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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:20260725T142016
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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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