Expediting patients’ access to medicines: Solutions to simultaneous submissions and approvals
20-31 March 2009, Surrey, UK
Major companies engaging in global development programmes are currently trying to reduce the development time in worldwide markets. Ideally, companies are looking for a global development programme that will lead them to simultaneous submissions and approvals. However this is juxtaposed by a perception of approval delays, rising requests for further clinical data, and greater chances of divergent outcomes.
It is hoped that the utilisation of new technologies that have the potential to better define patient populations and the efficacy and safety parameters for new medicines will enable a more predictable regulatory approval process and outcome. Companies and agencies are seeking ways to improve the efficiency and quality of clinical research, including innovative trial designs, use of new technologies/ biomarkers and pharmacogenomics. This workshop explored how these initiatives are progressing and discovered if they will enable companies to achieve global simultaneous submissions and approval to ultimately expedite patients’ access to new medicines.