The Webscout - Volume 22, Issue

There are different definitions of the adjective ‘good’, e.g. morally excellent; satisfactory in quality, quantity or degree; of high quality; excellent; well-behaved; etc. as the web dictionary tells us. In ‘good pharma’ the meaning of ‘good’ is…

Regulatory Writing - Volume 21, Issue

The European Medicines Agency looks to the future At the end of 2010, the European Medicines Agency (EMA) published a road map that laid out a ‘strategic vision for the operation of the European Medicines Agency’ from 2011 to 2015.1 According…

Gained in Translation - Volume 25, Issue

Welcome to the Translation Section editorial! The Italian word Itangliano means Italian that is very much influenced by the English language and most of all it refers to the great presence of English words that are not adapted into Italian.…

Position Statement - AMWA-EMWA-ISMP Joint Position Statement on Medical Publications, Preprints, and Peer Review - Volume 30, Issue

In medical publications, just as in research and development, quality depends on the expertise and integrity of researchers/authors as well as qualified peer reviewers and journal editors. However, the laborious and time-consuming process of the…

Harold Swanberg, MD: Why and how EMWA should remember him - Volume 32, Issue

Before the European Medical Writers Association (EMWA) and the American Medical Writers Association (AMWA), there was the Mississippi Valley Medical Editors Association (MVMEA). Most medical writers are unaware of the history of MVMEA and of how it…

Model-informed drug development in rare diseases - Volume 34, Issue

Model-informed drug development (MIDD) approaches maximise and connect information obtained on a drug during development, allowing better characterisation of its risk: benefit profile. MIDD is especially useful for rare diseases with few patients to…

Profile - Volume 26, Issue

The new European medical device regulation and guidance document on clinical evaluation An Interview with Dr Bassil Akra The successor of the currently applicable Medical Device Directives (MDD 93/42/EEC and 90/385/EE) combines both directives…

Good pharma - Volume 22, Issue

Drugs companies publish only a fraction of their results and keep much of the information to themselves. Drug companies are ‘debasing’ drug trials whose publication in journals can apparently confer scientific approval. Merck had fought for years to …

Passing the torch - Volume 21, Issue

This issue is the first where I will be serving as Editor-in-Chief of Medical Writing (MEW). Elise Langdon-Neuner, Editor-in-Chief since 2004, will be stepping down. This is yet another step in the evolution of the journal.

For those of you unfamili…

Message from the President - Volume 21, Issue

Dear Members I am sure you are all very familiar with this situation – sitting in front of a blank piece of paper (or to be more accurate a blank screen) and wondering where to start. Beginnings and endings always seem to be the trickiest part, but…