A compass for pharmaceutical development, manufacturing, and quality control in accordance with various regulations and guidelines.
A New Educational and Practical Magazine for Pharmaceutical, Raw Material, and Medical Device Companies ◎ Scheduled Special Feature Articles for the 2018 Fiscal Year!! ★ How to Address Advancing New Technologies and Industry Topics such as AI (Artificial Intelligence), Flow Synthesis, and iPS Cell Utilization! ------------------------------------------------ ● Publication: 15th of every month ● Format: A4 size, approximately 70 pages ● Annual Subscription Fee: 50,000 yen (excluding tax) * Available for annual subscription only * Special discounted prices (academic prices) are available for universities, public institutions, and medical facilities. Please inquire. Free sample issues available. Please contact us. ------------------------------------------------ ★ Highlights and Key Points for the New Fiscal Year (April 2018 Issue and Beyond)! - How to seize business opportunities in fields where investment in research and development is being made, such as regenerative medicine, cell pharmaceuticals, and combination products? - Implement strict data management and linkage without mistakes! - Latest topics to stay on track with continuous production and automation trends - Incorporation of the latest guidelines and amendments to regulations into business operations
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■ Annual Special Feature Schedule from April 2018 to March 2019 【Feature 1】 Trends in Drug Development, Topics in Regulatory Affairs, and Corresponding Responses April: Revision of ICH-E6 May: Human iPS Cells June: Regenerative Medicine July: Combination Products August: Utilization of Artificial Intelligence September: Early Development Candidates October: Revision of GPSP Ordinance November: Supportive Therapy for Cancer December: Conditional Early Approval System January: Biosimilar Patent Strategies February: eCTD Applications March: Clinical Trial Costs 【Feature 2】 Production/Quality Control Compliant with GMP Ordinance, PIC/S GMP, and ICH April: Flow Synthesis Technology May: Pharmaceutical Quality System June: Validation Required for GDP July: Data Integrity August: Production of Pharmaceutical Water September: Mid-Molecule Pharmaceuticals October: Regenerative Medicine GCTP November: Training for GMP Auditors December: GMP Inspections in Various Local Governments January: Cleaning Validation February: Monitoring of Manufacturing Processes March: User Requirements Specifications and Risk Assessment
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50,000 (excluding tax)
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P2
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P2
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The Technical Information Association is engaged in the work of shaping information for engineers and researchers. We research what kind of information engineers and researchers active in fields such as "research and development," "materials," "electronics," and "pharmaceuticals/medical devices" need, and we create products such as seminars, books, and correspondence courses!
