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X-WR-CALDESC:Events for EMWA
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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
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DTSTART;TZID=Europe/Belgrade:20260116T123000
DTEND;TZID=Europe/Belgrade:20260116T133000
DTSTAMP:20260725T121820
CREATED:20251201T142757Z
LAST-MODIFIED:20251201T142757Z
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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
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DTSTART;TZID=Europe/Madrid:20260127T130000
DTEND;TZID=Europe/Madrid:20260127T140000
DTSTAMP:20260725T121820
CREATED:20260107T164331Z
LAST-MODIFIED:20260113T155528Z
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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
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BEGIN:VEVENT
DTSTART;TZID=Europe/Madrid:20260130T130000
DTEND;TZID=Europe/Madrid:20260130T140000
DTSTAMP:20260725T121820
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
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