Heidrun Hildebrand has 30 plus years’ experience in drug development. Heidrun started her carrier in the Pharmaceutical industry as Quality Manager within Clinical Development and held different positions with increasing responsibility. Since 2017 Heidrun is part of the new Therapeutic Area Pediatric Development at Bayer. Heidrun is one of he co-leads of the EFPIA Consortium driving the IMI2 initiative to create a pan-European Paediatric Clinical Trials. Network.

Mette is Managing Director of "PIP Adviser" which provides expert regulatory advice on PIPs and PSPs. She has a background in authorities & industry. In the Danish Medicines Agency (2000-2006), she was nonclinical assessor of MAAs and EU Scientific Advice. She was member of the SWP, Gene Therapy WP, Biosimilar WP and PGWP and a rapporteur for CHMP and ICH guidelines. As Scientific Officer in EMA, Mette handled PIP procedures with PDCO, was in the FDA-EMA paediatric cluster and established the PDCO Nonclinical Expert Group. In Novo Nordisk (2009-2017), Mette lead all PIP/PSP procedures, was paediatric strategy advisor across the company and was in the EFPIA paed group. Mette also spent a year as Senior Director in Shionogi, London.

Pharmacist by training, with a masters in Science Communication Currently heads the team responsible for regulatory intelligence and policy for the EU for Novartis in Basel, Switzerland, supporting project teams in establishing their strategy for filing in the EU, including for paediatrics, and bringing this experience to ongoing discussions on the Paediatric Regulation. Prior to this, she worked for ten years at the European Medicines Agency in London, mainly in the field of information for the public. Chair of the EFPIA Paediatric Expert Group.

Dr Roberto De Lisa, Clinical Pharmacologist, joined the EMA in 2006. Since then he held various positions in Medical Information and Pharmacovigilance working for the CHMP Pharmacovigilance Working Party (PhVWP) and the Pharmacovigilance Assessment Committee (PRAC). As of 2015 he joined the Paediatric Office working as Paediatric Coordinator with a special interest in paediatric pharmacovigilance. Prior to joining the EMA, Dr De Lisa worked for the University Hospital San Giovanni di Dio in Cagliari for 5 years, conducting clinical trials and participating in the activities of the local Ethic Committee and in the creation of the Pharmacovigilance Centre. He obtained a Master Degree in PharmacoEconomics from the University of Milan in 2005.

Dr Karres is a Scientific Officer in the Paediatric Medicines Section at the European Medicines Agency in London, UK since 2009. Her main focus is currently on paediatric clinical drug development in the area of endocrinology/diabetes and pre-clinical development supporting the use of medicinal products in children. Dr Karres holds a M.Sc. degree from the University of Massachusetts, Amherst (US) in Molecular and Cellular Biology (2002) and a joint PhD in Molecular Biology from the University of Heidelberg and the European Molecular Biology Laboratory in Heidelberg/Germany (2007). Dr Karres is author of several scientific articles in high impact journals indexed by Medline.

Dimitrios Athanasiou was a PDCO member representing EURORDIS and WDO for the last 6 years. He holds a BA and an MBA in Financial Management He attended Eurordis Summer School and European Patient Academy (EUPATI) acquiring basic biotech and regulatory knowledge. As a full-time patient advocate in DMD, he is a board member of World Duchenne Organization (WDO), Chair of Rare Diseases Greece (RDG), and a member of PCWP in EMA.

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.

Dr. Dehlinger-Kremer’s has over 30 years experience in research industry, including 30 years of experience in global regulatory affairs, medical affairs, and pediatric leadership. Prior joining ICON, she served in executive leadership roles at global CROs, gained experience in global drug development in over 40 countries. Her vision and leadership extend to service with a number of professional organizations – e.g. observer member of Coordinating Group of Enpr-EMA at EMA, chair of Pediatric WG and President of European CRO Federation, EUCROF, chair of EFGCP Children’s Medicines Working Party and Board Member of EFGCP, active in iCAN. Named one of PharmaVOICE’s 100 Most Inspiring People in Life Sciences. PhD from J.W. Goethe University, FFM.

Christina is Global Head of Pediatric & Maternal Health Policy at Novartis. She graduated from the U Rochester Sch of Medicine & Dentistry and trained in Peds/Pediatric Critical Care Medicine at SUNY Buffalo. She has 20+ yrs of experience in Clinical Development and Regulatory Policy. Her activities advancing the environment for pediatric and maternal health include: ICH E11A Expert Work Group, C-Path International Neonatal Consortium, EFGCP Children's Medicines WP, IQ Consortia Clin Pharm Leadership Group Pediatric WG & NIH/NICHD National Advisory Council on Child Health & Human Development. In her career, Christina has over 40 peer-review published articles and 100 invited lectures.

