PVG – PSMF – System Master File Management-India (Complete) | Project Management Online Course by Udemy

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PSMF, RMP, ISCR, PSUR, Audit, SOP, Check List, QMS, Terminologies, Forms, Call Handling ADR forms, Narratives, examples

An excellent training about Project Management

PVG – PSMF – System Master File Management-India (Complete)

Indian MAH guidelines to comply with pharmacovigilance is published by regulatory authorities. This guidelines have 6 modules, our training program covers 6 modules, you have got a presentation of general guidelines, QMS, Quality control procedures, SOP needed for the process, Risk management plan, ICSR processing, review, narrative and coding, call handlers for adverse events, submission, procedure for collection of information for PSUR, TOC, check list of all modules, conducting audit for internal and external PVG & preparation for inspections. It does not cover one portion on signal detection as it is a complete different science.

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