Échanger. Collaborer. Inspirer.

Overview

Exchange. Collaborate. Inspire.

Join the Second Edition of the Landmark ISPE Europe Affiliate Collaboration on Annex 1 Compliance and Implementation

ISPE France | Italy | DACH | Ireland | Nordic Affiliates

Five ISPE Europe Affiliates are once again joining forces to present the Annex 1 Symposium - a groundbreaking event designed to foster collaboration, share knowledge, and deliver practical solutions in the critical field of Sterility Assurance.

Set in the historic heart of Lyon at the iconic Palais de la Bourse de Lyon, this prestigious symposium offers an exceptional opportunity to explore the challenges and evolving expectations introduced by the revised EU GMP Annex 1 for sterile pharmaceutical manufacturing.

This unique in-person event goes beyond traditional conferences. It is designed to actively engage participants through immersive workstreams that encourage dynamic discussions, real-world experience sharing, and collaborative problem-solving on the most pressing Annex 1 topics.

A stand-out feature of the programme is the Regulatory Town Hall — an unprecedented session where attendees will engage directly with EU regulatory authorities in an open, constructive forum to address questions, concerns, and implementation challenges.

Whether you are seeking expert insights, regulatory clarity, or meaningful industry connections, the Annex 1 Symposium 2026 is a must-attend for pharmaceutical professionals committed to excellence in sterility assurance.

ANNEX 1: WHAT YOU NEED TO KNOW

Key updates will include:

  • Filling Line Set-Up, Aseptic Process Simulations
  • Hydrogen Peroxide Decontamination or Sterilisation
  • Contamination Control Strategy (CCS) and Quality Risk Management (QRM) for Downstream Processes
  • Single Use Systems Integrity and Filter Testing
  • Robotics and Implementation of Automation
  • Data Integrity and AI in the light of the Annex 1

WHY JOIN THE ANNEX 1 SYMPOSIUM?

🔬 Technical Expertise

Hear from leading industry experts and EU regulators deeply involved in implementing the 2022 Annex 1 revisions.

🤝 Interactive Collaboration

Select workstreams to discuss contamination control strategies, cleanroom standards, aseptic processes, barrier technologies, disinfection protocols, data integrity, and more.

📜 Regulatory Town Hall

Meet EU/PIC/S inspectors and EMA regulators in an exclusive session - ask live questions on Annex 1 implementation challenges and compliance strategies.

🌐 Networking & Experience

Connect with fellow professionals during dedicated networking sessions, explore Lyon’s cultural heritage, and attend a memorable Gala Dinner in a historic setting.

Don’t miss this unique opportunity to connect, learn, and lead.

Vous trouverez le programme intégral ainsi que toutes les informations importantes sur le site web de l'événement : Inscrivez-vous dès maintenant pour réserver votre place !