2026 ISPE Annex 1 Symposium

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.

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

🔬 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.

Register now to secure your place!

We are pleased to share a curated list of hotel options that can be reserved directly for your stay.

Specially negotiated group hotel rates are below when you click on the links.

The rates may sell out or change at any time (no rooms are being held), so we would advise booking as soon as possible.

Hotel Silky By Happyculture

Maison Nô

Hôtel Mercure Lyon Centre Plaza République

Okko Hotels Lyon Centre

Best Western Saint Antoine

Info: Visit our Exhibition Area and discover the latest innovations from featured Exhibitors.

Info: Concurrent Workstreams: During this working session, audience will be split into 4 different concurrent streams and will be working closely together to solve a problem statement about aseptic challenges. Results will be discussed with Regulators during the Townhall on Day 2.

Info: Annex 1 challenges us to ground our manufacturing and contamination‑control strategies in sound scientific principles. Yet this requirement also raises an important question: to what extent are our current decisions genuinely science‑driven?
This workshop aims to explore that question by encouraging participants—through a short survey and an open discussion—to reflect honestly on how their choices are made today. Do we still rely heavily on tradition (“we’ve always done it this way”) or on optimistic assumptions (“our EM data is always good”)? Or are we consistently applying robust scientific methods such as CFD modelling, PAT tools, risk‑based analysis, and other data‑driven approaches?
By examining where we stand, we can better understand what it will take to fully align with Annex 1 expectations and evolve from habit‑based decision‑making to scientifically justified, transparent, and defensible practices.

Info: Ensuring Environmental Control: Monitoring during Aseptic Machine Setup with Open Isolator Doors
Routine Environmental Monitoring (EM) data collection is expected by authorities for filling machine setup. To establish a robust concept, careful consideration must be given to several interlinked aspects like operator gowning, non-viable and viable monitoring (including surface monitoring), and the sequence of activities in conjunction with the Vaporized Hydrogen Peroxide (VHP) decontamination process. This workshop focuses on new technologies and approaches to improve the situation.

Info: Contamination Monitoring and Implementation Challenges for Non-Sterile products: This is one of the most critical aspects of Annex 1, especially with the increased emphasis on rapid microbiological methods. During this work stream, we will explore this topic in-depth and evaluate how these technologies can be effectively applied to strengthen our contamination control strategy. Moreover, Annex1 implementation for non-sterile products will be analysed to cover some doubts and constraints such as its broader applicability on drug substances manufactured with low bio-burden expectations, as well as clean utilities—such as WFI—that are not required to be sterile.

Info: The application of Annex 1 in conjunction with QRM principles for monoclonal antibody drug substance production

Info: Visit our Exhibition Area and engage with featured Exhibitors.

Info: Moderated by Richard Denk, SKAN and Marsha Steed, Acting Head of Global SA Consultant, FUJIFILM

Info: Q&A Time with Speakers

Event Venue & Nearby Stays

Palais de la Bourse de Lyon, Place de la Bourse, Lyon, France

Concerts, fests, parties, meetups - all the happenings, one place.

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