BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//EMWA - ECPv6.16.1//NONSGML v1.0//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-WR-CALNAME:EMWA
X-ORIGINAL-URL:https://emwa.org
X-WR-CALDESC:Events for EMWA
REFRESH-INTERVAL;VALUE=DURATION:PT1H
X-Robots-Tag:noindex
X-PUBLISHED-TTL:PT1H
BEGIN:VTIMEZONE
TZID:Europe/Madrid
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20240331T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20241027T010000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20250330T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20251026T010000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20260329T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20261025T010000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20270328T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20271031T010000
END:STANDARD
END:VTIMEZONE
BEGIN:VTIMEZONE
TZID:Europe/Belgrade
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20240331T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20241027T010000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20250330T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20251026T010000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20260329T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20261025T010000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20270328T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20271031T010000
END:STANDARD
END:VTIMEZONE
BEGIN:VTIMEZONE
TZID:Europe/London
BEGIN:DAYLIGHT
TZOFFSETFROM:+0000
TZOFFSETTO:+0100
TZNAME:BST
DTSTART:20240331T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0100
TZOFFSETTO:+0000
TZNAME:GMT
DTSTART:20241027T010000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:+0000
TZOFFSETTO:+0100
TZNAME:BST
DTSTART:20250330T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0100
TZOFFSETTO:+0000
TZNAME:GMT
DTSTART:20251026T010000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:+0000
TZOFFSETTO:+0100
TZNAME:BST
DTSTART:20260329T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0100
TZOFFSETTO:+0000
TZNAME:GMT
DTSTART:20261025T010000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:+0000
TZOFFSETTO:+0100
TZNAME:BST
DTSTART:20270328T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0100
TZOFFSETTO:+0000
TZNAME:GMT
DTSTART:20271031T010000
END:STANDARD
END:VTIMEZONE
BEGIN:VTIMEZONE
TZID:Europe/Paris
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20250330T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20251026T010000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20260329T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20261025T010000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20270328T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20271031T010000
END:STANDARD
END:VTIMEZONE
BEGIN:VTIMEZONE
TZID:Europe/Bratislava
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20240331T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20241027T010000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20250330T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20251026T010000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20260329T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20261025T010000
END:STANDARD
END:VTIMEZONE
BEGIN:VTIMEZONE
TZID:Europe/Amsterdam
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20240331T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20241027T010000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20250330T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20251026T010000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20260329T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20261025T010000
END:STANDARD
END:VTIMEZONE
BEGIN:VTIMEZONE
TZID:Europe/Brussels
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20240331T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20241027T010000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20250330T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20251026T010000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20260329T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20261025T010000
END:STANDARD
END:VTIMEZONE
BEGIN:VTIMEZONE
TZID:Europe/Berlin
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20240331T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20241027T010000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20250330T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20251026T010000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20260329T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20261025T010000
