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Pharmacovigilance Convention Centre, Symbiosis Lavale Campus, Pune PowerPoint Presentation
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Pharmacovigilance Convention Centre, Symbiosis Lavale Campus, Pune
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  1. Pharmacovigilance Convention Centre, Symbiosis Lavale Campus, Pune

  2. Name of the Speaker:Dr. MilindSardesai 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 : • Early detection • Detection of increase in frequency • Identification of risk factors • Quantifying risks • 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: • AkhilaNayak • Anisha Mehta • Ebrahim Khan • Nikhil Dhorepatil • Shirin Khan • Swati Sonik • YogitaPatil (MBA –HHM 2013-15)