Gesine Bejeuhr, PharmD, PhD, is responsible for generating and implementing global pediatric regulatory strategies and for pediatric regulatory science innovation within Bayer AG. She also provides advice to pediatric development teams. Gesine represents Bayer in the Pediatric WGs of EFPIA, PhRMA, and BIO. She is Vice-Chair of EFPIA's Pediatric Expert Group and member of EFGCP's Children's Medicines Working Party. In her previous role at the German trade association vfa she was responsible for Regulatory Affairs, Production, Quality and Environment and in addition coordinated and co-chaired the Inter-Association-Task Force of EFPIA, Medicines for Europe and AESGP on eProductInformation (ePI) and a German pilot project on ePI.

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.

2008-2011 Postdoctoral researcher Department of Microbiology, Columbia University Medical School, New York (USA). 2011-2013 Trainee and then Scientific Administrator in the Anti-Infectives Office, European Medicines Agency. Since 2013 Scientific Officer in the Paediatric Medicines Office, European Medicines Agency. Responsible for assessment of PIP applications, modifications, waivers and compliance checks with PDCO, and for paediatric validations of marketing authorisations and other relevant regulatory submissions.

Detlef Niese is is a licensed pharmacist and board certified internist and member of the faculty of medicine in Bonn, Germany. After nearly 20 years in academic research, clinical practice and teaching he joined industry in 1992. From 2001-2013 he was head of External Affairs in Global Development at Novartis. Since retirement in MArch 2013 Dr.Niese works as independent consultant supporting private and public clients in the area of science policy and medicines development.

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.

Paolo Tomasi is Head of Paediatric Medicines at the European Medicines Agency. He is a physician, with a background in adult and paediatric endocrinology, and internal medicine. Before joining the Agency, he worked as assistant professor of medicine in Italy. He is the author of >40 Medline papers.

Efthymios is since 2007 a scientific officer in the scientific advice office of the European Medicines Agency. His areas of expertise include anti-infectives, vaccines, modelling and qualification of novel methodologies. Efthymios is coordinating all modelling activities within the Agency. Worked as modeller in industry. Obtained his pharmacy degree in Greece, 2002 and his MSc degree in PK/drug metabolism and modelling from Paris XI University, 2003.

Associate Director for Pediatrics, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration. Prior to coming to the FDA in 2008, Dr. Burckart was a Professor of Pharmacy and Pediatrics for 33 years at four universities. He was also past President of the American College of Clinical Pharmacology and the American College of Clinical Pharmacy.

Irmgard Eichler is Professor of Paediatrics and currently Senior Scientific Officer in Paediatric Medicines at EMA and co-chair of the European network of paediatric research at EMA (EnprEMA). She completed clinical training in Austria and South Africa and undertook research training in Paediatric medicine in Austria and completed a Postdoctoral Fellowship in the Division of Allergy & Pulmonary Diseases at the Children's Hospital at Stanford University Medical Center.

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.

I have been in the Pharmaceutical Industry for 20+ years, mostly in regulatory. I have held diverse regulatory affairs roles ranging from local UK marketing support to Global lead, policy roles and portfolio lead.

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.

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. Temeck received her Medical Degree from the Georgetown University School of Medicine. She is board certified by the American Academy of Pediatrics in general pediatrics and pediatric endocrinology. In her current position as the Team Lead of the international program in FDA’s Office of Pediatric Therapeutics, she leads and coordinates the interactions between FDA and global regulatory partners to discuss issues related to pediatric product development.

Dr. Treem is a trained pediatrician and pediatric gastroenterologist-hepatologist with a long career in academic pediatric gastroenterology as a clinician, clinical researcher, and teacher. In academia, he focused on clinical research in children with rare inborn errors of metabolism affecting the liver and intestine, treatments for ulcerative colitis and Crohns disease in childrenand a new orphan drug. He then joined Janssen and directed their pediatric drug development program for Aciphex. He is now a Senior Director of Pediatric Drug Development in the CHILD (Child Health Innovation and Leadership Department); Chairman of the Janssen Pediatric Center of Excellence; and co-chair of the Janssen Hepatic Safety Group.

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.

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.

I joined Alström Syndrome UK (ASUK) in 2003 when my son was diagnosed with the condition. I am now the National Development Manager responsible for overseeing the Family Support Service and I work closely with our medical teams in Birmingham, UK to support the highly specialised multi-disciplinary clinics. I also manage contracts with pharmaceutical companies to support clinical trials. I have been involved in various UK and EU projects focussing on patient engagement in clinical trial designs and drug development and I am a patient representative on the CIOMS XI working group: Patient Involvement in Development and Safe Use of Medicines. I am a patient representative on the UK Rare Disease Policy Board.