Medicines for children in Belgium: the way forward with BPCRN

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Medicines for children in Belgium: the way forward with BPCRN. Professor José Ramet. What the paediatricians know. Studies on medicines in adults not sufficient Specificity disease Effects on growth, development, maturation Specific adverse reaction. - PowerPoint PPT Presentation

Text of Medicines for children in Belgium: the way forward with BPCRN

  • Medicines for children in Belgium:the way forward with BPCRNProfessor Jos Ramet

  • Studies on medicines in adults not sufficientSpecificity diseaseEffects on growth, development, maturationSpecific adverse reactionWhat the paediatricians know

  • Child... not a small adult Infant... not a small child Preterm...not a small newborn

  • BPCRN

    De bijzonderheden van klinische studies voor de pediatrische klinische praktijk

  • de combinatie van ADMEbepaalt de expositie en dus hettijd/conc profiel

    De expositie in combinatie metde interactie tgv therapeutischetarget (receptor) bepaalt deconc/effect relatie.

    farmacokinetiek

  • DrugExposureResponseAbsorptieDistributieReceptoren InteractieBiotransformatieExcretieziektegroei ontwikkelingK. Allegaert

  • Ref: Nelsons textbook Pediatricslichaamsproporties

  • Ref: Kearns et al, NEJM 2003

  • Stakeholders

  • PartnersBalance 3 main stakeholdersEthical concerns

  • Partnership?Industry Role

    Discovery of new medicinesHigh throughput screening of compoundsDevelopment of new medicinesPre-clinical toxicologyHuman evaluation of dose, safety, efficacyPaediatric Role

    Define therapeutics needsDevelop validated end-points for efficacy and safetybridges adult studiesDevelop effective, efficient, ethically driven networks to conduct clinical studiesPerformed at all level of paediatric care

  • Objectives of BPCRN: Databaseexisting networks, experience, investigators, local facilitiesReference for health care professionals & pharmaceutical industry Interactionall stakeholdersbetween networks Training & educationnew centres & investigators Informationannual meeting stakeholdersprinted report of clinical research activities in various fields Role as facilitator

  • facilitator

    recruitment in various and/or dedicated centres attainment of required sample sizes increased performance of trials through inter-investigators exchange of experience circulation of information consolidated effort of all stakeholders to communicate practitioners in the field : aware of those new opportunities develop scientific excellence stimulate gifted medical students: consider careers in paediatric researchsupport major international research projects act on education , training , research stimulation

  • BPCRN

    Belgian PediatricClinical Research Network

    Rseau Belge de Recherche Clinique PdiatriqueBelgisch Netwerk van Klinische Research in de Pediatrie

  • Back up

  • ConclusionBelgian Paediatric Clinical Research NetworkObjectives of the network facilitator To do list define interested stakeholders proposal of procedure find support of the network: 2 years first things first: database

  • How to achieve this?1. Consulting2. Feasibility: qualified study centres3. Regulatory: application to authoritiesand ethics committees (national legalaspects)4. Study coordination5. Pharmcovigilance: procedures (reportingto authorities and ethics committees6. Investigator Recruitment: recruitmentprocedures7. Study Assistance8. Monitoring9. Data Management: IT-support for trial database, communication, homepage10. Biostatistics11. Tools, Templates & examples of agreementsand contracts, specific paediatric SOPs(Standard Operating Procedures)(including templates for patient information,consent and assent), 12. Trial know-how: transfer of knowledgeand experience concerning planning andconducting of clinical trials13. Training courses14. support services for investigators

  • Network Virtual structure , defined by formal agreement between individuals , organisations or structures sharing and collaborating towards the same objectives , goals and quality standards

  • Challenges What could Paediatric European networks contribution be to paediatric research?be able to respond to increased research needsdefinecenters of excellence organize a research task distribution in Europebe present at EMEA & related advisory groupsFrom private practice to research centre

    From clinical to fundamental

    Major advantage ofpaediatrics

  • Existing EU paediatric networks

    7 national networks public funding FR, NL, IT, DE ,..EU funded TEDDY sub-speciality ESPNIC, ESPN age-related neonatalstructure-related Pharmacovigilance networkspaediatric centres dedicated clinical research centres

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