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The European system of approval of new medicines comprises an European Union (EU)-wide authorisation procedure (the so called centralised procedure) alongside national procedures based on different EU Member States working together and recognising…
Science at the multilingual crossroads With Medical Writing's third issue, this seems to be a good time to recall why this journal features a section on multilingual aspects – and why this section is called what it's called. Medical writing,…
Every member of a working group or a team has a defined role, such as that of a leader or a mentor. Although every role has its own distinct definition, a great mentor can be a great leader and vice versa. One of the finest mentor leaders, explorer…
Suzanne Halliday, D.Phil., is the Vice President for Regulatory within the Notified Body BSI with extensive experience in compliance to the Medical Devices Directive (MDD), ISO 13485, risk management, clinical evaluations and investigations, meeting…
What are the various broadband options to consider when working from home and how can you ensure you’re getting the best from yours? Broadband failures can mean a headache for your clients and you risk looking unprofessional, so having a backup…
Reviews provide a synthesis of published literature on a topic and describe its current state-of-art. Reviews in clinical research are thus useful when designing studies or developing practice guidelines. The two standard types of reviews are (a)…
In April this year, the World Health Organisation (WHO) issued a statement on the public disclosure of clinical trial results (the full statement is available from http://www.who.int/ictrp/results/reporting/en/). In essence, this statement…
Hello, medical device fans! Social media is increasingly integrated into all aspects of our daily lives, even for many of you non-digital natives (myself included). In this issue, we look at how the medical device industry is beginning to utilise…
Many pharmaceutical and medical device companies are making huge environmental, social, and governance (ESG) commitments, such as striving to achieve carbon neutrality, and aiming to reach diversity, equity, and inclusion (DEI) goals. In order to…
A clinical investigation plan for a medical device must outline and justify all objectives of the clinical investigation, present and justify the investigational design and methodology, and state principal features of the statistical analysis. A…
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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