Ethical considerations for paediatric trials - how can ethics committees in the European Member States and the Paediatric Committee at the European Medicines Agency work together?
Date:
29/11/2011 to 30/11/2011
Location:
European Medicines Agency, London, UK
This two-day workshop is on ethical aspects of the design and conduct of clinical trials with the paediatric population for medicine development. It is aimed at ethics committee members assessing paediatric trials, European regulators including methodology experts and participants with a scientific background or paediatric experience from ethics committees, paediatric research networks, pharmaceutical companies or contract research organisations. Registration open until 01/11/2011. Places limited.
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Ethical considerations for paediatric trials (PDF/194.59 KB)
First published: 25/10/2012
Last updated: 25/10/2012
EMA/146065/2012 -
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Agenda - Ethical considerations for paediatric trials (PDF/63.93 KB)
Draft
First published: 20/09/2011
Last updated: 28/11/2011
EMA/740227/2011 -
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Presentation - Ethical considerations for paediatric trials (PDF/1.08 MB)
First published: 16/01/2012
Last updated: 16/01/2012 -
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Presentation - Ethical principles and practices in paediatric trials: emerging issues (PDF/1.45 MB)
First published: 16/01/2012
Last updated: 16/01/2012 -
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Presentation - Evaluation of paediatric investigation plans (PIPs) and ethical aspects of the design of paediatric trials proposed in the PIPs (PDF/1.01 MB)
First published: 16/01/2012
Last updated: 16/01/2012 -
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Presentation - Industry experience with ethical review of paediatric trials: Result of survey by the European Contract Research Organisation Foundation (PDF/875.17 KB)
First published: 16/01/2012
Last updated: 16/01/2012 -
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Presentation - Lessons learned on scientific-ethical issues from the Task-force in Europe for Drug Development for the Young (TEDDY) survey among European ethics committees (PDF/2.18 MB)
First published: 16/01/2012
Last updated: 16/01/2012 -
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Presentation - Methodological issues in paediatric trial design (PDF/140.65 KB)
First published: 16/01/2012
Last updated: 16/01/2012 -
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Presentation - Results of the European Medicines Agency survey among European ethics committees (PDF/95.55 KB)
First published: 16/01/2012
Last updated: 16/01/2012 -
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Presentation - Specific issues that research ethics committees face with paediatric trials (PDF/237.8 KB)
First published: 16/01/2012
Last updated: 16/01/2012 -
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Presentation - Trials with neonates: desirable scientific approaches, their ethical issues and potential solutions (PDF/2.08 MB)
First published: 16/01/2012
Last updated: 16/01/2012 -
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Presentation - Young research subjects - old problems (PDF/1.77 MB)
First published: 16/01/2012
Last updated: 16/01/2012