New discussion: PhV in medical research - XXVI

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Dear members,Moving to POST-APPROVAL SAFETY DATA MANAGEMENTThe definition and standards for AE/ADR expedited reporting are more or less same as in Pre-Approval safety data management and that what we learnt in older posts.In this regard, lets see the concept of "Class ADR" “Class ADRs†should not automatically be considered to be expected for the subject drug (e.g.Drug X) Should be considered expected only if described as specifically occurring with the product in the

local/regional product labelinge.g. “As with other drugs of this class, the following undesirable effect occurs with Drug X.†OR “Drugs of this class, including Drug X, can cause...†likewise.Regards,Dr. Vijay M. katekhayePostgraduate StudentDept. of Pharmacology,LTMMC & LTMGH, Sion,Mumbai - 400 022 Ph - +919619313060