Medical Devices - Volume 32, Issue

Spotlight on similar devices under the Medical Device Regulation This article evaluates the potential of similar devices in clinical documentations, such as clinical evaluation plans (CEPs), clinical evaluation reports (CERs), and post-market…

In the Bookstores - Volume 24, Issue

Statistical Thinking for Non-Statisticians in Drug Regulation (Second Edition) By John Wiley & Sons, 2014. ISBN: 978-1-118-47094-7 (hardcover).59.99 GBP. 368 pages.   Writing for Science Journals: Tips, Tricks, and a Learning Plan By Geoff…

The Crofter: Sustainable Communications - Volume 33, Issue

Section Editors: Louisa Ludwig-Begall, Sarah Kabani How close are we to sustainability? Author: Catarina Leitão I have always loved nature. When I was a kid, I preferred watching wildlife documentaries to cartoons. Those documentaries taught me…

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…

Journal Policies

Journal Policies   Editorial policies and peer review process All feature articles submitted to Medical Writing are reviewed by a member of the Editorial Board. All Editorial Board members are experts in the field of medical writing and members…

President's Column - Volume 27, Issue

Dear EMWA Members, As you are well aware, we have been celebrating our 25th anniversary as an organisation and have sent out specially designed buttons with the December issue of Medical Writing to commem - orate the occasion. To continue the…

Writing for orphan drugs: A compass to navigate document types and regional requirements - Volume 34, Issue

Medical writing for rare diseases encompasses the development of various regulatory documents that are required to obtain orphan drug designation and marketing authorisation for treatments targeting rare conditions. Effective planning and close…

Lay titles for clinical trials: Is industry achieving the balance? - Volume 32, Issue

Titles of clinical trials may directly influence whether patients, caretakers, or healthcare professionals will want to obtain more information about the trial. Major clinical trial registries require lay titles (referred to as “brief” or “public”…

News from the EMA - Volume 29, Issue

September 14, 2020 – The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has published its workplan which sets actions to be delivered in 2020–2021. With the European Medicines Regulatory Network focused on the…

Medical Devices - Volume 29, Issue

The Medical Devices Regulation (MDR 2017/745) has been postponed due to the coronavirus pandemic and will now take effect on May 26, 2021.1 Some manufacturers may regard this as a slight breather, but there are still enough obstacles to overcome.…