The Investigator's Brochure: A multidisciplinary document - Volume 23, Issue

The Investigator's Brochure (IB) is a multidisciplinary document that summarises the main elements of an entire development programme to date. Although the IB also serves other purposes, it is primarily written to enable investigators conducting…

Journal Watch - Volume 27, Issue

The vast majority of investigator brochures lack sufficient information to systematically appraise the strength of the supporting pre clinical findings

A guide to pre-approval regulatory documents - Volume 23, Issue

How to write for health websites - Volume 30, Issue

Medical writing for the internet is unique because of the way people find and consume online content. Unlike with a medical brochure handed to someone by their doctor or a hard copy of the latest health book that they’ve purchased, individuals are…

Authorship of clinical trial documents - Volume 25, Issue

Authorship of publications has been the subject of much public debate; however, authorship of clinical trial documents such as clinical study protocols, clinical study reports, investigator’s brochures and inform ed consent forms has not really been…

Regulatory Matters - Volume 25, Issue

The growing need for drug safety documents When I first started in regulatory writing (over a decade ago now, how time flies when you’re a medical writer), the types of document that I would be involved in were typically clinical study reports,…

Medical Communication - Volume 23, Issue

Imagine the scene… You'd like a new car. You'd like a top-of-the-range new car. And you'd like it for a decent price. So you have a look around, and pretty soon, you have a bundle of car brochures in your hand with a variety of models and prices. Do…

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,…

A first-timer's perspective on the 2013 EMWA conference in Barcelona - Volume 23, Issue

This story may sound familiar. Having spent my entire career on the academic bench, I decided it was time for a change. I still want to use my brain, I still want to be a part of the biomedical sciences, but I am ready to put the pipette down for…

The approval process of medicines in Europe - Volume 23, Issue

The European system of approval of new medicines comprises an European Union (EU)-wide authorisation procedure (the so called centralised procedure) alongside national procedures based on different EU Member States working together and recognising…