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Evaluation of Medicinal Products in Children
PED01 - G Pons |
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2011-2012 Academic Year Evaluation of medicinal products in childrenOrganized with the European Society for Developmental, Perinatal& Paediatric Pharmacology, and the University Rene Descartes Paris VThis seminar runs from February 21-24 and March 27-30. PRELIMINARY PROGRAMME AND REGISTRATION FORMS are available in the Documents section. Learning Outcomes 1. Describe maturation of body composition & physiology, and developmental pharmacology as barriers & opportunities for developing paediatric medicines. 2. Describe the main diseases of childhood & their extrapolation from adults to children. 3. Consider regulatory, legal & ethical requirements. Paediatric regulation, Paediatric Investigation Plan (PIP) of the EU, ethical guidelines. 4. Explain the pre-clinical requirements for drug development in neonates & children. 5. Evaluate drug evaluation & development of specific pharmaceutical formulations for different paediatric age groups. 6. Describe the pharmacodynamic & pharmacokinetic changes in fetuses & children during maturation & disease. 7. Explain & implement the methodological aspects & innovative methods from Phase I clinical trials to post-marketing studies in children. 8. Outline pharmacovigilance, pharmacoepidemiology, risk management plans & the extent of unlicensed & off-label use in medicinal products in children. 9. Assess the importance of networking for clinical research in children. 10. Outline clinical trial programs designed for the paediatric population. Go to Elective Modules |
Documents
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