2026 ISPE Nordic-Baltic Validation Summit

2026 ISPE Nordic-Baltic Validation Summit - Advancing Best Practices in Validation: Planning, Execution, and Reporting

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?
   

Speaker Line-up

Hear from industry leaders, regulatory experts, and validation professionals from across the Nordic and Baltic life sciences community. Through practical case studies, expert perspectives, and lessons learned, our speakers will explore how modern validation approaches can strengthen compliance, improve operational performance, and support innovation across the product lifecycle. Explore the full speaker line-up, session details, and conference schedule in the programme here.

Conference Location and Hotel Venue

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.

Participants travelling to Vilnius are encouraged to stay at the Radisson Collection Astorija Hotel, Vilnius, located in the heart of Vilnius Old Town. The hotel will host the summit’s Women in Pharma® Cocktail Reception and Gala Dinner on the evening of 15 September.

Transportation

Following the conference programme, complimentary buses will take participants from the VU Library Scholarly Communication and Information Centre (SCIC) directly to the hotel.

Hotel Booking

Accommodation is not included in the conference registration and must be booked separately. Rooms are subject to availability, so early booking is recommended.

Radisson Collection Astorija Hotel, Vilnius
Didžioji g. 35/2, Vilnius, Lithuania

View Hotel and Book Your Stay
 

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:

• Featured Presentation - BIO CITY - The Largest Biomanufacturing Hub in Europe.
  •  Speaker: Vladas Algirdas Bumelis, CEO & Chairman, Northway Biotech | Founder, BIO CITY
• Guided site tours

Why Join?

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.


Registration Fees

Join validation professionals, quality leaders, engineers, regulators, and industry experts from across the Nordic and Baltic region for two days of knowledge sharing, networking, and practical discussions on the future of validation.
 

Industry Professionals

ISPE Member – €420

Non-Member – €600

Non-Member + 1-Year ISPE Membership – €650

Baltic Professional Rate (Includes 1-Year ISPE Membership) – €450
 

Academia, Students & Emerging Leaders

Academia / Young Professional (ISPE Member) – Complimentary

Academia / Young Professional (Non-Member) – €30

Student / Emerging Leader (ISPE Member) – Complimentary

Student (Non-Member, Includes 1-Year ISPE Membership) – €30

Emerging Leader (Non-Member, Includes 1-Year ISPE Membership) – €150
 

What's Included?

Your registration includes:

• Access to all conference sessions

• Coffee breaks and lunch

• Networking opportunities with industry peers and subject matter experts

• Access to sponsor and exhibitor areas
 

Optional Site Tour Add-On

Northway Biotech BIO CITY Site Tour – €60

Experience an exclusive behind-the-scenes visit to BIO CITY, one of Europe's largest biopharmaceutical development projects. Participants will have the opportunity to tour Northway Biotech's state-of-the-art facilities and learn more about the future of biologics and gene therapy manufacturing in Lithuania. Capacity is limited to 40 participants and advance registration is required. Please note that the site tour is not included in the conference registration fee and must be booked separately.

Partnerships available

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) 2 TABLES LEFT

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
   

Event Sponsors

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