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 Advancements in 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 * Discounted prices (academic pricing) 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 such as regenerative medicine, cell pharmaceuticals, and combination products where research and development costs are being invested? - Implementing strict data management and linking without mistakes! - The latest topics to keep up with the trends of continuous production and automation - Incorporating 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: ICH-E6 Revision 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 by 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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The Technical Information Association works to shape 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 create products such as seminars, books, and distance learning courses!