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Paediatric Clinical Trials

Level:
Foundation
Area:
Drug Development
Code:
DDF28
Duration:
03:30:00
Workshop profile:
Medical writers, employees of the pharmaceutical industry, academic and commercial clinical research, ethics committee members and parents who are interested in paediatric drug development and want to understand the specific challenges of the child’s body when it is involved in clinical research
Objective:
Triggered by US and EU legislation, the value of clinical trials with children is now discussed more openly in public. Furthermore, pharmaceutical companies are now increasingly aware of the need to plan, prepare and report clinical trials with children.
Content:
The aim of the workshop is to familiarize every participant with the terminology, the historical background of paediatric legislation, physical and mental differences between children and adults, and the clinical paediatric landscape in Europe. This will help writers to understand the rationale behind and work within the framework of paediatric investigation plans (PIPs), paediatric clinical protocols, documentation for submission of paediatric trials to ethics committees and regulatory authorities. The workshop will comprise a mix of presentations and breakout sessions to give participants the opportunity to discuss ‘real life’ situations. Participants will learn the essentials of the physiology of children, the differences in Absorption, Distribution, Metabolisation and Excretion (ADME) of drugs in children, the growth of the different organ systems (including skin, brain, cardiovascular system, kidney, liver, and the gastrointestinal system), about specific logistic and monitoring challenges in performing clinical trials, and specific challenges in preparing the clinical study reports.