Webinar Topic
Extrapolation approach in paediatric clinical research: chances and bottlenecks
Webinar Date & Time
13th June 2017 from 10:00 to 11:30 (CET)
Webinar Overview
In the last decades, it has been widely accepted that the development of medicines for use in children should undergo strict qualitative, ethical and procedural rules, in order to appropriately authorise them for paediatric use.
Thus, considering the vulnerability of this population, all the efforts to minimise unnecessary studies in children have to be made. Moreover, economic burdens and methodological, feasibility and ethical issues strongly impact on the number of children that can be enrolled into a clinical trial and this becomes more complex in the case of rare diseases. For this reason, new methodological strategies have to be explored to exploit the rich source of data that are already available, especially for the adult population.
In this scenario, the extrapolation approach, intended as “extending information and conclusions available from studies in one or more source population, to make inferences for another target population”, is an important tool to adopt when planning a paediatric medicine development programme, possibly allowing for a reduction in new data to be generated for conclusion in paediatric populations.
This approach has been included in the recent ICH-E11 guideline revision and is increasingly adopted in the official paediatric development plans proposed to EMA and FDA.
This webinar will provide an overview of the use of extrapolation of efficacy and safety data in paediatric medicine development, pointing out positive experiences and difficulties. A case-study and several examples will be presented.
After this webinar, participants will have a better awareness of the opportunities and the requirements for the extrapolation approach in paediatric medicines development, with a particular insight on the regulatory scenario.
Presenters
Dr. Lucia Ruggieri
MSc in Paediatric Medicines Development and Evaluation
Researcher at Gianni Benzi Pharmacological Research Foundation
TEDDY Network Scientific Secretariat
Attendance Fee
€ 90,- for EUCROF non-members
€ 60,- for EUCROF members only.
Deadline for registration
12th June 2017
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