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The articles included in this section are a selection from the European Medicines Agency (EMA)’s News and Press Releases archive. More information can be found on the Agency’s website: www.ema.europa.eu
The articles included in this section are a selection from the European Medicines Agency (EMA)’s News and Press Releases archive. More information can be found on the Agency’s website: www.ema.europa.eu. Anuradha Alahari (editor)
The articles included in this section are a selection from the European Medicines Agency’s News and Press Release archive from July 2017 to September 2017. More information can be found on the Agency’s website: www.ema.europa.eu
Background: The European Union Clinical Trials Regulation 536/2014 (EU CTR) requires sponsors to submit summaries of clinical trial results in plain/lay language (Plain Language Trial Summaries [PLTS]). A multidisciplinary working group developed…
The post-authorisation safety study (PASS) is a pharmacovigilance activity often required as a post-marketing commitment to establish a safety profile or address specific safety concerns. An imposed PASS must be submitted in common technical…
Uri Kartoun (PhD in robotics, Ben Gurion University of the Negev, Israel) is a Staff Research Scientist and an IBM Master Inventor, co-developer of technologies such as MELD-Plus, EMRBots, Memory-memory (M2) Authentication, and Subpopulation-based…
Applications of artificial intelligence (AI)/machine learning (ML) components in drug development are growing exponentially. The trend is expected to continue. The growth has resulted in increased engagements on the part of regulatory agencies to…
Writing matters Writing matters – anything that matters in writing, or any writing that matters? I tend to interpret it the second way, but I asked Google what it thinks. It responded with some nice-to-read, worth-reading, and helpful sites. I…
Medical writing teams are crucial in the pharmaceutical industry at every stage of drug development. With growing regulatory pressure and shrinking profit margins, outsourcing these activities is considered a viable option that provides multiple…
Reviews provide a synthesis of published literature on a topic and describe its current state-of-art. Reviews in clinical research are thus useful when designing studies or developing practice guidelines. The two standard types of reviews are (a)…
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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