Raquel Billiones - Academia.edu (original) (raw)

Papers by Raquel Billiones

Medical Writing, Mar 1, 2021

Medical Writing, Mar 1, 2013

Medical Writing, Mar 1, 2012

Medical Writing, Mar 1, 2017

Medical Writing, Jun 1, 2021

What a year! A year of corona, crisis, and challenges. But also a year of innovations, breakthrou... more What a year! A year of corona, crisis, and challenges. But also a year of innovations, breakthroughs, 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 stepped up to the challenge to innovate and accelerate development, testing, and approval of COVID-19 treatments and vaccines at warp speed. In parallel, we did not stop the other work we were doing. The pharma industry continued to serve other patients in need of essential medicines and medical devices. I am also very proud of being part of a professional organisation that is resilient and robust enough to brave the pandemic and Brexit, and bounce back stronger than ever. As Magic Johnson once said, "When you face a crisis, you know who your true friends are." Amidst job hunting and lockdowns, I have seen who my true friends were.

Limnology and Oceanography, Mar 1, 2004

We studied genetic differentiation of two subarctic Daphnia species (subgenus Hyalodaphnia; Clado... more We studied genetic differentiation of two subarctic Daphnia species (subgenus Hyalodaphnia; Cladocera: Anomopoda) in relation to ecological and morphological diversification. Daphnia longispina and the recently discovered species Daphnia umbra are genetically differentiated based on mitochondrial 12S rDNA and internal transcribed spacer (ITS) regions. Genetic differentiation of 12S rDNA among the two sister taxa is in the range of differentiation among other Hyalodaphnia species (uncorrected genetic distance ϭ 0.11). Despite frequent interspecific hybridization among Daphnia (Hyalodaphnia) species, we found no interspecific hybrids of D. umbra and D. longispina. D. umbra is for the first time recorded to occur in Northern Finland and Russia (Pechora Delta), and to cooccur in neighboring sympatry with Daphnia longispina across a subarctic region in northern Finland. Species are ecologically differentiated: D. umbra occurred at higher elevations, in larger and deeper water bodies than D. longispina. Species did not differ significantly in levels of ultraviolet-protective melanin pigmentation but varied with regard to environmental preferences, such as fish predation and levels of total dissolved organic carbon (DOC). These findings argue that ecological differentiation and divergent selection might have caused speciation or at least are responsible for the maintenance of reproductive isolation among subarctic Daphnia (Hyalodaphnia) species. Water Management and Waste Water Treatment (RIZA) and M. R. Van Eerden for zooplankton samples from Pechora Delta.

Medical Writing, Mar 15, 2023

n very year, the number of clinical trials conducted globally is increasing rapidly (approximatel... more n very year, the number of clinical trials conducted globally is increasing rapidly (approximately 10,000 annually!). According to the WHO data statistics and analysis, the number of clinical trials conducted from 1999 to 2021 has accumulated to 671,228 clinical trials. 1 As of February 28, 2023, 443,624 clinical trials have been registered on ClinicalTrials.gov. The medical writer is heavily involved in clinical trials from A to Z and even beyond. Although we are not in the frontline, our role is nevertheless crucial as we develop most of the documents needed for trial start up, conduct, close out, and reporting (see Fig 1). This issue of Medical Writing is dedicated to the unsung heroes and heroines of clinical trials, medical writing professionals and scientists who help make clinical trials happen without visiting a clinic or interacting with a single patient. This issue starts off with a foreword from the European Medicines Agency (EMA) wherein Morgane Colin de Verdiere and

Medical Writing, Dec 19, 2022

Medical Writing, Sep 18, 2022

n elcome to the autumn issue of Medical Writing (MEW). We are excited to highlight two new featur... more n elcome to the autumn issue of Medical Writing (MEW). We are excited to highlight two new features of our publication.

Medical Writing, 2020

Even though in vitro diagnostic medical devices (IVDs) occupy only a very small market segment in... more 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, IVDs are regulated under the In Vitro Diagnostics Regulation 2017/746 (IVDR), with the planned date of application in May 2022. This article gives an overview of IVDs and the regulatory requirements under the IVDR in comparison to the more well-known Medical Device Regulation 2017/745. Considering the similarities in the regulatory landscape and the document requirements of the two regulations, medical writers well versed in mainstream medical devices have the skills and competencies to support IVDs under the IVDR.

Medical Writing, May 15, 2014

Medical Writing, Jun 1, 2013

Estuarine Coastal and Shelf Science, Mar 1, 1999

Water samples from the Scheldt estuary were collected in three fractions: (a) unfiltered water, (... more Water samples from the Scheldt estuary were collected in three fractions: (a) unfiltered water, (b) water filtered through a 50 m net and (c) water filtered through a 300 m net. Particles easily recognisable from the majority of the amorphous particles were isolated and their geometric dimensions measured. From the measurements, shape factors were calculated. Measurement of fractal dimensions was attempted. From the first fraction, the particles isolated and measured were circular and chained diatoms. In the second fraction, zooplankters were easily distinguishable and representatives of the three dominant groups (cladocerans, cyclopoids and calanoids) were measured. In the third fraction, detrital pieces from monocotyledon and dicotyledon plants were recognised, isolated and measured. Fractal dimensions were only measurable in particles from fraction 3. The geometric features, shape factors and fractal dimensions of the particles were tested and proven to be effective ' fingerprints ' to distinguish these particles from the majority of the unidentifiable amorphous particles in the samples.

Medicamentos de actualidad, 2010

Medical Writing, Dec 1, 2020

Medical Writing, Mar 1, 2016

Authorship of publications has been the subject of much public debate; however, authorship of cli... more 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 given much attention. This article looks at the common practices of authorship attribut ion and signing off on these documents and examines what the ICH guidelines, on which their contents are based, say about these issues. The implications of the EMA Policy 0070 on clinical trial disclosure are discussed.

Medical Writing, Jun 1, 2020

The new European Database on Medical Devices (Eudamed) is the platform to be used for the prospec... more 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 2022. This article discusses the ramifications and the potential solutions for manufacturers to comply with public disclosure expectations and requirements. Until Eudamed is available, posting on other databases is recommended so manufacturers can meet requirements for clinical investigation transparency and disclosure while sharing clinical investigation information necessary to maintain public trust.

Medical Writing, Mar 1, 2019

Medical Writing, Jun 1, 2018

The anonymisation report (AR) is a new and relatively unknown regulatory document, submitted as p... more 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 anonymisation in each package and the rationale for these methods. As of December 31, 2017, 64 ARs have been published on the clinical data website of the European Medicines Agency. A preliminary high-level analysis of these reports was performed, with the aim of gaining information on the current industry practices in anonymisation and AR preparation. After excluding 12 ARs from packages that did not contain protected personal data, 52 ARs were analysed. Information on anonymisation methodology, re-identification risk assessment, data utility assessment, and use of software is presented.

Medical Writing, Jun 1, 2017

Increased transparency is one of the provisions of the Clinical Trial and Medical Device Regulati... more Increased 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. These, as well as the patients implanted with or wearing these devices, have become part of the so-called Internet of Things, and are therefore vulnerable to cyber attacks. Disclosure of information, data, and documents pertaining to medical devices will increase this vulnerability. In the rapidly changing regulatory landscape, the role of medical writers in anonymisation of patient data takes on a whole new magnitude. It is not only about protecting patient privacy, it is about ensuring patient safety.