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A medical writer’s perspective on the relationship between EMA Policy 0070 and the General Data Protection Regulation
Advances in software and its application in a medical device and as a medical device have opened the door for many new technological capabilities in healthcare. Around the globe, government agencies have begun to take a heightened interest in how…
Pesticides, also known as crop protection products, are approved for sale through a process similar to that for authorising human medicines. For example, the toxicology data submitted are nearly identical to the nonclinical data generated for a…
The EU regulatory system is undergoing a major overhaul. Several new pieces of legislation are now in place to enforce harmonisation and transparency in clinical trials while ensuring data security and individual privacy. New and aspiring medical…
In 2015, the EMA Policy 0070 came intoeffect as part of EMA’s commitment toincreased data transparency. In short, clinicalreports included in regulatory applications forexample, marketing authorisations are pub -lished on the EMA web page and…
The thalidomide tragedy of the early 1960s cost several thousand lives, but it ultimately led to changes that will undoubtedly save many thousands more: it triggered a chain of events involving the WHO and the ICH that resulted in the…
Due to the increasing demand for phytochemicals, plant in vitro cultures are a noteworthy, environmentally sustainable method, enabling the biotechnological production of bioactive compounds. Medical writers can find writing scientific articles in…
AbstractIncreased transparency is one of the provisions of the Clinical Trial and Medical Device Regulations. This article discusses the impact of transparency and disclosure on medical devices. Many modern-day medical devices are software-driven.…
The surge in artificial intelligence (AI) prompts a reassessment of linguistic validation methods for patient-reported outcome (PRO) measures. The robust linguistic process, designed to adapt PRO measures for different cultures and languages, is…
In the December 2014 issue of Medical Writing, I reported that disgraced Iowa State University researcher Dong-Pyou Han was facing fraud charges for faking experiments on a new HIV vaccine.1 In spite of a guilty plea, on 1 July 2015 Dr Han was…
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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