On 13-14 September 2022 the 4th Nordic Conference on Paediatric Medicines was arranged in Helsinki, Finland. The event was supported by the Nordic Trial Alliance.
EU Paediatric Regulation (EC 1901/2006) came into force in 2007 with the aim to improve the health of the children in Europe by increasing the research and authorization of medicines for children and improving the information on medicines designed for children. Since 2013, the Pharma Industry Finland together with the Finnish Investigators network for Paediatric Medicines –FINPEDMED – have been facilitating academic and Pharma Industry collaboration for paediatric medicine development and clinical trials in the Nordic area. This collaborative conference was fourth in order following the 2017, 2018 and 2019 events.
This conference focused on the new clinical research environment, including EU Paediatric Regulation and Orphan Regulation, and the ongoing collaborative efforts benefiting the paediatric clinical trial processes in Europe. Large collaborative networks and research infrastructures support these changes and new processes by proving unique services and innovative solutions.
The conference had a total of 75 participants this year, which was extremely positive result after the long period without any f-2-f events after 2019.
See the full programme below.
The presentations (PDFs) are available here:
The landscape of Paediatric and Orphan medicines
Review of the Paediatric and Orphan Regulation
Making rare diseases less rare
Towards successful paediatric medicines development and access
Towards successful Paediatric Orphan Medicines Development
Nordic access to paediatric medicines
Digital Tools in Paediatric Trials
Age-Appropriate oral paediatric formulations in Hospitals
Better Medicines for babies, children and young people through a pan-European clinical trial network
Young Person’s Advisory Groups enhancing clinical trials
Leading Health Care for every Patient
ITCC in the Nordic Countries – the Finnish Perspective
Integration of Paediatric Development into Drug Development
The NordicPedMed Paediatric Research Network’s development progress
How to organize a paediatric Clinical Trials Unit
How to enhance the rare disease research (in the Nordic Countries)?
PROGRAMME
4th Nordic Conference on Paediatric Medicines – Shaping the environment
to facilitate research and access of paediatric and orphan medicines in EU
4th Nordic Conference on Paediatric Medicines – Shaping the environment
to facilitate research and access of paediatric and orphan medicines in EU
Day 1: Activities along the EU legislation reform in the new research environment
13:10 The landscape of Paediatric and Orphan medicines – Kalle Hoppu, Helsinki
13:25 Findings from the review of Paediatric Regulation and Orphan Regulation – Fabio D’Atri, European Commission, Belgium
13:50 How to make treatments for rare diseases less rare? -Tina Taube, Efpia, Belgium
14:15 Towards successful paediatric medicines development and access – Solange Corriol-Rohou, Efpia Clinical Research Expert Group, Astra Zeneca, France
14:40 Towards successful paediatric orphan medicines development – Gesine Bejeuhr, Pediatric Regulatory Leader, Bayer AG, Germany
15:40 Access to new paediatric medicines in the Nordic countries – Siri Wang, NOMA, Norway
16:05 Data and digital tools in Paediatric clinical trials – Rhian Thomas-Turner, Noah’s Ark Children’s Hospital for Wales, Cardiff & Vale University, U.K.
16:30 Age-Appropriate oral paediatric formulations in hospitals, Maria Rautamo, HUS Pharmacy and University of Helsinki, Helsinki
Day 2: How to facilitate paediatric clinical research and collaboration?
9:00 Update of c4c -Conect4Children – Katharine Cheng, Johnson and Johnson, U.K.
9:25 Supporting Pediatric Trials through c4c National Hubs and National Networks – Ricardo Fernandes, c4c Network Infrastructure Office and NH Forum, Lead STAND4Kids, Portugal
9:50 Young Person´s Advisory Groups enhancing clinical trials – Begonya Nafria, Sant Joan de Déu Children´s Hospital, Barcelona, Spain
10:05 How Helsinki University Hospital can support Clinical Trials? – Taneli Raivio, HUS, Helsinki
10:35 Nordic Pediatric Clinical Trial Unit development process – Tina Kjellén and Jenny Kindblom, Queen Silvia Children´s Hospital, Gothenburg, Sweden (presentation not available)
11:00 ITCC in the Nordic Countries, the Finnish perspective – Katja Eloranta, HUS New Children´s Hospital, Helsinki
12:25 Integration of Paediatric Development into Drug Development – 2 examples of how to do it
– Martine Dehlinger-Kremer, ICON Plc., EFGCP and EUCROF, Germany
o The role and benefit of a Centre for Paediatric Clinical Development
o How and when to include adolescents in adult research
13:00 The NORDICPEDMED Paediatric Research Network´s development progress -Pernille Skovby, DanPedMed, Rigshospitalet, Copenhagen, Denmark
13:30 How to organize a paediatric Clinical Trials Unit – Sauli Palmu, PeeTu / TAYS, Tampere
13:50 How to enhance the rare disease research? – Mikko Seppänen, HUS, Helsinki