Paediatric Medicines in the 21st Century

Venue: NH Berlin

Location: Berlin, Germany

Event Date/Time: Apr 23, 2007 End Date/Time: Apr 25, 2007
Early Registration Date: Feb 21, 2007
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Time has come to act. Find answers to the ethical debate, and to the question of how to best
integrate paediatric drug development into the global development process.
Many medicines to date used to treat children are either not licensed for use in children or are
prescribed outside the terms of their product licence (off-label prescription), transferring the
responsibility and liability of prescribing them to the treating paediatricians/physicians. This has
come as a result of legislative changes that caused fewer drugs to be recommended for use in
children due to insufficient clinical evidence of safety and efficacy more than 40 years ago.
Decades later the International Conference on Harmonisation (ICH) developed the first guidelines
for Good Clinical Practice (GCP), which led to the first passing of US Paediatric Legislation. Nine
years later the EC passed the EC Paediatric Regulation of the Development of Medicines for
Children, which came into force 26 January 2007. What has long been established practice in
the US under the Paediatric Exclusivity Provision Act, due to sunset in 2007, has now come into
force in Europe, demanding companies to address the important issue of dosing by testing
certain drugs - both new and already marketed medicines - in children. Many medical professionals
support paediatric clinical trials to avert fatal mistakes, and ethical guidelines on the conduct
of clinical trials involving children have recently been issued.
Listen to leading authorities and learn about:
ð¯ The current status of regulation and legislation in paediatrics
ð¯ How the FDA and EMEA can establish a way forward together
ð¯ Issues concerning the ethics of clinical trials in children
ð¯ Paediatric aspects in the general drug development process
ð¯ The decision making process in the development of pre-approved off-patent and
novel paediatric medicines
ð¯ Ways of optimising the clinical development process