ISPE Annex 1 Symposium

Profsis BV

Istituto degli Innocenti

Join a Landmark European Collaboration on Annex 1 Compliance ISPE Italy | DACH | France | Ireland | Nordics AffiliatesFor the first time ever, five ISPE European Affiliates are uniting to present the Annex 1 Symposium — a groundbreaking event designed to drive collaboration, knowledge sharing, and practical solutions in the vital field of Sterility Assurance.Set in the historic heart of Florence at the iconic Ospedale degli Innocenti, 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 built to actively engage participants through immersive workstreams that foster dynamic discussions, real-world experience sharing, and collaborative problem-solving on the most pressing Annex 1 topics.A standout 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're seeking expert insights, regulatory clarity, or meaningful industry connections, the Annex 1 Symposium is a must-attend for pharmaceutical professionals committed to excellence in sterility assurance. <h3>WHY JOIN THE ANNEX 1 SYMPOSIUM?</h3>🔬 Technical Expertise Gain exclusive insights from leading industry experts and EU regulators at the forefront of sterile manufacturing and Annex 1 implementation.🤝 Collaboration Join a focused workstream of your choice and engage in hands-on, solution-driven discussions with peers and professionals from across Europe.📜 Regulatory Update Participate in the unique Regulatory Town Hall — ask direct questions and receive actionable answers from regulatory authorities.🌐 Networking &amp; Experience Connect with fellow professionals during dedicated networking sessions, enjoy guided tours of Florence, 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. You can view and download the full brochure here:👉 <a href="https://www.dropbox.com/scl/fi/ruydq3obm9s7mo4wprsnv/ISPE-Annex-1-2025_Hotel-Brochure.pdf?rlkey=hwture4wvh9mj0kwlc7iaiq99&amp;st=o8ad1jgd&amp;dl=0" title="https://www.dropbox.com/scl/fi/ruydq3obm9s7mo4wprsnv/ISPE-Annex-1-2025_Hotel-Brochure.pdf?rlkey=hwture4wvh9mj0kwlc7iaiq99&amp;st=o8ad1jgd&amp;dl=0" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">ISPE Annex 1 2025 – Hotel Brochure</a>

Day 1 Programme

Registration and Welcome Lunch in Exhibition Area

Opening Remarks from Annex 1 Symposium Chairs

ISPE Board Message and Global Inspection Trends in Sterility Assurance

Future Manufacturing: Global Perspective on Small Molecules and Biologicals

Work Stream Introduction and Guidelines

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

Coffee Break in Exhibition Area

How can aseptic operations be properly addressed in ATMP facilities?

Work Stream 1: Annex 1 Challenges for ATMP Facilities

Smarter Transfer Strategies for Machine setup: Main challenges and solutions during machines' set-up, regarding direct and indirect product-contact parts. 

Work Stream 2: Direct/Indirect Product Contact Parts: Smarter Transfer

How can AI and data-driven systems revolutionise environmental monitoring in aseptic operations to enhance sterility assurance, reduce deviations, and enable predictive control?

Work Stream 3: Can AI Redefine Sterility Assurance?

Identify an effective solution for the reduction of HVAC consumption within both existing and new facilities, whilst maintaining compliance with Annex1 & US Requirements.

Work Stream 4: HVAC Savings & GMP Compliance with Annex 1 & US Requirements

Museum Visit and Gala Dinner

Day 2 Programme

Welcome Breakfast in Exhibit Area

As the President of the Italy Affiliate, Giovanni will present some highlights from the Affiliate throughout the year.

ISPE Italy Affiliate Highlights

ATMP Ecosystem and Annex 1 Compliance: Insights from the EMA Concept Paper

Building Capabilities in Parenteral Manufacturing

Designing Twin Aseptic Manufacturing: Navigating Annex 1 Compliance Globally

Networking  Break in Exhibition Area

Moderated by Richard Denk, SKAN and Francesca Maienza, Menarini Group

Regulatory Townhall 

Networking Lunch in Exhibition Area

Applying Annex 1 Sterile Product Principles to Non-Sterile Manufacturing

Annex 1 Contamination Control Guidance

Bridging the Gaps: A Practical Review of Annex 1 Implementation and Insights

Annex 1 H2O2 Cycle Development of a Fully Gloveless Aseptic Isolator

Roundtable and Q&A with all speakers, coffee time conversations and insights

Aseptic Talks: Camera Café

Conference Highlights

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ISPE Annex 1 Symposium

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