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTART;TZID=Europe/Madrid:20260325T130000
DTEND;TZID=Europe/Madrid:20260325T140000
DTSTAMP:20260725T231013
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/Belgrade:20260320T130000
DTEND;TZID=Europe/Belgrade:20260320T160000
DTSTAMP:20260725T231013
CREATED:20260309T173135Z
LAST-MODIFIED:20260309T173421Z
UID:10000021-1774011600-1774022400@emwa.org
SUMMARY:Getting Into Medical Writing
DESCRIPTION:13:00 – 16:00 CET \nThe GIMW group is pleased to offer another virtual Getting into Medical Writing session. In this 3-hour session\, experienced medical writers and EMWA members will present and discuss the vast scope of the medical writing profession and how EMWA can help you achieve your professional goals in this rewarding career path. \nAspiring/new medical writers will have the chance to hear first-hand the stories of successful medical writers and network with other professionals in the field. This session is fully virtual and open to non-EMWA members worldwide. \nThe session will cover: \n\nAn introduction to medical writing\nTypes of medical writing: Regulatory vs. MedComms\nFreelancing\nTransferable skills from academia\nAdvisory boards\nRecruiting process\nCVs & LinkedIn\nNavigating EMWA and its offerings\nThe upcoming conference in Barcelona\, May 2026\nQ&A and networking opportunities\n\nWe invite you to join us and to spread the word among those who might be interested. \nRegister here
URL:https://emwa.org/event/getting-into-medical-writing/
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/London:20260305T130000
DTEND;TZID=Europe/London:20260305T140000
DTSTAMP:20260725T231013
CREATED:20260202T165412Z
LAST-MODIFIED:20260212T131543Z
UID:10000018-1772715600-1772719200@emwa.org
SUMMARY:Clinical Evaluation Under MDR and IVDR: Practical Updates and Implementation Strategies for Medical Writers
DESCRIPTION:Clinical Evaluation Under MDR and IVDR: Practical Updates and Implementation Strategies for Medical Writers \n  \nHatem Rabeh\, MD\, MSc \n  \nThe recent updates to the MDR and IVDR frameworks have introduced important changes that directly impact how clinical evidence is planned\, documented\, and reviewed. For medical writers and regulatory professionals\, translating these regulatory updates into operational workflows remains challenging. \nThis webinar will provide a practical overview of the latest regulatory updates affecting clinical evaluation and performance evaluation. It will focus on how these changes influence clinical evaluation plans\, clinical evaluation reports\, post market clinical follow up activities\, and evidence lifecycle management. \nThrough real case examples and field experience\, participants will learn how to adapt documentation strategies\, align evidence generation with regulatory expectations\, and avoid common compliance pitfalls. The session is designed to support professionals involved in regulatory writing\, clinical documentation\, and evidence planning for medical devices and IVDs under the European regulatory framework. \n  \nKey takeaways for participants \n  \n\nUnderstand the main MDR and IVDR updates impacting clinical and performance evaluation activities\nLearn how to translate regulatory requirements into practical documentation workflows\nIdentify frequent compliance gaps observed during Notified Body reviews and how to prevent them\n\n  \nLevel: Intermediate/Advanced \n  \nTo register\, please click here \nRegister here
URL:https://emwa.org/event/clinical-evaluation-under-mdr-and-ivdr-practical-updates-and-implementation-strategies-for-medical-writers/
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Madrid:20260130T130000
DTEND;TZID=Europe/Madrid:20260130T140000
DTSTAMP:20260725T231013
CREATED:20260108T103245Z
LAST-MODIFIED:20260108T103245Z
UID:10000016-1769778000-1769781600@emwa.org
SUMMARY:EMWA Q&A event on publications writing
DESCRIPTION:13.00 CET \nA live Q&A Event \nWhether you are just starting out\, interested in transferring to publications writing\, or currently waist-deep in a challenging manuscript\, we hope to answer your questions\, provide tips\, and share our enthusiasm for publications medical writing. \nExperienced medical writers Barbara Bartolini\, Fiona Beck\, and Alexander Lowe will be in the hotseats. The session will be moderated by Evguenia Alechine. \nRegister Here
URL:https://emwa.org/event/emwa-qa-event-on-publications-writing/
CATEGORIES:Q&A
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Madrid:20260127T130000
DTEND;TZID=Europe/Madrid:20260127T140000
DTSTAMP:20260725T231013
CREATED:20260107T164331Z
LAST-MODIFIED:20260113T155528Z
UID:10000015-1769518800-1769522400@emwa.org
SUMMARY:Briefing Books Webinar
DESCRIPTION:January 27th\, 13.00 CET \nFrom Questions to Clarity: Crafting Effective Briefing Books \nAnja Ramsay\, PhD \nThis webinar explores briefing books as strategic tools for regulatory interactions with agencies such as EMA and FDA. These documents inform agencies about development programs and frame questions requiring guidance\, serving as a foundation for scientific dialogue rather than simple summaries. EMA emphasizes written scientific advice and mandatory templates\, allowing flexible timing\, while FDA relies on formal meetings (Type A\, B\, C) with structured timelines and no strict template. Essential components include background\, development overview\, questions with rationale\, and supporting data. Strategic writing principles—clarity\, consistency\, and alignment with development goals—are critical\, alongside tailoring content to agency expectations and anticipating regulatory concerns. The webinar also addresses challenges such as limited training on briefing books and highlights global practices for other agencies\, underscoring the vital role of medical writers in ensuring compliance and facilitating successful regulatory outcomes. \nTakeaway messages: \n· Takeaway message #1: Briefing books are strategic tools\, not summaries; they enable structured dialogue with regulatory agencies to inform them about development plans and frame precise questions for guidance. \n· Takeaway message #2: Be aware of the main differences: EMA provides written scientific advice\, has a mandatory template with flexible timing. FDA holds formal meetings (Type A\, B\, C)\, has no strict template\, but follows structured timelines. \n· Takeaway message #3: Well-prepared briefing books reduce regulatory risk\, streamline interactions\, and support efficient drug development. Strategic writing is critical to ensure clarity\, consistency\, and alignment with development goals. \nLevel: Foundation/Intermediate \nPrevious knowledge required: To fully benefit from the webinar\, the following background knowledge is recommended: \n· Basic Regulatory Framework: Familiarity with drug development stages (preclinical\, clinical phases) and regulatory submissions like IND\, NDA\, and MAA. \n· Regulatory Agencies: Awareness of major agencies such as EMA and FDA\, and their roles in approving medicines. \n· Medical Writing Fundamentals: Understanding of structured documents\, clarity principles\, and compliance with guidelines. \n· Clinical Development Concepts: Knowledge of study design\, endpoints\, comparators\, and terminology (e.g.\, orphan drugs\, CHMP\, SAWP). \nRegister here
URL:https://emwa.org/event/briefing-books-webinar/
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Belgrade:20260116T123000
DTEND;TZID=Europe/Belgrade:20260116T133000
DTSTAMP:20260725T231013
CREATED:20251201T142757Z
LAST-MODIFIED:20251201T142757Z
UID:10000014-1768566600-1768570200@emwa.org
SUMMARY:CORE Reference Project webinar
DESCRIPTION:The next CORE Reference Project webinar is scheduled for Friday 16 January 2026 (12.30-13.30 CET/11.30-12.30 UK time). \n External speaker Mirjana Miric from Worldwide Clinical Trials will present a webinar on the topic “CTIS and Clinical Trial Transparency: Strategies\, Challenges\, and CRO Insights.” The upcoming webinar will focus on the protection of personal data and commercially confidential information in clinical trial information submitted to Clinical Trials Information System. \nRegister here
URL:https://emwa.org/event/core-reference-project-webinar/
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Paris:20260114T180000
DTEND;TZID=Europe/Paris:20260114T190000
DTSTAMP:20260725T231013
CREATED:20251126T153432Z
LAST-MODIFIED:20251126T153432Z
UID:10000013-1768413600-1768417200@emwa.org
SUMMARY:Sustainability SIG – Meet & Share
