~Practical work for the development, approval, and manufacturing of research results in pharmaceuticals and biopharmaceuticals into "products"~
This seminar is aimed at intellectual property personnel and will provide a practical explanation of the overall picture of pharmaceutical development, including the basics of CMC, quality assurance, PMDA review, how to read CTD, technology transfer, comparability, and the distinction between trade secrets and patents. It will also cover advanced modalities, competitive analysis using public CTDs and PMDA review reports, and the role of the intellectual property department in technology transfer and licensing agreements with CDMOs. *For details, please check the related links or the seminar details in the catalog.*
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<Event Information> Format: Live Streaming (Zoom) / Archive Streaming Date and Time: 【LIVE Streaming】November 30, 2026 (Monday) 10:00 AM - 5:00 PM 【Archive Streaming】December 2 - December 16 (Available for viewing multiple times) Fee: 49,500 yen per person (tax included) Instructor: Satoshi Suzuki
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<Seminar Program (Tentative)> Chapter 1: The Relationship Between Pharmaceutical Development and Intellectual Property Chapter 2: Basics of CMC (Chemistry, Manufacturing and Controls) Chapter 3: Intellectual Property Generated in CMC Chapter 4: Patents and Trade Secrets Chapter 5: Role of the Regulatory Affairs Department Chapter 6: How to Read CTD and PMDA Review Reports Chapter 7: Concepts of Quality Assurance (QA) Chapter 8: Comparability Assessment Chapter 9: Technology Transfer, CDMO, and Licensing Chapter 10: Intellectual Property Strategies for Advanced Modalities Chapter 11: Case Studies Chapter 12: Summary and Discussion
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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.
