Medical Device Regulation: A necessary step towards more patient and user safety - Volume 26, Issue

Abstract The new Medical Device Regulation (MDR) has recently been approved, and after a transition period of 5 years, all medical devices will be approved and marketed according to these new regulations. This article compares the main changes of…

Covering a medical advisory board meeting and creating the report or publication: The role of the professional medical writer - Volume 25, Issue

Medical advisory board meetings are anintegral part of the healthcare and, inparticular, the pharmaceutical landscape.These meetings serve to identify knowledgegaps in a specific therapeutic area and tosuggest measures that could be implementedand…

Regulatory Writing Developments in paediatric regulation - Volume 22, Issue

Recently, both sides of the Atlantic have seen developments in paediatric regulation. In Europe, the EMA has published a new template for the paediatric investigation plan (PIP), which should help dispel some (but by no means all) doubts and…

Educating the medical writer: A 5-year update - Volume 28, Issue

This article is a 5-year follow-up to a 2013 publication: On Educating the Medical Writer. The current study was performed to examine the evolution of degree programme titles, certificate programmes, and the current trend toward so-called…

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 Communications and Writing for Patients - Volume 30, Issue

Dear All,

As I write this, at least some of us are likely to still be in some form of lockdown or quarantine. I pray that you and your families are all managing to stay as sane as possible, and I sincerely hope that you all stay safe and healthy.

I…

Lingua Franca and Beyond - Volume 27, Issue

Maria asked: “Write an article about editing for non-native speaking medical writers. … does not need to be long, and preferably ‘lightly’written. … [with] funny but at the same time educational stories to share in Lingua Franca…”

Creative medical writing - An oxymoron? - Volume 27, Issue

Is “creative medical writing” an oxymoron? I sincerely hope not! Indeed, if this is the case I will be sorely disappointed, as it is a career I wish to pursue precisely because it may allow me to exercise some creativity. I enjoyed both the arts and…

Medical Communications and Writing for Patients - Volume 31, Issue

In this issue, the Medical Communications and Writing for Patients section features two articles. The first piece, by Simon Linacre,  is a summary of the excellent work just completed by the Med Comms SIG. They have devised, run, and collated the res…

How the EU Medical Device Regulation is affecting the medical device landscape. An interview with Suzanne Halliday, the Regulatory Head of BSI, Medical Devices Notified Body - Volume 31, Issue

Suzanne Halliday, D.Phil., is the Vice President for Regulatory within the Notified Body BSI with extensive experience in compliance to the Medical Devices Directive (MDD), ISO 13485, risk management, clinical evaluations and investigations, meeting…