ISPE Annex 1 Symposium
Exchange. Collaborate. Inspire.
Date and time
Location
Istituto degli Innocenti
Piazza della Santissima Annunziata, 13 50121 Florence ItalyAgenda
12:00 PM - 2:00 PM
Registration and Welcome Lunch in Exhibition 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
ISPE Board Message and Global Inspection Trends in Sterility Assurance
Vivianne Arencibia – VP Quality & Compliance, Moderna
Daniel Osterby, SD Global Sterility Assurance, Moderna
2:45 PM - 3:15 PM
Future Manufacturing: Global Perspective on Small Molecules and Biologicals
Fabrizio Landi, President & Founder, Panakes Partners
3:15 PM - 3:30 PM
Work Stream Introduction and Guidelines
Stefano Piccoli, Qstep
3:30 PM - 4:00 PM
Coffee Break in Exhibition Area
4:00 PM - 6:00 PM
Work Stream 1: Annex 1 Challenges for ATMP Facilities
Germana Molinari, Wood
Pietro Bosi, IWT
Ander Izeta, Donostia University Hospital
Vittorio Rossi, LifeBee
4:00 PM - 6:00 PM
Work Stream 2: Direct/Indirect Product Contact Parts: Smarter Transfer
Volker Storn, Roche
Richard Denk, SKAN
Davide Soffieto, GSK
4:00 PM - 6:00 PM
Work Stream 3: Can AI Redefine Sterility Assurance?
Paul Clarke, Director Business Development, ABEC
Mark O'Connor, GSK
Alessio Rosati, PQE Group
Antonella Carito, GSK
4:00 PM - 6:00 PM
Work Stream 4: HVAC Savings & GMP Compliance with Annex 1 & US Requirements
Jean-François Duliere, ISPE
Emilio Motta, Jacobs
Keltoum Ghalib, Guerbet
Robert Kibele, Körber
8:00 PM - 10:00 PM
Museum Visit and Gala Dinner
Good to know
Highlights
- 1 day, 4 hours, 30 minutes
- In person
Refund Policy
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: