2nd Nordic Conference on Pediatric Medicines Final Program Monday 21 2018 registration & welcome Coffee: 12: 00-12: 45

2nd Nordic Conference on Pediatric Medicines Final Program

Monday 21.5.2018

REGISTRATION & welcome Coffee: 12:00-12:45

12:45     Welcome, Chair: Mia Bengtström, NTA / PIF, Finland

12:55     Nordic Trial Alliance NTA 2.0 Personalised medicine and Research Infrastructure for Nordic Health Data - Mia Bengtström, Senior Advisor, Pharma Industry Finland 

Chairperson: Jaakko Parkkinen, Medical Director, Pfizer Oy​                            

13:15     EU Pediatric Regulation 10 yrs – Results & Expectations – EU Commission - Fabio D'Atri Policy Officer, European Commission

13:45     European Network of Research Ethics Committees –EUREC – Perspectives for Pediatric clinical trials - Outi Konttinen, National Committee on Medical Research Ethics, Finland

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

14:30    EMA Regulatory up-date – PDCO – Siri Wang, Scientific Director, Norwegian PDCO (Paediatric Committee) delegate, Norwegian Medicines Agency

14:50    ICH E11 guidelines supporting pediatric trials and programs – Ralf Herold, Pediatric Development Leader Regulatory Policy & Intelligence, Bayer AG

15:15- 15:45 Coffee/Refreshments

Chairperson: Anne Lehtonen, Abbvie Oy, Medical Director

15:45     European new research infrastructure – Mark 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

16:35    Finnish Vaccine trials network – collaboration with NordicPedMed? – Timo Vesikari, Professor, Director of the Vaccine Research Center,  Tampere University, Finland

17:00    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

17:25    Pharma Industry Mission to Paediatric CTs in Europe - Geneviève Le Visage, Head of DRA EU Policy and Liaison, Novartis Pharma AG

17:50    Closing remarks – Mia Bengtström, Pharma Industry Finland

17:55     End of the first day -> local metro transportation to City

18:30 Reception at Old City Hall of Helsinki

Tuesday 22.5.2018

REGISTRATION: 08:00 - 09:00

Chairperson: Estelle Naumburg, Swedish Paediatric Society / SwedPedMed, Sweden

9:00       Welcome, Program of the day - Chair

09:10     Introduction: NordicPedMed – Kalle Hoppu, Professor, Chair of the Nordic Investigators Network for Pediatric Medicines (NordicPedMed)

National updates:

09:25 FinPedMed & IcePedMed – Pirkko Lepola, Excecutive Secretary of FinPedMed, General Secretary of NordicPedMed

09:40 SwedPedMed –Anders Rane, Senior Professor, Karolinska Institutet, Sweden

09:50 DanPedMed – Pirkko Lepola, NordicPedMed

10:00 NorPedMed – Britt Nakstad, Professor Neonatology, University of Oslo and Akershus University Hospital

10:10     Industry perspective and expectations for Nordic network - Jaana Santaholma, Country Medical Manager, Novartis Finland

Chairperson:  Pekka Lahdenne, Head of Digital and Innovation Service, Helsinki University Hospital, Dept. of Children and Adolescents

10:30     Introduction to Case presentations and Panel discussion: How the Paediatric Clinical Trial Units operate in Europe – Chair

10:40     Case 1: Sweden: Establishment of a pediatric trial unit. Sahlgrenska University Hospital in Gothenburg - Jenny Kindblom, Medical Director the Pediatric Clinical Research Center

11:10      Case 2: Netherlands: Radboudumc Amalia Children's Hospital - Jos Gilissen, Head of Paediatric Drug Research Centre

11:40- 12:40 Lunch

12:40     Case 3: Spain: Children's Hospital Sant Joan de Déu Barcelona - Joana Claverol Torres, Unit Coordinator of Clinical Research Unit

13:00    Case 4: Norway:  Britt Nakstad, Professor Neonatology, University of Oslo and Akershus University Hospital

13:30    Panel discussion – lead by Chairpersons of the day; all stakeholders; Q & A & The way forward? - Pharma Industry and national networks

14:30     Wrap-up: Conclusions & Action points 

14:40     End of the Conference & Good Bye – Mia Bengtström

14:45 Bus transportation to Airport