Post-approval regulatory writing - Volume 23, Issue

Message from the President - Volume 21, Issue

Dear Medical Writers Top of Form Bottom of Form The last time I wrote to you I briefly introduced myself and outlined some of the plans that I hope to realise during my year as president. However, as president I am only one of the members of the…

Risk Management - Volume 24, Issue

The thalidomide tragedy of the early 1960s cost several thousand lives, but it ultimately led to changes that will undoubtedly save many thousands more: it triggered a chain of events involving the WHO and the ICH that resulted in the…

Announcing AERTeM, the Spanish Association of Medical Writers - Volume 22, Issue

The Spanish Association of Medical Writers – in Spanish, the Asociación Española de Redactores de Textos Médicos (AERTeM) – is a young association focused on the specific needs of Spanish writers. Local organisations such as AERTeM can augment the…

Medical postcard from Australia, the world's largest island - Volume 22, Issue

The Australasian Medical Writers Association (AMWA) comprises about 300 journalists, writers, editors, and health professionals based in Australia and nearby island nations, particularly New Zealand and Fiji. AMWA has held a popular conference…

Medical writing in Finland - Volume 22, Issue

Finland has a flourishing pharmaceutical and life science industry and research scene. Medical writing, however, is an unfamiliar term to many Finns and there is no Finnish equivalent for the title ‘medical writer’. Those people who do medical…

Introduction - Volume 28, Issue

It is my privilege to present you the Medical Writing special issue garnering the current Trends in the Medical Writing sphere. With the perpetual amendments in the pharmaceutical industry and the ever-evolving approaches in operating and…

Publication management software for medical writers - Volume 29, Issue

Managing a complex publication plan for several products or indications with overlapping timelines can be challenging. Publication management software solutions are available to support the medical writer in planning, writing, approving, and…

Challenges of paediatric drug development and impact of paediatric legislation - Volume 21, Issue

Medical writers are increasingly involved in designing and documenting overall plans in paediatric drug development, e.g. EU PIPs (Paediatric Investigation Plans) and individual components, e.g. protocols and study reports. It is essential to…

History of biostatistics - Volume 25, Issue

The history of biostatistics could be viewed as an ongoing dialectic between continuity and change. Although statistical methods are used in current clinical studies, there is still ambivalence towards its application when medical practitioners…