Getting Your Foot in the Door - Volume 30, Issue

No setback comes without a blessing Like many things in the professional world, I got to know more about medical writing and see it as the next step in my professional life, thanks to a connection. A friend of a friend was a native Spanish speaker…

Clinical data publication by the EMA: The challenges facing the pharmaceutical industry - Volume 27, Issue

As of October 2016, EMA publishes clinicaldata on their clinical data website(https://clinicaldata.ema.europa.eu). Thisnew procedure applies to all marketingauthorisation applications submitted bypharmaceutical companies under thecentralised…

Non-clinical health writing - Volume 23, Issue

We medical writers have a unique and valuable skill set, which includes, most notably, the ability to understand and clearly communicate complex medical information. We are also experts at working with multifunctional teams, compiling detailed…

Out On Our Own - Volume 22, Issue

We are all riding high after meeting in Manchester at the EMWA conference in May 2013. It was wonderful to see so many colleagues coming together and enjoying the new-look events that EMWA offered us for the first time. Both the Symposium Day, and Ka…

Post-approval regulatory writing - Volume 23, Issue

Writing for medical devices compared to pharmaceuticals: An introduction - Volume 26, Issue

Abstract The inherent differences between medical devices and drugs have implications for clinical research and medical writing. In view of the current move to more stringent regu - latory requirements for the medical device industry, an increasing…

Establishing a patient publication steering committee: A case study with insights for medical writers - Volume 29, Issue

Development of a patient publication steering committee (PPSC) is an innovation in industry publication practices. In this brief article, we summarise how UCB Pharma, a global biopharmaceutical company, plans to partner with patients to establish a…

GPP3 – what is it, why is it necessary and what is new? - Volume 25, Issue

The good publication practice for pharmaceutical companies (GPP) guidelines were first published in 2003, then revised in 2009 (GPP2) and most recently in 2015 (GPP3). The latest version reflects the changes that have occurred in legislation…

For the greater good…Can agency competitors cooperate to advance medical publication practices? - Volume 24, Issue

The business of medical writing is competitive, but can it be cooperative? Is it time for agencies, which provide professional and ethical publication support to authors, to cooperate for the greater good of the medical publication profession?…

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…