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

2nd Nordic Conference on Pediatric Medicines

21-22 May 2018, Helsinki, Finland

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

The first Joint Nordic Conference on Pediatric Medicines was organized by NordicPedMed / Pharma Industry Finland in June 2017. This May we will continue to promote the strengths of the Nordic clinical research infrastructure and the research collaboration between the academic research networks and Pharma Industry.

We will disclose the newest information on the current strong development of the European pediatric clinical research environment and present some examples of best clinical practices, in order to gain more knowledge for developing Nordic level operations and become more attractive on a competitive global pediatric clinical trials arena.

Networking is also an important part of the conference. The Major of Helsinki has invited all participants to a networking event on Monday evening. 

Topics:

* EU Legal & Ethical & Regulatory Framework for Pediatric Clinical Trials Up-date
* Pediatric Regulation 10-yrs – Effects in Practice & Expectations for the next 10 yrs
* Industry & Network perspectives for Pediatric Medicines Development and Clinical Trials
* European Pediatric Research Infrastructure Initiatives for Pediatric Clinical Trials
* Young Persons as a New Stakeholders Group for Pediatric Medicines Development
* Funding & Future of the Pediatric Clinical Trial Conduction in Nordic Countries

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 

Chair: 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

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; all stakeholders; Q & A & The way forward? - Pharma Industry and national networks

14:30                  Wrap-up: Conclusions & Action points 

14:45                  End of the Conference & Good Bye – Mia Bengtström

Registration here

The conference is funded by Nordic Trial Alliance and pharma sponsor companies and is therefore free of charge. However, if you cancel your participation later than 7.5.2018 or do not show up, a registration fee of 200 €/day for the conference will be charged. If you cancel the networking event later than 14.5.2018, a 50 € fee will be charged. You will receive a confirmation message within 10 days of registration.

Hotel reservations

Clarion Hotel Helsinki, Tyynenmerenkatu 2, Helsinki, www.nordicchoicehotels.fi

Single room: 132 €/night, Double room: 152 €/night

Reservations by May 4th latest: reservations.cl.helsinki@choice.fi or tel. +358 10 850 3820. Group code "Ped2018".

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