Angelika Joos is a trained pharmacist. She is responsible for Regulatory Policy issues within MSD's Global Regulatory Affairs and Clinical Safety department. This role includes identifying regulatory policy priorities that align with MSD’s business priorities, leading cross-functional networks to define policy positions, and informing MSD’s regulatory strategy development. Angelika represents MSD in the IFPMA Regulatory Science Committee and is one of IFPMA's delegates to the ICH Management Committee. She is also involved in international policy activities though efpia as well as BIO and PhRMA international Committees. She served on the DIA Board of Directors from 2013-2020.

Mira Pavlovic is the Founder of Medicines Development and Training Services (Paris, France) and Associate Professor for Regulatory and HTA science at Lisbon University (Portugal). Mira consults on clinical drug development strategies for market access purposes as a member of the NDA Advisory Board, providing scientific advice and peer review of NDA reports at the request of pharmaceutical companies. She previously served as Head of Scientific Advice at the French Medicines Agency and a Vice-Chair of SAWP at the EMA. She was also Deputy Director for HTA and international affairs at the Haute Autorité de Santé, France, where she coordinated HTA early dialogues and work on common methodology of relative effectiveness assessment in Europe.

Claudine Sapède is Director, Global HTA Policy at Novartis. In this role, she focuses on value assessment, HTA and reimbursement decision-making approaches and their impact on patient access to innovative treatments. She engages with internal and external stakeholders involved in shaping HTA, pricing and reimbursement decisions. Claudine is currently a member of the EFPIA market access and HTA working groups, leading the workstream related to the implementation of the EU HTA Reg. Prior to this, she had different roles in the field of pricing and market access, at country and global levels. Her career of over 20 y in the pharma sector spans the full spectrum of evidence generation, value demonstration, MA strategies, pricing, and policy.

Olga Solomon studied Chemistry at the Aristotle University of Thessaloniki, Greece and holds an MSc in Food Science from the Gothenburg University, Sweden. Before joining the European Commission she worked for 5 years for a beverage producing company in Greece. Solomon joined DG SANCO in 2000 and worked for 10 years in the field of Food Safety in particular dealing with legislation on Food Contact Materials, Food Additives and Enzymes. In 2010, she moved to the Directorate 'Health Systems and Products' where she worked in the field of substances of human origin before taking up a post in the pharmaceutical sector in 2011. She is currently the Head of the DG SANTE Unit responsible for Medicines: policy, authorisation and monitoring.

Kristin Svanqvist, Governmental Affairs and Communications Sr Mgr, Amgen Norway. She is trained as a pharmacist and has been working within the field of reimbursement of pharmaceuticals and HTA since 2004. Her last position was with The Norwegian Medicines Agency as a head of the section for Reimbursement and HTA. The Agency is the decision making body for pharmaceuticals for the out care patients and for assessing the new medicines for the hospital sector. Kristin has also a position with in the Arctic University of Norway at the Department of Pharmacy.

Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French Medicines Agency/EMA and academia to the pharmaceutical industry, she has gained strategic experience in drug development. She is quite active within EFPIA, ICH and IMI, and passionate about paediatric drug development.

Kolasa has more than 20 years of academic and occupational experience in the healthcare sector. Her practical skills in the field of health economics were developed during six years employment contract at the Kalmar County Council in Sweden. For the last four years she has been developing experience with the pricing & reimbursement challenges in the field of medical devices. She holds a PhD degree in health economics and is an author of scientific IF publications in the field of health technology assessment and pharmacoeconomics. Nominated by the Ministry of Science to represent Poland in the COST Action CA17117, COST Association. Since Jan 2019, she is co-chair of Global Special Interest Group for Digital Health establish at ISPOR.

Vincent Houdry is a pharmacist by training and started his carrier in the pharmaceutical industry. Then he became pharmacist inspector for the French Ministry for health where he occupied several positions: in the Drug Agency, in the regional office in Bordeaux, in the social security directorate of the Ministry. After two years in the unit in charge of health threats in DG SANTE as a seconded national expert, he became technical advisor in the cabinet of the Minister for health, in charge of drugs, medical devices, and biology. After that, he became health attaché at the French Permanent representation in Brussels. Since July 2016, he works for the European Commission in DG GROW on the implementation of the Regulations on medical devices.

Michael Berntgen, Head of Scientific Evidence Generation at the EMA, Amsterdam, oversees robust medicine development. Collaborating with stakeholders, the department provides scientific advice, supports pediatric and orphan diseases, and manages the PRIME scheme. Michael, a pharmacist with a PhD, worked in pharmaceutical regulatory affairs in Germany and the UK from 1999 to 2006. Joining BfArM in 2006, he moved to EMA in 2007, holding various positions until becoming Head of the department in March 2020.

