2nd Nordic Conference on Pediatric Medicines 21-22 May 2018

The 2nd Nordic Pediatric conference was held in May 21-22 in Helsinki. 

There were presentations from all relevant stakeholders as the EU-commission, EMA PDCO, ICH, Patients, Pharma Industry and Ethics. The Nordic Pediatric Network (NordicPedMed) and the national networks were presented. Also some well-functioning pediatric sites presented their centers. 

The Innovative medicines initiative Connect 4 Children (IMI c4c), a new public-private partnership to improve clinical trial infrastructure to facilitate the development of new drugs for children in Europe, was launched at the conference. The Nordic pediatric networks participate in this consortium, making the Nordic countries even more attractive in the future.

At the end of the conference there was a panel to discuss all presented issues.

Networking was also an important part of the conference with lively discussions at the Reception at the Old City Hall of Helsinki as well as during coffee breaks and lunch.

The feedback has been overwhelming, and we will look into the possibility of arranging a similar meeting in 2019. We thank the Nordic Trial Alliance and the Sponsors for making this conference reality, free of charge.

Mia Bengtström, Pharma Industry Finland and Pirkko Lepola, FinPedMed/NordicPedMed

Presentations:

Monday 21.5.2018

Nordic Trial Alliance NTA 2.0 Personalised medicine and Research Infrastructure for Nordic Health Data - Mia Bengtström, Senior Advisor, Pharma Industry Finland                          

EU Pediatric Regulation 10 yrs – Results & Expectations – EU Commission - Fabio D'Atri Policy Officer, European Commission

European Network of Research Ethics Committees –EUREC – Perspectives for Pediatric clinical trials - Outi Konttinen, National Committee on Medical Research Ethics, Finland

EU Clinical Trial Regulation & EU CT Portal up-date Outi Konttinen, National Committee on Medical Research Ethics, Finland

EMA Regulatory up-date – PDCO – Siri Wang, Scientific Director, Norwegian PDCO (Paediatric Committee) delegate, Norwegian Medicines Agency

ICH E11 guidelines supporting pediatric trials and programsRalf Herold, Pediatric Development Leader Regulatory Policy & Intelligence, Bayer AG

European new research infrastructureMark Turner, Chair of the European Network of Paediatric Research at the European Medicines Agency (EnprEMA), Scientific Coordinator of the new European research infrastructure, University of Liverpool, and Heidrun Hildebrandt, Global Program Head, Research & Development, Pharmaceuticals, Pediatric Development, Bayer AG, Germany

Finnish Vaccine trials network – collaboration with NordicPedMed?Timo Vesikari, Professor, Director of the Vaccine Research Center,  Tampere University, Finland

YPAGs– Young Persons voice in Pediatric Drug Development processes – Jennifer Preston, Patient and Public Involvement & Engagement Priority Lead, NIHR Clinical Research Network Coordinating Centre, UK

Pharma Industry Mission to Paediatric CTs in Europe - Geneviève Le Visage, Head of DRA EU Policy and Liaison, Novartis Pharma AG

 

Tuesday 22.5.2018

Introduction: NordicPedMed – Kalle Hoppu, Professor, Chair of the Nordic Investigators Network for Pediatric Medicines (NordicPedMed)

National updates:

FinPedMed & IcePedMed – Pirkko Lepola, Excecutive Secretary of FinPedMed, General Secretary of NordicPedMed
SwedPedMedAnders Rane, Senior Professor, Karolinska Institutet, Sweden
DanPedMedPirkko Lepola, NordicPedMed
NorPedMedBritt Nakstad, Professor Neonatology, University of Oslo and Akershus University Hospital

Industry perspective and expectations for Nordic network - Jaana Santaholma, Country Medical Manager, Novartis Finland

Case 1: Sweden: Establishment of a pediatric trial unit. Sahlgrenska University Hospital in Gothenburg - Jenny Kindblom, Medical Director the Pediatric Clinical Research Center

Case 2: Netherlands: Radboudumc Amalia Children's HospitalJos Gilissen, Head of Paediatric Drug Research Centre

Case 3: Spain: Children's Hospital Sant Joan de Déu Barcelona - Joana Claverol Torres, Unit Coordinator of Clinical Research Unit

Case 4: Norway:  Britt Nakstad, Professor Neonatology, University of Oslo and Akershus University Hospital

 

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Sponsored by: