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Key factors a pharmaceutical company should consider while outsourcing medical writing services - Volume 23, Issue

Medical writing teams are crucial in the pharmaceutical industry at every stage of drug development. With growing regulatory pressure and shrinking profit margins, outsourcing these activities is considered a viable option that provides multiple…

Setting up and running a medical writing company - Volume 24, Issue

I am the founder and managing director of Scinopsis, a medical writing company based in France. Scinopsis is specialised in providing regulatory documents and medical communications to the pharmaceutical, biotechnology, and medical device…

Challenges of paediatric drug development and impact of paediatric legislation - Volume 21, Issue

Medical writers are increasingly involved in designing and documenting overall plans in paediatric drug development, e.g. EU PIPs (Paediatric Investigation Plans) and individual components, e.g. protocols and study reports. It is essential to…

Medical affairs writing: A key role to relay medical information to everyone - Volume 25, Issue

Medical Affairs is a link between the scientific and marketing units of a pharmaceutical company. Medical writers in this field are responsible for writing varied document types from regulatory reports to scientific publications, and marketing…

Editorial: Pharmaism - Volume 22, Issue

Criticising the pharmaceutical industry is a type of sport, and it is astonishing what nonsense people will believe about it. For example, it has been said that pharmaceutical companies will only conduct a clinical trial against another product that…

Regulatory Writing Briefing documents: A case apart - Volume 24, Issue

Health authority briefing documents (also known as briefing packs, briefing packages, and briefing books) are documents prepared by a pharmaceutical company to support its interactions (e.g. pre-submission meetings, requests for scientific advice,…

Journal Watch - Volume 21, Issue

Readability of informed consent forms, sponsor participation in industry trials, and conflict of interest disclosure. Informed consent is a crucial feature of clinical research trials. Guidelines on developing an informed consent form urge writers…

Writing for mixed-media training programmes - Volume 25, Issue

Effective learning and development tools are important in spreading and consolidating knowledge within any pharmaceutical or biotechnology company. Medical communications professionals may be involved in creating training materials for many…

Medical Communications - Volume 26, Issue

Dear all,The legal side of our job is something that most of us usually give little thought to. We assume that as scientists, we are automatically on the “right side” and therefore pretty bulletproof. Why should the law affect us, as longas we have…

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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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  • Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)

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