Pharmaceuticals and Medical Devices Package Insert Creation Management System "PMDOC X" Online Seminar 'page2022' [January 31, 2022 (Monday) - February 10, 2022 (Thursday)]

In response to the new documentation guidelines! Manage information with XML one source and generate six types of formats with the push of a button.

"PMDOC X" is a system that contributes to reducing the effort and errors involved in creating and revising pharmaceutical and medical device package inserts. *Examples of achievements are available. It manages pharmaceutical and medical device information in a single XML source and can generate six different formats for various purposes, such as submission to PMDA or for printing, with just one button click. It allows for easy creation of XML and PDF documents compliant with new pharmaceutical labeling guidelines, and revisions are automatically reflected in each document, thereby reducing the burden of revision tasks. [Features] ■ Contributes to reducing the labor and errors in revision tasks and maintaining consistency between documents ■ Allows for importing/exporting Word files using templates prepared in advance by our company ■ Achieves a clean layout easily through automatic typesetting ■ Enables setting of document approval routes according to your company's operational methods *Actual implementation examples are available in PDF format. *For more details, please refer to the PDF materials or feel free to contact us.

• Document and Data Management

When submitting attached documents to PMDA in XML/SGML or PDF format, mistakes are not allowed. A system that supports the creation and management of attached documents *with proven results available*.

- Pharmaceutical and Medical Device Document Creation Management System - PMDOC X [Features] Manages pharmaceutical and medical device information in a single XML source, allowing for the generation of six different formats tailored to various uses, such as PMDA submissions or printing, with the push of a button. Easily creates XML/SGML or PDF for PMDA submissions, with revisions automatically reflected across all documents, reducing the burden of revision tasks. *Examples of actual implementations are available in PDF format. *For more details, please refer to the PDF materials or feel free to contact us.

• Document and Data Management

A system that contributes to reducing the effort and mistakes involved in creating and revising pharmaceutical and medical device package inserts. Managed with XML one-source! *Examples of achievements available.

The attached documents that are believed to be thoroughly managed within the company are actually also managed by external vendors (printing and production companies). Is it possible that the PDFs of the attached documents managed by pharmaceutical and medical device manufacturers are in a format that cannot be edited, such as images, making it impossible for your company to make corrections? To quickly provide information even during urgent revisions, it is necessary to mitigate external risks and create an environment where your company can respond. 'PMDOC X' is a system that contributes to reducing the effort and mistakes involved in the creation and revision of pharmaceutical and medical device attached documents. It manages pharmaceutical and medical device information in a single XML source and enables the realization of six related formats with just one button. 【Features】 - Contributes to reducing the man-hours and mistakes in revision work and maintaining consistency between documents. - Allows for importing/exporting Word documents using templates prepared in advance by our company. - Enables easy realization of a clean layout through automatic typesetting. - Allows for setting up document approval routes according to your company's operational methods. *Examples of actual implementations are available in PDF format. *For more details, please refer to the PDF materials or feel free to contact us.

• Document and Data Management

Let's prevent information entry errors and inconsistencies with an XML-based "Document Management System for Pharmaceutical and Medical Device Information"!

The attached document is critical to life, and even if it pertains to approved pharmaceuticals or medical devices, any prescription or medical errors arising from mistakes in the document could lead to corporate liability, affecting the company's credibility and resulting in management issues. "PMDOC X" is a system that contributes to reducing the effort and errors involved in creating and revising pharmaceutical and medical device package inserts. It manages pharmaceutical and medical device information in a single XML source and can generate six related formats with the push of a button. 【Companies that should take note】 ■ Creating documents manually through copy and paste from multiple files ■ Need to create documents with the same content in multiple file formats, leading to duplicated revision work ■ Delays in information provision and product launch due to verification and revision tasks and more * Actual implementation examples are available in PDF format. * For more details, please refer to the PDF materials or feel free to contact us.

