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Post-authorisation safety studies (PASS), whether interventional or, more commonly, non-interventional (NI), can be used by entities such as the European Medicine Agency´s Pharmacovigilance and Risk Assess ment Committee to oblige drug companies to…
Amidst the dynamic landscape of pharma - covigilance legislation, medical writers have been gaining increased visibility and importance beyond what had been their traditional role of coordinating and facil it - ating the development of risk…
Who are we and what do we do ? The Regulatory Public Disclosure Special Interest Group (RPD SIG) was first conceived in December 2015 and is a group of EMWA members supporting other EMWA members. The RPD SIG objective is: “to provide a forumfor the…
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…
A risk management plan (RMP) is a complex regulatory document which is now required in the European Union as part of a medicine's approval process. This article offers practical guidance for medical writers who are interested in writing an RMP. In a…
The 45th EMWA Conference in Cascais, Portugal, has recently finished and we are all waiting for the upcoming annual event in Barcelona, Spain, next Spring. In the meantime, the Executive Committee is working hard on improving what EMWA has to offer…
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…
The thalidomide tragedy of the early 1960s cost several thousand lives, but it ultimately led to changes that will undoubtedly save many thousands more: it triggered a chain of events involving the WHO and the ICH that resulted in the…
Dear EMWA Members, As we came together in the historic city of The Hague in November 2015 for another successful and enjoyable conference, we were particularly delighted to welcome our Benelux members who turned out in force. The usual EMWA…
EMWA's 37th Conference will be held at the Fira Palace Hotel in Barcelona from Thursday, 7 November to Saturday, 9 November 2013. The Fira Palace Hotel is ideally situated in the trade-fair and exhibition area and is a short walk from Barcelona's…
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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