Stability Studies Conference 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.

08:30 Conference registration and networking

09:00 Conference starts

16:00 Conference closes

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.

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.