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PSMF and part of safety regular analysis
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Periodic Safety Reporting In India Introductory Course
PSUR is a regular document that get updated as per recent regulatory norms. It is needed for all the process related to safety surveillance and vigilance work. The PSUR have several component, it talks about the new safety information, emerging medical condition contraindicated, new information observed in the animal studies, information related to ongoing phase trials and planned post marketing surveillance studies. If a doctor and a literature report is found even this information is updated in the PSUR. Periodic report have measure of outcomes, daily dose use of the product, per day use and its impact, clinical trials, measures and its correlation with co morbid conditions. It allow authorities to take correct decisions, related to long term safety of the drug. In some case the faster approval path makes it difficult to understand the safety of the medication, or understand complete Benefit and risk ration of the drug. This presentation covers the PSUR requirement of the Guidelines of MAH for PMS safety. Chapter 3 explains the requirements and steps to be followed to prepare the report. The presentation is divided into the table of content, section of clinical trials data collection, reports of ongoing literature and safety studies, individual case reports and presentation in table format with division of source, gender and age groups.
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