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Book Title: 【eCTD, CDISC】 Management and Assurance of Data Used in Drug Approval Applications ◎ Tips for "Minimizing Inquiry Items" and "Anticipating Inquiry Items" are in this book! ■ Key Points of This Book 1. Handling of SEND applications and raw data from non-clinical trials 2. Practical responses and quality assurance for eCTD applications 3. Writing methods and key points to minimize inquiry items in CTD preparation 4. Creation of application data packages compliant with CDISC 5. Effective management up to the manufacturing and marketing approval application －－－－－－－－－－－－－－－－－－－－－－－－－－ ● Published: March 29, 2019 ● Authors: 57 ● Format: A4 size, 628 pages Hardcover Edition: Price: 88,000 yen (tax included) ISBN: 978-4-86104-741-1 ↓↓ The hardcover edition is out of print ↓↓ On-Demand Edition Available Price: 44,000 yen (tax included) ISBN: 978-4-86104-965-1 After receiving your order, we will perform simple printing and binding －－－－－－－－－－－－－－－－－－－－－－－－－－
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■Table of Contents Chapter 1: Handling of SEND Applications and Raw Data from Non-Clinical Trials Chapter 2: Process for Creating CDISC-Compliant Application Data Packages Chapter 3: Practical Responses and Quality Assurance for eCTD Applications Chapter 4: Data Integrity Measures to Ensure Reliability of Manufacturing and Marketing Authorization Application Data Chapter 5: Effective Management Leading to Manufacturing and Marketing Authorization Applications Chapter 6: Digitization and Operation of Clinical Trial-Related Documents Chapter 7: Writing Methods for Manufacturing and Marketing Authorization Applications for Biopharmaceuticals Chapter 8: Writing Methods and Key Points to Minimize Inquiry Items in CTD Preparation Chapter 9: Description of Manufacturing Methods, Variation Applications, and Master File Documentation and Utilization Chapter 10: Compliance Investigations, Overseas GCP Inspection Cases, and Corresponding Measures Chapter 11: Quality Testing and Implementation of Non-GLP Tests to Obtain Reliable Application Data Chapter 12: Other Considerations for Pharmaceutical Approval Applications ーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー *For more details, please refer to the brochure available for download under "Download Catalog."
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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!