Raquel Billiones

Editor-in-Chief/ Section Editor

Raquel Billiones has a PhD in Biology and >25 years combined experience in scientific and clinical research. She has been a regulatory writer for more than 15 years, covering both pharmaceuticals and medical devices. Her core competencies include clinical trials and submissions documents, data disclosure and protection, and project and people management. Over the years, she took on a wide range of industry positions, as freelancer, as employed regulatory writer, and as head of medical writing departments in the CRO and big pharma settings. Raquel is an active EMWA member since 2006, serving in various roles, including:

• Medical Writing editorial board member since 2010, currently Editor-in-Chief
                                    • Education Committee member and workshop leader
                                    • Co-founder of the SIGs on Medical Device and on Sustainability

                                     https://www.linkedin.com/in/raquelbilliones/

                                     editor@emwa.org

Contributions

From the Editor - On journalism, the Nobel Peace Prize, and the paths we travel by - Volume 30, Issue 4

The road to a Nobel Prize is not easy and journalist Maria Ressa can attest to that. I am both awed and inspired by her journey and find it fitting to pay tribute to her achievement in this issue on medical journalism. I must admit I am biased due…

The Crofter: Sustainable Communications - Volume 30, Issue 3

Greetings from the croft! In June, the Sustainability Special Interest Group (SUSSIG) marked its first year of existence and we have embarked on our second year with much enthusiasm. Kate Silverthorne has written an inspiring feature article in this…

From the Editor - Making responsible decisions – every day - Volume 30, Issue 3

For me, the most difficult task of medical writing is clicking that “SEND” button. After more than15 years in this field, the decision to send out and share a document with colleagues, regulatory authorities, even the public, is always accompanied…

Getting Your Foot in the Door - Volume 30, Issue 2

Below, two young colleagues share their experiences as mentees and the benefits they gained from such programmes. First, Geneviève Laumen tells it from the perspective of being part of an organised, structured mentorship. Next, Ivana Turek shares…

From the Editor - EMWA and Medical Writing: 12 months into the pandemic - Volume 30, Issue 2

What a year! A year of corona, crisis, and challenges. But also a year of innovations, break - throughs, and opportunities. I am one to focus on silver linings and here are some to think about. I am immensely proud of being part of an industry that…

Getting Your Foot in the Door - Volume 30, Issue 1

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…

Sleepless in times of COVID-19 - Volume 30, Issue 1

Melvin Sanicas, MD, is a physician, scientist, and medical communicator with a very strong social media presence. On top of his day job as medical director at Takeda Vaccines (Zurich, Switzerland), he does pro bono work for many not-for-profit…

From the Editor - On social media: Once a passive observer – now an active user - Volume 30, Issue 1

It is with great pleasure that I write my first editorial for this amazing issue on social media. The idea of this issue came to me in 2019, inspired by two special colleagues. I had social media accounts even before I became a medical writer. I…

Getting Your Foot in the Door - Volume 29, Issue 4

In early 2020, Namrata and I found ourselves in between jobs when COVID-19 entered our lives. In this edition of Getting Your Foot in the Door, we share our experiences and learnings while searching for employment in the midst of a global crisis.…

Passing the Torch: The Sequel/Filling Big Shoes - Volume 29, Issue 4

For the last 8 years, I have been serving as Editor-in-Chief of Medical Writing. I feel that it’s time to pass the torch to a new person with new energy and fresh ideas. As I wrote in 2012, “This is yet another step in the evolution of the…

Getting Your Foot in the Door - Volume 29, Issue 3

Once again, we have two incredible stories in this edition of GYFD. Priyanka shares with us her amazing story and the creative strategy she pursued to get a much needed industry job in corona times.

Eudamed's delay and its impact on discolsure of clinical investigations under the EU MDR - Volume 29, Issue 3

The new European Database on Medical Devices (Eudamed) is the platform to be used for the prospective registration of clinical investigations for medical devices under the Medical Device Regulations. However, Eudamed’s launch has been delayed till…

The In Vitro Diagnosgtics Regulation and the role of medicals writers - Volume 29, Issue 3

Even though in vitro diagnostic medical devices (IVDs) occupy only a very small market segment in the healthcare sector, they have a vital role to play. The importance of diagnostics was strongly underlined during the COVID-19 pandemic. In the EU,…

Getting your Foot in the Door - Volume 29, Issue 2

EMWA’s newest special interest group: Sustainability SIG - Volume 29, Issue 2

In 2015, the United Nations set 17 Sustainable Developments Goals (SDGs, Figure 1) as a “universal call to action to end poverty, protect the planet, and ensure that all people enjoy peace and prosperity by 2030”.1 Central to these SDGs is planetary…

The data economy: A glossary - Volume 29, Issue 2

The data economy comes with its own terminologies and buzzwords (Table 1), stakeholders (Table 2), and activities (Table 3). This glossary aims to help readers navigate this data-driven environment.

Editorial - Volume 29, Issue 2

Data are economic assets that power the so-called fourth industrial revolution. The healthcare industry is at the forefront of this “data economy”. Medical writers should understand how to use these data appropriately and responsibly. This issue of…

Getting Your Foot in the Door - Volume 29, Issue 1

Welcome to our first edition for 2020. Looking back to the year past, there were a lot of GYFD moments to acknowledge and be thankful for.

Getting Your Foot in the Door - Volume 28, Issue 4

“How did you get into the medical writing field?” is a question I often hear. This is a fairly easy question for me to answer. I saw a job advert back in 2005 in Germany, I applied for the position, I got the job, and I became a medical writer…

Getting Your Foot in the Door - Volume 28, Issue 3

The Vienna Conference is done and dusted. But the aftermath is so rewarding, as my knowledge has broadened and my network has widened. It was a joy to meet old colleagues but also get to know many people who are new to medical writing. In this…

Omics in silico and other trends in biomedical research: Impact on how and what we write - Volume 28, Issue 3

Medical writers and communicators write about biomedical research. It follows that the latest trends in this field translate to new trends in medical writing. This article provides a peek into the latest breakthroughsand developments in biomedical…

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…