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DTSTART;TZID=Europe/Madrid:20260325T130000
DTEND;TZID=Europe/Madrid:20260325T140000
DTSTAMP:20260725T220830
CREATED:20260128T102111Z
LAST-MODIFIED:20260202T165213Z
UID:10000017-1774443600-1774447200@emwa.org
SUMMARY:Responding Effectively to Health Authority Questions
DESCRIPTION:March 25th\, 13.00 CET \n  \nResponding Effectively to Health Authority Questions \n  \nBhawna Basin\, Christina Eichhorn \n  \nEffective responses to health authority questions are critical to the success of marketing applications such as Biologics License Applications (BLAs)\, Marketing Authorization Applications (MAAs)\, New Drug Applications (NDAs)\, and other global submissions as they represent the final steps before health authorities determine a product’s overall benefit-risk profile. These interactions offer opportunities to build trust with regulators\, demonstrate scientific integrity\, and showcase a team’s responsiveness. This webinar offers a clear\, practical overview of what health authority questions are\, why agencies issue them\, and how to navigate major versus minor queries. Participants will learn strategies for interpreting regulatory intent\, crafting clear and scientifically sound responses\, and applying best practices in communication tone\, structure\, and collaboration. Best practices for cross‑functional collaboration\, evidence presentation\, and managing timelines will also be discussed. This webinar is ideal for medical writers involved in global regulatory submissions. \n  \nTakeaway messages: \n\nUnderstand what health authority questions are and why health authorities issue them during the review of BLAs\, MAAs\, NDAs\, and other global submissions.\nAccurately interpret regulatory intent and present evidence effectively\, ensuring data are well‑organized\, supported\, and easy for reviewers to follow.\nCollaborate efficiently across functions to gather data\, align on messaging\, and develop cohesive responses under tight deadlines.\n\n  \nLevel: Foundation/intermediate \n  \nPrevious knowledge required: The following background knowledge is recommended: \n  \n\nExperience in preparing regulatory submissions like NDA\, BLA\, and MAA.\nProficient in the structure and requirements of Common Technical Document (CTD)‑formatted submissions.\nRegulatory knowledge about major health authorities such as EMA and FDA.\n\n  \n  \nTo register\, please click here \nRegister here
URL:https://emwa.org/event/responding-effectively-to-health-authority-questions/
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/London:20260427T170000
DTEND;TZID=Europe/London:20260427T180000
DTSTAMP:20260725T220830
CREATED:20260205T101955Z
LAST-MODIFIED:20260205T101955Z
UID:10000020-1777309200-1777312800@emwa.org
SUMMARY:One Narrative\, Different Formats: Turning scientific publications into understandable and engaging content
DESCRIPTION:April 27th\, 17.00 CET \nDarío Sánchez Martin\, PhD \nAbstract: Scientific and medical writers often write for extremely qualified audiences. Doctors\, PhDs\, and other highly educated people. But these people\, atop of the knowledge pyramid\, are a small fraction of society. Knowing about other formats to write about science beyond scientific publications\, clinical trial reports\, and highly complex documents is important in a society where knowledge is ever-growing demand. This short webinar will give you basic knowledge on how to turn complex science into content for all audiences\, from scientists to the general public. To do so\, we will begin with a short overview of general writing principles\, and follow into basic psychology to understand the people you write for. With these fundamentals\, we will cover how to write for any specific audience and how to do so in different content formats\, mainly social media and blog articles. Lastly\, and if time allows\, we will shortly go through an overview of visual aids (photos\, schematics\, drawings\, tables\, illustrations\, and text formatting) in written content\, and the basics of visual storytelling. \nTakeaway messages: \n\nUnderstanding your audience and their mindset is the first and most important step to communicate appropriately towards them.\nDifferent formats require different communication strategies\, mainly for opt-in vs forced readers.\nBlogs and social media content allow communications of complex concepts without loss of context if done well.\n\nLevel: foundation \nPrevious knowledge required: Basic knowledge of scientific publications and/or communications aimed at experts (doctors\, scientists)\, and different types of content\, basically LinkedIn/social media and blogs. \nTo register\, please click here \nRegister Here
URL:https://emwa.org/event/one-narrative-different-formats-turning-scientific-publications-into-understandable-and-engaging-content/
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Ljubljana:20260429T190000
DTEND;TZID=Europe/Ljubljana:20260429T200000
DTSTAMP:20260725T220830
CREATED:20260428T145835Z
LAST-MODIFIED:20260428T150029Z
UID:10000027-1777489200-1777492800@emwa.org
SUMMARY:EMWA General Meeting of Members
DESCRIPTION:We are pleased to invite you to the EMWA General Meeting of Members (previously known as the AGM or AM)\, which is taking place on Wednesday 29th April 2026 via Zoom. 19.00-20.00 CET / 18.00-19.00 GMT\n\nPlease register your attendance: Register here\n\nThis is your chance to hear important updates from the EMWA Executive Community\, ask questions\, connect with fellow members\, and learn more about the future of our organisation.
