Elsa Sklavounou

Effective Communication with National Competent Authorities During Linguistic Review Navigating the linguistic review process with National Competent Authorities (NCAs) can be challenging, but it's essential for ensuring that the product information meets regulatory standards across different regions. Here are some key strategies for success: 1. Comprehensive Responses: Provide responses to all comments and implement the changes requested in a timely manner. If you are not sure of a change, additional queries are crucial. This includes clear rationales for any deviations from standard texts, which can pre-empt potential questions and expedite approval. It will help to maintain a smooth review process. 2. Proactive Engagement: Engage proactively with NCAs. Regular updates and open lines of communication can help anticipate issues and address them before they become obstacles. It reduces the risk of last-minute surprises and ensures that any required adjustments are made well within the review timelines. This can also build trust and establish a positive working relationship, making future interactions smoother. 3. Detailed Documentation: Keep well-organized documentation of all the conversation carried out with the Competent Authority. It shows NCAs and other regulatory authorities that you are organized, responsive, and serious about compliance. In the event of an audit, you are well-prepared to demonstrate all the choices made during the linguistic review process. 4. Continuous Improvement: Learn from each process. Gather feedback, identify areas for improvement, and refine your communication strategies accordingly. This will also allow you to take into account the corrections for future product information texts. 5. Training and Preparation: Equip your team with the necessary training to handle NCA communications effectively. Understanding the regulatory landscape and common pitfalls can significantly enhance your interactions. Stay up to date with the new guidelines and regulatory standards available on the website of the NCAs. By fostering strong, transparent, and respectful communication with NCAs, we can not only streamline the linguistic review process but also build lasting relationships that facilitate regulatory compliance and market access. 🌐 Contact me for more information on the linguistic review process for your regulatory submissions!  #RegulatoryAffairs #LinguisticReview #EffectiveCommunication #PharmaceuticalIndustry #GlobalCompliance

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How is #ISO5060:2024 relevant to language service providers and their existing ISO certifications? We take a look at the newly-published standard "Translation services – Evaluation of translation output" ⬇️ https://lnkd.in/erwUgWBG #languageserviceproviders #isocertification #LSPs #translation #machinetranslation

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Université de Bordeaux researchers show how conditioning #LLMs with emotional context 😃😡 can improve 💫 #translation quality, introducing a new #MT pipeline where emotions are embedded into #LLM prompts. #machinetranslation #xl8 #t9n #largelanguagemodels

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Aimed at providing guidance for human evaluation of the translation output, ISO 5060 can be applied to workflows involving both human and machine translation with or without subsequent post-editing. The standard combines hands-on advice with the strategic considerations and general principles for translation quality evaluation. It is built on the analytic approach that involves a “bilingual examination of target language content against source language content while classifying any errors with respect to translation evaluation specifications and for the purpose of reaching a quality rating.”

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The ISO - International Organization for Standardization, the body in charge of developing and publishing international standards, has published a new standard on evaluation of translation output. ISO 5060 is the result of four years of work conducted by the ISO/TC 37/SC 5 technical committee for translation, interpreting and related technology, and the 18th document of this kind published by the unit (with a further seven being currently under development). Numerous experts on translation and quality evaluation formed part of the working group, with participants from more than 30 countries contributing to the creation of this new standard. Read more in this informative article from Slator: #xl8 #l10n #translation #localization #quality #terminology

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Our aims for offering French localization services are clear… 🌐 💻 Here is LuxuriousTranslate’s mission recapped in three bullet points. By offering our services, here are our main goals: ➡ Support France’s ecological transition. ♻ ➡ Maintain its strong position in terms of European sustainability. 🔅 ➡ And more importantly: provide French citizens with day-to-day sustainable solutions. 🚰 Helping businesses promote and democratize their innovations is key to the adoption of their critical solutions. By promoting more, you raise more awareness; and that’s the whole point behind the need to localize your business. 📈 Indeed, the aim behind all of this is to sensitize inhabitants by making clean technologies an integral part of our population's daily lives. 💆‍♂️ 💆‍♀️ LET’S INTERCONNECT EUROPE 🌍 ♻ Cleantech for France 🇫🇷 Cleantech for Europe 🇪🇺 Follow #LetsInterconnectEurope #LuxuriousTranslate #Localization #RenewableEnergy #Sustainableenergy #Sustainablebusiness #Agency #businessgrowth #France

