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.

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.

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.

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.

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.

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.

Paediatric training in Frankfurt (DE) and Belfast/UK with special interest in Neonatology, Haematology, infectious disease. Paediatric Consultant in Frankfurt and Uelzen. Since 2004 working as Head of PhV at Paul-Ehrlich-Institut (NCA), Coopted member for Paediatric PhV from 2006-2012 and member of PDCO at EMA from 2007-2013. Chair of PDCO since 2013.

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.

Fabio has a PhD in biochemistry and a master’s in management of biotech companies. After working several years as a university researcher, both in the public & private sector, he joined the EU Commission in 2004 where he has worked in several areas of the food legislation, from nutrition to food contact materials. In 2011 he joined the units dealing with pharmaceutical products in DG SANTE. He has worked on quality of medicines, falsified medicines and clinical trials. During 2016 & 2017 Fabio was seconded to the European Centre for Disease Prevention and Control (ECDC) in Stockholm and worked in particular on vaccination & antimicrobial resistance related issues. He has been in charge of the paediatric medicines file since late 2018.

David R Jones Expert Scientist (Pharmaco-Toxicologist). I have been a Toxicologist for over 30 years. I am responsible for the Safety Assessment of Clinical Trials Applications within the UK. I am the UK's representative on the EU's Safety Working Party (SWP). I also represent the SWP at ICH.

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.

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.

A PhD chemist by training with late Nobel Prize Laureate Donald J. Cram. In recognition of his contributions to the field of Medicinal Chemistry and longstanding experience in drug discovery he was appointed Associate Professor in Medicinal Chemistry at Uppsala University in Sweden. He has garnered his work experience from Hässle AB in Sweden (now AstraZeneca), the Medical Products Agency, Novo Nordisk A/S in Denmark, and most recently Sanofi in France. Thomas has served on the Board of the Drug Information Association in the US. He also was a member and chair of the Board of The Organisation for Professionals in Regulatory Affairs in the UK. Currently, he’s serving on the Board of the MedTech & Pharma Platform headquartered in Switzerland.

Nathalie is a senior scientific project manager at IHI within the Scientific Operations team, with responsibilities ranging from the coordination of activities within the team, the management of large and complex research projects and support to public-private consortia, to engagement with stakeholders with particular focus on regulatory bodies.Nathalie joined in 2012 the Innovative Medicines Initiative (now IHI), after having worked at the European Medicines Agency (EMA) over 15 years as a scientific administrator with various responsibilities related to the development and approval of medicinal products. She is a state-certified Doctor in Pharmacy with degree in international drug development and registration.

Pharmacist by training, with an additional Master’s Degree in Applied Toxicology. Karen has joined the Belgian Medicines Agency in 2011 where she works as a non-clinical assessor of marketing and clinical trial applications and scientific advice, with particular focus on paediatric medicines. She is a member of the PDCO’s Non-Clinical Working Group (NcWG) since 2012 and has been appointed as chair of this group in 2017. She is also the Belgian delegate to the PDCO. Since recently, she also represents the EU at ICH S11.

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.

Elin Haf Davies PhD began her career as a Children’s Nurse, before going on to gain her PhD at University College London. She was part of the paediatric team at the European Medicine Agency responsible for implementing the Paediatric Regulation in Europe. After 6 years as a regulator Elin left to start aparito, a digital health company providing remote patient monitoring specifically for clinical trials. Elin is also part of the IMI consortium ADAPTSMART, focusing on adaptive pathways.

Dr. Maldonado is Vice President of Pediatric Drug Development at J&J. Previously; he was Medical Officer at the FDA for 8 yrs, where he participated in scientific and policy processes leading to the Pediatric Exclusivity Initiative. His experience in pediatric drug development expands over 25 years

Founder and President of the Duchenne Parent Project Netherlands since 1995, Chair and co-founder of the World Duchenne Organization and board member of Eurordis. She is the mother of an adult son with Duchenne MD & orthodontist by training; chair of the Ethics Board & member of the Executive Committee of TREAT-NMD; volunteer for Eurordis; a patient expert for the European Medicines Agency. Involved in several publications regarding Standards of Care and drug development for Duchenne Muscular Dystrophy, concerning development of outcome measures & role of Biomarkers. She is co-author of a handbook on psychosocial aspects of DMD. She participates in several EU funded projects, such as Asterix, Adapt Smart, RD-Connect Vision-DMD & Share4Rare.

Aude Clement is a Senior Director in the Pharma Development Regulatory team at Roche. She currently contributes to building the organizational capability for digital technology based drug development tools and personalized healthcare digital solutions. Aude has two decades of experience in the Pharma industry, as a global regulatory lead and regional strategist for innovative medicines across modalities and therapeutic areas at Roche, Novartis, Sanofi and Pfizer. She holds a French Doctorate in Pharmacy and Master’s degree in International Drug Development & Registration. She recently completed the Quantic School of Business & Technology Executive MBA.

22 years of experience in early and late stage pre-clinical and clinical drug development of small molecules, biologics and gene therapy products. Current position: Executive Director, PreClinical Safety, Novartis Pharma, Switzerland. Role: Global PCS Therapeutic Area Head Neuroscience and Gene Therapies. Previous positions at Roche and University of California, San Francisco.