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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!)