Pricing

• ISPE Members: €650

• Non-Members: €875

Not an ISPE member yet? Learn more about the benefits of joining here.

What is Included

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. 

• Sightseeing activity on Day 2 to explore the cultural highlights of Riga.

Join us for two days of high-value content, networking, and cross-border collaboration in the heart of the Baltic region.

Speakers and Program Highlights

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:

Baltic Regulatory Overview

Iveta Vilcane – Head of Compliance Assessment Division, Latvian State Agency of Medicines

Quality, Science, and Strategy in the Pharmaceutical Industry

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)

Quality by Design and Advanced Validation Methods

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

Advanced Cleanroom Decontamination and Facility Design

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

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.

Hotel Booking Information

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.

Additional Details for the hotel

Extra Person Policy in the Room

• 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

Room Rate Includes:

• 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.