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Some considerations on the safety evaluation section of clinical study reports for studies with anticancer drugs - Volume 21, Issue

The International Conference on Harmonisation (ICH) guideline E3 describes the structure and content of clinical study reports (CSRs). However, this standard structure should be interpreted according to the type of study and data, including…

Lay summaries for Phase 1 trials in healthy volunteers - Volume 29, Issue

Lay summaries of Phase I trials in healthy volunteers pose a challenge because their endpoints are complex, the targeted indication may not be known when they are conducted, their results are often reported years after the trial ended, and the…

Writing applications for Paediatric Investigation Plans and waivers - Volume 21, Issue

Under EU legislation, a Paediatric Investigation Plan (PIP) and/or a waiver must be agreed in advance with the European Medicines Agency (EMA), for all new medicinal products seeking marketing authorization; the same applies for already authorized…

My medical writing journey: How I discovered self-mentoring and used it to improve my career and life - Volume 30, Issue

Medical writers can greatly benefit from receiving mentorship, mentoring others, and learning how to keep themselves accountable through self mentoring. Through mentorship, they can get unique advice to accelerate their career development and…

Origin and development of English for Medical Purposes. Part II: Research on spoken medical English - Volume 23, Issue

In the second part of the review on ‘English for Medical Purposes’, I present the main results of the research conducted on spoken interaction in medical settings. I start with those EMP studies that have a clear pedagogical goal, followed by EMP…

Thriving (and not just surviving) in a VUCA healthcare industry - Volume 28, Issue

VUCA stands for volatility, uncertainty, complexity, and ambiguity. The healthcare sector is considered a VUCA industry, constantly changing through rampant mergers and acquisitions, rapidly evolving regulations, and leading-edge innovations. So how…

Changing methods to assess targeted therapies in oncology - Volume 27, Issue

New methods have been developed to evaluate targeted therapies, since the classic sequence – phase I, toxicity; phase II, efficacy; phase III, comparison with standard treat ment – is no longer effective for evaluating these new treatments. In…

In this issue… The Medical Writing Business - Volume 24, Issue

As medical writers, we strive not just to survive but to thrive. Threats, opportunities, and complications come from many directions, and how to best position ourselves, our departments, and our companies requires much thought. Money is important…

From EMWA's new President Carola Kraus - Volume 30, Issue

A year of EMWA firsts has passed and while we are still not in a post-pandemic phase, one can see that our profession has regained its momentum. In the past, you might have experienced the need to explain to family members and friends what “medical…

In this issue of Medical Writing - Volume 23, Issue

Some of you might remember the old days when writing was done with a typewriter, spreadsheets were big pieces of paper, and slides were printed on film. Thanks to computers, these are old memories, and we can all be much more productive. Software…

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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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