Stability Studies Conference Ireland 2026

Start this year’s Stability Studies Conference with our exclusive networking reception the evening before. This relaxed and informal gathering is the perfect opportunity to connect with peers, speakers and experts before our full conference on the 21st of October.

Why attend?

• Expand your network – Meet fellow professionals managing stability studies in a relaxed setting and build connections before the event to enhance your conference experience
• Engage with experts – Gain early access to industry leaders and experts sharing their invaluable knowledge and experiences throughout the conference. This is your moment to ask questions, gain insights, and establish connections with the leading experts in stability studies
• Discuss stability challenges – Share experiences and insights with peers facing similar issues, from storage constraints to compliance hurdles, and gain fresh perspectives before the main event

Enjoy drinks and canapés as you exchange best practices, discuss the latest trends and challenges, or simply unwind with like-minded professionals. Don’t miss out on this unique opportunity to grow your professional network and gain fresh perspectives in a relaxed and friendly atmosphere.

Registration and light breakfast from 08:30 am.

Start the day by connecting with fellow stability professionals, quality leaders, formulation scientists, and industry experts from across the pharmaceutical and life sciences sectors. Enjoy a light breakfast while exploring the latest trends, challenges, and innovations shaping stability programs today.

Join us as we open the fifth annual Stability Studies Conference, hosted by Q1 Scientific – Ireland’s only dedicated event focused on stability.

What are we really trying to learn from a stability study and how do we design one that answers the right questions? Stability studies are not only a regulatory requirement; they are a critical tool for understanding product quality, shelf life, storage conditions, and risk across the product lifecycle. Designing a stability study can seem straightforward on paper but in practice, the right design depends on the product, the phase of development, the intended market, and the decisions the data will need to support.

In this practical session, Aideen Glynn will go back to basics and explore why stability studies matter, what they are designed to tell us, and how to build a study from the ground up. From defining the study objective and selecting storage conditions to choosing timepoints, test parameters, and sample quantities, this talk will walk through the key decisions involved in designing a meaningful and defensible stability programme. Ideal for those newer to stability, or anyone looking for a clear refresher on the fundamentals.

Many of the recent regulatory guidance on analytical procedures for the control of drug substances and drug products have emphasised a life cycle approach. According to this model, analytical method suitability is demonstrated during development and validation (by meeting the Analytical Target Profile/appropriate performance criteria) and over the life cycle of the method (through continuous performance verification). This presentation considers the impact of data variability on the decision to release or fail a batch for measurements that lie close to the specification limit. The keys to success include identifying and controlling sources of data variability (from sampling to result reporting), setting appropriate limits for validation acceptance criteria, and tight but realistic analytical control (including system suitability) parameters. The presentation will include a discussion of recent regulatory changes (ICH Q2 (R2), the proposed USP <1221> and the draft update to USP <1225>).

One of the most highly rated aspects of previous Stability Studies Conferences has been the opportunity to connect with peers facing similar challenges. Stability Exchange has been specifically designed to make those connections easier, more meaningful, and more valuable.

This year, we’re running two Stability Exchange sessions across the conference programme, giving attendees even more opportunities to connect. Based on the overwhelmingly positive feedback from last year, we’re providing more time for discussion, networking, and sharing experiences.

Stability Exchange offers a fun, focused, and low-pressure way to meet fellow attendees. This interactive networking session brings stability professionals together through a series of short, facilitated conversations focused on stability challenges. You’ll meet professionals from pharmaceutical, medical device, and life sciences companies, share experiences, compare approaches, and learn how others are navigating stability requirements.

As the first of two Stability Exchange sessions, this session is designed to help you start building connections early in the conference. Over 30 minutes, you’ll rotate through short, small-group conversations with other stability professionals to share experiences and start conversations that can continue afterwards. Each round includes a prompt or stability-related challenge to start a conversation, so there’s no need to prepare or worry about what to say.

We know networking can feel overwhelming, especially in a large conference setting. That’s why this session is structured to be welcoming and easy to join, whether you’re an introvert, new to the field, or simply looking to expand your network.

Whether you’re looking for fresh ideas, expert advice, future collaborators, or simply reassurance that others face the same challenges you do, Stability Exchange provides a welcoming environment to start those conversations.

Why attend?

• Meet fellow stability professionals from across the industry
• Exchange practical ideas and best practices
• Discuss common challenges in a relaxed setting
• Build valuable professional connections
• Expand your stability network beyond your own organization

Take a well-earned break and continue the conversations started throughout the morning. Grab a coffee, enjoy light refreshments, and reconnect with colleagues, speakers, and fellow attendees.

Some of the most valuable conference insights come from informal discussions between sessions. Use this time to ask follow-up questions, exchange experiences, and build connections with peers who share many of the same stability, quality, and regulatory challenges.

Why attend?

• Network with stability professionals and industry experts
• Discuss key learnings from the morning sessions
• Share experiences and best practices
• Explore potential collaborations and new connections

The updated ICH Q1 draft explicitly encourages scientifically justified, model‑informed strategies for shelf‑life estimation. Kinetic modelling aligns perfectly with this direction: it provides a rigorous, transparent framework for extrapolation, supports risk‑based decision‑making, and strengthens the overall stability argument for regulatory submissions. Rather than relying solely on time‑consuming real‑time studies, companies can integrate kinetic insights early, refine formulations faster, and reduce uncertainty in product performance. The benefits are enormous. Development timelines shrink. Stability failures are detected earlier. Resources shift from repetitive testing to strategic experimentation. And because kinetic models capture the true behaviour of a product under stress, they offer a level of predictive power that conventional approaches simply cannot match. This session will show how adopting advanced kinetic modelling not only aligns with regulatory expectations but also unlocks a smarter, more agile, and more scientifically robust path to pharmaceutical stability assessment.

Following a morning of presentations and discussions, join fellow attendees for a second Stability Exchange session before lunch.

This interactive networking session gives you another opportunity to connect with stability professionals, exchange ideas, discuss common challenges, and build valuable industry connections. Through a series of short, facilitated conversations, you’ll explore practical stability topics, share experiences, and gain insights from peers across the pharmaceutical, medical device, and life sciences sectors.

Whether you’re reconnecting with someone you met earlier in the day or making new connections, this session is designed to help continue the conversations that matter most.

Why attend?

• Continue discussions from the morning sessions
• Exchange practical ideas and experiences
• Gain fresh perspectives on stability challenges
• Strengthen professional connections
• Head into lunch with new contacts and conversations to continue

Join us for a complimentary lunch and continue the conversations started throughout the day. This informal networking session provides a valuable opportunity to discuss key takeaways, exchange ideas, and build relationships with stability professionals from across pharmaceutical, medical device, and life sciences companies.

Whether you want to ask more questions about a presentation topic, seek advice on a stability challenge, explore potential collaborations, or simply connect with peers facing similar regulatory and operational demands, this final networking session offers the perfect setting to do so.

Take the opportunity to meet our speakers, connect with the Q1 Scientific team, and continue expanding your professional network within the stability community.

As we wrap up the fifth annual Stability Studies Conference, Stephen Delaney will reflect on the key insights, themes, and connections made throughout the day.

Whether you’re heading back to the lab, the office, or the next phase of your development program, depart with actionable insights to elevate your stability programs.