Since October 2015, Julie has been coordinating of the Biosimilar Medicines Group, a sector group of Medicines for Europe. Before that, Julie was part of Medicines for Europe’s regulatory and scientific affairs team for 8 years, with responsibilities in the areas of Quality, Compliance, Environment, Health & Safety as well as Bioequivalence. MSc in Pharmacology by background, she previously worked for the pharmaceutical industry. Her work consists in the coordination of Biosimilar policy related activities and external liaison with policy makers, EU institutions, Medicines Agencies, International organisations, industry and professional associations as well as a broad range of stakeholders.

Dr Niels Vermeer currently works as a detached national expert at the Pharmacovigilance and Epidemiology Department of the European Medicines Agency. Niels was trained as a pharmacist and epidemiologist, and has been with the Dutch Medicines Evaluation Board (MEB) since 2011, after having worked as a pharmacist for a few years following his graduation. Niels has authored several scientific articles on the challenges encountered in the pharmacovigilance of biologicals, which resulted from studies performed under the umbrella of the regulatory science collaboration between the MEB and Utrecht University. In 2015, Niels obtained his PhD from Utrecht University, with a dissertation on pharmacovigilance of biologicals.

Dr Jørgen Jahnsen is a professor of medicine and gastroenterology at the University of Oslo and a consultant at Akershus University Hospital. After completing his specialist training in internal medicine and gastroenterology at Aker University Hospital, Oslo in the 90's he finished his PhD regarding bone metabolism and body composition in inflammatory bowel diseases (IBD). Dr Jahnsen has long experience in epidemiology research and is a member of the IBSEN study group. He has also done a lot of research in the field of medical treatment of IBD, especially with biologics and has been national coordinator for several phase 2 and 3 trials. In addition he is a member of the working committee of the NOR-SWITCH study.

MSc in biochemistry ; PhD in molecular biology. Leader for National centre of Peptide synthesis; University of Oslo (2 yrs). Worked as Project leader with EPO at the IOC accredited Doping laboratory in Norway (10 yrs). As Senior scientist at the University of Oslo as part of the Glycobiology Network (10 yrs). Last 10 yrs Senior Advisor at the Norwegian Medicines Agency working as clinical assessor in oncology, advanced therapy and biologicals, including biosimilars. Member of the Biosimilar working party since 2013.

Kevin is a researcher at Escher, the Lygature platform for regulatory innovation, and PhD student at the WHO Collaborating Centre at Utrecht University. After finishing his Bio-Pharmaceutical Science degree at Leiden University in 2013, he started working for Exon Consultancy in the field of pharmaceutical policy and regulation. During his work as a consultant he was also involved in a number of Escher activities, such as the Escher project ‘Pharmacovigilance of biologics’. In 2015, Kevin started his PhD on topics around Medicines Adaptive Pathways to Patients (MAPPs) and pharmacovigilance, with a special focus on biologics.

Dr Richardson is a pharmacist, with a Ph.D. in pharmaceutics from The Queens University, Belfast. He worked in industry in the area of formulation research and on drug delivery and controlled release systems for small and large molecules. He has worked for the UK MHRA as a pharmaceutical assessor prior to joining the European Medicines Agency, where he now has the role of Head of Quality.

Gianluca Trifirò is MD, clinical pharmacologist and pharmacoepidemiologits working as Associate Professor of Pharmacology at the Academic Hospital of Messina with honorary position at Department of Medical informatics of Erasmus Medical Center of Rotterdam (NL). Scientific coordinator of an Academic Master program on “Use of Real-world data for evaluations in Pharmacovigilance, Pharmacoepidemiology ad Pharmacoeconomics” at University of Messina. Clinical pharmacologist of Phase I Clinical Trial Unit of Bambino Gesù Pediatric Hospital of Rome (Italy). Member of Steering Group of European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP®) at the European Medicine Agency.

Dr. Hillel P. Cohen PhD is Executive Director of Scientific Affairs at Sandoz, helping explain the principles of biosimilars and biosimilar policies to the healthcare community, patient advocacy groups, and health authorities. He has published and given presentations in the areas of biosimilar education, switching, interchangeability, naming and safety. Dr. Cohen led Sandoz efforts for the first biosimilar presentation (Zarxio®) to an FDA advisory committee and participated in both BsUFA 2 and BsUFA3 negotiations on behalf of industry. Hillel is active on the Education Committees including the Biosimilars Council and the Biosimilars Forum. Dr. Cohen received a BA from New York University and a PhD in Biology from Dartmouth.

Dr. Busch-Sørensen is a physician with 7 years of clinical practice mainly in internal medicine. Has passed the special module of Biostatistics & Epidemiology (part of Master of Public Health) as well as being bachelor of commerce in Marketing all at Copenhagen University. Dr. Busch-Sørensen has published multiple peer-reviewed manuscripts. Dr. Busch-Sørensen is serving as member of the board of the Danish Pharmacoepidemiology Society. He has been invited to speak on GVP, GPP, and Data Privacy as he has arranged and hosted multiple molecular profiling meetings between industry and academia. The IT angle in data privacy has been addressed extensively too, including validation of systems, ICH E15 implementation and training.

Richard DiCicco co-founded Harvest Moon Pharmaceuticals USA, Inc. in 2007 with an established pipeline of complex generic products. Harvest Moon Pharma develops, manufactures, markets and exports complex generics and biosimilars. Biosimilars include second wave mAbs ranibizumab, bevacizumab, natalizumab, omalizumab and cetuximab to be filed in the US and EU; and third wave mAbs eculixumab, golimumab, certolizumab, ustekinumab, pertuzimab, pembrolizumab and ipilimumab currently in analytical comparability studies. These mAbs are manufactured in the USA and comply with both FDA and EMA mAb revised guidelines. Mr. DiCicco is a member of the Editorial Board of the Journal of Generic Medicines.

Professor Arnold Vulto was trained as a pharmacist and pharmacologist and did a PhD at the Rudolf Magnus Institute for Neuroscience at Utrecht University (The Netherlands). He is currently responsible for teaching pharmacology & therapeutics for medical students at Erasmus University Rotterdam. He is head of the Unit Teaching, Research & Education, including clinical trial management of the ErasmusMC Hopsital Pharmacy. He is supervising 6 residents in hospital pharmacy.