhD in Physiology at the same university. After his PhD he moved to the National Institute of Public Health and Environment (RIVM). He worked in the toxicological risk assessment and was active in various international working groups and commissions (EU,WHO, OECD, US EPA). After leading the Center for Integrated Risk Assessment for a number of years at RIVM, he became acting director for Nutrition, Medicines and Consumer Safety. From 2011 to 2014 he was Director of Environment and Safety at RIVM dealing with environmental policy and physical safety including preparedness and response activities. The Netherlands presented a new Pharma policy in January 2016 and proposed an active agenda on pharmaceutical policy during the Dutch Presidency of EU council in 2016. Since 2016 Marcel van Raaij is appointed as chairman of the Steering Committee of the BeNeLuxA initiative where The Netherlands, Belgium, Luxembourg, Austria and Ireland are working together on sustainable access to medicines in their countries.

Ellen ‘t Hoen LLM, PhD Director - Medicines Law & Policy Ellen ‘t Hoen (1960) directs Medicines Law & Policy, a group of legal and policy experts offering services to international organizations, governments and non-governmental organisations. She is a researcher affiliated with the Global Health Law Unit of the University Medical Centre Groningen. She is the former director of policy for Médecins sans Frontières’ Campaign for Access to Essential Medicines and former executive director of the Medicines Patent Pool. She has published widely and is the author of several books. In 2017 she received the Prix Prescrire for her latest book “Private Patents and Public Health: Changing intellectual property rules for public health.” She holds a Masters in Law from the University of Amsterdam and a PhD (cum laude) from the University of Groningen, The Netherlands.

Floris ten Have Partner - Stibbe N.V. With his expertise in all areas of EU and Dutch competition law, Floris advises multinational companies active in numerous industries and has extensive experience, for example, in the pharmaceutical and financial sectors. His practice covers the full range of topics within the antitrust area, including merger control, cartel investigations and litigation, abuse of dominance and state aid cases. In 2014 Floris completed a secondment at Quinn Emanuel Urquhart & Sullivan, LLP in New York where he gained experience with regard to US antitrust litigation. Floris has a Master of Law from University of Amsterdam and regularly teaches competition law.

Alexander Ott Senior Patent Attorney - Sandoz Biography soon available.

Kristin Cooklin Global Head of Patents - Zentiva Kristin Cooklin is the Global Head of Patents at Zentiva in Prague. Kristin and her team are responsible for supporting and advising clients with respect to all patent issues at all product stages- including development, in-licensing, litigation and launch. In 2014 she joined Novartis where she held several different roles in its Sandoz Division in Munich, Germany, most recently as the Global Head of IP Litigation ex-US. In 2018 Kristin left Novartis to join the Zentiva and lead and develop the patent team during its transformation after divestment from Sanofi. Prior to going in-house at Novartis Kristin spent over a decade in Washington DC working in AmLaw 100 law firms as a patent litigator focusing primarily on pharmaceutical and life sciences litigation. She participated in all stages of cases, from initial strategy through trial and appeal. Kristin is a US attorney at law and patent attorney. She has handled counseling, litigation and launches of pharmaceutical products across the world with a focus on the US and Europe and was responsible for the successful IP strategy and launch of several of the first biosimilar products launched around the world.

Jacek Myszko Senior Counsel - Sołtysiński Kawecki & Szlęzak Jacek Myszko is a senior counsel at one of the major Polish law firms, Sołtysiński, Kawecki & Szlęzak. He focuses his practice on IP-related issues and various aspects of pharmaceutical law. Jacek graduated with a law degree from the Nicolaus Copernicus University in Torun, Poland and with a diploma in EU studies from the J. Monnet European Studies Centre. He also completed an IP law programme at the Jagiellonian University in Cracow, Poland and various international courses organised by, inter alia, the University of Cambridge (English and EU law), the Catholic University of America and Columbus School of Law (business and trade law). He has advised Polish and foreign clients on all aspects of trademark and patent protection; various aspects of medicinal product distributions schemes, including direct distribution, distribution via public tenders and application of reimbursement regulations; restructuring and acquisition (including audits) of pharmaceutical companies and pharmacies; issues related to contacts of pharmaceutical companies and medical devices companies with health-care professionals (training, scientific conferences, etc.). Jacek also supports on the regular basis the nationwide association operating within the pharmaceutical sector (preparing position papers regarding various aspects of pharmaceutical market, representation during academic events/conferences etc.).

Sergio Napolitano Legal and External Relations Director – Medicines for Europe Sergio Napolitano is Legal and External Relations Director at Medicines for Europe. He has been recently nominated in a list of the 50 most influential people worldwide in IP law, policy and business. Before joining Medicines for Europe, Sergio Napolitano worked in the Directorate General for External Policies of the European Parliament where he was part of the Secretariat of the Committee on International Trade (INTA). In 2012, he authored a Report of the European Parliament on "The Role of the Congress in Shaping the US Trade Policy". He previously worked in the Trade Policy Department of the Permanent Representation of Italy to the EU on multilateral, plurilateral and bilateral trade negotiations, EU investment policy and IPR. Sergio Napolitano is qualified for mediator certification in most American states. He holds a degree in Law from the University of Naples Suor Orsola Benincasa, an Erasmus Diploma at the Université Paris-Sorbonne, and a LL.M. on EU and European Public Law from the University College of London (UCL).