Raquel Billiones

Associate Editor

Raquel Billiones is a life scientist (BSc, MSc, PhD in Biology) with > 25 years experience in scientific research, writing and teaching. She switched from the academia to medical writing in 2006 and never looked back. She is currently working as a senior regulatory medical writer for the digital CRO Clinipace Worldwide in Zurich, Switzerland. She also runs a family enterprise consisting of her spouse and twin adolescent boys. Raquel has been on the MEW editorial staff since 2010.

Contributions

Getting Your Foot in the Door - Volume 28, Issue 2

In this June edition of GYFD, I’d like to share a diagram developed by my colleagues at the Swiss Association of Pharmaceutical Professionals (SwAPP). The diagram serves as a road map for those looking for their place in the healthcare industry. Can…

Medicinal products and medical devices in clinical trials conduct and disclosure - Volume 28, Issue 2

“Medicinal products and medical devices are different species…they live in parallel universes” according to a medical device expert. But is it really so? This article challenges that notion by comparing the Clinical Trial Regulation EU No.…

Thriving (and not just surviving) in a VUCA healthcare industry - Volume 28, Issue 1

VUCA stands for volatility, uncertainty, complexity, and ambiguity. The healthcare sector is considered a VUCA industry, constantly changing through rampant mergers and acquisitions, rapidly evolving regulations, and leading-edge innovations. So how…

Careers in medical writing - Volume 28, Issue 1

Medical writers are a breed apart. Unlike many other professions we come from a diverse range of educational and often early professional backgrounds. Yet we find our way to medical writing – or perhaps medical writing finds its way to us – and most…

Getting Your Foot In The Door - Volume 27, Issue 4

Before one can get one’s foot in the door, one needs to be aware that there is actually a doorway. This is the mission of the EMWA Ambassador’s Programme – to inform the world about medical writing as a career path. In other words, we set up signs…

Getting Your Foot in the Door - Volume 27, Issue 3

GYFD congratulates the EMWA Internship Forum team for another great event in Barcelona. Also in this edition, first time attendee Clare Chang shares with us some insights she gained in herquest for getting that first medical writing job. I am sure…

Getting Your Foot in the Door - Volume 27, Issue 2

Landing the first medical writing job is not easy. Clare Chang’s contribution describes her journey, the challenges she faced, and the different measures she took to overcome these hurdles. EMWA is very much aware of these challenges, as addressed…

Anonymisation reports from 2016 to 2017: A preliminary analysis - Volume 27, Issue 2

The anonymisation report (AR) is a new and  relatively unknown regulatory document,  submitted as part of the redacted package of  a marketing authorisation application under  the EMA Policy 0070. The report documents  the methodology of…

Navigating the EMA clinical data website - Volume 27, Issue 2

This paper describes how to register, access, and navigate the EMA clinical data website. One of the authors (RB) is a medical writer and accessed the site from the perspective of a pharmaceutical industry professional. The other author (AS) is not…

Getting Your Foot in the Door - Volume 27, Issue 1

One of the most challenging questions faced by academic life scientists at some point in their career is whether to pursue research or to look for suitable positions within industry. While the shift from academia to industry might result from a…

Getting Your Foot in the Door - Volume 26, Issue 4

On internships, scribes, and work experience.For this edition of GYFD, I would like to provide some background information about internships, including the history of the term and answers to some frequently asked questions about it. The objective is…

Getting Your Foot in the Door - Volume 26, Issue 3

In this edition of GYFD, EMWA Internship Forum (IF) lead Derek Ho gives us a rundown on the second Live IF in Birmingham. Don’t forget – Barcelona is the next IF venue! The second contribution is from Laura Rodriguez. Laura is not a medical writer…

Regulatory Matters - Volume 26, Issue 2

Brexit and the European Medicines Agency The British government has formally triggered Article 50, setting in motion Brexit and negotiations can begin in earnest. If before, politicians could gloss over the complexities, they are now obliged to…

Getting Your Foot in the Door - Volume 26, Issue 2

In this June edition of GYFD, we are presenting the first part of a series on visa regulations and work permits related to internships in the EU. I would like to thank Van-Anh Dao for doing the legwork of researching the German requirements. We will…