Flora is a pharmacist by training. She is heading the team of Health Technology Assessment at the European Commission in DG Health (SANTE), Unit "Medical devices and health technology assessment". The team is responsible for the Legislative Proposal on HTA, for the Secretariat to the HTA Network, and oversees the activities of the Joint Action EUnetHTA. Flora joined the EC in 2006 in DG CNECT, she worked in the ICT for the Health Unit. Before joining the EC she was the Secretary General of the PGEU, the European Association of Community pharmacists and also worked in a community pharmacy.

Dr. Johansen has a PhD in clinical epidemiology from University of Copenhagen and has been working in the field of clinical pharmacology, diabetology and epidemiology for several years. During her career, Dr. Johansen has gotten extensive insight into the use of several data sources e.g. the Danish National Patient Register, National Prescription Register and the National Health Insurance Register in policy- and decision-making. In 2018, Dr. Johansen joined the Danish Medicines Agency, the department of medical evaluation and biostatistics as Senior Medical Officer.

William Malbecq is Executive Director, Biostatistics at MSD. He has worked for over 34 years in statistics within the pharmaceutical industry, in support of drug development mostly at MSD. He manages the global HTA-Statistics team located in Europe and is the regional head of BARDS-Europe (Biostatistics and Research Decision Sciences – Europe). In his present role, he leads a group of statisticians who develop scientifically based arguments aiming to provide fair accessibility to MSD drugs and vaccines making a real difference in patient’s lives. Malbecq holds a DSc in Mathematics/Statistics from the University of Brussels. His research interests are in survival analysis, longitudinal data and indirect treatment comparisons.

Paul McCleverty is currently the EMEA regional lead for the oncology therapeutic area in J&J. Outside of Janssen he is a member of the EC Expert Committee on Cancer Control, has recently worked on the Efpia MAPPs working party and is leading the Efpia initative on disease interception. He has worked within the pharmaceutical industry in both discovery and development for over 20 years at Astra Zeneca, Pfizer, GSK and Janssen. After 7 years in R&D Paul transferred to regulatory. For the last 18 years he has been a regional / global team leader in multiple therapeutic areas including cardiovascular, metabolic, antifungals, antivirals, antibiotics, pain, GU, GI, ophthalmology, neuroscience and oncology.

Katja Neubauer holds a master degree in biology. She is a senior official in the European Commission and has worked for 18 years in the Commission's Directorate-General for Health, in positions both in the food safety and health area, including deputy Head of Unit for Healthcare Systems for over 4 years. In her current position as Senior Expert for eHealth and Digital Single Market, she leads a team in charge of innovation in healthcare (eHealth). The team is developing a system for cross-border exchange of patient data and runs the eHealth Network of EU Member States' high officials promoting digital healthcare. She also implements communication on digital transformation of health and care that the commission adopted in April 2018.

Francis Arickx is head of the directorate Reimbursement of Medicines and Pharmaceutical Policy within the Health Care Department at the National Institute for Health and Disability Insurance (NIHDI RIZIV/INAMI) in Belgium. He manages administrative and scientific assessments, and appraisal of reimbursement claims for medicines, orphan drugs, and medical nutrition. Francis is former secretary general for the Commission for Reimbursement of Medicines and represents the Institute and Belgium on national and European platforms. He coordinates the BeNeLuxA Initiative. Francis graduated in pharmaceutical sciences from the University of Ghent. He teaches Health Policy in the Pharmaceutical Sciences Department at the University of Antwerp.

Hubert Galmiche is pharmacist. He holds a master's degree in clinical pharmacology and is specialised in evaluation and negotiation of health products and services. Galmiche started his career at the French Agency for the Safety of health products in the assessment of drugs before joining French National Authority for Health (HAS). He has more than 15 years of working experience in the medical device sector. Galmiche leads a team at HAS which is in charge of assessing medical devices for the French National Medical Device and Health Technology Evaluation Committee.

Dr. Hannah Patrick has worked as Consultant Clinical Adviser at NICE since 2008. She works part time as a clinical haematologist. Prior to joining NICE, she worked as a public health physician in South Africa and then in Bexley, London. Through working at NICE Dr. Patrick has gained extensive specialist experience in the commissioning and use of observational data to inform national guidance development. For the last 3 years she has been working on six ‘Commissioning through Evaluation’ projects for the NHS England. Moreover, Dr. Patrick has worked part time as a haematologist in London. The clinical work has provided her valuable insights into practical challenges to real world data collection.

Anja Schiel has studied Biology at the Johannes Gutenberg-University, Mainz, Germany. She received her PhD from the Free University in Amsterdam in 2006 and worked several years as Post-Doc before starting at the Norwegian Medicines Agency (NoMA) in 2012. At NoMA she is working as special adviser/Statistician/Methodologist both on regulatory (EMA) and HTA projects. She has been Chair of EMA’s Biostatistics Working Party 2017 - 2019 and just finished her 3-year term as Chair of the Scientific Advice Working Party (SAWP) at EMA. She continues currently as alternate member of the SAWP and is Member of the new Methodology Working Party (MWP) recently established at EMA. She also leads the international HTA team at NoMA.

