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A medical writer’s perspective on the relationship between EMA Policy 0070 and the General Data Protection Regulation
Anuradha Alahari (section editor) EMA recommends revocation of authorisation for sickle cell disease medicine Adakveo OPEN framework extended to a wider range of medicines Global regulators agree on way forward to adapt COVID-19 vaccines to…
Estimands represent a new way to look at key aspects of clinical research and will become increasingly important for medical writers. Estimands are detailed definitions of quantities to be estimated using clinical trial data, which make allowance…
The first thing we must say is a huge “thank you” to Dr Juan Garcia Burgos and Mr Paul Blake for taking the time in an unprecedentedly manic year for the EMA to write a foreword for this issue of Medical Writing. The fact that they have prioritised…
The new European medical device regulation and guidance document on clinical evaluation An Interview with Dr Bassil Akra The successor of the currently applicable Medical Device Directives (MDD 93/42/EEC and 90/385/EE) combines both directives…
The Medical Device Regulation (MDR) mentions the term “Clinical Development Plan” (CDP) only twice, both of which are in than the MDR into what the CDP entails and to propose the best strategies for a manufacturer to plan their medical…
As the EMA refines its requirements for the external publishing of clinical study reports, the workload of medical writing teams is increasing to include robust processes for clinical study report anonymisation. Until now, life sciences firms have…
"From the Editor-in-Chief: Journal Watch is the re-birth of a previous column edited by Nancy Milligan. We are happy to welcome Hervé Maisonneuve, MD as the new Section Editor for Journal Watch. Hervé is a contributing editor for several scientific…
Bad Pharma provides a hyper-critical account of the pharmaceutical industry's approach to conducting, publishing and using clinical research and development. However, its attack on the drug regulators is unfair and its examination of the medical…
Both the federal Plain Writing Act and the mission of the US Centers for Disease Control and Prevention (CDC) to protect and promote people's health require CDC to communicate clearly so that people can understand and act on the important health…
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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