The Development Safety Update Report (DSUR) is a structured document intended to submit to the health authorities for the drugs under developmentannually. The DSUR include the comprehensive and thoughtful information based on the annual review and evaluation of the safety information collected during the reporting period from the drug developmental program irrespective whether or not it is marketed. Since the DSUR include an annual review of the information, huge flow of the information can be expected from the different stakeholders for the particular DSUR which should be analyzed, process and finalized within the stipulated timeline. In order to overcome this challenge we developed a SPEED concept in house for the effectively managing the time and preparation of the DSUR with higher accuracy. This concept utilizes, 1. Day -90 approach 2. Effective resource and workload management 3. The DSUR coordinators Following this concept, we achieved a significant improvement in the DSUR process and achieve improved overall DSUR quality under stringent timelines.
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