DESCRIPTION:Since the COVID pandemic\, the relevance of the One Health approach to understand and address the complex health and planetary issues we face is receiving greater recognition. At the global and EU level\, there are calls to inform\, integrate\, and coordinate cross-sector policies and actions based on One Health concepts. The SUS-SIG welcomes all EMWA members to come join a special Meet & Share session entitled\, “One Health is over 20 years old. What is next?” on Wednesday\, January 14\, 2026 from 18:00-19:00 hr (CET). This session will be led by One Health and EcoHealth consultant Craig Stephen\, DVM PhD FCAHS. Come join us and share your questions and experience with the One Health approach! \nAbstract \nThe phrase “One World – One Health” was coined and trademarked in 2004. Since then\, One Health has found its way into numerous proclamations\, agreements and policies at the multilateral\, regional\, national and local level. At no time in recent history\, have so many agencies and governments been mentioning the interconnections of human\, animal and environmental health. But as more and more organizations use the term for an ever-widening scope of activity\, can One Health deliver? One Health is neither new nor unique. Several similar concepts are as old as time or have blossomed then faded over the last 5 decades. This talk will explore the gap between One Health’s good intentions and the reality of its application. It will propose some key opportunities and obstacles that need to be addressed to achieve the ideal of interspecies and intergenerational health equity and address the increasing acuteness and number of planetary emergencies. This talk will draw on Craig Stephen’s over 30 years experience working in this milieu. \nSpeaker Biography \nCraig Stephen DVM PhD FCAHS has devoted his career to developing ideas\, people\, policies and evidence to concurrently promote the health of people and animals and their shared environments. He uses population health and health promotion concepts on a wide set of issues ranging from conservation\, to climate change\, to emerging diseases. This work has been recognized through his election as Fellow of the Canadian Academy of Health Sciences. As a One Health and EcoHealth consultant\, Craig works globally with all levels of government\, the non-profit sector\, community groups\, universities and industry to examine complex health issues at the nexus of people\, animals and environments. His aim is to help develop sensible\, practical and evidence-based policies that promote an inter-species and inter-generational approach to health. Craig is a veterinarian and epidemiologist. He currently leads the McEachran Institute\, which is a Canadian charity dedicated to provoking disruptive thinking and forging collaborative solutions that protect animals\, health\, and society in a rapidly changing future. \nTo register click here
URL:https://emwa.org/event/sustainability-sig-meet-share/
CATEGORIES:Meet & Share
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Bratislava:20251211T130000
DTEND;TZID=Europe/Bratislava:20251211T140000
DTSTAMP:20260725T231013
CREATED:20251119T163614Z
LAST-MODIFIED:20251124T084245Z
UID:10000012-1765458000-1765461600@emwa.org
SUMMARY:Diversity and inclusion in clinical trials
DESCRIPTION:December 11th\, 13.00 CET \nDiversity and inclusion in clinical trials \nDarius-Jean Namdjou\, PhD \nUnderrepresentation of certain groups\, e.g. via gender\, ethnicity\, socioeconomic status and further parameters\, is affecting clinical trials\, particularly in late-stage development trials. The resulting inequalities in access to clinical trials have led\, as current research indicates\, to consequential issues concerning e.g. efficacy and/or safety of authority-approved medicines in these underrepresented populations. In agreement with the overall goal of a more patient-centric drug development\, the topic of inclusion to clinical development has been recently addressed by EMA in its Draft Reflection Paper on Patient Experience Data (PED)\, while US FDA’s thinking on diversity has been described in guidance documents on Diversity Action Plans for pivotal clinical trials. Holistically on a global scale\, both topics were addressed in the WHO guidance document on best practices for clinical trials. The scope of this presentation is to inform about current efforts to foster equality in access to clinical trials and to make the webinar participants aware of the corresponding developments affecting future global drug development. \nLearning objective: \nReceive the necessary knowledge on inclusion\, diversity and strengthening the patient voice in clinical development to start raising awareness\, including triggering thinking processes on respective practical implementation \nLevel: Intermediate \nTo register\, please click here