Puns, promises, and metaphors: Medical device trade names - Volume 26, Issue 2

Abstract Medical writing covers not only drugs but also medical devices. This article looks at the lighter side of writing about medical devices. It shares observations about the vocabulary used and especially focuses on trade names. It also looks…

Medical devices in the disclosure era and the role of medical writers - Volume 26, Issue 2

AbstractIncreased transparency is one of the provisions of the Clinical Trial and Medical Device Regulations. This article discusses the impact of transparency and disclosure on medical devices. Many modern-day medical devices are software-driven.…

Getting Your Foot in the Door - Volume 26, Issue 1

In this edition of GYFD, we are happy to present to you two great contributions. Danae Rokanas shares with us some interesting statistics and important lessons learned from the first Live Internship Forum (IF) inMunich. In the second piece, St…

Getting Your Foot in the Door - Volume 25, Issue 4

It’s been almost six months since the first EMWA Internship Forum (IF) in Munich. See what our IF team have to say about their first IF experience on pages 62-63. Even though we are already planning the next one for the spring meeting in Birmingham…

Getting Your Foot in the Door - Volume 25, Issue 3

Welcome to Getting Your Foot in the Door or GYFD for short, the latest addition to MEW’s regular sections. It all started at the EMWA 2015 autumn meeting in The Hague. Derek Ho met up with the EMWA Executive Committee (EC) to talk about his idea of…

Biostatistics and medical writing: Synergy in preparing clinical trials documents - Volume 25, Issue 3

Biostatisticians and medical writers are among the key people who develop important documents for clinical trials. These documents include clinical study protocols, statistical analysis plans, statistical outputs, and clinical study reports. This…

Authorship of clinical trial documents - Volume 25, Issue 1

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…

A guide to pre-approval regulatory documents - Volume 23, Issue 2

The following table provides a list of the most common pre-approval regulatory documents for drugs with their associated guidelines and regulations. The clinical study report (p86), clinical study protocol (p93), investigator's brochure (p96), and…

Document templates for medical writers - Volume 23, Issue 1

A document template is defined as ‘a file that serves as a starting point for a new document’. This article looks at the specialised templates used by medical writers in their trade with a focus on the commercially available products. Templates…

Out On Our Own - Volume 22, Issue 4

The EMWA autumn conference is always so well placed in November, giving us the chance to meet friends and colleagues before the onslaught of traditional end of year festivities. Barcelona's conference was no exception. We were pleased to welcome new…

Out On Our Own - Volume 22, Issue 2

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…

Regulatory medical writing in Switzerland - Volume 22, Issue 2

Switzerland is practically unknown in the drug/medical device regulatory landscape despite being home to some of the world's biggest pharmaceutical firms. This article briefly describes the regulations governing clinical trials in Switzerland and…

Out On Our Own - Volume 22, Issue 1

The fourth EMWA freelance business survey Introduction This fourth survey follows those conducted in 2003, 2007, and 2010.1–3 The first survey was conducted with a paper questionnaire distributed to both freelancers and small businesses…

Out On Our Own - Volume 21, Issue 4

Successful migration from the personal computing to Apple computing environment for regulatory medical writers When renewing computer hardware, migration from one system to another, arguably, should not be overlooked. Some of the challenges…

Out On Our Own - Volume 21, Issue 3

Another summer has come and gone. In this issue of OOOO, we are happy to feature Paul Woolley's novel approach of comparing employment and freelancing. I am sure many of us can identify with some of the points he raises. We thank Debbie Jordan for…

Out On Our Own - Volume 21, Issue 2

After a wonderful May spring week in sunny Cyprus – it was good to see so many of you at the Freelance Business Forum (FBF) – it's back to business as usual with a packed issue. The FBF minutes summary has not made it into this issue due to print…

Out On Our Own - Volume 21, Issue 1

Welcome to the first OOOO of 2012. Let us start with Tool Box where Julia Powell gives us a review of Toggl, a handy desktop time tracking tool to help us measure our productivity. Then, Anu brings us another brain-teasing medical writing jumble.

Good Writing Practice - Volume 21, Issue 1

The Good Writing Practice initiative was launched in the December 2010 issue of TWS1 by Alistair Reeves and Wendy Kingdom. The aim is to go beyond the classic style guide and provide advice on practical aspects of writing that make texts easier to…