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A shot at demystifying the risk management plan for medical writers - Volume 24, Issue

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…

From the Editor - Making responsible decisions – every day - Volume 30, Issue

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…

Medical writing in India at a crossroads - Volume 22, Issue

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 –…

Medical Devices - Volume 33, Issue

Section Editor: Payal Bhatia Mastering the art of the state of the art (under EU MDR 2017/745) Author: Clotilde Jumelle Establishing the state-of-the-art (SOTA) represents a crucial aspect of a clinical evaluation under the European Medical…

Overcoming confidential information challenges faced by study sponsors today - Volume 32, Issue

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…

Unlocking the potential of patient data through responsible sharing – has anyone seen my keys? - Volume 29, Issue

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…

Writing Matters - Volume 21, Issue

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…

Medical Devices - Volume 32, Issue

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…

Race and ethnicity in biomedical literature: A narrative review - Volume 31, Issue

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…

Plain language summaries of clinical trial results: What is their role, and should patients and AI be involved? - Volume 33, Issue

Plain language summaries (PLSs) of clinical trial results are vital tools in the clinical development process for enhancing transparency and encouraging and facilitating patient engagement. The production of a PLS is now mandated in the EU for all…

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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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