Lutz is Senior Director in Pharmacometrics at Pfizer in Sandwich/UK where he leads Modelling&Simulation activities in Rare Diseases. After graduating in Medicine from the FU-Berlin in 1992 he joined the Clinical Pharmacology/Pharmacometrics departments of Aventis (1993-2002), then GSK in London (2002-2007), before moving to Pfizer in 2007. He’s particularly interested in M&S opportunities in paediatrics, with general interest in evidence synthesis in special populations and rare diseases. He is co-founder/organizer of the PAGE conference dedicated to advance pharmacometric modelling approaches, and led the IMI-DDMoRe consortium created to improve the quality, efficiency and cost effectiveness of Model-Informed Drug Discovery & Development.

Senior health engineer with 15 years of global drug development experience in children & rare diseases. Cecile joined C-Path as scientific director, prior to C-Path, she was with a medtech company for 2 years and scientific officer in the Paediatric division of Science & Innovation at EMA for 12 years where Cecile has been leading the EMA extrapolation strategy and was an expert for the ICH E11(R)1 guideline.

Katie is the founder and acting CEO of the Little People children’s cancer charity in Romania & Republic of Moldova providing psychosocial support services in 10 hospitals with nearly 100% patient reach. She has set up the Romanian Community of Childhood Cancer Survivor Teenagers and Young Adults. Katie was a co-chair of the FP 7 project PanCareSurFup WP6/7 Implementation/Feasibility sub-group and has been responsible for patient accrual for WP 17.6 survey for ENCCA. She’s a steering group member for the European Network for Teenagers and Young Adults with Cancer. Since May 2015 she is one of the Directors of PanCare. In 2016 she became a member of the EFGCP Children’s Medicines Working Party. She is the co-founder of Youth Cancer Europe.

Neonatologist with a special interest in early phase drug development and improving the availability of high quality medicines to children and babies. Has studied 20 medicines in neonates and pregnant women including antibiotics, excipients, treatments for in utero growth restriction, inotropes, postnatal steroids and surfactant. Current work is focused on developing research infrastructure for pediatric medicines research in Europe and beyond.

Dr. Enrica Alteri is a Doctor in Medicine and Surgery from the University of Rome “La Sapienza” and holds post graduate qualifications from the National Cancer Institute USA and EUCOR/ECPM. Dr. Alteri has many years of experience from within the pharmaceutical Industry, specifically in the areas of drug discovery, clinical safety and pharmacovigilance. Dr. Alteri joined the European Medicines Agency as Head of Safety and Efficacy on 02 July 2012, which was followed by her appointment as Head of Human Medicines Evaluation Division in August 2013. On 01 September 2016 Enrica was appointed Head of Human Medicines Research & Development Support Division.

Meike joined Novartis in 2012 as Global Program Regulatory Manager, leading global regulatory development and life cycle activities in Oncology. Prior to Novartis, Meike worked as regulatory manager at Biotest AG, Germany, and Biotest Pharmaceuticals, US, focusing on early development of immuno-oncology products. She earned her PhD in molecular and cell biology at the University of Tuebingen, Germany, working on molecular genetics of murine organ development and organ function.

Dr Daren Austin is a Senior Fellow and Senior Director of Clinical Pharmacology at GlaxoSmithKline. He has over 17 years of experience working in all areas of Translational and Clinical Pharmacology across multiple therapeutic areas. During this time he has focussed on the development of biopharmaceuticals and the application of advanced methods to paediatric drug development. Originally trained in Theoretical Physics, and prior to joining GSK, he received a Wellcome Trust Senior Fellowship in Biomathematics at Oxford University where he studied the evolution of antibiotic resistance, and retains an academic interest in this area. When not engaged in Clinical Pharmacology or mathematical modelling, you will find him racing bicycles.

After studying medicine and health care management, Ralph Bax completed his training as a paediatrician at the Children’s University Hospital in Munich, Germany. He specialised in neonatology and neonatal neurology and led the department of developmental neurology. His main research interests were in the field of brain electrophysiology and haemodynamics in preterm neonates. In 2007 he joined the paediatric team at the EMA, where he mainly worked in the field of assessing PIPs in neonatology, neuropaediatrics and on public health aspects such as unmet paediatric medical needs. Ralph is the neonatal contact point at EMA and is the Agency’s liaison to the International Neonatal Consortium. Since January 2016 he has taken on his current role.

