05.09.2008

European Commission, DG RTD, the Health Directorate and Polish National Contact Point

In contrast to the situation in adults, most medicines used to treat the children of Europe have
not been tested and are not authorised for use in children: the health and therefore quality of
life of the children of Europe may suffer from a lack of testing and authorisation of medicines for
their use. 

With this in mind, a specially dedicated topic of the Seventh Framework Programme will offer
financial support to consortia carrying out studies dedicated to provide evidence for specific
paediatric use of off-patent medicinal products currently used off-label. 

The results of these studies will be eligible for submission to Regulatory Authorities as a
Paediatric Use Marketing Authorisation (PUMA), which is a new type of marketing authorisation. This
is devised specifically for these off-patent medicinal products that are developed exclusively for
use in children and which will allow for their use to treat new diseases and new populations. 

An issue of added interest for New Member States is the question of how to integrate their
activities into a critical mass of resources and expertise needed to provide leadership in the
framework of longer term local and national cooperation. A representative of a national Paediatric
Research Network will speak about managing such a network and how to adapt to the rapidly changing
environment for paediatric research so as to become a world force in this domain.

Medical University of Warsaw,
61 Zwirki i Wigury St, 
Senate Conference room	
Warsaw,Poland

Anna Pytko
e-mail: anna.pytko@kpk.gov.pl 

BEZPŁATNE

Financial support (travel expenses) is foreseen for participants from New Member States.
To apply for financial support please contact: Isabel.CANUETO-MORO@ec.europa.eu

  On-line (Lista przyjętych zgłoszeń), zakończenie rejestracji : 2008-09-03 12:00

09:45 – 10:15 Welcome coffee and registration

The event is chaired by Dr. Marek Migdal (Children’s Memorial Health 
Institute in Warsaw, Member of the Paediatric Committee EMEA)

10:15 – 10:25 Welcome by Prof. Anna Kaminska (Warsaw Medical 
University)

10:25 – 10:35 Paediatric Networking in the EU Introduction 
Fergal Donnelly (European Commission DG RTD F)
                    

10:35 – 11:20 The German Paediatric Network – PAED-Net 
Dr. Monika Seibert-Grafe (IZKS, University Medical Center Mainz)

11:20 – 12:05 Paediatric Medicines Regulation 
Agnès Saint-Raymond (European Medicines Agency EMEA)

12:05 – 12:30 Discussion and Questions

12:30 – 13:15 Lunch

13:15 – 13:20 Health NCP Net introduction - support for FP7 Health proposes
Anna Pytko (Polish National Contact Point - KPK PB UE)

13:20 – 14:10 Off-Patent Medicines for Children - how to apply, results of 
the last call 
Fergal Donnelly (European Commission DG RTD F)


14:10 – 14:50 Presentation of successful application in Seventh Framework 
Programme 
Prof. Evelyne Jacqz-Aigrain (Pharmacologie pédiatrique et acogénétique, 
INSERM )

14:50 – 15:15 Discussion and Questions

15:15 – 15:35 Coffee

15:35 – 16:00 Conclusions and Closure

HOTELS:

Jan III Sobieski Hotel 
the hotel we recommend, because is close to the airport, the meeting place and the city centre.
Moreover NCP have a special rate negotiated with the hotel (4/5.09.2008 -105 Euros with internet
access and breakfast, 95 Euros with breakfast but without internet access; 5/6.09.2008 and
6/7.09/2008 - 95 Euros with internet access and breakfast, 85 Euros with breakfast but without
internet access).
Deadline for booking room in special prices is 1 September  2008. 
Rooms booking
a) e - mail : rezerwacja@sobieski.com.pl 
b) fax: 04822 6598828
Please, when booking, give the keyword “PAEDIATRIC EVENT” 

The hotel website:
http://www.janiiisobieskihotel.com 


http://www.en.rezerwuje.com/Warsaw - other hotels in Warsaw

Paediatric Medicines Regulation-A.Saint-Raymond.pdf 
 Paediatric Medicines Regulations - Agnes Saint-
Raymond 
(1099.1 KB)
FP7 Health & Paediatrics 2008 Warsaw-F.Donnelly.pdf 
 Off-patent medicines for children - Fergal Donnelly 
(577.9 KB)
FP708 presentation English-E.Jacqz-Aigrain.pdf 
 Presentation of successful aplication - Evelyne 
Jacqz-Aigrain 
(1028.2 KB)
2008_07_21_German_PAED-Net_MSG.pdf 
 The German Paediatric Network - Monika Seibert-
Grafe 
(728.4 KB)
080904 FP7 HUGO.pdf 
 Hugo project presentation 
(1954.4 KB)
venue.doc 
 venue 
(931.5 KB)
The EC Paediatric Event.doc 
 Detailed information about the Peadiatric Medicines meeting 
(28.0 KB)