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:
  Marți, 29 noiembrie 2011, Toată ziua
• Locație:
  European Medicines Agency, Amsterdam, the Netherlands

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.

Documents

Ethical considerations for paediatric trials

Reference Number: EMA/146065/2012

Agenda - Ethical considerations for paediatric trials

Draft Reference Number: EMA/740227/2011

Presentation - Ethical considerations for paediatric trials

Presentation - Ethical principles and practices in paediatric trials: emerging issues

Presentation - Evaluation of paediatric investigation plans (PIPs) and ethical aspects of the design of paediatric trials proposed in the PIPs

Presentation - Industry experience with ethical review of paediatric trials: Result of survey by the European Contract Research Organisation Foundation

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

Presentation - Methodological issues in paediatric trial design

Presentation - Results of the European Medicines Agency survey among European ethics committees

Presentation - Specific issues that research ethics committees face with paediatric trials

Presentation - Trials with neonates: desirable scientific approaches, their ethical issues and potential solutions

Presentation - Young research subjects - old problems

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