Nathalie Bere has a BSc in Psychology and a Master in Public Health. Nathalie has been working with European Medicines Agency (EMA)since 1998 and is currently responsible for its engagement with patients and consumers. Patients bring specific knowledge and expertise from their real-life experience of the condition and its treatment to the scientific discussions, and their contributions lead to better regulatory outcomes. Over the years, Nathalie has tested and implemented methods for the inclusion of the patient’s voice in all aspects of the medicines regulatory lifecycle and she continues to further strengthen these interactions and ensure they are fit for purpose in an evolving health landscape.

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.

Dr Amy Cheung is a Senior Clinical Pharmacometrician in Quantitative Clinical Pharmacology and project manager of AstraZeneca Paediatric Working Group. She obtained a 1st-class honours degree in engineering at University of Warwick and a doctorate from the School of Pharmacy and Pharmaceutical Sciences, University of Manchester. She has experience in supporting drug development programmes on clinical trial design and modelling and simulation (phase 1-3), established brands in oncology and other TAs. Her research focuses oncology, paediatric, geriatric, structural identifiability and PBPK. She sits in paediatric group in Simcyp consortium, EFPIA Model Informed Drug Discovery and Development working group and IQ-CPLG-Pediatric Working Group.

Sabine Derey is a pharmacist by training and also holds a master degree in International Drug Development and Registration from the University of Paris XI (2012). She joined GSK (West London, UK) in Global Regulatory Affairs in 2012 and currently works as a Global Regulatory Manager. As part of her experience she had the opportunity to support several pediatric development programmes. Prior to this, Sabine had the opportunity to work as a pharmacist extern at the Children’s Hospital of Eastern Ontario (CHEO), Ottawa, Ontario, Canada where she was involved with 2 paediatric studies.

Dr Pamela Dicks has been the manager of the Scottish Children’s Research Network which provides expertise and infrastructure to support paediatric clinical trials in Scotland, within the National Health Service for 8 years. She is also the coordinator of the network’s Young Persons Advisory Group, a founder member of European Young Persons Advisory Groups network, on the board of directors of the International Children’s Advisory Network and the Coordinating Group of the European Network of Paediatric Research networks at the European Medicines Agency. Pamela holds a Ph.D. and post-doc in endocrinology.

Bruno Flamion is an MD/PhD from the University of Brussels, Belgium, with clinical expertise in internal medicine and nephrology (1983-1996). Research Associate at the NIH, Bethesda, MD, USA (1988-1992), and at the Belgian National Fund for Scientific Research (1992-1996). Head of the Laboratory of Physiology and Pharmacology at the University of Namur, Belgium, for 20 years (1996-2016). Professor of Physiology and Clinical Pharmacology since 1996. Member of the CHMP and various committees at the EMA (2000-2012), London, UK, including chairmanship of the Scientific Advice WP (2005-2010). VP, Head of Strategic Development at Actelion Pharmaceuticals (2016-2017), then Idorsia Pharmaceuticals (since June 2017), both in Allschwil, Switzerland.

Laura joined EMA in 2010 in orphan medicines, more recently with joint appointment in pediatrics. Active in rare diseases since 2005 as member of EU RDTF, author of EUROPLAN Recommendations, and co-leader of one of the first ERN pilot projects, in EMA she led efforts towards more systematic assessment of significant benefit of orphan medicines, a work that received first prize at the 2016 ECRD conference. Laura is pulmonologist and immuno-allergist and she held roles in academic hospitals in different EU countries. She provides expertise in her therapeutic areas across EMA including in biomarker qualifications, and guidelines. Laura is also trained in disaster medicine and was part of the EMA Ebola Task Force during the West Africa crisis.

Jolanta Gulbinovic is currently the Chief Expert, Head of the Unit for Cooperation with the EMA and International Relations and Professor at Dept. of Pathology, Forensic medicine and Pharmacology at the Vilnius University. She received the MD in paediatrics at Vilnius University and did the PhD on drug utilization in Lithuania. Furthermore, she had a training in Clinical Pharmacology at Karolinska Institute in Stockholm. After that she worked as a Clinical Pharmacologist at Vilnius university hospital for more than ten years and as a Clinical Assessor at the Swedish Medicines Control Agency for more than three years. Recently she has been elected to the executive board of the European association of clinical pharmacology and therapeutics.

Edmund Jessop has been practising public health for the NHS in England for 30 years. From 2002, he has been medical adviser to the team which plans, funds and monitors services for patients with very rare disease. Edmund has acted as UK representative to the various EU Expert Groups on Rare Disease.

