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 Regulatory Matters
					 - Volume 32, Issue
				Regulatory Matters
					 - Volume 32, Issue 
			
		Current clinical trial disclosure landscape in China Author and Section Editor: Zuo Yen Lee Section Editor: Clare Chang In China, before the launch of the current national clinical trial registry in 2013, i.e., ChinaDrugTrials.org.cn…
 Biomanufacturing and One Health
					 - Volume 32, Issue
				Biomanufacturing and One Health
					 - Volume 32, Issue 
			
		At a time when the scope of One Health is expanding, the term “biomanufacturing” has taken on new significance as a new route to more sustainable manufacturing in the face of the current overwhelming reliance on fossil resources for fuel, energy,…
 President's Message
					 - Volume 32, Issue
				President's Message
					 - Volume 32, Issue 
			
		Moving to the virtual space… EMWA’s fall conference was a virtual event, but with a twist – local hubs were established to permit a face-to-face experience for participants in Benelux, France, Germany, Italy, Portugal, Serbia, and Switzerland. In…
 The role of translators: Adaptation of mental health tests beyond clinical research
					 - Volume 33, Issue
				The role of translators: Adaptation of mental health tests beyond clinical research
					 - Volume 33, Issue 
			
		This article explores the role of translation and translators within the process of test adaptation. With similarities to the linguistic validation process in clinical research, test adaptation is a complex multistep and iterative process in which…
 Translating “medicalese”: The case of informed consent forms
					 - Volume 33, Issue
				Translating “medicalese”: The case of informed consent forms
					 - Volume 33, Issue 
			
		Informed consent forms (ICFs) are documents used in clinical research to inform prospective participants about – and obtain their consent for – partaking in a clinical trial. Evidence suggests that ICFs may not be fit for purpose because their…
 Localisation of promotional materials for pharma
					 - Volume 33, Issue
				Localisation of promotional materials for pharma
					 - Volume 33, Issue 
			
		Unwarranted changes by the client, lengthy approvals, and multiple rounds of revision – localisation of promotional materials for pharmaceutical companies can become a nightmare if the localisation specialist is unaware of heavy regulations in the…
 The ethics of medical translation
					 - Volume 33, Issue
				The ethics of medical translation
					 - Volume 33, Issue 
			
		Much has been written about the ethics of medical interpreting, but not so much about purely written translation. What moral principles apply (or should apply) when I translate a document for a client? Do I need to invent these principles myself, or…
 Plain language summaries of clinical trial results: What is their role, and should patients and AI be involved?
					 - Volume 33, Issue
				Plain language summaries of clinical trial results: What is their role, and should patients and AI be involved?
					 - Volume 33, Issue 
			
		Plain language summaries (PLSs) of clinical trial results are vital tools in the clinical development process for enhancing transparency and encouraging and facilitating patient engagement. The production of a PLS is now mandated in the EU for all…
 Population diversity in clinical trials for rare diseases: A regulatory writer’s perspective
					 - Volume 34, Issue
				Population diversity in clinical trials for rare diseases: A regulatory writer’s perspective
					 - Volume 34, Issue 
			
		Ensuring population diversity in clinical trials is essential yet challenging and increasingly complex in the rare disease landscape. The unique challenges in clinical development for rare diseases include limited medical and scientific knowledge,…
 Essential investments in optimising clinical research for rare disease
					 - Volume 34, Issue
				Essential investments in optimising clinical research for rare disease
					 - Volume 34, Issue 
			
		The complexities associated with clinical trials for (ultra) rare diseases include regulatory and logistical hurdles and the challenge of building trusting relationships with health authorities, patients, and clinicians. Significant obstacles…
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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