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Ensuring accuracy in life sciences translation is a multi-step process that plays a vital role in patient safety, regulatory compliance, and global research success. At RWS, we follow a structured approach to guarantee the highest quality in every project. Our translators are not only fluent in their target languages but also experts in life sciences, ensuring the correct use of complex medical and scientific terminology. Each translation is then subjected to rigorous quality assurance through proofreading and review by subject matter experts, minimizing errors and ensuring consistency. We also focus on cultural adaptation, ensuring that content is localized to meet the specific needs of different regions, from patient materials to regulatory submissions. Finally, compliance is a top priority. Our translations adhere to the highest regulatory standards, keeping your projects aligned with global guidelines. This thorough process ensures accuracy at every step, helping life science companies deliver clear, effective, and compliant communications worldwide. Learn more at: https://hubs.ly/Q02X9jx80 #LifeSciences #TranslationAccuracy #MultilingualSolutions #RWS #PatientSafety #GlobalHealth #Localization #RegulatoryCompliance

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Need assistance with #translations for #medicaldevice development, drug authorizations, or post-approval of your medicinal drugs or devices in the EU? Lionbridge's new blog breaks down the EU's #multilingual policy to help you ensure compliance.

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Recap from #ATD New Orleans 2024: +10, 000 people, Neuroscience ?! and Ai vendors all over-- So I did a survey, who's doing what? Did they figure it out? [[spoiler: some did!]] 1) Articulate Rise will have a bilingual review format, exportable bits, and VERSIONING--language versions! Coming July? 2024 2) VYOND video animator now supports export/import of files for translation. Synthetic Avatars are heating up, and more--shameless pitch for my webinar: https://lnkd.in/enKHMt5d 29-May, Wednesday 2024

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Dear community, Is there a standardized method for evaluating localized audio, similar to the methods used for assessing translation quality (LQA)? This would be used to assess the quality of AI-generated audio. #AI #AudioEvaluation #Localization #QualityAssessment #LQA #MT

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In our latest article, we discover the benefits and limitations of machine translation 🤖🦾: https://lnkd.in/daGv4KFt #MachineTranslation #MachineLearning #PostEditing #ArtificialIntelligence #AI #Translation #BenefitsofMachineTranslation

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Editors, how easy do you find it to translate your text into multiple languages 🌐? 🌍 Seeds Consulting AS, an Enonic partner, has just launched an awesome app for editors to translate their articles into other languages. By combining Enonic's advanced CMS technology with Google's AI engine, Seeds has created an innovative solution that seamlessly translates content into multiple languages automatically, all within Enonic’s Content Studio. 🧠 Egil F. Nes, CTO of Seeds, is the brains behind the solution, and here's what he had to say: "Our goal is to make Enonic users even more satisfied by offering them tools that streamline editorial work. Everyone writes best in their native language, but many also need to be able to publish their websites in multiple languages, either in full or in part." #ContentManagement #Translation #EnonicMarket #CMS #Innovation

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Swedish

When it comes to #videogame testing, Functional Quality Assurance (FQA) and Localization Quality Assurance (LQA) are often treated as separate entities. But is that the best approach? Our experts say, "Not quite!" Our new blog post can help level up your game testing.

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For all RWS Trados users out there 👋 Go check out Anita's latest post 📜 about the ETUG – The European Trados User Group!

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🚀 Explore the future of translation and localization with AI! 🤖 Our latest blog article by Philippe Schiflers dives into the innovative roles emerging at the intersection of linguistic expertise and technology. Don't miss out—read the full article now⏩ https://zurl.co/oz6B Let us know what you think in the comments! #LPGblog #AI #LanguageTech

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Preparing for the European Accessibility Act (EAA): Key Insights for Publishers   The European Accessibility Act (EAA), effective June 28, 2025, mandates that all digital products and services, including e-books and e-readers, be accessible. Mary Elliott and Cristina Mussinelli offer crucial guidance for publishers to ensure compliance, from enhancing ePubs to understanding new standards.   Read the full article for essential tips on navigating these upcoming regulations: https://shorturl.at/k6Ide   #EAA #DigitalInclusion

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