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Post-approval regulatory writing – How different is it from writing pre-approval documents? - Volume 23, Issue

Regulatory writing has various facets to it with good writing skills as a preliminary requirement. Well written reports form the basis of all regulatory submissions for marketing approval and its success largely depends on the research information…

For the greater good…Can agency competitors cooperate to advance medical publication practices? - Volume 24, Issue

The business of medical writing is competitive, but can it be cooperative? Is it time for agencies, which provide professional and ethical publication support to authors, to cooperate for the greater good of the medical publication profession?…

Developing a treatment for ovarian cancer - Volume 21, Issue

Ovarian cancer is a really nasty disease. Although, like most cancers, it is curable if caught early enough, in practice it is not usually diagnosed until it is too late for curative treatment. It initially responds well to treatment and patients…

How the EU Medical Device Regulation is affecting the medical device landscape. An interview with Suzanne Halliday, the Regulatory Head of BSI, Medical Devices Notified Body - Volume 31, Issue

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…

Sluggish downloads, lagging video calls: Tips for the remote worker to tame technology - Volume 31, Issue

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…

Writing narrative style literature reviews - Volume 24, Issue

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)…

Regulatory Writing: New developments in public disclosure of clinical trials - Volume 24, Issue

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…

Medical Devices - Volume 30, Issue

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…

Interview: A career journey in sustainability: Three questions for Alex Schuman, Head of Corporate Sustainability and Diversity, Equity and Inclusion, Schrödinger - Volume 31, Issue

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 beginner´s guide to writing clinical investigation plans and reports for medical devices - Volume 31, Issue

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…

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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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