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A survey on current use of software tools for systematic literature reviews - Volume 32, Issue

Adoption of the EU Medical Devices Regulations and In Vitro Diagnostics Regulations has led to increased demand for systematic literature reviews. This article reports on a survey investigating the current use of software platforms and tools by…

EMWA News - Volume 27, Issue

One of the benefits of being an EMWA member is having access to the webinar programme. In 2018, we are providing a new webinar almost every month of the year either in live or recordedformats. Thanks to our wonderful speakers, this year we’ve had…

Document management systems for medical writing - Volume 28, Issue

Clinical trial data are rightfully protected by robust regulations; given these requirements and increasing demands from clients, a validated and compliant electronic document management system is now a necessity for established medical writing…

New rules for artificial intelligence in Europe - Volume 31, Issue

The proposal for a European Artificial Intelligence Act is unsettling medical device manufacturers because it might change the risk assessment of their devices and cause additional efforts regarding vigilance and technical documentation. Conflicting…

Non-interventional Post-Authorisation Safety Studies (NI-PASS): A different type of report - Volume 23, Issue

Although Post-Authorisation Safety Studies (PASS) have been around since 2001, most regulatory writers would have been unaware of their existence until the recent changes in European regulations, which include mention of these studies as part of…

Pharmaceutical clinical trials transparency and privacy - Volume 29, Issue

With the introduction of new clinical trial transparency regulations around the world, transparency functions have had to adapt to a range of reporting requirements. In 2007, the FDA Amendments Act (FDAAA) established requirements for trial sponsors…

Overcoming confidential information challenges faced by study sponsors today - Volume 32, Issue

As health authorities aim to increase clinical trial transparency and visibility to the public, pharmaceutical manufacturers are facing new pressure points. New regulations require the disclosure of clinical trial application data, many of which cont…

Reveal, Rebalance, Release: Thoughts on mentoring young professionals in the industry - Volume 30, Issue

Making the first steps as a medical writer in the pharma and biotech industry can be challenging. Three general principles can help managers foster the growth and development of their team members: Reveal, Rebalance, and Release. Reveal means that…

Nanoapplications – From geckos to human health - Volume 23, Issue

Nanotechnology, the manipulation of matter on a molecular scale, is all around us in our everyday lives. Chocolate, non-dairy creamer, and sunscreen are examples of consumer products with a high content of nanoparticles. Nanotechnology holds great…

Insulin biosimilars - Volume 28, Issue

Insulin was first purified in 1921 by Frederick Grant Banting and Charles Herbert Best at the University of Toronto. Soon after, the benefits of using insulin to treat diabetes was discovered, the patent was sold to the University of Toronto for $1,…

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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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