Paediatrician and lawyer by training, also holding a postgraduate degree in pharmacovigilance. Has worked in the pharmaceutical industry for twelve years in Hungary, Denmark and in the UK at various companies, in the areas of clinical research and pharmacovigilance. Scientific Officer at the EMA for ten years.

Seán Kilbride has a PhD in neuroscience from Trinity College Dublin, Ireland. He was a Post-Doctoral researcher in molecular biology at Royal College of Surgeons in Ireland, and Dana Farber Cancer Institute, Harvard Medical School, Boston. He joined the Health Products Regulatory Authority in 2013 as a Clinical Assessor, where he focussed on the assessment of clinical trial safety data. Seán is the current representative for Ireland at European Commission’s Clinical Trials Expert Group and is also the EU Heads of Medicines Agencies (HMA) Clinical Trials Facilitation Group (CTFG) co-secretariat.

George Kirk is a Global Medicines Leader and Director of Global Products in the Oncology Global Medicines Development function at AstraZeneca and is responsible for the cross-functional leadership, project management, development and delivery of new Oncology products to market. In his current role, he has responsibility for programs that encompasses pivotal Phase III trials in Lung Cancer, Thyroid Cancer and Pediatric Oncology. George has been at AstraZeneca for 21 years and has spent the last 11 years in project management roles. Prior to project management, George spent the previous 10 years in Pharmaceutical Development as a Team Manager.

Patricia is a clinical pharmacologist at the William Harvey Research Institute, Queen Mary University of London and a consultant physician at Barts Health NHS Trust. Her research is in drug utilisation and adverse event evaluation. She is currently on secondment at the Pharmacovigilance and Epidemiology Department of the European Medicines Agency where she leads the Patient Registries Initiative http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000658.jsp.

Koen Norga studied medicine at the University of Leuven. He completed training in paediatrics and paediatric oncology at Children’s Hospital Boston and at Texas Children’s Hospital, and he obtained a PhD in Molecular & Human Genetics from Baylor College of Medicine. He is currently heading the paediatric oncology unit at the Antwerp University Hospital. With a keen interest in paediatric drug development, he is a member of the Paediatric Committee (PDCO) at EMA since 2010 and vice-chair since fall 2013.

Stefan Pfister was appointed Director „Preclinical Program“ of the new Therapy and Research Center for Pediaric Oncology and Hematology in 2016. Since 2014, he is professor for pediatric neurooncology and devision head at the German Cancer Research Center (DKFZ). He received his MD from Tübingen University, his clinical education at Mannheim and Heidelberg Uni. Hospitals, and completed postdoc fellowships at Dana-Faber Cancer Institute/Harvard Medical School, and DKFZ. His research focuses on the genetic and epigenetic characterization of childhood brain tumors by applying next-generation profiling methods, the development of faithful models, and the preclinical testing of new treatment. In 2012, he received the German Cancer Award.

Jacqueline Phillips joined Johnson & Johnson in the Global Medical Safety Organization in the role of medical safety officer and safety management team chair. She is currently Director of Pediatric Product Development. She was an Associate Professor of Pediatrics at Rutgers Medical School and Medical Director of the Pediatric Intensive Care Unit. She has extensive experience in clinical and basic science research, as well as safety and performance improvement strategies. Responsibilities included compliance with health authority regulations, and she has presented on topics such as prescription drug error reduction and maximizing patient safety.

Dr Pirard is involved for more than 15 years in the field of rare genetic diseases and orphan medicinal product development. She works as public affairs director at Sanofi-Genzyme and is the co-chair of the industry EFPIA-Europabio joint task force on rare diseases and orphan medicinal products which brings together companies with an interest in developing treatments for rare disorders.

Kit Roes is Professor of Clinical Trial Methodology at the Julius Center of the University Medical Center Utrecht. His research focus is on design and analysis of clinical trials, with an emphasis of innovative designs and bridging the gap between clinical trials and real world evidence. He participates in the Regulatory Science Network Netherlands and is chair of Methodology at the Dutch Medicine Evaluation Board. His experience includes over 15 years in research and development in the pharmaceutical industry and life sciences, serving clinical research and drug development as expert as well as in different (international) senior management positions.

Stephanie Rosenfeld studied medicine and was awarded her Medical Doctor’s degree (Dr. med.) for research on haemochromatosis. In 2001, she started her occupational career as an MD in internal medicine at the university hospital of Regensburg. Since 2004, she is an employee of Sanofi-Aventis Deutschland GmbH with career steps in pharmacovigilance and pharmacoeconomics. With a university degree in Health Business Administration (MHBA), she broadened her qualifications in the area of health business. Since 2012, Stephanie Rosenfeld is heading the department “Evidence Based Medicine/ Health Economics and Outcomes Research” with a strong focus on AMNOG and the access and reimbursement of innovative medicinal products.

