Much has been written about the ethics of medical interpreting, but not so much about purely written translation. What moral principles apply (or should apply) when I translate a document for a client? Do I need to invent these principles myself, or is there help available? In this article I explore the personal moral principles we might apply to our work, and the institutional backup that is available, for instance the Institute of Translation and Interpreting’s Code of Conduct. I explore what a code of ethics for medical translators might look like.

Greetings from the croft.One of the things that I appreciate about the UN Sustainability Development Goals (SDGs) is how they made me realise that sustainability extends beyond climate change.The SDGs also remind me about inter-relatedness between environmental, social (including health), and economic issues, and how there are multiple ways to make a positive contribution.I'm inspired by the contributions fellow EMWA member Nicole Bezuidenhout makes to sustainability through her volunteer work for a nonprofit called Lightup Impact.In this edition of the Crofter, Nicole and her colleagues from Lightup Impact, Valeria Santoro and Jeniffer Muganda, delve deeper into the concepts of sustainable development, the SDGs that Lightup Impact aims to address, and how effective communication has been key to their success.We also asked Nicole some questions to learn more about how she became a volunteer with Lightup Impact, how her volunteer work and day job complement each other, and other things.It's also my pleasure to introduce Louisa Ludwig-Begall and Sarah Kabani who are taking over the reigns as co-editors of the Crofter.Both have been directly involved in much needed sustainability-related healthcare research and are keen sustainability enthusiasts.Be sure to get in touch with them to discuss ideas and share your sustainability experiences.

As with every medical device expert seminar series (ESS), we learned something new at the ESS held at the EMWA Conference last May in Prague.With the Medical Device Regulation (MDR) in full swing, the speakers not only discussed MDR-compliance challenges but also shed light on niche products, such as in vitro diagnostics (IVDs), combination products, and medical device software (MDSW).With great pleasure, we summarise the key messages of each of the four presentations for our readers.

Vonessa Costa look at language access as a fundamental component of health equity.The language we use has a big impact on how a message is received and plays a part in contributing towards health equity.Trans lating highly technical and scientific concepts into a language that a non-specialised audience understands helps make informa tion accessible and closes knowledge gaps.For this reason, among others, plain language has been a hot topic as of late, as demonstrated by the 56th EMWA conference last year.Romina Marazzato Sparano delineates five strategies for adapting technical content for lay audiences, offering practical guidance for writers seeking to convey complex medical concepts in a clear and engaging way.Rachel Jenkins, Johanna Todd, and Olivia Alexander offer a publisher's perspective on maximising patient en gage ment with Plain Language Summary of Publication articles (PLSPs) and strategies for enhancing the trustworthiness of medical publications among patient audiences.One factor that contributes to building trust is the quality of the information we provide.Accuracy is paramount, and in medical translation, inaccuracies can have major implications.Andrew Bell and Pedro Aguilar Torres examine the use of computer-assisted translation tools and quality assurance measures specifically to translate medical reports, with a view to maximising accuracy; Iain Matheson and Barbara Kollmer provide insights from the language service provider (LSP) perspective, examining both human and automated approaches.Another crucial aspect of providing quality translations is ensuring they are appropriate for their intended audience.This involves careful decisions on how to render cultural and linguistic nuances.Karol Tapia de Moya explores how translators navigate these aspects to adapt mental health tests beyond clinical research settings, and Raluca Chereji looks at the challenges of translating "medicalese" in informed consent forms.In this issue, we also look at the role of translation in a product's path to market.Emi Pell and Valerie Carlson focus on the importance of translation in patient engagement, recruitment and retention in clinical trials through its ability to foster trust, ensure safety, and increase efficiency in diverse healthcare settings.Karen M. Tkaczyk delves into the intricacies of translating medical device documentation, taking account of the unique challenges posed by regulatory requirements, while Ekaterina Accuracy is paramount, and in medical translation, inaccuracies can have major implications.

Research on psychotropics is gaining more popularity worldwide and support from drug regulatory agencies, which recognise the unmet medical needs of certain patient communities, such as patients with mental disorders and patients with cancer who experience depression. Cannabinoids and psilocybin have shown promising results in preclinical studies and clinical trials, but the current clinical evidence is scarce, and the regulatory requirements are strict due to high potential for drug abuse. The US FDA has recently released a draft, non-binding guidance on clinical trials with psychedelics. Europe is currently falling behind the US and Canada in terms of regulating psychotropic substances. The article provides a general introduction on conducting clinical trials with psychotropics and the regulatory requirements (as of October 2023) when submitting marketing authorisation application. In the near future, as more data becomes available, research on psychotropics will definitely shape the European regulatory landscape.

This Medical Writing issue focuses on the crucial role of medical writing and communications in biotechnology and product development in healthcare. In the pharmaceutical and medical device industries, biotechnology uses biological systems and living organisms in R&D and production processes for product development. Some biotechnologies include biologic and biosimilar pharmaceuticals, vaccines, and advanced therapy medicinal products, including gene and cell therapies and tissue engineered products.

This article takes you on an intriguing exploration of the intertwined histories of biotechnology and medical writing. From ancestral plant cultivation to revolutionary advancements in genomics, proteomics, and bioinformatics, we delve into the profound evolution and influence of biotechnology on humanity. We also shine a spotlight on the critical role of medical writers, who meticulously document, interpret, and communicate these scientific breakthroughs to wider audiences. This article offers a key to understanding the convergence of science and communication, highlighting the incredible journey of biotechnology and medical writing.

The articles included in this section are a selection from the European Medicines Agency (EMA)' s News and Press Releases archive. More information can be found on the Agency' s website: www.ema.europa.eu.

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