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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…
April, 6, 2017 – Following two years of experience with safety monitoring of nationally authorised medicines via the single assessment of periodic safety update reports (PSURs), the EMA has issued additional guidance and recommendations as part of…
This paper describes how to register, access, and navigate the EMA clinical data website. One of the authors (RB) is a medical writer and accessed the site from the perspective of a pharmaceutical industry professional. The other author (AS) is not…
As of October 2016, EMA publishes clinicaldata on their clinical data website(https://clinicaldata.ema.europa.eu). Thisnew procedure applies to all marketingauthorisation applications submitted bypharmaceutical companies under thecentralised…
April 12, 2018 – The European Medicines Agency's (EMA) and its European and international partners have successfully strengthened their interactions to improve the oversight of active pharmaceutical ingredient (API) manufacturers worldwide, as…
The articles included in this section are a selection from the European Medicines Agency (EMA)’s News and Press Releases archive. More information can be found on the Agency’s website: www.ema.europa.eu
In our daily work in a company or freelance setting, we interact with other relevant functions, typically biostatistical, medical, programming, and data management colleagues, so that we can deliver wellrounded deliverables that take account of…
The articles included in this section are a selection from the EMA's news and press release archive for December – February 2015. More information on the work of the EMA can be found on its website: http://www.ema.europa.eu.
The articles included in this section are a selection from the EMA's news and press release archive for August–November 2014. More information on the work of the EMA can be found on its website: http://www.ema.europa.eu
The articles included in this section are a selection from the EMA's news and press release archive for March–June 2014. More information on the work of the EMA can be found on its website: http://www.ema.europa.eu.
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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