Beatrix Döerr
Section Editor
Contributions
This article focuses on the medical device specific aspects of clinical investigations and does not aim to be a comprehensive introduction to clinical trials. We highlight the key differences to clinical studies of medicinal products in the…
Dear All, As I’m sure you are aware, EMWA’s Special Interest Groups (SIGs) have been hard at work hosting “Meet & Share” sessions throughout the year. These sessions aim to encourage open and honest discussion between medical writers on a…
EMWA’s Special Interest Group on Medical Communication initiated a reply to an article that made unfounded derogatory remarks about medical writers (MWs). Without providing any evidence, in an article about the development of randomised clinical…
Time to say goodbye! After having served on EMWA’s Executive Committee (EC) for six years in various roles, my term ended at our Spring conference in May. These have been rewarding years, with lots of work, but also lots of unforgettable experiences…
It fills me with sadness that we had to cancel our spring face-to-face (F2F) conference in Riga. It’s been 1 ½ years since our last in-person meeting! Yet we hope that we at least will have the chance to meet in Cascais this autumn.
But I also have…
As I write this, 2020 is drawing to a close. Although it has been an enormously challenging year, I want to take a moment to recognise a high point – the successful completion of EMWA’s first virtual conference. What a milestone and major…
What a busy time! The EMWA Professional Development Committee, the Conference Team, and the Executive committee are working very hard on organising the virtual conference in November, which we hope will be a unique experience for you. The…
Like many medical writers, I started in another career first. For me, it was practising veterinary medicine in a clinic, then going into clinical research in humans, and then on to medical writing. Designing clinical trials, sample size…
In the last issue, I started to share my opinion on the recently published “implant files”.1,2 As this topic could be discussed endlessly, I focused on an article in a German newspaper, the Süddeutsche Zeitung, that provided a summary about the “10…
During a visit to Greece more than 15 years ago when I was involved in an animal protection campaign, I met a journalist who was investi gating prohibited fishing methods that local fishermen were using. When he was asked by the animal protection…
The good news first: Patient-reported outcomes (PRO) are basically the same in both the medical device and the pharmaceutical sectors. There are the general quality of life tools such as the EQ-5D or the Short-Form Survey questionnaires (e.g. SF-12,…
Want to learn more about medical device regulations? Then read some of the presentations held at EMWA’s medical device symposium this year: https://www.emwa.org/conferences/emwa-symposia/.
The spring EMWA conference held in Barcelona is now behind us – and what a conference it was for medical device writers and those who want to become one! A full symposium day on medical devices with more than 200 registrants and two fully booked…
The 6th EMWA symposium day will focus on medical devices in general, the recent changes in the European legislations, and opportu - nities for medical writers. The symposium is for regulatory writers and medical communi - cators alike, and will…
The new European medical device regulation and guidance document on clinical evaluation
An Interview with Dr Bassil Akra
The successor of the currently applicable Medical Device Directives (MDD 93/42/EEC and 90/385/EE) combines both directives…
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…
Medical writers commonly are hired to write for traditional journals targeting the highest possible impact factor. However, as medical writers, we should be aware of alternative options. In September last year, I had the pleasure to meet Michael…
Time to say goodbye.As I will step down from my role as EMWA’s Public Relations Officer in May 2017, I will no longer be on top of the EMWA news and will, therefore, step down from my role as section editor. It is with great pleasure though that I…
When I attended my first conference as Public Relations Officer in Dublin, I was approached by “newbies” looking for a job. I was quite impressed that people invested such a considerable amount of money to attend the conference in the hope of…
Baby alarm in the Social Media Team! The future of EMWA’s social media team is secured as we are expecting three babies. Utmost efforts have been taken to ensure they are equally distributed across the Twitter, Facebook and LinkedIn teams.Seriously,…
This issue of Medical Writing (MEW) is about statistics, so what is more appropriate than interviewing a research methodologist who focuses on epidemiology and statistics in clinical research? I am happy that we were able to win Professor Peter Jüni…
A lot was going on from April to June this year. Certainly the main event was our spring conference in Munich. Aside the established workshops, Freelance Business Forum, Expert Seminar Series, and updates on Special Interest Groups – it included an…
On her private Twitter profile, Julie (Juliane) describes herself as “freelance medical editor, mother, immunologist with an interest in tropical diseases and vaccines”. Julie works as a freelance medical writer and editor, is managing editor at…
EMWA team responds to ICMJE requirements on sharing clinical trial data
In January 2016, the International Committee of Medical Journal Editors (ICMJE) proposed requirements on sharing clinical trial data, in Darren Taichman’s editorial, Annals of…
In 2015 EMWA launched its webinar programme, providing members with an online training resource. Your feedback has been valuable in helping us to shape an exciting and extended programme for 2016, presented by inspirational speakers, all highly…
Laura C Collada Ali wears different hats: she is a medical writer plus a medical translator, and has extensive experience delivering multilingual authoring and translation services across a wide range of independent research organisations. She is a…