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Medical device manufacturers must continuously evaluate all clinical data available for their products marketed in Europe. With the European Medical Device Regulation 2017/745 coming into force in May 2021, manufacturers are required to assess…
April, 6, 2017 – Following two years of experience with safety monitoring of nationally authorised medicines via the single assessment of periodic safety update reports (PSURs), the EMA has issued additional guidance and recommendations as part of…
Dear Editor, EMWA and other organisations (eg, AMWA, ISMPP) support the principles of Good Public at - ion Practice (GPP). As a co-author of the recent GPP3 guideline1 and leader of the professional medical writer section, I was concerned by a…
The Investigator's Brochure (IB) is a multidisciplinary document that summarises the main elements of an entire development programme to date. Although the IB also serves other purposes, it is primarily written to enable investigators conducting…
The rapid growth of mobile health (mHealth) led to the development of internationally harmonised guidance for software as a medical device (SaMD) by the International Medical Device Regulators Forum (IMDRF), covering definitions, risk…
Following an extensive period of drafting, consultation, negotiation, and re-drafting the new European Legislation came into effect in July this year. The new measures will be the biggest change to medicines legislation since the creation of the…
For most of us, medical writing is highly technical. We prepare regulatory or clinical documents or write materials targeted to medical doctors. Medical writing for lay audiences is different, and it does not come naturally to most of us because…
The preparation of pharmacovigilance documents is a global and cross-functional activity. The pharmacovigilance medical writer has a key position in this complex activity, leading the whole document creation process. This process includes drafting…
Dear EMWA Members, When we surged en masse onto the dance floor at the Dublin Conference Spring Dinner, supercool ceilidh band ‘Perfect Friction’ were astonished, wondering ‘…what are these medical writers all about?’ We certainly breathed life…
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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