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From EMWA's Outgoing President Beatrix Doerr - Volume 30, Issue

Time to say goodbye! After having served on EMWA’s Executive Committee (EC) for six years in various roles, my term ended at our Spring conference in May. These have been rewarding years, with lots of work, but also lots of unforgettable experiences…

Layperson materials in the sphere of biosimilars and generic medicines - Volume 28, Issue

Generics and biosimilars offer effective treatment alternatives to branded reference drugs at a lower cost. Despite their widespread use, patients have mis conceptions regarding their efficacy and safety. Layperson materials offer an important means…

Clinical Evaluation Reports from the medical writer’s perspective! - Volume 26, Issue

Abstract Clinical evaluation is a structured ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device. The clinical data include current knowledge of the condition to be treated, published literature about the…

Writing for orphan drugs: A compass to navigate document types and regional requirements - Volume 34, Issue

Medical writing for rare diseases encompasses the development of various regulatory documents that are required to obtain orphan drug designation and marketing authorisation for treatments targeting rare conditions. Effective planning and close…

A decade of change: A new ISMPP has arrived - Volume 22, Issue

Founded originally as a not-for-profit society to provide education, advocacy, and best practices for those involved in medical publication planning, the International Society for Medical Publication Professionals (ISMPP) has grown in size to over…

The Webscout - Volume 21, Issue

Diabetes and Psychology You all may know that diabetes is a metabolic disease leading to secondary micro- and macrovascular complications, like nephropathy, neuropathy, and cardiovascular diseases. You may also know that these microvascular…

Essential investments in optimising clinical research for rare disease - Volume 34, Issue

The complexities associated with clinical trials for (ultra) rare diseases include regulatory and logistical hurdles and the challenge of building trusting relationships with health authorities, patients, and clinicians. Significant obstacles…

Risk Management - Volume 24, Issue

The thalidomide tragedy of the early 1960s cost several thousand lives, but it ultimately led to changes that will undoubtedly save many thousands more: it triggered a chain of events involving the WHO and the ICH that resulted in the…

Translating “medicalese”: The case of informed consent forms - Volume 33, Issue

Informed consent forms (ICFs) are documents used in clinical research to inform prospective participants about – and obtain their consent for – partaking in a clinical trial. Evidence suggests that ICFs may not be fit for purpose because their…

In the Bookstores - Volume 24, Issue

Do you know the difference between compliment and complement? Do you know your breeches from your breaches? Do you know why the word ‘Ghoti’ should be pronounced ‘fish’? Answers to these questions and many other interesting facts regarding the…

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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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