Power Point presentation of BPDN

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

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In all actions concerning children, the best interests of the child shall be a primary consideration
Convention on the Rights of the Child art 3

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


AIMS

ARTICLES

concept paper Liver Immaturity emea
concept paper gut flora JP Langhendries
concept paper cardivascular Immaturity emea
concept paper renal immaturity emea

 

USEFUL DOCUMENTS AND LINKS

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

CONFERENCES

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)

TRIALS IN PROGRESS

- Survey of familial hypercholesterolmia: download the pdf questionnaire