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Course Content
Pharmacovigilance & Its Objectives, Significance
Significance of Aggregate safety reports in patient safety and drug safety
Aggregate Reports and Its Types
Correlation between ICSR & Aggregate Reports
Basic discussion on: PBRER, PSUR, DSUR, RMP
Relation between PSUR and PBRER
General terminologies used in Medical writing
Understanding the relevant GVP modules
Points to consider while authoring a PBRER
Authoring a PBRER, PSUR, DSUR, RMP
Detailed discussion of format and presentations ofthe following ASRs
Relation between DSUR with PSUR
Risk & Benefit assessment
Quality of a great Medical writer
Professional & interpersonal Skills for being a great medical writer
Medical Writing as a career & it’s prospects
Possible interview questions & how to answer
About Course
Medical Writing
This program is designed to provide a thorough understanding of pharmacovigilance safety reports,their significance, preparation, and types. Students,who aim in working in the medical writing, pharmacovigilance, signal detection, regulatory authority and clinical research industries will benefit from this program.
