KOREA LIFE SCIENCE WEEK
HOME SEMINAR & CONFERENCE > Data Integrity Forum 2025

Data Integrity Forum 2025

Overview

Title Data Integrity Forum 2025
Subject The New Standard for Digital GMP: Deep Dive Analysis and Response Strategies for EU GMP Chapter 4, Annex 11 Revisions, and the New Annex 22(AI)
Date & Time October 1 (Wed), 2025 | 10:00 – 15:30
Venue Conference C, COEX Exhibition Hall D (3F), Seoul, Korea
Registration Pre-registration (Complimentary)
Register for forum

Program

Time Program Speaker
10:00-10:10 Registration
Part 1: Analysis of Chapter 4 & Annex 11 Revisions
10:10-10:40 The Evolving Regulatory Landscape: Impact and Implications of Major EU GMP Updates (Ch4, A11, A22) Keynote Speech
10:40-11:10 Analyzing Chapter 4 Revisions: Strategies for Enhanced Data Governance and Document Lifecycle Management Session 1
11:10-11:20 Break
11:20-11:50 Key Changes in Annex 11 Requirements: Management of CSV and IT Infrastructure in Cloud Environments Session 2
11:50-12:20 Annex 11 and Data Integrity: Enhanced Requirements for Audit Trail Review and System Security Session 3
12:20-13:20 Lunch Time
Part 2: Analysis of New Annex 22(AI) & Integration Strategy
13:20-13:50 Introduction of the New Annex 22: Principles and Regulatory Requirements for Applying AI/ML in GxP Environments Session 4
13:50-14:20 Deep Dive into Annex 22: AI Model Validation, Performance Monitoring, and Human Oversight Requirements Session 5
14:20-14:50 Case Study: Implementing Integrated Digital Quality Systems Reflecting the Latest Regulatory Updates (Ch4, A11, A22) Session 6
14:50-15:00 Break
Part 3 : Discussion & Wrap-up
15:00-15:20 Expert Discussion: Key Challenges and Practical Solutions for EU GMP Digital Regulatory Compliance Panel Discussion
15:20-15:30 Summary and Closing

※ This program is currently being updated. Topics and speaker details are subject to change.

Forum Venue

Conference C in the exhibition Hall D(3F), COEX, Seoul

Contact Us

Show Management Office

KYUNGYON EXHIBITION CORP.

E-mail. sales@lifescienceweek.com