Hello Guys,
Nowadays, Automation and Artificial Intelligence (AI) in Pharmacovigilance is a “Buzz” word in Pharmacovigilance industry.
Automation empowers organizations to recognize greater efficiency, quality of work and the speed at which manual tasks can be accomplished while re-directing valuable resources to focus on higher-order tasks.
Automation helps in addressing the global requirements of detection, assessment and understanding of drug-related problems including signal detection, risk management, adverse event reporting etc.
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| Automation and Artificial Intelligence (AI) in Pharmacovigilance |
Why Pharmacovigilance (PV) Automation is need of an hour?
- Rapid increase in volume of adverse event (AE) cases
- Strict and complex Global regulations
- Cost minimization
- Data science and automation evolving for signal detection and case management
- More focus on risk/benefit analysis and signal management
- Need for advanced safety data analytics tools
- Focus on patient centricity
What are different Automation Platforms in Pharmacovigilance?
It includes
- Artificial Intelligence (AI)
- Machine Learning (ML)
- Robotic Process Automation (RPA)
- Natural Language Processing (NLP)
- Big Data Analytics
How Automation helps in Pharmacovigilance process?
- Reducing ICSR Case Processing Time
- Improved Employee Productivity
- Reducing Literature Screening Time
- Enhanced Signal Management Processing
- Cost Savings
- Improvements in Drug’s Risk-Benefit Profile
Traditional PV process vs. Automation PV process
Traditional PV process involves following steps:
- Receive and reconcile Adverse Events
- Case triage and checking case validity
- Duplicate check and data entry in PV database
- Quality check
- Validate & review uploaded AE data
- Report generation
Automation PV process involves following steps:
- Case owner open the case
- Automated retrieval of cases, prioritization, validating details and updating status
- Perform duplicate check & uploading data in PV database and data entry
- Case now open for QC & reports
If you would like to know more details about Automation in Pharmacovigilance, I am providing links for recorded sessions.
I hope you got some clarity on Automation and Artificial Intelligence (AI) in Pharmacovigilance. Please comment and share with your colleagues.
Regards,
PV Drug Safety Academy