Ireland 2025

Start this year’s Stability Studies Conference with our new and exclusive welcome 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 23rd 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

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

Kick off the conference with this fast-paced, 10-minute, thought-provoking session grounded in real conversations with stability professionals working for pharmaceutical and medical device companies. Through our Stability Strategy Sessions, Q1 Scientific has gathered the most pressing questions our customers are asking. Questions that reveal the shared challenges we all face in managing stability programs.

This isn’t a sales pitch, it’s a moment to reflect, connect, and set the tone for the day. We’ll share the top themes that keep our customers up at night.

We’ll also run a quick live poll to hear directly from you. What’s your biggest challenge right now? Your responses will help shape conversations throughout the day and ensure the sessions address what matters most to you.

Why attend

This opening session is designed to unite the room around shared challenges and spark meaningful conversations. It’s about understanding the landscape, not selling solutions. Within the room, we have decades of stability expertise, so the Stability Studies 2025 Conference is your opportunity to ask questions, share experiences, and have open conversations with your peers.

Catherine is a regulatory strategy and CMC expert with over 20 years of professional experience in global regulatory strategy, small molecule CMC, and international consultancy covering the entire product lifecycle.

A Pharmacist by training, Catherine started her career in the pharmaceutical industry in product development with 3M Healthcare and subsequently spent >8 years as a Pharmaceutical Assessor with the Health Products Regulatory Authority (HPRA) in Ireland assessing all types of applications for small molecule drug products (e.g. Clinical trials, CHMP scientific advice, National, MRP, DCP, and Centralised marketing authorisation applications, variations, renewals). During this time, she was a designated national expert at the EMA and a member of the Joint CHMP / CVMP Quality Working Party.

Catherine spent the last 10 years as a Regulatory / CMC consultant with global consulting organisations providing leadership to the consulting team and technical support to international clients and set up Imbolc Pharma Consulting in May 2024 to provide personalised services to the Pharma and Biotech industry in Europe.

Catherine holds a BSc (Pharm) in Pharmacy from Aston University, Birmingham, UK, and a PhD in Drug Delivery from the School of Pharmacy University of London (now part of University College London), London, UK.

Drug eluting stents (DES) have become a standard of care for the treatment of symptomatic atherosclerotic coronary artery disease. DES combine drug and device components, and are therefore combination products within the meaning of section 503(g) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 353(g). Stability testing of drug eluting stents (DES) is performed to provide evidence on how the quality of the product varies with time under the influence of a variety of environmental factors such as temperature, humidity and light, and to support the establishment of product shelf life or expiration dating period and recommended storage conditions. Stability studies are critical for ensuring the maintenance of product quality, safety and efficacy throughout the shelf life, and together with testing performed to demonstrate that the functionality of the stent and delivery system (i.e., mechanical performance), coating integrity and package integrity have not degraded over the requested shelf life are considered as pre-requisite for the acceptance and approval of any DES product.

FDA recommends that the stability studies of DES be conducted in a planned way following the guidelines issued for stability testing by ICH, WHO and/or other agencies. However, these regulatory guidelines are mainly designed to address stability studies that need to be conducted to determine the shelf life of pharmaceutical products. There is currently no clearly established regulatory basis or information in the scientific literature on how to conduct the stability testing of DES. This presentation attempts to discuss key points to consider when designing the stability studies to be performed during the DES lifecycle, as well as some other important aspects related to the stability testing of DES.

Dr Kamberi holds a double major in chemical engineering & industrial chemistry. She received her PhD from Oita University in Oita, Japan and completed postdoctoral studies from Stanford University in Palo Alto, California. Dr Kamberi has over 25 years of pharmaceutical and medical devices experience with increasing levels of responsibility across functional disciplines including analytical R&D, bioanalytical, pre-clinical research,  biocompatibility, quality control and stability. She is currently the Sr director of Global Analytical Chemistry, Bioanalytical, Stability and Biocompatability of Abbott Medical Devices, a worldwide premier medical device organization. Marika is author/co-author of more than 60 papers published in peer-reviewed journals, conference proceedings, and book chapters, and of 10 US patents.

New for this year’s conference, Stability Exchange offers a fun, focused, and low-pressure way to meet fellow attendees. Based on feedback from last year’s participants, this 30-minute session is designed to help you make fast, meaningful connections with stability professionals across the pharmaceutical, medical device, and life sciences sectors.

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.

