Pharmacovigilance
Convention Centre,
Symbiosis Lavale Campus, Pune
Name of the Speaker: Dr. Milind Sardesai
Designation: Assistant Director, Lupin
Pharmaceuticals Limited
Topic : Pharmacovigilance
SUMMARY
• Sir started with the definition of Pharmacovigilance.
• Pharmacovigilance is a science and activities relating
to the detection, assessment, understanding and
prevention of adverse effects or any other possible
drug related problems.
Pharmacovigilance Aims :
1. Early detection
2. Detection of increase in frequency
3. Identification of risk factors
4. Quantifying risks
5. Preventing patients from being affected unnecessarily
PV activities
Case processing & aggregate reporting
Signal detection & risk management
Integrated approach in Pharmacovigilance
• Pre-marketing risk assessment
• Integrated safety
• Approval
• Post marketing safety assessment
• Re-assess & modify
• New safety information
SOP in ethics committee
Informed consent & safety reports
Protocol development & clinical trial documentation
Report Prepared By:
• Akhila Nayak
• Anisha Mehta
• Ebrahim Khan
• Nikhil Dhorepatil
• Shirin Khan
• Swati Sonik
• Yogita Patil
(MBA –HHM 2013-15)