Learning Objectives
By the end of this webinar, participants will be able to:
Describe the key elements of the new EU pharmaceutical package and recent EMA updates affecting pediatric drug reviews and product label changes
Analyze how European regulatory modernization may influence pediatric clinical trial activity and how Canadian children and families may benefit
Evaluate lessons learned and potential obstacles from the European experience to identify opportunities for Canadian regulators and interest-holders
Meet the Speakers!
Dr. Ricardo Fernandes, MD, PhD, is the Chief Medical Officer for the conect4children Stichting, Lead of the STAND4Kids portuguese pediatric clinical trial network, Associate Professor in Clinical Pharmacology at the Faculty of Medicine, University of Lisbon, and Consultant Pediatrician. His research background includes clinical epidemiology, clinical trial methodology, clinimetrics and synthesis research, with training and research in the Netherlands (Amsterdam Medical Centre) and Canada (University of Alberta). He collaborated in the inception of pediatrics research collaborations such as the StaR Child Health initiative and the Pediatric Emergency Research Networks. He served with the European Respiratory Society (as Group Chair) and the Cochrane Collaboration (as Director of the Cochrane Child Health Field). He was a Work Package and National Hub lead in the conect4children/c4c IMI/IHI consortium that created a paneuropean clinical trial network, and a founding Board Member of the conect4children-Stichting (Foundation). He is the current elected Co-Chair of EnprEMA, the network of pediatric research networks at the European Medicines Agency.
Dr Dominik Karres is a medical doctor with an MD in paediatric drug development. After training in paediatric haematology/oncology in Germany, he worked in paediatric oncology drug development in the UK. He has more than ten years of regulatory experience, including scientific roles at the UK’s MHRA, and is now a Senior Scientific Officer at the European Medicines Agency (EMA) in the Paediatric Medicines Office. At EMA, he oversees the assessment of paediatric investigation plans (PIPs) and contributes to EU and global initiatives advancing paediatric (oncology) drug development. His roles include leading European implementation of the ICH E11A guideline on extrapolation, but also representing EMA on the ACCELERATE Scientific Steering Committee, and serving in the leadership of the Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women’s Hospital and Harvard project, ‘Promoting Global Clinical Research in Children’. He is also an HTA/payer engagement specialist, supporting the regulatory–HTA interface under the new EU HTA Regulation. He served as regulatory lead for the recently published ‘joint HTAb–regulatory perspectives on evidence challenges, uncertainty management, and potential solutions’.