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ADVANCED CERTIFICATION TRAINING PROGRAM IN MEDICAL WRITING

Medical Writing is the activity of producing scientific documentation by a specialized writer. The medical writer typically is not one of the scientists or doctors who performed the research”.

Medical writing in the pharmaceutical industry can be subdivided into two broad categories: 

Regulatory medical writing: as the name suggests, deals in writing documents related to regulatory authorities e.g. FDA, EMEA, and DCGI, etc. These can include documents related to submission for receiving approval for conducting new clinical trials, submission documents for obtaining approval for marketing a drug, device, or biologic, etc. Mainly regulatory writing will consist of writing clinical study protocols, clinical study reports, informed consent forms, investigator brochures, etc. Writing of these documents has to follow important regulations and guidelines as applicable. These documents in general discuss the data a company gathers in the course of developing a medical product.

Educational medical writing: as the name suggests deals with writing educational content for a particular audience. The audience for example can be health practitioners or the general lay public. Educational medical writing in general consists of writing literature about newly launched products, making presentations for various conferences and meetings, etc.


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