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Using social media as the patient's voice in the benefit-risk assessment of drugs: Are we ready? - Volume 24, Issue

There is no doubt that the public interest in healthcare-related issues is growing. This, coupled with the surge in the use of social media, leaves the pharmaceutical industry with a set of unique opportunities and challenges. The screening and…

Registration and ethics committee approval for observational studies: Current status and way forward - Volume 26, Issue

Randomised controlled trials (RCTs) have always been recognised as the highest level of evidence in medical research. However, they cannot address the questions that one comes across in real-world clinical practice. Observational studies can answer…

Biostatistics, data management, and medical writing: A multidisciplinary approach to the development of the CTD integrated summaries - Volume 29, Issue

Analyses of integrated databases of efficacy and safety are a Food and Drug Administration (FDA) requirement. They are very useful in evaluating the safety and efficacy data gathered in multiple clinical studies. However, their utility is dependent…

Medical writers moving the needle on patient-centred communication and engagement - Volume 34, Issue

Patient and public involvement and engagement (PPIE) in clinical trial design, conduct, and reporting provides an opportunity for patients and members of the public to provide input on what is important to them. This supports patient-centric trial…

The changing face of (benefit-)risk management - Volume 24, Issue

Over the last 20 years the focus of post-approval management of medicines has changed from risk management to the assessment and management of benefit-risk. In the EU this has been reinforced by changes in the legislation underpinning…

GPP3 – what is it, why is it necessary and what is new? - Volume 25, Issue

The good publication practice for pharmaceutical companies (GPP) guidelines were first published in 2003, then revised in 2009 (GPP2) and most recently in 2015 (GPP3). The latest version reflects the changes that have occurred in legislation…

When less is more: Medical writers as guardians of curated content - Volume 28, Issue

In this data-driven era, the type and format of publicly available medical and scientific information is significantly changing. Medical writers can serve as guardians of the information entering the public domain by ensuring accuracy and…

The Webscout - Volume 24, Issue

When thinking about the topic of this issue I questioned why for some people business is a source of fun while for others it is not. We all know that factors like time pressure, an inadequate working environment and a lack of variety in our tasks…

Letter to the Editor: Because you're worth it? - Volume 23, Issue

To the Editor – I read the recent article on the fourth EMWA freelance business survey1 with great interest and some considerable concern. When freelance writers express an interest in working with Rx Communications, one of the first things we ask…

Collecting metrics in medical writing – the benefits to you and your business - Volume 28, Issue

Collecting and using metrics may not be at the forefront of all medical writers’ minds, but they can be an important asset to writers and managers, from freelancers to those working within companies, large or small. Keeping a record of pertinent…

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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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