"Transforming Pharmacovigilance with
AI-Driven Predictive
Analytics and Big Data"
SUBMTTED BY SUBMITTED TO
Name: RAJU KUMAR
Enrollmentno.: 206/BPH/DIPSAR/2021 Professor (Dr.) P.K. SAHOO
Roll no.: 1332106 (Registrar DPSRU)
INTRODUCTON
Benefits of
Pharmacovigilance
Patient safety
Public health
Rational use of drugs
Risk management
Drug quality
Secondary benefits
Faster detection of adverse events
Improved data quality
Challenges in Manual
Pharmacovigilance
Data Volume and Complexity
Inconsistent Data Quality
Labor-Intensive
Time consuming process
Regulatory Compliance
Integration with Other Systems
Concept of AI in
Pharmacovigillance
AI refers to the simulation of human intelligence processes by machines, including learning,
reasoning, and self-correction.
Types of AI
Narrow AI: which is designed for a specific task
General AI: which has human-like cognitive abilities across a range of tasks.
Application of artificial
intelligence in
pharmacovigilance
ADVERSE EVENT DETECTION PREDICTIVE SAFETY ANALYTICS
SIGNAL DETECTION AND ASSESSMENT ENHANCEMENT OF CINICAL TRIALS
PERSONALIZED MEDICINE AND DRUG SAFETY COMMUNICATION
PHARMCOGENOMICS
PATIENT-REORTED OUTCOME MONITORING
AUTOMATION OF ROUTINE TASKS
DRUG REPOSITIONING AND REPURPOSING
SENTIMENT ANALYSIS
MEDICATION ERROR DETECTION
DRUG INTERACTION PREDICTION
POST MARKETING SURVIELLANCE
ENHANCED DATA INTEGRATION
AI COMPLIANCE
Al compliance is a process that involves making sure those Al-powered systems are compliant
with all applicable laws and regulations.
It includes checking that companies and individuals do not use Al-powered systems to break any
laws or regulations
It ensures that the data used to train Al systems is collected and used legally and ethically;
Al compliance guarantees that Al-powered systems are not used to discriminate against any
particular group or individual and are not used to manipulate or deceive people in any way;
It involves verifying that nobody uses Al-powered systems to invade individuals' privacy or cause
any harm to them;
Why is Al Compliance
Important
Al compliance is essential for various reasons: first, it ensures that organizations use Al legally
and ethically. Somebody can use Al-powered systems to make decisions that significantly impact
individuals.
Organizations must ensure that these decisions comply with applicable laws and regulations.
Second, Al compliance helps to protect organizations from potential legal and financial risks.
Suppose authorities find an Al- powered system to be non-compliant. In that case, organizations
may be subject to fines, penalties, or other legal action. Finally, Al compliance helps to protect
the privacy and security of individuals. Al- powered systems can collect and process large
amounts of personal data.
Organizations must ensure that this data is collected and used legally and ethically, or they may
face hefty fines.
