2nd Annual · 2026
MaxPotent Pharma Summit Milan 2026
6–7 May 2026 · Ramada Plaza by Wyndham, Milan, Italy. The second annual edition brought regulators, pharma innovators and CDMOs to Milan for two days on containment performance, HBELs and data integrity, ISPE containment guidance, nitrosamine risk assessment and in-vivo CAR-T manufacturing.
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Venue
Ramada Plaza by Wyndham
Milan, Italy · 6–7 May 2026
Watch
The 2026 Highlights Film
Two days at the Ramada Plaza by Wyndham, condensed into two minutes.
Programme
The Delivered 2026 Agenda
Exactly as it ran at the Ramada Plaza by Wyndham, Milan.
08:00
Registration & Welcome Coffee
08:55
Opening Remarks by the Chairperson
Dean Calhoun, CEO, Affygility Solutions, USA
Session 1: Navigating EU Regulations & Compliance Strategies
09:00
Global Expectations, Unified Approach: HBELs Through the Lens of Data Integrity and Governance
Dean Calhoun, CEO, Affygility Solutions, USA
09:30
Verification and Monitoring of Containment Performance
Tara Dennis, Occupational Hygiene Manager, SafeBridge Europe, UK
10:00
Application of the new ISPE Good Practice Guide: Containment for Potent Compounds
Ana Fernandez, Pharmaceutical Technology Manager, Syntegon Telstar Technologies SLU
10:30
Networking Coffee Break
11:15
‘Potent’ and ‘HPAPI’ Occupational H&S in Project Design and Delivery
Justin Mason-Home, Director, HPAPI Project Services, UK
Session 2: Advanced Containment Strategies & Facility Design
12:00
Manufacturing of High Potent Drug Substance and High Potent Drug Products by a CDMO
Fabio Zenobi, EHS Director, BSP Pharmaceuticals S.p.A.
12:30
Containment technologies session
Roberto Furlan, Sales Manager, CSV Containment
13:00
Networking Lunch Break
14:00
European Legislation for High Containment
Giorgio Mari, Senior Process Engineer, Exyte
14:30
HPAPI Exposure and Risk Management: Lessons Learned and Validation of a Pragmatic Control Banding Approach
Kees Hommes, Sr. Occupational Hygienist, OH Consult
15:00
Innovative Containment Solutions for Processing Pharmaceutical Powders
Torsten Nuss, Senior Sales Manager Pharma, Hosokawa Alpine AG
15:30
Tactical Approaches to the Toxicological Qualification of Non-Genotoxic Impurities in HPAPIs
Chiara Gazerro, Regulatory Toxicologist, ToxHub Srl
16:00
Networking Coffee Break | End of Conference Day 1
09:00
Registration & Welcome Coffee
09:55
Opening Remarks by Chairperson
Dean Calhoun, CEO, Affygility Solutions, USA
CDMO Partnerships, Market Growth & Emerging Therapies
10:00
A Risk-Based Approach for Non-Conventional Supplier and CMO Qualification in GxP Audits
Yanet Flor, Founder, Quality Director and Auditor, GMP Check
10:30
Comparative Analysis of Flex and Rigid Isolator Systems
Michael Schweizer, Head of Sales, Lugaia AG Containment Solutions
11:00
Containment solutions session
Sean Codling, Managing Director, CTS Europe Limited
11:30
Coffee Networking Break
12:15
Enhancements to the N-Nitrosamine Risk Assessment Process
Mike Urquhart, Scientific Director, GlaxoSmithKline
12:45
In-Vivo CAR-T: A Paradigm Shift in Manufacturing and Quality
Ezequiel Blanco, CAR-T Cells Specialist & Growth Manager, GMP Check
13:15
Networking Lunch Break
14:15
Stability Studies in Pharmaceutical Development: From Product Quality to Material Compatibility
Angéline Mpemba Boni, Quality Control Analyst, Takeda
14:45
Rethinking HPAPI Facility Design: Bridging Design and Operational Reality
Carolina Quimbel, GMP Consultant, Ex-Richmond Laboratories, Argentina
15:15
Real-Time Containment Verification: Case Studies from the Front Lines
Winnie Chu, PhD, Nanozen Industries, Canada
15:45
Future-Proofing HPAPI Manufacturing: Containment, Risk Management, and Technology Integration
Panel
Moderator: Dean Calhoun (Affygility Solutions). Panellists: Ana Fernandez (Syntegon Telstar), Fabio Zenobi (BSP Pharmaceuticals), Roberto Furlan (CSV Containment), Torsten Nuss (Hosokawa Alpine), Michael Schweizer (Lugaia AG), Sean Codling (CTS Europe)
16:45
Closing Remarks by Chairperson | End of Conference Day 2
Dean Calhoun, CEO, Affygility Solutions, USA
GALLERY
Moments from Milan 2026
Testimonials
What Sponsors and Delegates Say
“
The event was exceptionally well organised, offering ample networking opportunities with a large number of attendees and presenters. The hospitality was excellent, and it was a pleasure to interact with colleagues while highlighting the importance of toxicology in areas such as containment, risk assessment, and both worker and patient protection. We look forward to collaborating with Convolign on future events as well.
Martin Kohan
Managing Toxicologist, SafeBridge Europe, UK
“
We truly felt we were at the right place. Over the past two days, we had insightful discussions around containment systems. The event brought together many customers, key manufacturers, and leading engineering companies, making it a great platform to exchange knowledge, information, and experience. We will definitely look forward to joining next year’s edition.
Stefano Butti
Technical Sales Director, FPS Pharma & Food Systems Srl
“
Congratulations to the entire team of Convolign Business Consulting for organising such a wonderful event. It was a perfect platform to gain insights into the key factors and technologies shaping high potent drug manufacturing. We also had excellent opportunities to network with peers and connect with new clients.
Andrea Confetti
Chairman, Dipharma Francis Srl
“
The event was highly informative, and we made some excellent industry contacts to introduce our systems to. The footfall was impressive, and the presentations were insightful. Overall, it was a great event for us, and we look forward to attending the next edition.
Mike Shemeld
Technical Sales Manager, CTS Europe
“
We had an excellent delegate turnout. The one-to-one meetings were very well organised and provided a great platform to connect with leaders from across various segments of HPAPI drug development. Truly a valuable opportunity for meaningful discussions and collaborations.
Roberto Furlan
Sales Manager, CSV Containment
“
I found the event very engaging, with a wide range of interesting topics covered. The venue was excellent, offering plenty of opportunities for networking, and the hospitality was truly remarkable.
Andrea Weiss
International Business Strategist, AM Instruments
Sponsors & partners
Who Backed Milan 2026
The organisations that sponsored, exhibited and partnered on the 2nd Annual edition.
Participants