President's Message - Volume 30, Issue

After several lockdowns, “everyday” life is beginning to return, although COVID-19 continues to be a destructive force in many parts of the world. In Germany, where I am currently located, COVID-19 cases have been rather low (with occasional…

Legal remedies for medical ghostwriting: Imposing fraud liability on guest authors of ghostwritten articles - Volume 22, Issue

There are persistent concerns about the influence of the pharmaceutical and device industries on the medical literature, and particularly on the reporting of clinical trials, which can include the distortion of the true evidence base of medical…

Post-approval regulatory writing - Volume 23, Issue

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…

Allergen immunotherapy in the European regulatory environment - Volume 27, Issue

Allergen immunotherapy (AIT) modulates the immune system to prevent and relieve allergic symptoms. Unlike allergen avoidance and medication to control symptoms, AIT targets the underlying pathophysiology of allergic diseases. AIT is now considered a…

A role for medical writers in overcoming commonly held misconceptions around FAIR Data - Volume 29, Issue

More and more, computers must participate with physicians and patients as trusted partners in assessing medical options and tracking outcomes. But before the computer can become a routine medical assistant, data and computational services must…

Translation Section - Volume 21, Issue

Quality matters in medical translation In recent years, ‘translation quality’ has become a buzzword in the translation industry. Particularly since the introduction of European standard EN 150381 in 2006 and the certification process that has come…

Out On Our Own - Volume 22, Issue

We are all riding high after meeting in Manchester at the EMWA conference in May 2013. It was wonderful to see so many colleagues coming together and enjoying the new-look events that EMWA offered us for the first time. Both the Symposium Day, and Ka…

Writing applications for Paediatric Investigation Plans and waivers - Volume 21, Issue

Under EU legislation, a Paediatric Investigation Plan (PIP) and/or a waiver must be agreed in advance with the European Medicines Agency (EMA), for all new medicinal products seeking marketing authorization; the same applies for already authorized…

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.