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

SAVE THE DATE: Joint NORDICPedMed / PIF Nordic Conference on Pediatric Medicines

21-22st May 2018, Helsinki, Finland

Venue: Ilmarinen/Team Finland building, Porkkalankatu 1, Helsinki, Finland

Topics

  • EU Legal & Regulatory & Ethical Framework for Pediatric Clinical Trials
  • Pediatric Regulation 10-yrs – Effects in Practice & Expectations for the next 10 yrs
  • Regional Network perspectives for Pediatric Medicines Development and Clinical Trials
  • New European Initiatives & Infrastructures for Pediatric Clinical Trials
  • Young Persons as a New Stakeholders Group for Pediatric Medicines Development 

Draft Program Monday 21.5.2018

REGISTRATION & welcome Coffee: 11.30 a.m.-12:00 a.m. 

Welcome Mia Bengtström, NTA / PIF, Finland

12:00    EU Pediatric Regulation 10 yrs – Results & Expectations – EU Commission - TBC
12:30    EMA Regulatory up-date – PDCO – Siri Wang, Norway
13:00    EU ICH Guidelines related to Pediatric CTs up-date – EFPIA –  TBC
13:30    EU CT Regulation & EU CT Portal up-date– EMA – Fimea – TBC
14:00    European Network of Research Ethics Committees – Perspectives for Pediatric CTs - TBC

14:30- 15:15 Coffee /Refreshments

15:15    European new research infrastructure – TBC
16:00    Finnish Vaccine trials network – collaboration with NordicPedMed? – Timo Vesikari, Tampere University, Finland
16:30    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
17:00     Closing remarks, End of the first day – Chair

Networking Reception at 18:00

Draft Program Tuesday 22.5.2018

REGISTRATION: 08.30 a.m.-09:00 a.m.

Chairperson:  Estelle Naumburg, President of the Swedish Paediatric Society of Children and Medicines, Sweden
Panel composition: Pharma Industry and national networks

09:00     Introduction: NordicPedMed –Kalle Hoppu, Finland
09:20     National updates:

FinPedMed – Pirkko Lepola, Finland
SwedPedMed –Anders Rane, Sweden
DanPedMed – TBC
NorPedMed –TBC
IcePedMed – TBC

10:20 Industry perspective and expectations for Nordic network - TBC
10:50  Panel discussion

11:30- 12:30 Lunch

12:30 Introduction for the program and Case presentations: How the Paediatric Clinical Trial Units operate in Europe – TBC
12:45 Case 1: Sweden: Establishment of a pediatric trial unit. Sahlgrenska University Hospital in Gothenburg - Jenny Kindblom, Medical Director the Pediatric Clinical Research Center
13:10 Case 2: Netherlands: Radboudumc Amalia Children's Hospital - Jos Gilissen, Head of Paediatric Drug Research Centre
13:35 Case 3: Spain: Children's Hospital Sant Joan de Déu Barcelona - Joana Claverol Torres, Unit Coordinator of Clinical Research Unit
14:00 Case 4: Norway

14:30- 15:15: Coffee

15:15     NordForsk – Research in the Nordic Region - TBC
15:30     Nordic Research funding opportunities; NTA 2.0 Personalised Medine - TBC
15:45     Discussion – all stakeholders; Q & A & The way forward? Conclusions & Action points
16:00     Take Home Message & Good Bye – Mia Bengtström            

16:15     End of the Conference

To be confirmed later: We are looking for Sponsors to make the Conference free on charge. If you want to sponsor the conference, please contact Dr Mia Bengtström, mia.bengtstrom@pif.fi.

Registration & more information soon