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DTSTART;TZID=Europe/Ljubljana:20260617T130000
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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
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DTSTART;TZID=Europe/Ljubljana:20260618T130000
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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
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