European Society for Developmental
Perinatal and Paediatric Pharmacology

28 - 30 May 2019, Basel, Switzerland

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Thursday May 30, 2019


OSAKA ROOM – 09:00-18:30

09:00 – 09:30

Welcome and introduction to the educational symposium

Kalle Hoppu

09:30 – 10:00

General introduction to the theme of the symposium
• The concept of children as “Therapeutic Orphans”
• Off-label and unlicensed use of medicines in children
• The paediatric initiatives (US, EU, WHO)    

Kalle Hoppu

10:00 - 11:00

Basics of developmental/paediatric pharmacology
• Birth to adulthood, pharmacodynamics and pharmacokinetics
• Considerations of dose calculation
• Routes of administration in children

Greg Kearns

11:00 - 11:30  Break

11:30 - 12:00

Drug safety in children
• Are adverse effects more common or rare in children?
• Adverse effects related to or affecting growth and development
• Dosing errors                  

John van den Anker

12:00 -12:30

Pharmacological aspects in case of severe disease in children in relation to the pharmacodynamics and pharmacokinetics?

John van den Anker

12:30 – 13:30  Light lunch

13:30 - 14:00

When evidence is absent can we extrapolate data from  adults to children or should we do clinical trials?
• Off-label or off-knowledge use of medicines?
• Experimental therapy vs. clinical trials

John van den Anker

14:00 - 15:00

Paediatric formulations
• Formulations most suitable for use in children
• Considerations of excipients used in paediatric formulations
• Extemporaneous formulations    

Greg Kearns

15:00 – 15:30

Ethical aspects of drug research in children

Greg Kearns

15:30 – 16:00 Break

16:00 – 16:30

Understanding the basics of drug development in children
• Finding the right dose
• Demonstrating efficacy
• Demonstrating safety
• Regulatory assessment and why it is important

Kalle Hoppu

16:30 - 17:00

What you need to know as an investigator of a paediatric clinical trial
• What is a good study and what is not
• Good Clinical Practice (GCP)
• Recruiting children for a study
• Protocol deviations
• Adverse Events               

Greg Kearns

17:30 - 18:00

Questions and General Discussion


Kalle Hoppu

18:00 - 18:30

Summary & Closing of the meeting (including evaluation)

Kalle Hoppu

Information about speakers:

Kalle Hoppu is an Associate Professor of Pediatric Clinical Pharmacology at the University of Helsinki, Finland

Gregory Kearns is President of the Arkansas Children’s Research Institute and Chief Research Officer at Arkansas Children’s Hospital

John van den Anker is the Eckenstein-Geigy Distinguished Professor of Paediatric Pharmacology at the University of Basel Children’s Hospital in Switzerland and President of the European Society for Developmental Perinatal and Pediatric Pharmacology (ESDP)