Regulatory medical writing is an integral part of Medical Communications, but is often overlooked. In simple terms, it involves writing of the documents required for the approval of drugs by the regulatory authorities.
The regulatory authorities like FDA, Health Canada, European Medicines Agency and others assess the efficacy and safety of the drugs through all phases of their clinical trial and ultimately approve their use in patients.
Regulatory writing helps these authorities in doing so by preparing a variety of clinical documents. Starting with description and reporting of the data from clinical trials, it prepares regulatory submission documents and produces post-approval reports on the use of the treatment in patients.
Thus, a regulatory medical writer has to prepare a whole range of documents like Investigator’s Brochures, Clinical Protocols, Patient Information Sheets, and Clinical Study Reports.
While preparing such documents, he needs to work closely with study Clinicians, Statisticians, and Chief Investigators. He must understand the Good Clinical Practice (GCP) observed in clinical trials and publish the documents in accordance to the guidelines set by these regulatory authorities.
Never underestimate the importance of these high-quality regulatory documents; they add a lot of value to the clinical trial studies.
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