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Preparing anonymisation reports in general and for an orphan drug in particular - Volume 27, Issue

In 2015, the EMA Policy 0070 came intoeffect as part of EMA’s commitment toincreased data transparency. In short, clinicalreports included in regulatory applications forexample, marketing authorisations are pub -lished on the EMA web page and…

Editorial - Volume 27, Issue

A paradigm shift in clinical trial data reporting is occurring as data becomes increasingly publically accessible. The EMA was the first regulatory authority to publish clinical data included in marketing authorisation applications.

Regulatory Matters - Volume 29, Issue

Ever since the EMA mandate for plain-language summaries of clinical trials was codified in Clinical Trial Regulation EU No. 536/2014, medical writers have grappled with the task of making these documents accessible to the public, including to…

Teaching English for Medical Academic Purposes at the Faculty of Medicine in Belgrade, Serbia - Volume 22, Issue

The Faculty of Medicine in Belgrade, Serbia, has a long tradition of learning and teaching English for Medical Academic Purposes (EMAP). EMAP is considered extremely important for our medical students' academic and professional life. Our EMAP…

Celebrating its past, European Medicines Agency looks to the future of public communication - Volume 34, Issue

As the European Medicines Agency (EMA) marks its 30th anniversary with a series of events at its offices in Amsterdam, one area in the spotlight is EMA’s communication with the public. The Agency has made significant strides in this area over the…

Medical Communications and Writing for Patients - Volume 34, Issue

Section Editor: Lisa Chamberlain James Communicating with the Public Special Interest Group Meet and Share: An overview of the EU General Data Protection Regulation, the EMA Policy 0070, and how they relate to AI Author: Veronica K.…

Regulatory writing - Volume 21, Issue

The EMA, the FDA, and Health Canada head to head A recent issue of the New England Journal of Medicine carried an article comparing the regulatory review times of novel therapeutics by three different regulatory agencies (FDA, EMA, and Health…

Preparing clinical study reports for external sharing - Volume 27, Issue

As the EMA refines its requirements for the external publishing of clinical study reports, the workload of medical writing teams is increasing to include robust processes for clinical study report anonymisation. Until now, life sciences firms have…

Real-world evidence and real-world data in contemporary healthcare: A critical overview - Volume 34, Issue

The European Medicines Agency (EMA) has increasingly recognised the value of real-world data (RWD) and real-world evidence (RWE) in this ever-changing regulatory landscape. Regulatory decisions have been traditionally based primarily on data from…

Real-world data and evidence: A European regulatory perspective - Volume 34, Issue

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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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