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Have you been commissioned to write a review? Reviews are useful for drawing attention to issues and benefits related to a product. One thing they are not, however, is something to be feared, if you are organised and have a clear idea from the…
Founded originally as a not-for-profit society to provide education, advocacy, and best practices for those involved in medical publication planning, the International Society for Medical Publication Professionals (ISMPP) has grown in size to over…
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…
A successful medical writer needs to be an excellent time manager, communicator, and team player, and show great attention to detail and commercial awareness, in addition to possessing core writing skills and the ability to evaluate and…
I'm sitting down to write this having just returned from the DIA Euro meeting in Amsterdam. As always, it was a busy and successful meeting, with many ‘themes’ of presentations being given at once. However, this year there were many presentations…
The clinical research landscape is gradually changing as we enter the era of big data. Big data sources are multiplying as existing sources collide to create expanded platforms that serve wider areas of expertise. Clinical study designs…
Laura C Collada Ali wears different hats: she is a medical writer plus a medical translator, and has extensive experience delivering multilingual authoring and translation services across a wide range of independent research organisations. She is a…
CORE Reference (www.core-reference.org) facilitates the authoring of a content-driven clinical study report (CSR) that is as “public disclosure-ready” as possible. It has potential to increase the quality of final CSRs and enhance consistency within…
Although the medical device and pharmaceutical industries are related, they are governed by distinct regulatory systems. Despite the similarities, the inherent differences between medical devices and drugs have implications for clinical research…
The new EU Medical Device Regulation 2017/745 (MDR) requires companies to provide a periodic safety update report (PSUR) and a post market surveillance report (PMSR). Creating these reports will strengthen the post market surveillance and vigilance…
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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