Regulatory Update: Globalisation of Paediatric Clinical Trials
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What does it take to conduct high quality Paediatric Trials?
Legislation for paediatric trials in the US and Europe has been developed and both continenants are beginning to work closer on the harmonisation of regulations. But, there are still different interpretations at to what is acceptable and what is ethical.
Dr. Alexander Cvetkovich Muntañola, Senior Director Clinical Development, INC Research LLC Spain, explains to Pharma IQ that we need to become experts in the design of paediatric trials protocol and respect the specifics of Paediatric Trials. Added to this, trials involving different regions need to work together to further develop and train the authorities in these emerging regions so that we have a standardised approach globally.
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Tags:
Paediatric Clinical Trials
paediatric drug development
Paediatric Regulatory requirements
integrated paediatric drug development
