2026 ISPE Annex 1 Symposium

Profsis BV

Palais de la Bourse de Lyon

<h3>Join the Second Edition of the Landmark ISPE Europe Affiliate Collaboration on Annex 1 Compliance and Implementation</h3><h4>ISPE France | Italy | DACH | Ireland | Nordic Affiliates</h4>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.<h4>ANNEX 1: WHAT YOU NEED TO KNOW</h4>Key updates will include:<ul><li>Filling Line Set-Up, Aseptic Process Simulations</li><li>Hydrogen Peroxide Decontamination or Sterilisation</li><li>Contamination Control Strategy (CCS) and Quality Risk Management (QRM) for Downstream Processes</li><li>Single Use Systems Integrity and Filter Testing</li><li>Robotics and Implementation of Automation</li><li>Data Integrity and AI in the light of the Annex 1</li></ul> <h4>WHY JOIN THE ANNEX 1 SYMPOSIUM?</h4>🔬 Technical ExpertiseHear from leading industry experts and EU regulators deeply involved in implementing the 2022 Annex 1 revisions.🤝 Interactive CollaborationSelect workstreams to discuss contamination control strategies, cleanroom standards, aseptic processes, barrier technologies, disinfection protocols, data integrity, and more.📜 Regulatory Town HallMeet EU/PIC/S inspectors and EMA regulators in an exclusive session - ask live questions on Annex 1 implementation challenges and compliance strategies.🌐 Networking &amp; 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!

<h3>Hotel Accommodation Options for the Event</h3>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.<a href="https://groups.guestreservations.com/eh/534em-3o0r" title="https://groups.guestreservations.com/eh/534em-3o0r" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">Hotel Silky By Happyculture</a><a href="https://groups.guestreservations.com/eh/534em-5rqi" title="https://groups.guestreservations.com/eh/534em-5rqi" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">Maison Nô</a><a href="https://groups.guestreservations.com/eh/534em-5qe8" title="https://groups.guestreservations.com/eh/534em-5qe8" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">Hôtel Mercure Lyon Centre Plaza République</a><a href="https://groups.guestreservations.com/eh/534em-5p3w" title="https://groups.guestreservations.com/eh/534em-5p3w" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">Okko Hotels Lyon Centre</a><a href="https://groups.guestreservations.com/eh/534em-5x9g" title="https://groups.guestreservations.com/eh/534em-5x9g" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">Best Western Saint Antoine</a>

Day 1 Programme

Registration and Welcome Lunch in Exhibition Area

Opening Remarks from Annex 1 Symposium Chairs

ISPE Global Message: ONE ISPE

Parallel Efforts and Aseptic Challenges in CDMOs Operations

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

Networking Coffee Break in Exhibition Area

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.

Workstream Explanation & Guidelines

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.

Work Stream 1: How Far Are We from Scientifically Justified Decisions?

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.

Work Stream 2: Monitoring Aseptic Machine Setup with Open Isolator Doors

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.

Work Stream 3: Contamination Monitoring and Implementation Challenges

Networking  Gala Dinner

Day 2 Programme

Welcome Coffee in Exhibition Area

ISPE France Affiliate Highlights

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

Annex 1 Application in conjunction with QRM principles for monoclonal (...)

Sterility Assurance - an Enabler to Comply with Annex 1

FDA Warning Letter Deficiencies in Aseptic Processing

Visit our Exhibition Area  and engage with featured Exhibitors.

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

Regulatory Townhall

Networking Lunch in Exhibition Area

Annex 1: The Art of Aseptic Assurance

Water Monitoring with Rapid Microbio-Testing Trends

PUPSIT Implementation: New Line Design Philosophy, Technical Challenges

Aseptic Talks: Camera Café

Closing Remarks

Day 3 Site Visit

Site Visit - SANOFI - Marcy l'Étoile

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2026 ISPE Annex 1 Symposium

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