The EMWA Budapest Working Group: A 2-year collaboration to make recommendations for aligning the ICH E3 guideline with current practice and developing clinical study protocol guidance - Volume 23, Issue

International Conference on Harmonisation (ICH) E6 and ICH E3, developed nearly 20 years ago, are the current regulatory guidance documents for developing clinical study protocols (CSPs) and clinical study reports (CSRs). Ambiguity in the…

Journal Watch - Volume 26, Issue

Data sharing is encouraged by institutions and journals: Authorship of “shared” papers should be clearWhen researchers share data, the teams analysing them want to publish their results. How should authorship of publications be defined? Who are the…

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…

The horror and the pity: Obesity and diabetes - Volume 21, Issue

Something less beguiling for a horror-story addict than the emergence of obesity would be hard to imagine. Start by reading the 27 August 2011 issue of the Lancet. One article predicts that the obesity rate in the UK will make the tremendous leap fro…

EMWA social media team - Volume 23, Issue

Medical writing in paediatrics: Children and the future - Volume 21, Issue

‘Children are one-third of our population and all of our future.’ Select Panel for the Promotion of Child Health, 1981 With the falling birth rate I wonder if they still are a third of the population, but there is no doubt that they are our…

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…

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…

The unique challenges of clinical trials in rare disease: A regulatory writer’s perspective - Volume 32, Issue

Designing clinical trials in rare diseases comes with a specific set of challenges including limited knowledge around the natural history of a disease, small sample size available for trial participation, regulatory guidance that is not calibrated…

Foreword from the European Commission - Volume 31, Issue

Already 1 year has passed since the date of application of the new Medical Devices Regulation (EU) 2017/745 (MDR), replacing the previous Directives 90/385/EEC and 93/42/EEC from 26 May 2021, while for the new In Vitro Diagnostic Medical Devices…