Florian Schmidt is the deputy head of unit of the Commission’s pharmaceutical unit B.5 in the Directorate-General for Health and Food Safety (DG SANTE). He is a lawyer by training and joined the Commission in 2004. For several years he followed the paediatric legislation and participated in meetings of the Paediatric Committee at EMA. He was involved in the drafting of the 2013 Commission Report on the Paediatric Regulation and the subsequent 2017 report, which was published end of 2017.

Yvonne Schmidt is a scientific advisor at the Federal Joint Committee (G-BA) in Berlin, Germany. She studied biology at the Free University of Berlin and the Jagiellonian University of Kraków, and obtained her PhD at the University Hospital Charité Berlin. Following three years of postdoctoral research in the field of neuroscience, she completed a professional training in clinical research and pharmacovigilance. Since the beginning of 2016, she is involved in the early advice and the benefit assessment of pharmaceuticals at the G-BA with a particular interest in paediatric medicines.

Georg Schmitt obtained his doctoral degree in Zoology and Toxicology at the Ulm University, Germany. He has 27 years of experience in safety assessment and is passionate about pediatric drug development. In his role for nonclinical pediatric support Georg advises project teams on strategies and acts as author/reviewer of regulatory documents. Georg is a member of the expert working group for the ICH S11 guideline (Nonclinical Safety Testing in Support of Development of Pediatric Medicines) and chair of a cross-company ‘Industry Forum for Pediatric Non-Clinical Safety’. He is a Eurotox Registered Toxicologist (ERT) and member of the Swiss Record of Professional Toxicology, the Swiss Society of Toxicology, and the European Teratology Society.

I am Anna Sherriffs, I am 16 years old and currently in my final year at school. I was diagnosed with JIA at 3 years old and I have been a regular attendee at children’s hospitals ever since. At present my treatment includes three weekly infusions of tocilizumab. I really enjoy taking part in sports, in particular horse riding and netball. I have been a member of the Scottish Children’s Research Network Young Persons Advisory Group for three years, where I have gained a better of understanding of how new medicines are tested and why we need to include children in clinical trials. We learn about different medical conditions, clinical trial design and review documents and patient information sheets for children and young people.

Andrew Thomson is a statistician in the Taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and across all therapeutic areas and is the lead scientific secretariat of the Methodology Working Party. He also is the lead of the Statistics subgroup of ICH E11A on paediatric extrapolation, sits on ICH E6 R3 Annex 2 group, and is the Regulatory Chair of both groups. Before joining EMA, he headed the Epidemiology Unit in the Vigilance and Risk Management of Medicines Division of the MHRA, the UK regulator and was also previously a Statistical Assessor within the Licensing Division of the MHRA.

Trained as a Paediatric Oncologist, he got his PhD in Pharmacology. He is Professor of Oncology in University Paris-Sud and head of Clinical Research at Gustave Roussy, a large comprehensive cancer center in France. For the last 20 years, he has dedicated his research, clinical and training activities to the development of new drugs for children and adolescents with cancer. He is former President of SIOPE, the European Society of Paediatric Oncology and currently President of the EU academic Consortium for Innovative Therapies for Children with Cancer. He is chairing the ACCELERATE multistakeholder platform to speed up innovation in paediatric oncology. Author of more than 215 publications, he is member of several Scientific Councils.

Siri Wang is Scientific Director at the Norwegian Medical Products Agency (NOMA). She is pharmacist by education and holds a PhD in pharmacology from University of Oslo. She has worked in hospital pharmacy for 15 years, mainly as counseling/clinical pharmacist, specifically involved in paediatric and geriatric medicine. Since 2007 Siri has been delegate to the Paediatric Committee (PDCO) at EMA. She was chair of PDCO’s Formulation Working Group from 2008 until 2013 and chair of CMDh/EMA Working Party on Paediatric Regulation from 2019 until 2023. Siri has been at NOMA full time since 2010 and has in her role a particular focus on paediatric medicines, covering the life cycle perspectives from development to actual access for children.

Lynne Yao, M.D., is the Director, Division of Pediatrics and Maternal Health in the Office of New Drugs, Center for Drug Evaluation and Research. The Division of Pediatrics and Maternal Health oversees quality initiatives which promote and necessitate the study of drug and biological products in the pediatric population; and improve collection of data to support the safe use of drugs and biological products in pregnant and lactating individuals. She collaborates with numerous stakeholders both inside and outside of FDA to advance development of safe and effective therapies for children, and pregnant and lactating women.