Optimizing the value of regulatory writers - Volume 31, Issue

An expanding need for clinical documentation and regulatory health authority interactions during drug development has drawn increased attention to the role of the regulatory medical writer. This role is frequently misunderstood and poorly…

President's Message - Volume 25, Issue

Dear EMWA Members, Our Munich 2016 Spring conference was a great success that showcased a mature association leading on important topical issues. EMWA’s outward looking perspective developed over the past couple of years is the focus of my final…

News and Notes from the World of Medical Writing - Volume 30, Issue

The Philippine Association of Medical Journal Editors, Inc. (PAMJE) held its 3rd Annual Convention on September 20-23, 2021, with the theme, “Upholding Research Integrity in the Time of Pandemic.” The virtual event was attended by 392 participants…

Message from the President - Volume 23, Issue

These two years in the Executive Committee flew by. They will remain in my heart for ever. It is difficult to summarise the emotions and the things we accomplished these last two years. When this adventure started in Cyprus, Susan Bhatti, the…

Good Writing Practice - Volume 26, Issue

Conceptual component omission is a distraction to a content expert who expects specific argumentative conceptual components in the various sections of a journal article. As evidence, some of the components have become standardised in structured…

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…

Pharmaceutical clinical trials transparency and privacy - Volume 29, Issue

With the introduction of new clinical trial transparency regulations around the world, transparency functions have had to adapt to a range of reporting requirements. In 2007, the FDA Amendments Act (FDAAA) established requirements for trial sponsors…

Advancing the Medical Writing profession: The Joint Position Statement on the Role of Professional Medical Writers - Volume 26, Issue

A wintry London in January saw the release of the first joint position statement on the role ofthe professional medical writer (page 7). But why do we need such a statement and what does it say? The Executive Committee identified the need to update…

Medical Devices - Volume 30, Issue

Annex I of ISO 14155:2020 (International Organization for Standardization) helps define the various stages of clinical investigations for medical devices as well as the types of study designs. The following flowchart summarises Annex I, to assist…

Out On Our Own - Volume 24, Issue

Editorial

All of us are aware by now that we can't live without technology and not only at work. With advice, aids, appliances and apps in abundance, we are at the point where we can't see the wood for the trees. Thank goodness we have advice from M…