Stefanie Rechtsteiner

Contributions

Pharmacovigilance - Volume 31, Issue 1

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)

Same but different: Basic tools for biosimilar and generic pharmacovigilance writing - Volume 28, Issue 2

Biosimilars are medicinal products, which are highly similar to an already authorised biological product; generics are identical copies of an already authorised chemical entity. As for any other medicinal product,biosimilars and generics require the…

Medical Communications - Volume 25, Issue 3

Anyone working in pharmacovigilance (PV) will already have spent many months working their way through the ever changing updates and reforms to the Risk Management Plan (RMP), and the newly legislated RMP summary. Those not working in PV will…

Medical writing for two audiences – The RMP public summary - Volume 24, Issue 4

With the introduction of the new EU Legislation in 2012, RMP requirements have changed significantly, triggering content- and process-related changes. An RMP is written as part of a submission dossier and is submitted for assessment to the EMA. The…

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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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