We are pleased to invite you to our upcoming two-day seminar,
“Key Updates in EU GMP Chapter 4 & Annex 11 Revisions, and the New Annex 22 on Artificial Intelligence,”
taking place on 15 & 16 January 2026 at Domotel Kastri, Athens (Hall: Athena I).
The European Medicines Agency (EMA) has recently published the long-awaited revisions of EU GMP Chapter 4 and Annex 11, along with the release of the new Annex 22 – Artificial Intelligence.
These regulatory updates represent a major step forward for the life sciences sector, setting new expectations in data integrity, computerized system validation, and AI governance.
Seminar Highlights
- Detailed understanding of updated structure and expectations of EU GMP Chapter 4.
- Exploration of Annex 11’s key revisions and their implications for Computerized Systems.
- Introduction to Annex 22 (AI) and its implications in regulated environments.
- Practical approaches, documentation strategies, and inspection readiness.
Who Should Attend
Professionals in:
- Commissioning, Qualification, and Validation
- Computerized Systems Validation
- Data Governance
- Digital Transformation
- Information Technology
- Quality Assurance
- Regulatory Affairs
Key Takeaways
- Comprehensive understanding of Chapter 4’s expanded documentation expectations.
- Insights into Annex 11’s updated focus on system control and cybersecurity.
- Clear overview of Annex 22’s scope and regulatory intent.
- Practical guidance on aligning procedures, documentation, and systems with EMA expectations.
Details
15 & 16 January 2026
Domotel Kastri Athens Hotel,
Hall: Athena I
Registration Fees
• Early Bird (until 25/11/2025): €370.00
• Regular (until 09/01/2026): €450.00
• Group (3+ participants): €350.00 per attendee
Join us to stay ahead of regulatory developments shaping the future of pharmaceutical and biotech compliance.
To register, simply click the link below or scan the QR code:
We look forward to welcoming you in Athens!