ISPE Nordic Affiliate presents its first Annex 15 event in the Baltics. NOTE 18 AUG 2025. Due to too short registration possibility and thereby too few registered participants we have decided to postpone the conference until September 2026. Registration is closed and we will contact all speakers, sponsors and registrants personally. Thanks to all of those that signed up.
Join us for the first-ever ISPE Nordic Affiliate Conference, taking place in the scenic coastal town of Jūrmala, just 25 minutes from Riga. This two-day gathering brings together pharmaceutical professionals, regulators, academia, and solution providers to explore innovation, compliance, and collaboration across the Nordic and Baltic life sciences community. Find more information at ispe.org.
Get to Know the Baltics: This is more than just a conference — it’s an invitation to experience Jūrmala, Latvia’s iconic seaside resort town. Known for its white sandy beaches, pine forests, charming wooden architecture, and fresh sea air, the setting offers a unique blend of relaxation and inspiration.
Connect with Regulatory Voices: Learn from regulatory authorities and industry experts about key trends and challenges shaping pharma in the region.
Networking Opportunities: Take part in structured networking breaks, two seated lunches, and our signature Social Dinner on the evening of 17 September at Small Guild of Riga.
Sightseeing Experience: Enjoy a guided sightseeing opportunity during the event — explore Riga’s historic Old Town or Jūrmala’s beach promenade with fellow attendees.
Support Emerging Talent: The conference is free for up to 10 emergent leaders and/or students, with active outreach to local universities and academic communities (must sign up for ISPE Membership).
ISPE Members: €650
Non-Members: €875
Not an ISPE member yet? Learn more about the benefits of joining here.
Your conference registration includes:
Coffee breaks and light snacks on both days
Lunch on Day 1 (17 September) and Day 2 (18 September)
Bus transportation and social dinner on Day 1 at the historic Small Guild in Old Riga.
Join us for two days of high-value content, networking, and cross-border collaboration in the heart of the Baltic region.
This is a two-day event dedicated to cutting-edge discussions on qualification and validation in life sciences. This year’s focus includes Annex 15, evolving regulatory trends, and the growing collaboration between Nordic and Baltic pharmaceutical manufacturing leaders. Find the drafted program here.
Whether you are part of a multinational, a regional CMO, or an emerging biotech, this event offers practical insights, up-to-date regulatory guidance, and invaluable networking opportunities to help you advance your validation programs.
The event will be hosted by Arie Menachem, Chair of the ISPE Nordic Affiliate and Vice President of Quality Audits & Inspections at Novo Nordisk. He will be joined by Dr. Polina Dombure, Director of the ISPE Nordic Affiliate and CEO of Inpharmatis Group, who also serves as Membership Co-Chair.
We are honored to welcome Dr. Hosams Abu Meri, Latvian Minister of Health, for the official opening.
Throughout the conference, you’ll hear from leading experts across the region, including:
Iveta Vilcane – Head of Compliance Assessment Division, Latvian State Agency of Medicines
Annex 15 as a Driver of Operational Excellence: From Compliance to Integrated Strategy
Marco Castaldo – Product Manager, Marchesini Group S.p.A.
Science and Latvia’s Pharmaceutical Future
Kristaps Jaudzems – Dean, Faculty of Medicine and Life Sciences, University of Latvia (LU)
Process Validation Lifecycle – FDA's Guidance and Perspective
Arie Menachem – Chair, ISPE Nordic Affiliate; VP of Quality Audits & Inspections, Novo Nordisk
Comparative Analysis of Paper-Based, Electronic, and Paperless Validation
Michał Timler – Director of Digital Transformation & Strategic Partnerships, eLife Science
Strengths and Limitations of Statistical Methods in Validation and Verification
Diana Ratkevich – Head of R&D Division, Qualified Person, JSC Grindeks
Quality Begins at Concept: GMP Design Review Toolkit for Life Sciences Facilities
Mary Lennon – Director of GMP and Regulatory Compliance, Jacobs
Towards Continuous Cleanroom Decontamination: Implementation of Far-UVC
Jordi Amagat – Segment Manager, LifeScience and Pharma, UV Medico
Please note: The final speaker lineup is still being finalized, and additional sessions will be announced shortly. We are in ongoing dialogue with senior representatives from key regional authorities, including the Investment and Development Agency of Latvia (LIAA), the Estonia State Agency of Medicines, and the State Medicines Control Agency of Lithuania. Their participation is expected and will further enrich the regulatory perspective of the program.
