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Adverse event reporting: A brief overview of MedDRA - Volume 23, Issue

Since its inception 20 years ago, the Medical Dictionary for Regulatory Activities (MedDRA) has become the lingua franca of safety reporting in a regulatory context. The standardised reporting across different regulatory regions and languages is a…

Medical Communications and Writing for Patients - Volume 28, Issue

The more eagle eyed among you will have noticed that we are changing the title of this section to “Medical Communications and Writing for Patients”. Not the shortest of titles, I know, but hopefully it is a more accurate reflection of the content…

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…

Participant information – an ethics committee view - Volume 29, Issue

The participant information sheet (PIS) is one of the documents that promote most discussion and concern for research ethics committees (REC). This article looks at ways to ensure the PIS meets their requirements based on the specific experience of…

Creative medical writing: An oxymoron? - Volume 27, Issue

According to the Merriam-Webster Dictionary, creativity is “the ability to create”, and to create means “to make or bring into existence some - thing new”.1As it applies to writing, creativity is most often associated with imaginative, fictional…

Message from the President - Volume 21, Issue

Dear Medical Writers Top of Form Bottom of Form I expect I am not the only one who at this time of year looks at their calendar in disbelief and asks how on earth another 12 months can have disappeared so quickly? The end of the year is always an…

EMWA’s newest special interest group: Sustainability SIG - Volume 29, Issue

In 2015, the United Nations set 17 Sustainable Developments Goals (SDGs, Figure 1) as a “universal call to action to end poverty, protect the planet, and ensure that all people enjoy peace and prosperity by 2030”.1 Central to these SDGs is planetary…

Patient-reported outcome measure translation: An overview - Volume 27, Issue

The unique nature of patient-reported outcome (PRO) measures presents unique challenges for translation. Regulators emphasise the importance of maintaining conceptual equivalence across all languages in multilingualand multinational trials, while…

Learning and teaching clinical writing - Volume 22, Issue

Clinical writing, a specialised type of medical writing, refers to the types of writing health professionals use on a daily basis such as medical charts and forms. It requires knowledge of both formal and informal medical language and culture. An…

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…

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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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