[Book] Management and Assurance of Data Used in Pharmaceutical Approval Applications with eCTD and CDISC (No. 1987BOD)

Technical specialized books ◎ Bridging the "gap" between the "applicant" and the "examiner"!

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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Details of the FaceMe Security 8.3 Update < Revamped UX for Action & Alert Rule Settings > Previously, individual settings were required for each action even within the same rule. By completely overhauling the UI and UX, we have transformed the operation screen to allow for intuitive and efficient configuration. ▶ Key Update Points - Multiple actions (notifications, access control, VMS integration, etc.) can now be set within a single rule. - The settings screen has been consolidated into a single page, allowing for an overview and editing of the entire configuration at a glance. < Enhanced Integration Features with Face Terminal (Facial Recognition Terminal) > FaceMe Security integrates with the MSK Knoctoi series (Standard/Lite), enabling door opening and closing based on facial recognition results without the need for additional devices. This update allows for detailed configuration of door opening and closing rules based on location, time of day, and groups of individuals, enabling more flexible access management tailored to on-site operations. ▶ Expected Implementation Scenarios - All employees can enter the entrance, while only administrators can enter specific areas at night, etc.

We will introduce the implementation results of the sensor technology developed by the Hotron Group, which has been cultivated over more than half a century, through customer case studies. In addition to automatic door sensors, we also offer a wide range of vehicle detection sensors and nursing/care sensors. We have many implementation examples available, so please take a look at the case study page.

[To the owners of parking lots and parking lot construction companies] "I'm worried about not colliding with pedestrians when leaving the parking lot in my car..." Among vehicle entrances to parking lots, stores, residences, and factories, those particularly facing sidewalks or roadways are expected to pose risks of dangerous incidents such as collisions with pedestrians or between vehicles. To alleviate such concerns, Hotron proposes a [Departure Warning Sensor] that detects vehicle departures using various sensors and alerts the surroundings with LED lights and buzzers. The device consists of a simple configuration of "Sensor" + "Controller" + "Switching Power Supply (24V)" + "LED Rotating Light." *Please note that a separate control panel including the controller and switching power supply (24V) is required when using the departure warning system. *We kindly ask customers to arrange for the switching power supply (24V), LED rotating light, control panel, circuit breakers, etc. Since it can be retrofitted, it can also be used for existing parking lot entrances. We hope this will contribute to safer vehicle passage for everyone. ◎ For more details, please contact us or download the catalog.

NTT TechnoCross Corporation (Headquarters: Minato-ku, Tokyo, President: Atsuko Oka, hereinafter referred to as "NTT TechnoCross") announced that its health management system "HM-neo" achieved a market share of 18.4% among major companies with 3,000 or more employees in the health management solutions market, according to a survey conducted by Deloitte Tohmatsu Economic Research Institute, Inc. (Headquarters: Chiyoda-ku, Tokyo, President: Shigeo Watanabe) for the fiscal year 2024, securing the No. 1 share.

At a cabaret club located in Kanagawa Prefecture, we have introduced our commercial aroma diffuser "MajestaFragrance." Different scents are created for the floor and the VIP room. After the introduction, we have received feedback from customers saying things like "It's calming" and "It has created an elegant atmosphere." MajestaFragrance not only delivers fragrance but also enhances the overall value of the space. If you are interested in scent design, please feel free to contact us.