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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)

Closed

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

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