Training Course: Medicines in children – what you need to know?
Transcription
Training Course: Medicines in children – what you need to know?
GRIP Roadshow Training Course: Medicines in children – what you need to know? Organised by Department of Clinical Pharmacology Bispebjerg Frederiksberg University Hospital Copenhagen and GRIP* (Global Research in Paediatrics) Lecturers/Chairs Kalle Hoppu, MD, PhD, Associate Professor of Paediatric Clinical Pharmacology, Hospital for Children and Adolescents and Dept. of Clinical Pharmacology, University of Helsinki, Helsinki, Finland, Stephanie Läer, Prof. Dr. med., Head, Institute of Clinical Pharmacy and Pharmacotherapy, Heinrich-Heine Universitaet Duesseldorf PROGRAM Day1 27 November 2015 Time Topic 9.00-9.30 Welcome and introduction to the course and to GRIP General introduction to the theme of the course 09.30-10.00 The concept of children as “Therapeutic orphans” (25+5 min) Off-label and unlicensed use of medicines in children The paediatric initiatives (US, EU, WHO) Basics of developmental/paediatric pharmacology 10.00-11.00 Birth to adulthood, pharmacodynamics and pharmacokinetics (55+5 min) Considerations of dose calculation Routes of administration in children 30 min Break Drug safety in children 11.30-12.00 Are adverse effects more common or more rare in children? 25+5 min Adverse effects related to or affecting growth and development Dosing errors 12.00-12.30 Pharmacological aspects in case of severe disease in children in relation 25+5 min to the pharmacodynamics and pharmacokinetics? 60 min Lunch When evidence is absent can we extrapolate data from adults to 13.30-14.00 children or should we do clinical trials? (25+5 min) Off-label or off-knowledge use of medicines? Experimental therapy vs. clinical trials Paediatric formulations 14.00-15.00 Formulations most suitable for use in children (55+5 min) Considerations of excipients used in paediatric formulations Extemporaneous formulations 15.00-15.30 Ethical aspects of drug research in children 30 min Break Understanding the basics of drug development in children 16.00-16.30 Finding the right dose (25+5 min) Demonstrating efficacy Demonstrating safety Regulatory assessment and why it is important What you need to know as an investigator of a paediatric clinical trial 16.30-17.30 What is a good study and what is not (55+5 min) Good Clinical Practice (GCP) Recruiting children for a study 24.08.2015 Teacher Kalle Hoppu Kalle Hoppu Stephanie Läer Kalle Hoppu Stephanie Läer Kalle Hoppu Stephanie Läer Kalle Hoppu Kalle Hoppu Stephanie Läer Page 1 of 3 17.30-18.00 Protocol deviations Adverse Events General Discussion. Summary & closing of the meeting (including evaluation) Kalle Hoppu *The GRiP project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 261060. Medicines in children – what you need to know? Grænseflader mellem pædiatri og farmakologi PROGRAM Dag 2 28 November 2015 Tid Emne Underviser 9.00-9.10 Introduktion af dagens program Hanne Rolighed Christensen Helle Holst 9.10-9.40 Phase 1-2 paediatric haematology and oncology Teoretiske og praktiske forhold omkring PKPD modelling i pædiatriske forsøg Én Indgang til Kliniske Forsøg Pause 9.40-10.15 10.15-10.45 10.45-11.15 Karsten Nysum Trine Meldgaard Lund Kristian Teglkamp 11.45-12.15 Hvilken mulig betydning immunreaktioner har når man giver kemoterapi Toksikologi og børn 12.15-12.35 Rekommandationsliste i pædiatrien 12.35-13.30 Frokost 13.30-14.00 Sikker medicinering i pædiatrien særlige udfordringer ved magistrale lægemidler og off-label forbrug Helle Holst 14.00-14.30 Udfordringer ved etablering af klinisk forankrede databaser Jesper Johannesen 14.30-15.00 Off‑label i psykiatrien Torben , Laursen 15.00-15.15 Pause 11.15-11.45 15.15-16.15 16.15-16.30 Ph.d. session: "Web-baseret monitorering af børn og unge med inflammatoriske tarmsygdomme" ”Medicinering af overvægtige Børn” Opsamling Klaus Müller Kim Dalhoff Hanne Rolighed Christensen Katrine.Carlsen Christina Gade *Endnu to pladser så byd endelig ind Lokalitet: Auditoriet, Hovedvejen, indgang 14 Frederiksberg Hospital Nordre Fasanvej 57 | 2000 Frederiksberg https://publikationer.regionh.dk/pdf/full-716/kort-over-frederiksberg-hospital.pdf Tilmelding:Inden 1 november 2015, ”Først til mølle princippet” Til:[email protected] Deltager gebyr: 300 kr., indbetales ved tilmelding på konto Nordea - Danske kr. Reg.nr. 2149 kto. 6448956669 SKIV: E-12825-01-03-02 og Navn (vigtigt at E koden sættes på, da vi ellers ikke kan se pengene er sat ind!)