Over 30 minutes, you’ll rotate through short, small-group conversations with other stability professionals to share experiences and spark conversations that can continue throughout the day. 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.

Whether you’re looking to exchange ideas, find collaborators, or simply connect with other stability professionals, Stability Exchange is your chance to build relationships and grow your network, without the awkwardness.

This presentation addresses the need to demonstrate acceptable microbial quality or sterility for different dosage forms.  It covers regulatory requirements, including common errors when setting specifications for, and reporting the results of, microbial enumeration tests, bioburden and bacterial endotoxins.  It also deals with the use of water activity results and historical data to justify reduced testing plans for non-sterile solid dosage forms, and the use of container-closure integrity in place of sterility testing.  The recent USP General Chapter (<1071>) on rapid sterility testing will also be reviewed.

Dr. Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a senior analytical chemist. Mark has served as both Honorary Secretary and Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016. He has worked at a senior level in a number of companies with responsibility for analytical development and equipment qualification.

In 2010 Mark was appointed Scientific Manager of a UK-based pharmaceutical CRO, with responsibility for guiding the direction of drug development programmes as well as establishing collaborations with academia and instrument manufacturers. In 2013, he set up his own company to provide training and consultancy services to the pharmaceutical industry. His consultancy work has involved, amongst other things, managing the analytical aspects of pharmaceutical development programmes and conducting data integrity audits.

He is in demand as a trainer in topics such as chromatography, spectroscopy, dissolution testing, data integrity, control of impurities, technical writing, stability/stress studies, method validation, extractables and leachables, and root cause analysis.

This presentation will discuss the latest predictive stability strategies and how they may be employed for regulatory filings. The presentation will give examples of use for early, late, and commercial drug substance and drug product regulatory filings for small molecule pharmaceuticals. A look to the future, with regards to the draft ICH Q1 guidance, will explore how the application of predictive stability may change over the coming years.

Luke has worked in the pharmaceutical industry within analytical development of small molecules for 8 years, predominantly focusing on predictive stability for formulation development and shelf-life assignment. At AstraZeneca, he leads the Predictive Stability group in Global Product Development as an Associate Principal Scientist. He has experience in using stability risk assessments with accelerated predictive stability studies to reduce lead-time in development, and to set shelf-life/retest periods in regulatory filings. He specializes in data science, modelling, and degradation.

“Stability Considerations for the Development of Protein Therapeutics” will discuss specific regulatory requirements as per ICH Q5C, selection of storage conditions based on product profile, and approaches to stability study design and analytical methodologies.

Declan Lowney is the Director of Stability Sciences in Analytical Development – Biologics within Johnson & Johnson Innovative Medicine R&D, and provides technical leadership in stability science and enhanced expertise in stability related ICH and Regulatory guidance. Declan joined J&J in 2006 and has supported the commercial approval of over 10 products . Prior to joining J&J, Declan has over 10 years’ experience in the pharmaceutical industry covering broad number of areas including R&D, QC, QA, Regulatory Affairs and Pharmacovigilance. Declan has a BSc in Industrial Chemistry from the University of Limerick,  an MSc in Organic Chemistry from University College Cork and a Post graduate diploma in Pharmaceutical Manufacturing Technology (QP Qualification).

Risk Revolution! is a monthly Podcast series seeking to advance the maturity of risk management practices across the life science sector. Hosted by passionate Risk Management practitioners Nuala Calnan, Val Mulholland and Lori Richter, we cover topics that challenge professionals within the biopharmaceutical and medtech industries and aim to shake up the paradigm to revolutionize the ways in which we perceive and proactively manage risk.

This October, Risk Revolution is going LIVE!!!

The Risk Revolution Podcast – “Stability Under Pressure”

In today’s fast-moving pharma landscape, shelf life isn’t just about time — it’s about risk. This LIVE podcast episode explores how science and risk-based thinking are reshaping stability strategies across the product lifecycle.

Key takeaways:

• Why traditional stability testing is giving way to predictive, data-driven approaches
• How ICH Q12 and real-time stability are enabling smarter decisions
• Where risk-based thinking can save time, cost, and resources, without compromising quality
• Common pitfalls and misconceptions when transitioning to a modern stability strategy
• What the future holds: AI, digital twins, and the next evolution of shelf-life modelling

Whether you’re in QA, regulatory, or technical operations, this live episode offers insights to help you lead the change.

As we wrap up the fourth 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.