Basic perspectives on the preparation of approval applications related to pharmaceutical manufacturing and quality control.
This seminar will introduce methods for efficiently creating the quality submission documents (CTD-Q) by focusing on the most challenging issue faced by document creators: "overall consistency." We will discuss optimal solutions from the perspective of the entire CTD, principles for deriving optimal solutions, information management, teamwork and proposal skills, creating beautiful documents, checks, and English proficiency, all in relation to producing consistent documentation. *For more details, please refer to the related links or the seminar details in the catalog.*
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Event format: Live streaming (Zoom) / Archive streaming Date and time: 【LIVE streaming】 July 15, 2026 (Wednesday) 13:00 - 16:30 【Archive streaming】 July 17 - July 31 (Available for viewing multiple times during this period) Tuition fee: 29,700 yen (tax included) Instructor: Shigeto Negi (Representative of Route T Engineering Office)
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<Seminar Program (Tentative)> Chapter 1: Optimal Solutions from the Overall Picture of CTD Chapter 2: Principles Leading to Optimal Solutions Chapter 3: Information Management Chapter 4: Teamwork and Proposal Skills Chapter 5: Beautiful Documents Chapter 6: Checks Chapter 7: English Proficiency Chapter 8: Summary
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We support Japan's "monozukuri" (manufacturing) with reliable services ranging from patent research and other intellectual property business solutions to technical translation services and intellectual property/engineer education. We offer high-quality services backed by over 40 years of experience at reasonable prices.
