MEDICINES FOR CHILDREN

The EAP Medicines for Children Strategic Advisory Group was established to advocate for equal access to safe, modern and affordable therapeutic medicine options to support diagnosis, treatment and prevention of diseases – especially for children/young persons in Europe.

Karel Allegaert

Chair

Dr. Karel Allegaert, MD, PhD, is a paediatrician-neonatologist with expertise in clinical pharmacology. He is a professor at KU Leuven, Belgium, and a clinical consultant at Sophia Children’s Hospital, Rotterdam. His research focuses on developmental perinatal pharmacology and neonatal and paediatric pain, supported by European and national grants, with over 300 PubMed citations (H-index 33). Dr. Allegaert is a member of the Royal Academy of Medicine of Belgium, president of the European Society of Developmental Pharmacology, and section head for clinical pharmacology at the European Society of Pediatric Research.

Burning Issues Include

  • The correct administration of medicine in children (appropriate formulations and the dosage).
  • The lack of medicines that are appropriate for, and specifically aimed, at children.
  • Excessive prices of some orphan drugs for rare diseases / high expense low volume medications.
  • The remaining large number of prescriptions of off-label drugs in our patients.
  • Lack of Investment in drugs for specific paediatric indications/needs.
  • Insufficient infrastructure/networks to perform multicentred paediatric trials across Europe.

Agendas of medicines for children

MINUTES

MEDICINES FOR CHILDREN

Valletta, Malta, 13 May 2022

Spring Meeting 2022

VIRTUAL | January 20, 2022

Winter Meeting 2022

Presentations

REACH Strategic Advisory Group

Press Releases / Statements

Off-label use of medicines in neonates, infants, children, and adolescents: a joint policy statement by the European Academy of Paediatrics and the European Society for Developmental Perinatal and Paediatric Pharmacology

EAP Statements
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Core-MD Project

Coordinating Research and Evidence for Medical Devices (CORE-MD)

New ways to test high-risk medical devices.

 

Manufacturers of medical devices need to test their products before being allowed to market them. Specifically, they require clinical data showing their medical device is safe and efficient. In this context, the EU-funded CORE-MD project will translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators. The project will propose how new trial designs can contribute and suggest ways to aggregate real-world data from medical device registries.


It will also conduct multidisciplinary workshops to propose a hierarchy of levels of evidence from clinical investigations, as well as educational and training objectives for all stakeholders, to build expertise in regulatory science in Europe. CORE–MD will translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators, to achieve an appropriate balance between innovation, safety, and effectiveness. A unique collaboration between medical associations, regulatory agencies, notified bodies, academic institutions, patients’ groups, and health technology assessment agencies, will systematically review methodologies for the clinical investigation of high-risk medical devices, recommend how new trial designs can contribute, and advise on methods for aggregating real-world data from medical device registries with experience from clinical practice The consortium is led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, and involves all 33 specialist medical associations that are members of the Biomedical Alliance in Europe.

EAP Representative:

  • BERTHOLD KOLETZKO
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