Message from the President - Volume 22, Issue

A year has passed so quickly and it is time for me to step down and hand over to Andrea Rossi, the new EMWA President and the first Italian to take on this important position. On reading through the various messages I sent you during the past year,…

Early benefit assessment of new drugs in Germany: Framework for submission of dossiers by pharmaceutical companies - Volume 22, Issue

For the early benefit assessment of new drugs in Germany, medical writers are involved in the preparation of dossiers submitted by pharmaceutical companies to the main decision-making body of the German statutory healthcare system, the Federal Joint…

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…

Regulatory Public Disclosure - Volume 31, Issue

A great deal has happened in the world of regulatory public disclosure in Europe in 2022 with the EU Clinical Trials Regulation (CTR) 536/2014 coming into force at the end of January 2022. We collectively attempt to assimilate knowledge and…

The Lay Protocol Synopsis: Requirements and feasibility - Volume 32, Issue

The EU Regulation 536/2014 included a requirement for companies to produce a Protocol Synopsis with a recommendation for a version in lay language. This requirement stated, among other things, a maximum length of two pages. This article outlines the…

The Webscout - Volume 25, Issue

Medical Communications ‘Medical Communications’ is an unspecific term. Sometimes it is used only to describe publications, medical education, and public relations; sometimes it also includes regulatory writing and advertising.

Veterinary Medical Writing - Volume 31, Issue

For this issue of Veterinary Medical Writing, we have two articles from the veterinary world. The first is about the niche but increasingly in demand service of veterinary public relations (PR). Louisa Marcombes (editor)

Good Writing Practice - Volume 30, Issue

Grammatical misagreement in tense

I – Present, present perfect

Introduction

Each of the sections of a journal article contains anticipated conceptual components, which can be expressed by a specific verb tense for the perspective of time and the d…

Medical writing around the world - Volume 22, Issue

As many of you are already familiar, Medical Writing began as The Write Stuff, a publication written by and for EMWA members. One of the goals in making the transition to Medical Writing was that it would become an international journal with readers…

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…