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The preparation of pharmacovigilance documents is a global and cross-functional activity. The pharmacovigilance medical writer has a key position in this complex activity, leading the whole document creation process. This process includes drafting…
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…
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)
Dear members, I am delighted to launch the Pharmacovigilance (PV) section in this journal issue! Those of you who have been around for a while may know that, in the past, PV-related articles were published either as feature articles or as guest…
Following an extensive period of drafting, consultation, negotiation, and re-drafting the new European Legislation came into effect in July this year. The new measures will be the biggest change to medicines legislation since the creation of the…
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…
Recently, the EMA released the revised Module V – Risk Management Systems (Rev 2) of Good Pharmacovigilance Practices (GVP) accompanied by a revised version of the guidance on the format of the risk management plan (RMP) in the EU – in integrated…
This article outlines the latest legislation for some of the most common post-authorisation documents (Risk Management Plans, Periodic Safety Update Reports, and Post-authorisation Safety Studies) and explains the role of the strategic medical…
Although Post-Authorisation Safety Studies (PASS) have been around since 2001, most regulatory writers would have been unaware of their existence until the recent changes in European regulations, which include mention of these studies as part of…
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…
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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