Five questions for Ruggero Galici on nonclinical medical writing - Volume 32, Issue

Ruggero Galici is Senior Director of Nonclinical and Clinical Pharmacology Medical Writing at Alexion Pharmaceuticals Inc, AstraZeneca Rare Disease Unit and heads up global early phase regulatory medical writing activities. In this role, he…

Regulatory Matters - Volume 34, Issue

Section Editors: Clare Chang, Zuo Yen Lee

The AI-enabled medical writer: A new era for regulatory writing

Authors: Jenni Pickett, Vanessa de Langsdorff

As artificial intelligence (AI) becomes increasingly integrated into the pharma ceutical indust…

Lingua Franca and Beyond - Volume 31, Issue

How to make our life easier? It was my pleasure to invite my colleagues from the European Association of Science Editors (EASE) to share their editorial experience with us medical writers. By doing this, we can improve our writing, which will…

REACH chemical dossiers? Yes, please! - Volume 23, Issue

Medical writing knowledge and skills can be applied relatively easily to other areas of technical regulatory writing, with a bit of home study. One such area is in the compilation and write-up of REACH (Registration, Evaluation, Authorisation, and…

Medical Devices: An exciting industry at a crossroads - Volume 26, Issue

Welcome to this special edition of Medical Writing focusing on medical devices. When I volunteered to act as the guest editor for this issue, I did so knowing that we are at a crossroads in Europe. The Medical Device Directive is about to be…

EU Regulations - Volume 29, 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…

Recent and upcoming regulatory changes in the European Region: Opportunitiess for medical writers - Volume 29, Issue

The European regulatory landscape for clinical trials and medical devices is in the midst of major transformation. Older policies are giving way to new regulations that emphasise more harmonised and streamlined processes for document submittal,…

Writing for lay audiences - Volume 24, Issue

For most of us, medical writing is highly technical. We prepare regulatory or clinical documents or write materials targeted to medical doctors. Medical writing for lay audiences is different, and it does not come naturally to most of us because…

Medical Communication - Volume 22, Issue

I'm sitting down to write this having just returned from the DIA Euro meeting in Amsterdam. As always, it was a busy and successful meeting, with many ‘themes’ of presentations being given at once. However, this year there were many presentations…