URL:https://emwa.org/event/diversity-and-inclusion-in-clinical-trials/
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Amsterdam:20251210T160000
DTEND;TZID=Europe/Amsterdam:20251210T170000
DTSTAMP:20260725T231013
CREATED:20251031T160059Z
LAST-MODIFIED:20251031T160059Z
UID:10000011-1765382400-1765386000@emwa.org
SUMMARY:Visual Comms SIG Meet & Share – Visual Storytelling to Communicate Medical Science to Children
DESCRIPTION:Visuals improve comprehension by capturing a story and translating it into a big picture. Especially in medical communication\, which is full of technical terms and complex language\, health information can become difficult to digest and overwhelming. In this Meet & Share\, Janaine will discuss how to use images and/or graphs to explain a medical condition. Importantly\, she will also explore how to use creativity and simple associations to turn medical and scientific knowledge into fun visual storytelling\, including: \n· Use everyday objects and turn them into illustrations to explain medical conditions\, for example\, using the peel of an orange to explain the meninges in meningitis. \n· Inclusion of fairy tales\, where a princess might become sick from an allergy\, and her journey can help children understand symptoms and treatments. \nTo register click the button below \n register
URL:https://emwa.org/event/visual-comms-sig-meet-share-visual-storytelling-to-communicate-medical-science-to-children/
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/London:20251114T080000
DTEND;TZID=Europe/London:20251129T170000
DTSTAMP:20260725T231013
CREATED:20250527T132933Z
LAST-MODIFIED:20251031T141104Z
UID:10000002-1763107200-1764435600@emwa.org
SUMMARY:EMWA 60th virtual conference
DESCRIPTION:
URL:https://emwa.org/event/emwa-60th-virtual-conference/
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Madrid:20251112T150000
DTEND;TZID=Europe/Madrid:20251112T170000
DTSTAMP:20260725T231013
CREATED:20250723T091548Z
LAST-MODIFIED:20251022T071115Z
UID:10000006-1762959600-1762966800@emwa.org
SUMMARY:Getting into Medical Writing Virtual Session
DESCRIPTION:Virtual only \nREGISTER HERE \nGetting into Medical Writing Virtual Session \nWednesday 12th November 2025\, 3-5 pm CET \nThe GIMW Organising Committee is pleased to offer another virtual Getting into Medical Writing session. In this free\, 2-hour session\, experienced medical writers and EMWA members will present and discuss their transition stories into medical writing\, what a day in their job looks like\, useful skills\, training opportunities\, networking strategies\, and more. \nAspiring/new medical writers will have the chance to ask questions and network with other professionals in the field. This session is fully virtual and open to non-members of EMWA from all over the world. \nThe session will include: \n\nTransition into medical writing\nDifferent types of medical writing\nFreelancing vs. employment\nTransferable skills\nTraining opportunities\nQ&A and networking opportunities\n\nWe invite you to join us and to spread the word among those who might be interested. \nAgenda \n\nFrom academia to regulatory writer (Matthew Edmonds)\nFreelance medical writing as a thriving business (Sofia Urner)\nChanging from patient-facing clinical work to medical writing (Fiona Beck)\nFrom academia to scientific leadership (Francesca Cappellini)\nStepping into Leadership: From Medical Writer to Manager (Sarah Hopwood)\nHow I created my dream job (Evguenia Alechine)\nQ&A and online networking (in breakout rooms; 3 rounds; 6 rooms)\nIn and around EMWA and the upcoming virtual conference (Abe Schevack)\n\nREGISTER HERE
URL:https://emwa.org/event/getting-into-medical-writing-virtual-session/
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/png:https://emwa.org/wp-content/uploads/2025/07/GIMW-12Nov2025.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Belgrade:20251014T130000
DTEND;TZID=Europe/Belgrade:20251014T140000
DTSTAMP:20260725T231013
CREATED:20250829T124744Z
LAST-MODIFIED:20250829T124744Z
UID:10000009-1760446800-1760450400@emwa.org
SUMMARY:Upgrading your protocol writing skillset: best practice insights for protocol development 
