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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…
In our daily work as coaches and writing trainers, we often work with young scientists who are at the beginning of their careers. When they want to publish their first scientific research paper or when they decide to give their first lecture at an…
The EU regulatory system is undergoing a major overhaul. Several new pieces of legislation are now in place to enforce harmonisation and transparency in clinical trials while ensuring data security and individual privacy. New and aspiring medical…
As the EMA refines its requirements for the external publishing of clinical study reports, the workload of medical writing teams is increasing to include robust processes for clinical study report anonymisation. Until now, life sciences firms have…
Good writing practice is not a formal set of rules about how to write, like the requirements of GCP or GMP. Our aim is to highlight that the focus of all writers should always be on their readers, and that writers should make their texts as easy as…
Translation for medical devices often presents a unique set of challenges arising from the products’ complex natures and associated regulatory requirements. Beyond medical expertise, linguists – from translators and editors to bilingual quality…
We medical writers have a unique and valuable skill set, which includes, most notably, the ability to understand and clearly communicate complex medical information. We are also experts at working with multifunctional teams, compiling detailed…
For most of us, medical writing is highly technical. We prepare regulatory or clinical documents or write materials targeted to medical doctors. Medical writing for lay audiences is different, and it does not come naturally to most of us because…
Dear Medical Writers It is time for me to give you another brief update on the activities of the EMWA Executive Committee (EC) and our plans for 2013, as well as a short preview on the spring conference in Manchester. The autumn conference…
‘Why write a clinical study report (CSR)? What are the guidance documents? Can I interpret them? Can I deliver my CSR on time?’ This article addresses these questions – and others, provides a companion guide to CSR authoring for preregistration drug…
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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