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A useful reference for writing pharmacovigilance documents Like other areas of medical writing, pharmacovigilance (PV) medical writing has many detailed regulations, guidance documents, and templates associated with it. As such, there is a…
Over the last 20 years the focus of post-approval management of medicines has changed from risk management to the assessment and management of benefit-risk. In the EU this has been reinforced by changes in the legislation underpinning…
A risk management plan (RMP) is a complex regulatory document which is now required in the European Union as part of a medicine's approval process. This article offers practical guidance for medical writers who are interested in writing an RMP. In a…
For me, the most difficult task of medical writing is clicking that “SEND” button. After more than15 years in this field, the decision to send out and share a document with colleagues, regulatory authorities, even the public, is always accompanied…
Pharmaceutical regulatory medical writing for document submissions to Western health regulatory agencies has been undertaken in India for almost 10 years. From humble beginnings in a couple of non-Indian pharmaceutical multinational giants –…
As health authorities aim to increase clinical trial transparency and visibility to the public, pharmaceutical manufacturers are facing new pressure points. New regulations require the disclosure of clinical trial application data, many of which cont…
The sharing of individual participant-level clinical data is now an almost routine extension of the clinical study life-cycle, and increasingly a vital element of leveraging real-word data. Responsible clinical study data sharing of appropriately…
Spotlight on similar devices under the Medical Device Regulation This article evaluates the potential of similar devices in clinical documentations, such as clinical evaluation plans (CEPs), clinical evaluation reports (CERs), and post-market…
Writing matters to medical writers … or at least it should. But sometimes we are more consumed with the content of a document than the writing itself. And some might even argue that detailed medical or scientific information cannot be written as…
Race and ethnicity are not clearly defined in biomedical literature and misaligned with genomics and epigenomic findings; the guidelines for consistent reporting in publications and regulations from health authorities are lacking. Minority…
Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.
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