Stay tuned for updates as we confirm the remaining slots.
Venue & Accommodation
Baltic Beach Hotel & SPA
Jūras iela 23/25, Jūrmala, LV-2015, Latvia
https://balticbeach.lv
Located directly on Jūrmala’s iconic white sand beach, the 5-star Baltic Beach Hotel & SPA offers an exceptional combination of conference facilities and relaxation. Just 15 minutes from Riga International Airport and 25 minutes from Riga city center, the venue provides a peaceful yet accessible setting for ISPE Nordic’s Baltic Event.
Attendees can enjoy spa amenities, seaside views, fine dining, and the vibrant surroundings of Jūrmala.
Promo Code: ISPE25
Booking Period: 05 June - 01 August 2025
Stay Dates (Validity Period): 15 - 22 September 2025
Discount: 25% off Best Available Rate
Booking Process:
Enter promo code ISPE25 on www.balticbeach.lv, or
Contact the hotel directly via email: res@balticbeach.lv
Payment Policy: 100% prepayment at time of booking
Cancellation Policy: Free cancellation until 01 September 2025
Availability: Limited number of rooms available at the discounted rate. Early booking is recommended.
Please Note:
ISPE Nordic Affiliate is not affiliated with any third-party booking agencies or vendors. To ensure you receive the official event discount and booking conditions, we strongly recommend booking directly with Baltic Beach Hotel & SPA using the promo code ISPE25 or by contacting the hotel via the official email address: res@balticbeach.lv.
0–4.99 years: Free of charge (including provision of a Baby Cot)
5–15.99 years: EUR 35 for an extra bed
16+ years: EUR 80 for an extra bed
Rich Sea View Breakfast with Prosecco
Baltic Beach Club Restaurant & Bar
Access to the Private Beach Club and Exclusive Sunbeds Area (all-day access)
Baltic Beach Club
Sea Wellness Complex: Enjoy 90 minutes per day (except on the departure day) including:
Sea Wellness Complex Details
25 m lap pool with warm sea water
Roman Steam, Himalayan, and Cedar Wood saunas
Kids pool, waterfall, and underwater massage jets
Access to Powerlab Fitness Professional Gym
In-Room Amenities: Tea, coffee, and complimentary water
WI-FI Connectivity
Call for Speakers
We not just talking about Annex 15 compliance - we are rethinking its potential as a catalyst for innovation, operational excellence, and smarter validation systems.
We are looking for fresh perspectives on questions like:
How can Annex 15 become a framework for operational excellence, not just regulatory fulfillment?
How do we shift from reactive validation to proactive, risk-based lifecycle management?
What’s the real role of digitalisation, AI, and platform technologies in modern validation strategy?
Whether your experience lies in manufacturing, quality, compliance, tech transfer, or regulatory affairs, we invite you to share a story, solution, or learning journey that pushes the conversation forward.
Share your story here: https://sessionize.com/ispe-baltics-event/Elevate your brand and connect directly with decision-makers in pharma and biotech across the Nordic and Baltic regions.
Includes:
One (1) exhibition table in our sponsor zone (valued at €1,500).
Two (2) full conference tickets.
2 passes to the Stand-Up Social Dinner (Sept 17) at Small Guild of Riga.
(Tentative) Invitation to the Speaker Welcome Dinner *2 tickets on 16 September.
Choose Your Table:
Sponsors can select from 10 available tabletop locations (highlighted in yellow). View the layout in our Canva overview.
Have questions or want to reserve your spot? Reach out to Nadia Thorius (ISPE Nordic Affiliate Secretary) at nadiathorius@gmail.com for more information and assistance with the registration process.
Exclusive brand placement on all attendee lanyards (150+ expected).
High visibility throughout the entire event.
Deadline: Submit high-res logo to ISPE by 15 August 2025 to nadiathorius@gmail.com
Up to 4 sponsor-provided roll-ups near coffee stations.
Great visibility in high-traffic areas.
Up to 4 sponsor-provided roll-ups near lunch stations.
Great visibility in high-traffic areas.
ISPE Opening Night Social incl. Stand Up Dinner – €2,000 - (2 Available)
Make a lasting impression at the most festive moment of the conference on Day 1. Off-site location at Small Guild of Riga.
Includes:
Premium brand visibility with 2 sponsor-provided roll-ups.
Verbal recognition by the event host during the evening program.
Logo featured on signage.