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The approval process of medicines in Europe
- Volume 23, Issue
The European system of approval of new medicines comprises an European Union (EU)-wide authorisation procedure (the so called centralised procedure) alongside national procedures based on different EU Member States working together and recognising…
Report on the EMA Workshop on clinical trial data and transparency
- Volume 22, Issue
Access to patient data gathered in clinical trials is a highly controversial and complex issue that needs to balance three aspects: the public right to transparency regarding data used to approve new medicines, protection of the data privacy rights…
Providing value for medicines in older people
- Volume 22, Issue
The global population is ageing, but inequalities remain in older people's access to treatment, especially people 75 years of age and older. These people receive less frequent interventions and lower quality medical treatment than their younger…
A shot at demystifying the risk management plan for medical writers
- Volume 24, Issue
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…
News from the EMA
- Volume 25, Issue
The articles included in this section are a selection from the European Medicines Agency’s News and Press Release archive for August 2016 – Oct 2016. More information can be found on the Agency’s website: www.ema.europa.eu of medicines to treat…
News from the EMA
- Volume 25, Issue
The articles included in this section are a selection from the European Medicines Agency’s news and press release archive for November 2015 to March 2016.
News from the EMA
- Volume 25, Issue
The articles included in this section are a selection from the European Medicines Agency’s news and press release archive for April 2016 to July 2016.
News from the EMA
- Volume 29, Issue
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.
News from the EMA
- Volume 27, Issue
The articles included in this section are a selection from the European Medicines Agency’s News and Press Release archive from July 2018 to September 2018. More information can be found on the agency’s website: www.ema.europa.eu
News from the EMA
- Volume 28, Issue
The articles included in this section are a selection from the European Medicines Agency (EMA)’s News and Press Releases archive from July 2019 to September 2019. More information can be found on the Agency’s website: www.ema.europa.eu.
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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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