药代动力学与实验治疗学杂志

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Process Optimization and Role of Artificial Intelligence in Global Pharmacovigilance

Dr. Ujjawala Salvi

To optimize Pharmacovigilance operations from cost effective, compliance, and safety perspectives is the need of the hour. A structured methodology for assessing drug safety operations has helped companies increase compliance at reduced cost.

 

To recognize the need to conduct process analysis, developing and prioritizing project portfolio, performing the analysis, and finally implementing the findings covering all Pharmacovigilance activities: case processing activities such as case intake, data entry, assessment and reporting and signaling activities such as signal detection, evaluation and risk management.

 

Managing Business Processes to Improve and Optimize Case Processing

Planning - the first step Control - the final say Process Improvement Methodology - assessment and improvement Assessing case processing - flow charts and pain points Improving case processing - identify redundancies,