James M Visanji

Contributions

Regulatory submissions of non-interventional post-authorisation safety studies - Volume 26, Issue 3

The post-authorisation safety study (PASS) is a pharmacovigilance activity often required as a post-marketing commitment to establish a safety profile or address specific safety concerns. An imposed PASS must be submitted in common technical…

Medical writing for cancer trials and submissions - Volume 21, Issue 1

Cancer is currently a high-priority area for drug development. Most cancers are immediately life-threatening diseases demanding urgent treatment and therapies are usually highly toxic. This poses a range of specific challenges for the ethical…

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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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