Real-world data to real-world evidence for assessing efficacy and effectiveness: Opportunities and challenges for new medicines development, regulatory review and health technology assessment

23-24 JUNE 2016 TYSONS CORNER, VIRGINIA, US

Workshop objectives

  • Discuss how sources of real-world data and the special analytics being applied to them could provide a robust platform for the collection and use of real-world evidence in company, regulatory and HTA decision making.
  • Identify the types of data sources, collection technologies and methodologies that could provide robust, fit-for- purpose information and the potential hurdles for these being used in regulatory and HTA decision making.
  • Recommend the opportunities for use of new collection and analytical methodologies and technologies using RWD to enable the assessment of efficacy and effectiveness in the post-authorisation period.