DESCRIPTION:October 14th\, 13.00 CET \nJonathan Mackinnon\n\nThe skillset of medical writers is constantly evolving. Influences from patient centricity\, trial complexity\, technology\, and project management mean that we’re now expected to bring more skills than ever before to our daily work. We are no longer “only” expected to author the protocol by capturing the decisions of a small team of contributors\, rather incorporate multiple fragmented information streams\, balance complexity with clarity\, understand and implement technology\, and manage increasingly complex team structures.\nThe webinar will provide an overview of the current best practice techniques used by a global medical writing team to handle these new and growing challenges. The learning objective of the webinar is to provide guidance and methodology to help medical writers approach contemporary protocol development.\n\nLevel: Intermediate/advanced\n\nPrevious knowledge required: General protocol structures/content\, familiarity with developing protocols or regulatory documents\, ICH E6(R3)\, ICH E8(R1).\n \nTo register\, please click here
URL:https://emwa.org/event/upgrading-your-protocol-writing-skillset-best-practice-insights-for-protocol-development/
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20250916T130000
DTEND;TZID=Europe/Brussels:20250916T140000
DTSTAMP:20260725T231013
CREATED:20250805T075812Z
LAST-MODIFIED:20250805T075812Z
UID:10000007-1758027600-1758031200@emwa.org
SUMMARY:Transitioning into Regulatory Medical Writing: Essential Skills and Career Pathways
DESCRIPTION:13:00 – 14:00 CET \nKatrin Zaragoza Dörr\, CEO & Founder – Medrika Consulting S.L. \nThis webinar explores the career of regulatory medical writing\, focusing on the unique skill set required to excel and pathways to enter the profession. \nParticipants will gain insights into the distinct competencies that differentiate regulatory writers from other medical writing professionals\, while examining their strategic importance in drug development. By reviewing regulatory document objectives\, audiences\, and development processes\, attendees will understand the role an empowered regulatory writer can play. The session also covers day-to-day responsibilities and project management functions\, as well as the different working modalities a regulatory writer can encounter. \nWe’ll explore diverse career progression routes\, employment opportunities\, and practical resources for career transition\, whether directly from a medical writing role\, or from other professional backgrounds. \nLevel: Foundation\, and intermediate \nPrevious knowledge required: None.
URL:https://emwa.org/event/transitioning-into-regulatory-medical-writing-essential-skills-and-career-pathways/
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Berlin:20250912T080000
DTEND;TZID=Europe/Berlin:20250912T090000
DTSTAMP:20260725T231013
CREATED:20250905T114232Z
LAST-MODIFIED:20250905T165759Z
UID:10000010-1757664000-1757667600@emwa.org
SUMMARY:Sustainability SIG Meet & Share on Evidence-based Science Communication
DESCRIPTION:Sustainability SIG Meet & Share on Evidence-based Science Communication \nFriday\, Sept. 12\, 2025 from 9-10 a.m. (CET) \nCommunicating effectively about sustainability-related issues is challenging. Evidence-based science communication bridges communication research and practice\, making our approach to content creation more engaging\, intentional\, and… more scientific. A scientific approach to writing helps us create more trustworthy and inclusive content\, ultimately making it more impactful. \nIn this Meet & Share\, Santiago Gisler\, PhD will introduce the basics of evidence-based science communication. He’ll also address the following: \n· How do you use your scientific mindset to make a difference with climate communication? \n· What does storytelling mean\, and what is the actual reason we use stories? \n· How do AI\, jargon\, and inclusive science events impact our outreach? \nAbout the presenter: \nSantiago Gisler is a communicator and coach with years of experience in science communication and editing. He enjoys processing complex information into clear\, engaging\, and impactful content. Santiago mentors and coaches communicators\, helping them strengthen their strategic approach to projects and communication skills. He holds a PhD in cancer research and molecular genetics\, which equips him with a critical and nuanced understanding of how to approach science communication effectively.
