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Seminar on Efficient Creation of CTD-Q Documentation

The I.R. Technical Education Institute is hosting an online seminar focused on enhancing the efficiency of creating the Common Technical Document - Quality (CTD-Q). This event will place significant emphasis on the important aspect of overall consistency within CTD-Q submissions, exploring the ‘Seven Perspectives’ that can lead participants to create high-quality applications effectively.

Why Join This Seminar?

When it comes to submitting pharmaceutical approval applications, there are three crucial requirements that must be met: compliance with regulations, scientific accuracy, and overall consistency. Among these, maintaining overall consistency can be particularly challenging for those preparing the documents. Often, even when individual knowledge is available, ensuring a coherent and connected narrative across the entire document presents a substantial hurdle.

Seminar Overview

During this seminar, attendees will learn strategies for treating known knowledge not just as isolated points but as interconnected areas that foster a complete and consistent view. By the end of the seminar, participants will acquire practical insights that help streamline the CTD-Q creation process.

Event Details:

• - Seminar Name: Efficient CTD-Q Creation: Seven Perspectives
• - Format: Online (Live & Recorded)
• - Date & Time: Live Session on July 15, 2026, from 13:00 to 16:30 JST

Archive Access: Available from July 17 to July 31, 2026 (unlimited access during this period)

• - Registration Fee: 29,700 yen (tax included) per participant (Discounts available for multiple participants)
• - Lecturer: Shigeto Neki, Head of Route T Technical Office

What Will Be Covered?

The seminar will introduce ways to create quality CTD-Q documentation efficiently, guided by the Seven Perspectives. While some of the content may be familiar to attendees, the focus will be on ensuring that each perspective is viewed in context rather than in isolation, promoting the development of consistently aligned documents. We aim for the insights shared in this seminar to serve as a stepping stone for attendees, helping them envision themselves as capable creators of CTD-Q submissions.

Seminar Program:

1. Understanding CTD Holistically
1.1 CTD Structure
1.2 Understanding M3
1.3 Understanding CMC through C&M&C

2. Deriving Optimal Solutions
2.1 CTD Risk Management
2.2 The Structure of M3 Text and Risk Analysis

3. Information Management
3.1 Document Organization
3.2 Linking Documents

4. Teamwork and Proposal Skills
4.1 Creating Documents as a Team
4.2 Enhancing Proposal Skills

5. Creating Beautiful Documents
5.1 The Importance of Aesthetic Quality
5.2 Mastering MS Word Techniques

6. The Power of Checks
6.1 Overcoming Weaknesses
6.2 The Checklist Approach

7. English Proficiency

8. Conclusion

Target Audience:

• - Professionals involved in pharmaceutical development
• - Individuals interested in learning about the CTD-Q submission process
• - Beginners tasked with CTD-Q documentation
• - Individuals looking to enhance their skills in CTD-Q submission

For more information, visit the seminar page:
CTD-Q Creation Seminar

The I.R. Technical Education Institute is committed to continuously providing practical knowledge and expertise through a variety of services such as seminars, e-learning, training sessions, and publications for professionals in the manufacturing sector.

Discover More About Our Organization:

Nihon I.R. Co., Ltd. has over 50 years of experience in offering specialized services including patent and intellectual property solutions, technical information research, education for engineers in the manufacturing industry, and the production of technical content.
Website: nihon-ir.jp
Technical Education Site: engineer-education.com
Address: 3rd Floor, CYK Kanda Iwamotocho, 15-1 Kanda Iwamotocho, Chiyoda-ku, Tokyo 101-0033
Phone: 03-6206-4966