Dublin, April 14, 2026 (GLOBE NEWSWIRE) -- The "Stability Testing of Pharmaceuticals and Biopharmaceuticals (May 20th - May 22nd, 2026)" training has been added to ResearchAndMarkets.com's offering.
This course will keep you abreast of the latest developments, providing a complete, practical, and scientifically grounded approach for small molecules and biologics alike.
Master modern stability testing so that you can design, justify, and defend robust stability programmes fully aligned with the existing ICH Q1A-Q1F + ICH Q1E + ICH Q5C + EU/CPMP & WHO Guidelines and new ICH Q1 (Draft).
As products become more complex and supply chains more global, it is crucial to stay up to date with the latest regulatory expectations, statistical approaches, and best practices for stability programme design.
Stability requirements continue to tighten, with the updated ICH Q1(Draft) bringing enhanced clarity around protocol justification, statistical modelling, pooling decisions, and data interpretation. Organisations that fail to modernise their stability programmes risk delays, failed submissions, and avoidable resource costs.
Who Should Attend:
- Development scientists
- Analytical chemists
- Stability programme leaders
- QC/QA specialists
- Regulatory affairs professionals
- CMC and technical development teams
- Formulation scientists
Key Topics Covered:
Day 1
- Regulatory foundations for stability programmes
- Overview of new ICHQ1 draft
- Stability Study Types , Conditions and Protocols
- Photostability (ICH Q1B)
- Packaging Considerations
- Governance of stability samples and facilities
Day 2
- Requirements for existing products, line extensions and variations
- Data treatment, shelf-life assignment and extrapolation
- Matrixing and bracketing stability studies
- Bulk stability
- Environmental zones considerations
Day 3
- Stability for biopharmaceuticals
- Degradation pathways
- Analytical and bio assay considerations
- Cold chain and frozen storage stability
- Design of modern stability programme using updated ICHQ1
CPD Hours: 18
Speakers
Paul Palmer
Paul R Palmer is a Director / Pharmaceutical Consultantanda practicing EU / UK Qualified Person.Hehas over 35 years experience in the pharmaceutical industry in the development, manufacture and supply of medicinal products and medical devices.
Throughout his career, Paul has intentionally taken on all opportunities as they arose in order to develop a broad range of knowledge with an in-depth detailed understanding of manufacturing, storage, distribution, research, computerised systems, as well as the facilities and services to support each.
People and systems have always been a core focus, how to ensure best use, optimise and enhance efficiency. He has a level of curiosity rarely displayed in people taking on the qualified person role in pharmaceutical manufacturing. Culture, behaviour and psychology are all significant influences on the systems and processes we implement, but are often ignored.
For more information about this training visit https://www.researchandmarkets.com/r/ln77pb
About ResearchAndMarkets.com
ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