URL:https://emwa.org/event/emwa-general-meeting-of-members/
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/London:20260505T080000
DTEND;TZID=Europe/London:20260508T170000
DTSTAMP:20260725T220830
CREATED:20250527T133043Z
LAST-MODIFIED:20250527T133143Z
UID:10000003-1777968000-1778259600@emwa.org
SUMMARY:EMWA 61st Spring Conference
DESCRIPTION:To be held in the beautiful city of Barcelona
URL:https://emwa.org/event/emwa-61st-spring-conference/
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Berlin:20260611T160000
DTEND;TZID=Europe/Berlin:20260611T170000
DTSTAMP:20260725T220830
CREATED:20260513T142134Z
LAST-MODIFIED:20260513T142956Z
UID:10000028-1781193600-1781197200@emwa.org
SUMMARY:The Role of AI in Medical Writing: Beyond Drafting Speed\, Accuracy\, QC Burden and What Actually Works
DESCRIPTION:Thursday 11th June @ 4pm CET \nSpeakers: Barry Drees\, PhD and Louise Martinsson\, PhD \nDiscussing: \n\nIs “faster drafting” solving the wrong problem? or shifting the burden into downstream QC\nLean writing vs. legacy habits- Why most documents still say more than regulators\nConsistency at scale- Why global teams struggle to produce stable\, aligned outputs\nAI in practice- Where it genuinely helps- and where it quietly introduces risk\nThe uncomfortable shift- Why regulatory writing is becoming a data and evidence problem- not a drafting exercise\n\n  \nRegister here
URL:https://emwa.org/event/the-role-of-ai-in-medical-writing-beyond-drafting-speed-accuracy-qc-burden-and-what-actually-works/
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Ljubljana:20260617T130000
DTEND;TZID=Europe/Ljubljana:20260617T135000
DTSTAMP:20260725T220830
CREATED:20260330T145654Z
LAST-MODIFIED:20260514T155737Z
UID:10000022-1781701200-1781704200@emwa.org
SUMMARY:CORE Reference Webinar
DESCRIPTION:Wednesday 17th June @ 13.00-13.50 CET \nOur next CORE Reference webinar will be presented by Marcie Roche (Argenx) who will share her insights in ICH M11\, More details to follow. Register in advance for this webinar: \nTitle: ICH M11: an integrated and forward‑looking CeSHarP perspective \nAbstract: Viewed through a regulatory medical writing lens\, ICH M11 (CeSHarP [Clinical Electronic Structured Harmonised Protocol]; adopted 19 November 2025) reframes clinical study protocols as structured\, reviewable\, and reusable source documents that preserve scientific intent and decision-making transparency. The harmonised template and technical specification reduce variability\, support interoperable electronic exchange\, and minimise unnecessary repetition through consistent content placement. \nWith the convergence of established industry approaches\, TransCelerate’s Common Protocol Template (V11\, 2026) was realigned to ICH M11\, reflecting a reconciliation of legacy authoring practices with emerging global standards that support operational efficiency and submission readiness. \nWhile CPT V11 reflects the ICH M11 protocol template and associated technical specification\, the level of detail and content implementation requires medical writing judgment beyond simple adherence to the template. \nWithin the clinical study documentation continuum\, disciplined lean authoring\, traceability\, and the critical evaluation of content for use or AI‑assisted text remain essential to ensure that protocol decisions remain aligned with downstream reporting (as reflected in the CORE Reference framework). \nThis webinar encourages medical writers and regulatory professionals to take a deliberate\, forward‑looking approach to their craft\, recognising that precise structure and clear intent are essential to scientific integrity and effective communication. \nBio: Marcie A. Roche\, PhD is a senior director of medical writing at argenx with over 20 years of pharmaceutical industry experience. She promotes the strategy and development of clinical and regulatory documents that support global health authority submissions and related agency interactions. Her work prioritises clear\, consistent\, guideline-aligned content that integrates complex concepts into lean authoring narratives\, valuing cross-functional leadership and mentoring medical writers. \n  \nRegister here \nAfter registering\, you will receive a confirmation email containing information about joining the meeting.