URL:https://emwa.org/event/sustainability-sig-meet-share-evidence-based-science-communication/
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Madrid:20250911T130000
DTEND;TZID=Europe/Madrid:20250911T140000
DTSTAMP:20260725T231013
CREATED:20250826T122521Z
LAST-MODIFIED:20250826T123759Z
UID:10000008-1757595600-1757599200@emwa.org
SUMMARY:Regulatory Writing SIG Meet & Share on Nonclinical CTD Modules
DESCRIPTION:Thursday 11th September 13:00-14:00 CET \nAt this Meet & Share\, Dr Arthur Noach will give an overview of the various types of studies that make up the nonclinical package described in the modules of the Common Technical Document (CTD). He will explain how the safety studies are interconnected\, why they are included in the nonclinical modules\, and which aspects are important to describe in the regulatory documentation. Some of you will have heard Arthur speak in 2024 at the EMWA Spring Conference in Valencia where he presented on a similar topic as part of the Expert Seminar Series on Nonclinical Regulatory Writing. \nAfter the presentation\, attendees will be encouraged to ask questions and provide input. We hope you’ll also share your own experiences\, whether that is as a freelance writer\, or working as a regulatory writer at a sponsor or CRO. \nArthur Noach is nonclinical expert and senior consultant at Venn Life Sciences in Breda\, the Netherlands. With over 25 years of experience in the pharmaceutical industry\, he specializes in designing the package of nonclinical studies to be performed prior to starting clinical studies and beyond\, based on international guidelines for small molecules\, biologics and vaccines. He has extensive experience in writing the nonclinical sections of briefing books\, Investigator Brochures and IND modules (eCTD format). He is also a consultant and principal investigator for pharmacokinetic and toxicokinetic studies performed at Venn\, for both non-GLP and GLP studies. \nTo register click here \nAny questions please email info@emwa.org
URL:https://emwa.org/event/meet-share-on-nonclinical-ctd-modules/
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Amsterdam:20250715T130000
DTEND;TZID=Europe/Amsterdam:20250715T140000
DTSTAMP:20260725T231013
CREATED:20250613T152335Z
LAST-MODIFIED:20250613T152841Z
UID:10000005-1752584400-1752588000@emwa.org
SUMMARY:Search Engine Optimisation (SEO) Health Blog Writing for Medical Writers: Build Visibility and Trust Online
DESCRIPTION:13:00 – 14:00 CEST \nValerie Leroux \nMany medical writers are asked to write “SEO-friendly” blog content — but often receive little guidance on what that really means. Should you focus on keywords? Length? Structure? Sources? And how do you ensure SEO doesn’t compromise medical accuracy or credibility? \nIn this practical session\, we’ll break down exactly how SEO applies to health blog writing\, so you can confidently deliver content that performs well online and maintains professional standards. \nYou’ll learn: \n· What clients really expect when they request SEO content \n· How to apply E-E-A-T (Experience\, Expertise\, Authority\, Trust) to boost both SEO and credibility \n· How AI is affecting SEO health writing (and where your skills remain irreplaceable) \n· The most common SEO mistakes writers make and how to avoid them \n· Simple techniques to optimize blog headlines\, introductions\, and references \nLevel: Foundation \nPrevious knowledge required: None \nTo register; email info@emwa.org
URL:https://emwa.org/event/search-engine-optimisation-seo-health-blog-writing-for-medical-writers-build-visibility-and-trust-online/
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Madrid:20250613T090000
DTEND;TZID=Europe/Madrid:20250613T100000
DTSTAMP:20260725T231013
CREATED:20250519T150625Z
LAST-MODIFIED:20250519T150625Z
UID:10000001-1749805200-1749808800@emwa.org
SUMMARY:Sustainability SIG – Meet & Share: “Nutrition for us and our planet”
DESCRIPTION:In this Meet & Share\, SUS-SIG member M. Carolina Rojido will discuss the intersection of nutrition\, human health and planetary health. She will also share tips and caveats for writing about nutrition and results of studies that involve nutrition. \nM. Carolina Rojido is a general physician with a master’s in health administration\, and certificates in lifestyle medicine\, plant-based nutrition and nutrition coaching. She worked in the United States for nine years\, gaining experience in oncology\, imaging and clinical gerontology research. Now based in France\, she works as a freelance medical writer/scientific communications consultant and sustainable nutrition coach\, interacting with lay and scientific audiences. \nRegister at info@emwa.org and join us and share your questions and experience!
URL:https://emwa.org/event/sustainability-sig-meet-share-nutrition-for-us-and-our-planet/
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/London:20250611T123000
DTEND;TZID=Europe/London:20250611T131500
DTSTAMP:20260725T231013
CREATED:20250604T123026Z
LAST-MODIFIED:20250604T123026Z
UID:10000004-1749645000-1749647700@emwa.org
SUMMARY:CORE Reference Webinar
DESCRIPTION:Statistical anonymization software for utility-preserving privacy protection in clinical documents for public disclosure. \nEmail info@emwa.org to secure your space.
URL:https://emwa.org/event/core-reference-webinar/
END:VEVENT
END:VCALENDAR