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Soft skills needed for freelance medical writers - Volume 32, Issue

Every professional needs to develop a set of hard skills and soft skills to grow and prosper in a designated field, and freelance medical writers are no exception. However, freelancing requires a unique combination of skills, given the independence…

Medical Devices - Volume 33, Issue

Section Editor: Payal Bhatia EMWA’s medical device expert seminar series brings together speakers with different expertise providing valuable insights into the medical device industry. Medical device Expert Seminar Series: Beyond traditional…

Innovative use of master protocols for pivotal studies in rare diseases - Volume 34, Issue

Recent years have seen the development of clinical study protocols that introduce more complex design features into the usual gold-standard randomised controlled trials (RCTs). Complex protocols are potentially useful for drug evaluation in the…

Out On Our Own - Volume 24, Issue

Editorial In this issue, Satyendra Shenoy, a member of a few years from Mumbai tells us about the tribulations – if not trials – of realising his lifelong ambition to settle in Germany. What eventually made this possible was discovering, as a…

Out on Our Own - Volume 27, Issue

One of the main reasons why the Freelance Business Group (and the whole of EMWA as well) is thriving and growing is because of the number of our members who volunteer to carry out our activities and help in implementing new initiatives. Becoming a…

Regulatory Matters - Volume 34, Issue

Section Editors: Clare Chang, Zuo Yen Lee Briefing documents: Facilitating health authority interactions Author: Clare Chang Briefing documents, essential for facilitating interactions between pharmaceutical companies and health authorities…

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)…

The work model of hybrid freelancing - Volume 32, Issue

Must we choose between a path as a self-employed, freelance medical writer, or as an in-house employee? It might come as a surprise that a medical writer can enjoy both worlds. If you dream of becoming a freelance medical writer but dread losing…

Value of medical writing: The regulatory writer's perspective - Volume 31, Issue

The American Medical Writers Association formed a working group in 2020 focused on understanding and communicating the value that regulatory medical writers contribute to project teams, companies, and the wider research community. The working…

Protection of personal data and commercially confidential information under the Clinical Trials Regulation (EU) No. 536/ 2014 – EMA “Revised CTIS Transparency Rules" - Volume 33, Issue

The Clinical Trials Regulation (EU) No 536/2014 (CTR) came in force on January 31, 2022, specifying requirements for performing clinical trials in the EU and the European Economic Area (EEA). The CTR and the Clinical Trials Information System (CTIS)…

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Scope

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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