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Pharmacovigilance
- Volume 32, Issue
Ecopharmacovigilance: A review of cause, impact, and remedies The Pharmacoviligance section in this issue opens the door to a very interesting topic: ecopharmacovigilance. This article is the result of a collaboration among volunteers of EMWA’s…
Pharmacovigilance
- Volume 31, Issue
The Pharmacovigilance section of this issue is related to the first Meet & Share online event held in December 2021 by the EMWA Pharma - covigilance Special Interest Group (PV SIG) – with more than 70 attendees! Tiziana von Bruchhausen (editor)
Pharmacovigilance
- Volume 31, Issue
The Regulatory Expert Seminar session at the 2021 Spring EMWA Conference took us on an amazing journey through marketing authorisation applications from a regulator’s and medical writer’s perspective. One of the presentations focussed on the…
International teams: How to survive a long-distance work relationship among medical writers
- Volume 31, Issue
How does a team of medical writers working in different countries navigate different time zones and cultures to get their work done remotely? In this interview, a team of six medical writers and one editor working at P95, a private research…
President's Message
- Volume 32, Issue
From scurvy to Covid-19: The role of clinical trials, and medical writing’s crucial role in the process The medical writing community is intrinsically involved in regulatory documentation that spans the entire timeline of clinical research – from…
Medical Writing
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…
Writing reports of modelling and simulation analysis: Our experience in the field of pharmacometrics
- Volume 32, Issue
Pharmacometric analyses generate mathematical models that can describe and simulate the pharmacokinetics and pharmacodynamics of drugs. The role of these modelling and simulation (M&S) analyses is growing both in drug development and regulatory…
Regulatory initiatives for artificial intelligence applications: Regulatory writing implications
- Volume 32, Issue
Applications of artificial intelligence (AI)/machine learning (ML) components in drug development are growing exponentially. The trend is expected to continue. The growth has resulted in increased engagements on the part of regulatory agencies to…
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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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Louisa Ludwig-Begall / Sarah Kabani
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