URL:https://emwa.org/event/core-reference-webinar-2/
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Ljubljana:20260618T130000
DTEND;TZID=Europe/Ljubljana:20260618T140000
DTSTAMP:20260725T220830
CREATED:20260330T150243Z
LAST-MODIFIED:20260415T155137Z
UID:10000023-1781787600-1781791200@emwa.org
SUMMARY:Data Compliance for Freelance Medical Writers
DESCRIPTION:Thursday 18th June @ 13.00-14.00 CET \nVena Verga-Danemar\, J.D.\, LL.M. (Tilburg)\, LL.M.-MAS (Geneva) \nFreelance medical writers and communicators handle personal data in everyday freelance practice: in the tools they use\, the documents they produce\, and the business they run independently. Data protection obligations can arise in all three areas\, but many freelancers have only limited visibility on where those obligations sit. \nThis webinar provides a practical overview of three commonly overlooked compliance areas in independent freelance practice: the data protection implications of everyday digital tools and client agreements\, the personal data that can remain embedded in shared documents\, and the obligations that apply to the freelancer’s own business data\, separate from any client arrangement. \nKey takeaways for participants \n1. Understand the data protection implications of the digital tools used in freelance medical writing practice\, and what client agreements should address in relation to those tools.\n2. Recognise the main places where personal data can remain embedded in shared documents.\n3. Distinguish between the obligations that apply when working under a client’s instructions and those that apply to the freelancer’s own business data \nLevel: Foundation \nPrevious knowledge required: The session is grounded in real freelance workflows and assumes no prior legal knowledge. This webinar is designed for EMWA members working independently as freelance medical writers and communicators. \nTo register\, please click here \nRegister here
URL:https://emwa.org/event/data-compliance-for-freelance-medical-writers/
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Ljubljana:20260709T130000
DTEND;TZID=Europe/Ljubljana:20260709T140000
DTSTAMP:20260725T220830
CREATED:20260330T150455Z
LAST-MODIFIED:20260415T155807Z
UID:10000024-1783602000-1783605600@emwa.org
SUMMARY:Writing for Localisation
DESCRIPTION:Thursday 9th July @13.00-14.00 CET \nAna Sofia Correia\, Medical Translator and Writer \n\nMedical and scientific content is often developed for use across multiple countries\, languages\, and audiences\, yet writing and translation are still frequently treated as separate stages. This can result in ambiguity\, terminology inconsistencies\, and cultural or regulatory mismatches that create avoidable rework and delays.\n\n\nThe webinar will explore how sourcewriting decisions directly influence translation and adaptation outcomes\, and how a localisation-aware approach can improve clarity\, consistency\, and usability from the outset. The session will cover common source-text features that make translation more difficult\, practical ways to improve localisation readiness when writing in English\, and a simple framework to support decisions on whether content should be translated\, localised\, rewritten\, or transcreated. It will also address terminology decisions and the importance of considering the broader context when content is intended for global communication. Participants will leave with practical insights to help them create source content that is clearer\, more adaptable\, and better suited for use across markets. \nKey takeaways for participants: \n\nRecognise common source-text features that make translation and adaptation more difficult.\nApply practical writing principles to create clearer\, more localisation-ready source content.\nUse a simple framework to decide when content requires translation\, localisation\, rewriting\, or transcreation.\n\nLevel: Foundation to intermediate \n\nPrevious knowledge required: None. No prior localisation or translation experience is required. The webinar will be particularly relevant for medical writers and content developers who collaborate with global teams\, affiliates\, or translation partners.\n\n\nTo register\, please click here\n\n\nRegister here
URL:https://emwa.org/event/writing-for-localisation/
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Ljubljana:20260803T120000
DTEND;TZID=Europe/Ljubljana:20260803T130000
DTSTAMP:20260725T220830
CREATED:20260714T085435Z
LAST-MODIFIED:20260714T085649Z
UID:10000029-1785758400-1785762000@emwa.org
SUMMARY:Getting into Medical Writing: Regulatory Writing Q&A
DESCRIPTION:Getting into Medical Writing: Regulatory Writing Q&A \nMonday 3rd August 12pm CET – 1pm CET (1 hour) \nRegister Here
URL:https://emwa.org/event/getting-into-medical-writing-regulatory-writing-qa/
CATEGORIES:Q&A
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Ljubljana:20260923T130000
DTEND;TZID=Europe/Ljubljana:20260923T140000
DTSTAMP:20260725T220830
CREATED:20260330T150719Z
LAST-MODIFIED:20260703T104617Z
UID:10000025-1790168400-1790172000@emwa.org
SUMMARY:Visual Communication
DESCRIPTION:Wednesday 23rd September @ 13.00-14.00 CET \nDetails to follow
URL:https://emwa.org/event/visual-communication/
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Ljubljana:20261030T130000
DTEND;TZID=Europe/Ljubljana:20261030T140000
DTSTAMP:20260725T220830
CREATED:20260330T150858Z
LAST-MODIFIED:20260330T150858Z
UID:10000026-1793365200-1793368800@emwa.org
SUMMARY:Leveraging Data Analytics for Efficient Multi-Country Regulatory Submissions
DESCRIPTION:Friday 30th October @13.00-14.00 CET \nDetails to follow
URL:https://emwa.org/event/leveraging-data-analytics-for-efficient-multi-country-regulatory-submissions/
CATEGORIES:Webinar
END:VEVENT
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