Validation is evolving. With increasing regulatory expectations and growing technological possibilities, the industry is moving beyond traditional compliance-driven approaches toward more integrated, risk-based, and lifecycle-oriented validation strategies.

At the 2026 ISPE Nordic-Baltic Validation Summit, we will explore how validation can move from a regulatory requirement to a driver of operational excellence, efficiency, and innovation. Through practical case studies, lessons learned, and forward-looking discussions, participants will gain insights into how modern validation approaches can support both compliance and business value.

Topics of discussion include:

• How can Annex 15 become a framework for operational excellence, not just regulatory compliance?
• How do we shift from reactive validation to proactive, risk-based lifecycle management?
• What role can digitalisation, AI, and platform technologies play in shaping modern validation strategies?
• How can organisations strengthen collaboration between manufacturing, quality, engineering, and regulatory teams to improve validation outcomes?

 
Location

The 2026 Summit will take place in Vilnius - VU Library Scholarly Communication and Information centre (SCIC). 

Vilnius is increasingly establishing itself as an important life sciences and innovation hub within the Nordic-Baltic region, with continued investments in biotechnology, research, advanced manufacturing, and technology ecosystems. As the city strengthens its position as a growing European biotech destination, it provides a fitting setting for discussions on the future of validation and pharmaceutical innovation.

Preliminary Speaker Line-up

The preliminary program is beginning to take shape. Join industry experts and practitioners as we explore emerging trends and practical applications shaping the future of validation - including AI, lifecycle approaches, cleaning strategies, and modern validation practices.

Additional speakers and program details coming soon.

• Validating the Probabilistic: A Risk-Based Framework for AI System Qualification in GMP Environments
  Speakers: Chris Dayton, CEO & Co-Founder, Quality Assured AI | Adam Pinkert, Senior Advisor: Quality & Regulatory, Quality Assured AI
• How Do You Validate an AI System? A Hands-On Workshop for Validation Professionals (Workshop)
  Speaker: Chris Dayton, CEO & Co-Founder, Quality Assured AI
• Enzyme Indicators in Practice: A Practical Guide to Rapid Validation Across the H₂O₂ Lifecycle
  Speaker: Antoine Verslype, International Business Development Manager, Protak Scientific
• Strategic Changes to a Legacy Cleaning Approach
  Speaker: Dijana Hadziselimovic, Technical Services Lab Manager

Exclusive Site Visit: BIO CITY Gene Therapy Center

As part of the 2026 ISPE Nordic-Baltic Validation Summit, participants will have the opportunity to join an exclusive site visit to BIO CITY’s Gene Therapy Center in Vilnius.

BIO CITY, located in Vilnius, Lithuania, is Europe’s largest biomanufacturing project, developed by Northway Healthcare Group companies under the Northway Biotech brand. Founded by Prof. Vladas Algirdas Bumelis, BIO CITY brings together R&D, process development, and clinical and commercial biologics manufacturing within a single integrated ecosystem.

The site you will visit is dedicated to the development and manufacturing of gene therapies, including pDNA and viral vectors.

Site Visit Details

Date: Wednesday, September 16, 2026
Time: 14:00–16:00
Location: Gene Therapy Center, Melkio g. 7, Vilnius
Capacity: Up to 40 participants

The visit will include:

• A short presentation session
• Guided site tours

Featured Presentation

BIO CITY – The Largest Biomanufacturing Hub in Europe

Speaker: Vladas Algirdas Bumelis
CEO & Chairman, Northway Biotech | Founder, BIO CITY

Sponsorship Opportunities

2026 ISPE Nordic-Baltic Validation Summit

Partner with the ISPE Nordic Affiliate and support a growing Nordic-Baltic life sciences community focused on validation, operational excellence, digitalisation, and pharmaceutical manufacturing best practices.

The 2026 ISPE Nordic-Baltic Validation Summit brings together professionals across validation, CQV, quality, engineering, manufacturing, automation, and regulatory compliance in a professional, knowledge-sharing environment designed to encourage collaboration and industry advancement.

Sponsorship opportunities are designed to create meaningful visibility, networking, and engagement with a highly relevant pharmaceutical and biotech audience while supporting professional development and community-building initiatives across the Nordic-Baltic region.

Please note that sponsorship opportunities are limited and allocated on a first-confirmed basis. 

Tabletop Partner – €2,200

(Limited to 6 partners)

Includes:

• 2 full conference tickets
• 2 gala dinner tickets
• Access to the cocktail reception for 2 attendees
• Participation in organised networking transportation activities
• Dedicated tabletop exhibition space in the main networking area
• Opportunity to display one tabletop banner/roll-up within allocated space
• Company logo visibility on:
  • event landing page
  • selected promotional materials
  • sponsor recognition slides during the event
• Recognition as an official event partner
• Access to networking sessions, coffee breaks, and lunch areas

Please note: Site tours are not included.


Optional Sponsorship Enhancements

Gala Dinner Supporter - €2,500

(Exclusive opportunity)

Support one of the summit’s primary networking experiences and host customers, colleagues, or invited guests in a professional and informal setting.

Includes:

• 2 additional gala dinner invitations for customer/prospect guests
• Reserved hosted seating opportunity during the gala dinner
• Recognition as official Gala Dinner Supporter
• Enhanced logo visibility during the gala dinner
• Recognition during dinner welcome remarks
• Recognition on sponsor slides and event landing page
• Opportunity to place approved branded materials at the venue
• Enhanced visibility during attendee networking activities
  
  

Why Join The Conference and Site Tour?

Validation is no longer only about demonstrating compliance — it is increasingly becoming a strategic capability that supports innovation, operational performance, and smarter decision-making across the product lifecycle.

The preliminary program is expected to include practical case studies and industry perspectives on:

• AI and probabilistic systems in GMP environments
• Virtual qualification and digital validation approaches
• Lifecycle-based validation strategies
• Risk-based decision making
• Cross-functional collaboration between engineering, manufacturing, quality, and regulatory teams

Join validation, quality, engineering, manufacturing, and regulatory professionals from across the industry to explore emerging trends, exchange practical experiences, and connect with peers helping shape the future of validation.

More speaker announcements coming soon.