• Document and Data Management

In recent years, the pharmaceutical and medical industries have faced urgent challenges, including the digitization of standard operating procedures (SOPs) and the strengthening of continuous education and human resource development. In this webinar, we will introduce a comprehensive system that not only streamlines operations but also consistently supports education and human resource development by integrating Agatha's SOP management cloud solution "Agatha SOP" with "Ave-TMS," a training management system provided by BIO-TREND BIOPRODUCTS, with whom Agatha has recently signed a distribution agreement. [Program] Part 1: 14:00 - 14:20 "Introduction to Agatha Solutions" Agatha Inc. Sales & Marketing Department, Quality Group Part 2: 14:20 - 15:00 "Ave-TMS Demo Presentation" BIO-TREND BIOPRODUCTS Project Manager, Choi Woo-Chun *For Q&A, please fill out the survey displayed after the webinar, and we will respond later.

[Speaker] Toshio Kawamoto, Managing Director / Head of Cross Creation Group, NTT Data Management Research Institute, Business Transformation Unit, and Co-representative of Social Innovation Alliance Japan Denmark Takaaki Sukegawa, Senior Manager [Lecture Items] 1. Competitiveness and Governance in the Post-Generative AI Era - Toshio Kawamoto [13:00 - 14:00] 1. Introduction to NTT Data Management Research Institute 2. Major countries' perspectives on AI utilization 3. Considerations for companies when building AI governance 4. Examples of AI governance construction in Japan 5. Introduction of our company's achievements in related projects 6. Q&A / Business card exchange 2. On-Site AI Risk Management in Europe ~Introduction to Trends in AI Utilization in Europe and Advanced Centralized AI Risk Management Solutions~ - Takaaki Sukegawa [14:10 - 15:10] 1. Overview of centralized AI risk management 2. Detailed approach 3. Introduction of case studies applying the approach 4. Q&A / Business card exchange

[Speaker] Daiki Suzuki, Senior Researcher, Nature and Climate Division, SOMPO Institute Plus Inc. [Key Lecture Content] As we enter 2025, global environmental and sustainability regulations are at a turning point. There are rapid movements of backlash, such as the retreat of U.S. climate policy under the second Trump administration and the simplification of regulations symbolized by the EU's omnibus bill. While the situation is difficult to predict, long-term demands such as investor expectations and decarbonization continue, and in Japan, the mandatory disclosure of sustainability is steadily progressing. In this lecture, we will overview the complex domestic and international situations surrounding sustainability and explore the direction companies should take in the future, incorporating case analyses. [Lecture Topics] 1. Overview of sustainability regulations 2. Unchanging expectations of capital markets and long-term trends 3. Detailed analysis of regional regulations 4. New regulatory frontiers 5. Direction of corporate responses, etc. 6. Q&A

[Instructor] Attorney Shinya Tsuchiya, Ishizaki & Yamanaka Law Office [Key Lecture Content] When various problematic behaviors occur among employees, such as poor work attitude, harassment, and lack of cooperation, if the employer mismanages the response, it can not only significantly disrupt workplace order and operational efficiency but also potentially invalidate the legal effectiveness of disciplinary actions or personnel measures taken against the employee in question. To avoid such risks, appropriate and consistent responses based on employment regulations and internal systems are required. On the other hand, dealing with "problematic employees" often places a significant psychological and practical burden on busy supervisors and HR personnel. In order to maintain smooth business operations, it has become essential to provide support to those responding and to prepare as an organization. In this seminar, we will systematically organize practical knowledge that is useful in the field, focusing on legal points and practical strategies to consider when responding to various types of "problematic employees" that have recently become more apparent, while assuming specific scenarios.

[Instructor] Takahisa Saito, Human Resources Consultant, Saito Social Insurance and Labor Office [Key Lecture Content] Human resource systems support the foundation of an organization. However, if the operation is neglected, the system itself will collapse. There are various systems, but among them, the "grade system, evaluation system, and wage system" can be considered the three major elements. We must design these three major elements with operational considerations in mind. In other words, it is important that the system is easy for management to operate. There is no need to overthink it. Additionally, as work style reforms progress, we must also consider the response to equal pay for equal work. I believe that what lies ahead after organizing the current situation is the "limited regular employee" system. In this seminar, we will share anticipated information and provide clear explanations. Furthermore, for those attending in person, meaningful information exchange is possible through mutual confirmation during Q&A sessions. [Lecture Items] 1. Trends and Perspectives Surrounding Human Resources 2. Basics of the Grade System 3. Basics of the Evaluation System 4. Basics of the Wage System 5. Considering Equal Pay and Job-Based Employment 6. Q&A / Business Card Exchange