1. Pharmacovigilance Convention Centre, Symbiosis Lavale Campus, Pune

2. Name of the Speaker: Dr. Milind Sardesai Designation: Assistant Director, Lupin Pharmaceuticals Limited Topic: Pharmacovigilance

3. 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.

4. 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

5. 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

6. Report Prepared By: Akhila Nayak Anisha Mehta Ebrahim Khan Nikhil Dhorepatil Shirin Khan Swati Sonik Yogita Patil (MBA –HHM 2013-15)