Alison Cave is Chief Safety Officer at the Medicines and Healthcare products Regulatory Agency. She holds a BSc Honours degree and PhD and has significant academic research and regulatory experience with roles at Kings College London, the Wellcome Trust, UK Research and Innovation and the European Medicines Agency.
-Where does real world data fit in the evidence hierarchy for developing orphan medicines?
-What are the opportunities and challenges for using real world data generated from rare disease patients?
-How can innovative approaches help to integrate real world evidence in supporting effective decision making by different stakeholders?
-Is there good alignment between decision makers on the value of real world data?