In his current role within Sanofi’s Global Health Economic and Value Assessment group, Chris leads on the use of real world data to support market access over the lifecycle of medicines, including in development. He is the co-chair of the EFPIA Real World Evidence Community group. Chris graduated from Oxford University with a degree in Biochemistry; is a qualified chartered accountant and has a Masters in Health Economics from City University, London. Over the last 20 years he has also lead health outcomes groups and real world evidence projects at SmithKline Beecham, Lilly, and GlaxoSmithKline.

François is a patient and works at the European Organisation for Rare Diseases as Director of Treatment Information and Access since 2003. He's been involved in EUnetHTA since the first Joint Action back in 2010, and supervises Eurordis policy and advocacy on HTA. François also represents Eurordis at the European Medicines Agency.

Cynthia Iglesias is senior health economist at the Department of Health Sciences, University of York; and Professor at the Department of Business and Management, Aalborg University. She has a first degree in Actuary, National Autonomous University of Mexico; and both a MSc in Health Economics and a PhD in Health Sciences from the University of York. Her main areas of interest are health technology assessment, economic evaluation of medical devices, uncertainty characterisation and Bayesian statistical methods for economic evaluation. She is particularly interested in the contribution of these methods to healthcare policy decision making. Cynthia is one of the two health economists at the Medical Technologies Advisory Committee at NICE.

Tom Metcalfe graduated in Biochemisty from King's in London and has an MBA from the Open University. He currently works in the Ecosystems team in Roche Pharma's Personalised Healthcare Centre of Excellence. He also represents Roche Pharma in the EFPIA Innovation Board Sponsored Committee. Prior to that he worked for Roche as a Strategic Innovation Leader in Global Development from 2015 to 2018. He served as CEO of Oncotest GmbH, a CRO providing preclinical profiling services in Oncology from 2011 to 2104 and worked for Roche Pharma and Diagnostics in a variety of roles from 1993 to 2011 including as Head of the Personalised Healthcare Portfolio and the Roche Biomarker Program.

Dr. Marco Petschulies studied pharmacy at the universities of Tuebingen, Germany, and Hamburg, Germany. During his dissertation between 2009 and 2013 he had worked as a research fellow at the Institute of Pharmacy of the University of Hamburg, Germany. Since 2013 he is working at the Pharmaceutical Department of the Federal Joint Committee in Berlin, where he gives advice to pharmaceutical companies and is involved in the early benefit assessment of new drugs. Marco also had a coordinating role in several European advice procedures.

Meriem Bouslouk-Marx (PhD in dentistry, MSc International Health) joined the Pharmaceuticals Department of Germany’s top health policy body, the Federal Joint Committee (G-BA), in 2011 and has worked on the implementation of AMNOG, the Act on the Reform of the Market for Medicinal Products, from the start. Her main responsibilities included conducting consultations with industry on clinical study design and appropriate comparators, assessing reports by the Institute for Quality and Efficiency in Health Care (IQWiG), and drafting G-BA resolutions under AMNOG which became binding amendments to the German Pharmaceutical Directive. During this time, she conceptualised and co-ordinated the health policy procedure for orphan drugs at the G-BA.

Sini is working as Regulatory, Drug Development and Manufacturing Director at EFPIA since 2014 and leads the team since 2018. She is responsible for various regulatory policy and advocacy activities in relation to regulatory science and regulatory strategy. She has previously worked over 5 years at AZ R&D Global Regulatory Affairs in Sweden and 3 years as Executive Director of Finnish Pharmacists' Society. She is currently doing a part-time PhD for professionals programme at the University of Utrecht and WHO collaboration centre for pharmaceutical policy and regulation. She is a Board member of Industrial Pharmacy Section in International Federation for Pharmacists and Pharmaceutical Sciences since 2010.

Inés Hernando joined EURORDIS as ERN and Healthcare Director in February 2018. She monitors the European landscape on rare disease healthcare from a policy and advocacy perspective. Inés supports the establishment of European Reference Networks (ERNs) leading the EURORDIS team that manages the 24 European Patient Advocacy Groups (ePAGs). Previously she worked for two years at COCIR as eHealth Senior Manager where she led the organisation's work on digital health. She also worked for eight years in the Spanish Electronic Health Record initiative as eHealth Coordinator where she provided overall programme management. Inés holds a Master’s in Health Economics, Policy and Management from the London School of Economics.

Ansgar Hebborn is Roche Pharma's Head of Access Policy Affairs Europe. He represents Roche in relevant industry associations e.g. in Brussels as the chair of EFPIA’s European HTA Working Group. During the past few years, he has taken an active role as advisor and stakeholder representative in various HTA collaboration networks e.g. EU HTA Network, EUnetHTA and the HTAi Policy Forum Committee, and also has been involved in the foundation of other initiatives in this field e.g. the Green Park Collaborative, the HTAi Asia Policy Forum and SwissHTA. In an earlier role as health economist and outcomes research specialist for Roche in the US, he has gathered extensive experience with real world data research.