Dr. Sudo, Senior Director of the Quality Assurance Department, will Deliver a Special Lecture at the 34th Educational Forum of the Safety Evaluation Forum

2026.10.15

Dr. Hirokazu Sudo, Senior Director of Quality Assurance will deliver a special lecture at the 34th Educational Forum of the Japanese Society for Safety Evaluation Research, to be held on November 5–6, 2026, at Tosei Hotel & Seminar Makuhari in Narashino, Chiba, Japan.

If you plan to attend the conference, we encourage you to join the session and hear the presentation.

Conference Name: The 34th Educational Forum of the Japanese Society for Safety Evaluation Research

Date & Time:November 5, 2026 (Thu.), 1:00–2:00 p.m.

Location: Tosei Hotel & Seminar Makuhari in Narashino, Chiba, Japan.

Title: A Practical Guide to Reliability Standards-Based Studies Used in New Drug Applications

Presentation Summary
In pharmaceutical research and development, it is essential not only to establish the scientific validity of the data obtained, but also to ensure data reliability—that is, reproducibility and traceability—by documenting how the data were acquired, recorded, evaluated, and retained. This lecture will provide a systematic, practice-oriented explanation of the reliability standards required for new drug applications, covering fundamental concepts, study conduct, the handling of data and records, record retention, and key considerations for outsourced studies. It will also present approaches for balancing data reliability with R&D speed and efficiency through risk-based quality assurance.

Axcelead’s Soulution
Axcelead leverages its expertise in both drug discovery research and quality assurance to help customers establish quality management systems tailored to their research objectives, stage of development, and associated risks. Rather than uniformly increasing the level of oversight, we work with customers to understand their research goals and challenges and jointly define the level of quality required. We provide solutions grounded in day-to-day research practice, including studies conducted in consideration of the reliability standards required by regulatory authorities for new drug applications, data and record management, and assurance of the reliability of outsourced studies. As a trusted quality assurance partner, we help customers achieve both data reliability and greater speed and efficiency in R&D.
If you need assistance establishing a quality management system for reliability standards-based studies or methods for evaluating contract research facilities, please contact us.