ISPE Annex 1 Symposium
Exchange. Collaborate. Inspire.
Date and time
Location
Hospital of Innocents
12 Piazza della SS. Annunziata 50121 Firenze ItalyRefund Policy
Agenda
12:00 PM - 2:00 PM
Registration and Welcome Lunch in Exhibit Area
2:00 PM - 2:15 PM
Opening Remarks from Annex 1 Symposium Chairs
Thomas Carganico, PQE Group
Richard Denk, SKAN
2:15 PM - 2:45 PM
Global ISPE Message and Focus on Inspection Trends
Vivianne Arencibia – VP Quality & Compliance at Moderna
2:45 PM - 3:15 PM
Future Manufacturing: Global Perspective on Small Molecules and Biologicals
Fabrizio Landi - President & Founder at Panakes Partners
3:15 PM - 3:45 PM
Coffee Break in Exhibition Area
3:45 PM - 4:00 PM
Work Stream Introduction and Guidelines
Stefano Piccoli - ISPE Italy BoD and at CEO Qstep Srl
4:00 PM - 6:00 PM
Work Stream 1 - Italy: Annex 1 Challenges for ATMP Facilities
Germana Molinari - Wood
Pietro Bosi - IWT
Enrica Piccini - Menarini Group
4:00 PM - 6:00 PM
Work Stream 2 - DACH: Re-qualification of Cleanrooms and Clean Air Equipment
Volker Storn - Roche
Richard Denk - SKAN
4:00 PM - 6:00 PM
Work Stream 3 - Ireland: Can AI Redefine Sterility Assurance?
Paul Clarke - Director, Business Development at ABEC
Mark O'Connor - GSK
Alessio Rosati - PQE Group
4:00 PM - 6:00 PM
Work Stream 4 - France: Air Change Rate Reduction
Jean-François Duliere - ISPE
Emilio Motta - Jacobs
8:00 PM - 10:00 PM
Museum Visit and Gala Dinner
About this event
Join a Landmark European Collaboration on Annex 1 Compliance
ISPE Italy | DACH | France | Ireland | Nordics Affiliates
For 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.
WHY JOIN THE ANNEX 1 SYMPOSIUM?
🔬 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 & 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!
Hotel Accommodation Options for the Event
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: