Grant: Science Policy Fellowships

Health Canada plays a critical role in authorizing drugs for the Canadian market through a thorough evaluation of the pre-clinical and clinical data provided by the industry sponsor to demonstrate the drug's safety and efficacy. In some cases, the evidence supplied by the industry-sponsored clinical trials may not be sufficient to support regulatory approval, especially in the cases of paediatric drugs which have not been systematically tested in children. As such, there is a growing need in Canada to integrate academic paediatric clinical researchers to support therapeutic product licensing and establish standards of paediatric care in Canada. This ensures that all the proper safety and efficacy endpoints are met by industry sponsors when submitting data for review by Health Canada. The goal of this Fellowship is to examine options that would allow the best use of data generated by academic clinicians for the purpose of improving regulatory decision-making.