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The etiquette in clinical trial research requires companies to respect rules and to be precise and accurate. The new EU Clinical Trials Regulation 536/2014 (EU CTR) pushes companies and health authorities one step further – to be more flexible and…
All of us are aware by now that we can't live without technology and not only at work. With advice, aids, appliances and apps in abundance, we are at the point where we can't see the wood for the trees. Thank goodness we have advice from M…
The Chinese pharmaceutical regulatory landscape and medical publication policies have gone through drastic changes in recent years, and they continue to evolve. These changes provide great opportunities and many challenges to medical writers in…
Ethical and evidence-based medical communications are gaining increasing importance in emerging pharmaceutical markets, outside of North America and Western Europe. In large pharmaceutical companies resources are limited, and small and mid-sized…
A step – no a leap – forward In 2012, the journal’s precursor, The Write Stuff, became Medical Writing under the guidance of then Editor-in-Chief Elise Langdon-Neuner. The Write Stuff had been managed almost single-handedly by Elise, and the shift…
Pradaxa, a new drug for the treatment of blood clots, has been revealed to produce some negative side effects on a minor population of patients, according to a new study. However, the road leading to the publication of this study revealed that…
The 6th EMWA symposium day will focus on medical devices in general, the recent changes in the European legislations, and opportu - nities for medical writers. The symposium is for regulatory writers and medical communi - cators alike, and will…
Criticising the pharmaceutical industry is a type of sport, and it is astonishing what nonsense people will believe about it. For example, it has been said that pharmaceutical companies will only conduct a clinical trial against another product that…
Medical writing plays an integral part in the pharmaceutical industry, be it for originator or generic drug companies. Most writers are working for medium to large research-based companies. However, even for generic drug firms many documents need to…
The prerequisite for obtaining marketing authorisation is an appropriate and robust data package that demonstrates a medicinal product’s quality and its efficacy and safety in the proposed indication. Pharmaceutical companies can face regulatory…
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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