Requirements for running clinical trials in paediatrics for the EU (Clinical Training)
Venue: Online Event
|Event Date/Time: May 19, 2011||End Date/Time: May 19, 2011|
Serious medication errors due to the off-label and unlicensed use of medicines in the paediatric population have led the EMA and the FDA to develop the regulations for testing medicines in the paediatric population. The Paediatric Regulation in the EU mandate pharmaceutical companies test medicines on children. It is essential that children have safe, effective medicines but this needs to be balanced against the money companies will make. Pharmaceutical companies therefore need scrupulous ethical safeguards to ensure fully informed consent from parents and assent from the children. This will facilitate children's research needs and refute accusations of using children for profit.
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