Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor at the Faculty of Health Sciences, University of Copenhagen. From 2004-9 ST worked at the Danish Medicines Agency acting as member of CHMP and additionally CAT at the European Medicines Agency. Following a short period involved in developing best practice guidelines for primary care ST rejoined the DKMA as Head of the Licensing. From 2013-22, Prof Thirstrup worked asdirector and strategic consultant for NDA Group AB. From June 2022 Prof Thistrup is the Chief Medical Officer of the European Medicines Agency.

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.

Per Troein has been with IMS for 18 years and is responsible for supplier and associations relationships. One of IMS’ priorities is to have the best understanding of those dynamics to secure the most appropriate data, to be the best partner with the different data partners, and to be able to support the industry and also when appropriate governments. He is a well known speaker in the field of distribution trends and pricing and is very active in consulting projects in the area. Prior to joining IMS, Per worked 13 years for Pharmacia. His last 6 years were spent in strategic development as a VP including several major mergers and acquisitions.He holds an MSc in engineering from Lund’s Institute of Technology and an MBA from INSEAD.

Xavier Kurz graduated in 1982 as a Medical Doctor at the University of Liege, Belgium. He specialised in Tropical Medicine and worked for several years in public health projects in Africa and Asia. He obtained a MSc (1991) and a PhD (1997) in Epidemiology and Biostatistics at McGill University, Montreal, Canada. He then joined the Department of Pharmacology of the University of Liege and the Belgian Centre for Pharmacovigilance (Ministry of Health) as scientific expert. He joined the European Medicines Agency (EMA) on 1st September 2005. He is currently leading the Data Analytics team within the Data Analysis and Methods Task Force.

Dr Elena Wolff-Holz is a physician and regulator at the Paul-Ehrlich-Institut. She is Chair of the Biosimilar Medicinal Products Working Party (BMWP) and also serves as a Member of the Scientific Advice Working Party of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. Previously, Elena worked for 14 years in the biotech industry in various senior clinical development and medical marketing functions at Centocor Inc (now J&J) and Amgen. She is a Lecturer at J.W. Goethe Universität, Frankfurt, DGRA, MEGRA and the FORUM Management Institute. Her work has resulted in several (co-) authorships in scientific journals and several presentations at (inter-)national conferences.

Pieter Stolk, PhD, was trained as a pharmacist with a PhD from Utrecht University. Pieter is interested in all aspects of medicines regulation and policy (with a focus on marketing authorisation and HTA of medicines). He has been involved in several EU public private partnerships (incl. IMI GetReal) contributing to both the content and consortium management. He has worked as an independent consultant for governments, companies, NGOs and research organizations.

Dr. Raffaella Balocco is a pharmacist Doctor and has a PhD in Pharmacology. She worked at the "Mario Negri Institute for Pharmacological Researches" in Milan before joining the World Health Organization in 1993. From 1993 until 2001 she worked in the regulatory support Unit within WHO and travelled extensively all around the world. Since 2001 she has been the manager of the WHO International Nonproprietary Name (INN) Programme. Dr Balocco is the Secretary of the WHO INN Expert Committee. She is also member of a number of national and international bodies dealing with nomenclature of medicinal substances and has been lecturing in various universities all over the world the science of drug nomenclature.

Dr Kang joined WHO HQ in January 2009 and has been in charge of development/implementation of WHO guidelines for regulatory evaluation of biologicals, particularly biotherapeutics including biosimilars. Prior to joining WHO, Dr Kang was a scientific officer for twelve years at Korea Ministry of Food and Drug Safety who was responsible for reviewing license applications, quality control, and inspection of biological products. In 2004, she worked on the project to develop HCV DNA vaccine at the Vaccine and Infectious Disease Organization-International Vaccine Center in the University of Saskatchewan in Canada.

Alexander Roediger (1968), Swiss and German, MA and Executive Master of Business Administration, is Director European Union Affairs of MSD Europe, Inc. His focus is biologics and general pricing & reimbursement policy; he works with different EU institutions in Brussels, particularly with the European Parliament and the Commission, the industry association EFPIA, and other pan-European organizations of civil society. He is currently chairing the Healthcare Committee of the American Chamber of Commerce to the EU and the Biosimilars Working Group of the European Biopharmaceuticals Enterprises (EBE).

Dr Barry is an Executive Pharmaceutical assessor at the HPRA and a member of the EMA BMWP and an alternate member of the EMA BWP. His regulatory expertise includes evaluation of quality/CMC data of new product applications, scientific advice, variations and clinical trials for biological products (mAbs, recombinant proteins, biosimilars and ATMPs). He is Rapporteur/Co-Rapporteur (quality) for several EMA centralised biological products. He is actively involved in developing the use of Prior Knowledge in regulatory filings and in new regulatory approaches to address CMC challenges in accelerated and adaptive pathways. Seán has a degree in genetics from Trinity College Dublin and a PhD in Molecular Biology from University College London.