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Protocol development is a critical milestone in the clinical drug development process for all pharmaceutical companies conducting clinical trials. A regulatory medical writer (RMW) plays a crucial role in the protocol development and peer review…
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…
The EU Medical Devices Regulation (MDR) brought about new post-market clinical follow-up (PMCF) requirements for medical devices. Whereas complaint monitoring and literature searches were often sufficient under the Medical Devices Directives (MDD),…
Excessive post-noun modification, usually as adjectival prepositional phrases, occurs fre - quently in research writing. Occurring less frequently, and less distracting, is excessive prenoun adjectival modification (i.e., stacked modifi cation). The…
Dear EMWA MembersI was asked if the time between conferences is a quiet time. Having been in post just over 2 months at the time of preparing this report, I can most definitely state – NO! New initiatives are regularly proposed and I am often…
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…
This roundup of news from the EMA includes information on vaccines to protect against dengue, therapy to treat transplant patients with post-transplant lymphoproliferative disease, the withdrawal of marketing authorisations for amfepramone…
The most successful people attribute their success to an effective mentoring network. Developing a great mentor network is critical to ensuring long-term professional development and growth. This article presents an overview of the mentoring…
In our post-truth era of media and communications, implementing a sound content strategy can help your message reach the right individuals. It is time for experts and healthcare companies to lead the change as ethical and credible sources of…
In this post-truth era we live in, the validity of facts from climate change and evolution to the shape of the earth and even vaccine safety is challenged by misinformation. As scientists,we should make greater efforts to engage with the public and…
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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