the European Regulation on
Medicine for Pediatric Use has been adopted by the European Parliament
on 7th September 2005. l. Text
of modified proposal COM(2005) 577 final of 10 November 2005
Final agrement Eur Parl May 2006
BELGIAN PEDIATRIC DRUG NETWORK
BELGIAN PEDIATRIC CLINICAL
TRIAL NETWORK
B.P.D.N.
pediatricdrug.be
MEMBER SPECIALITY OF THE BELGIAN SOCIETY OF PEDIATRICS BVK
/ SBP
update June2008
Belgian pediatric drug network - Belgian Pediatric Clinical Trial Network
Date and place of constitution: 20 January 2005, Academy of
Medicine, Brussels
Founding committee:
Etienne SOKAL , president
Myriam VANWINCKEL
, secretary
Karel ALLEGAERT
Daniel BRASSEUR
Jean Paul LANGHENDRIES
José RAMET
Johan VANDEWALLE
Bart VANOVERMEIRE
Aims
Articles
Usefull documents and links
Websites of interest
Current Trials
Conferences
concept
paper Liver Immaturity emea
concept
paper gut flora JP Langhendries
concept
paper cardivascular Immaturity emea
concept
paper renal immaturity emea
Regulatory
EU
EU
regulation proposal on medicine for pediatric use EN
Réglement européen
relatif aux médicaments pédiatriques FR Voir
aussi la note résumée June 2006
EU verordening betreffende geneesmiddelen
voor pediatrisch gebruik NL
European directive good clinical practice
Position statement of the Medicines in Europe Forum on the pediatric directive En Dec 2004
Belgium
Loi
belge experimentation sur les personnes humaines 07/05/2004 Fr
Wet
inzake experimenten op de menselijke persoon 07/05/2004Nl
Moniteur/staatsblad
Annexe
1 à la circulaire relative à la loi du 7 mai 2004 relative aux expérimentations
sur la personne humaine
Bijlage
1 bij de circulaire betreffende de wet van 7 mei 2004 inzake experimenten op
de menselijke persoon
USA
FDA
regulation: assessment of safety & efficacy of drugs for pediatric patients
Scientific
EMEA
discussion: impact of renal immaturity when investigating pediatric medicines
Press release SBP-BVK 17-03-2005
WEBSITES OF INTEREST
European Clinical Research Infrastructures Network ECRIN
Direction générale des médicaments- directoraat generaal geneesmiddelen (Belgium)
European commission - pharmaceutical unit
The way to new medicines A M Hubert, SBP 22 03 2005
Why do we need a belgian network of expertise ? (Clic left & download) (Daniel Brasseur, June 2008)
- Survey of familial hypercholesterolmia: download the pdf questionnaire