Stability Testing Of Pharmaceuticals And Biopharmaceuticals Scheduled For May 19-21, 2027, Focusing On Stability Programme Design Under ICH Guidelines And The New ICH Q1 Draft
Dublin, Oct. 14, 2026 (GLOBE NEWSWIRE) -- "Stability Testing of Pharmaceuticals and Biopharmaceuticals (May 19th - May 21st, 2027)" has been added to ResearchAndMarkets.com's offering.
Key Event Facts
- Course: Stability Testing of Pharmaceuticals and Biopharmaceuticals Date: May 19-21, 2027 Time: May 19th 09:00 to May 21st 17:00, GMT+1 Format: Online (live) Duration: 3 Days Focus: Stability programme design, data treatment, shelf-life assignment, and biologics stability under current and draft ICH guidance
As products grow more complex and supply chains more global, staying current with regulatory expectations, statistical approaches, and best practice in stability programme design has become essential. Stability requirements continue to tighten. The updated ICH Q1 draft brings greater clarity on 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.
The course gives a practical, scientifically grounded approach for both small molecules and biologics. It carries 18 CPD hours.
Course Content
Day 1:
- regulatory foundations for stability programmes overview of the new ICH Q1 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 studies bulk stability environmental zone considerations
Day 3:
- stability for biopharmaceuticals degradation pathways analytical and bioassay considerations cold chain and frozen storage stability designing a modern stability programme using the updated ICH Q1
Why You Should Attend
- Understand what the new ICH Q1 draft changes for protocol justification, statistical modelling, and pooling decisions. Apply data treatment, shelf-life assignment, and extrapolation methods that stand up to regulatory review. Use matrixing, bracketing, and photostability (ICH Q1B) approaches to design efficient stability studies. Address biologics-specific requirements, including degradation pathways, bioassays, and cold chain and frozen storage stability. Earn 18 CPD hours upon completion of the course.
Business Relevance
The course content applies directly to professionals responsible for designing, running, and defending stability programmes. It supports an understanding of how current and draft ICH guidance affects submissions, variations, and shelf-life decisions for both small molecules and biologics.
Who Should Attend
- development scientists analytical chemists stability programme leaders QC/QA specialists regulatory affairs professionals CMC and technical development teams formulation scientists
The course runs May 19-21, 2027. Professionals responsible for stability programmes should plan their participation ahead of these dates.
Featured Speakers
- Aneta Jell: Quality and Training Manager at Paul R. Palmer Limited, where she oversees global contract manufacturing quality. She has over 20 years of experience in quality assurance across manufacturing, contract operations, and quality leadership in the pharmaceutical industry. Her expertise covers GMP, ISO 9001, ISO 17025, and QMS administration, including audits, CAPA, deviations, and technical agreements. She is a qualified QMS lead auditor. Farah Nadeem: Operations Manager at Paul R. Palmer Limited, pharmaceutical consultant, and Trainee Qualified Person. She is a pharmacist with over 20 years of experience in the development, manufacture, and supply of medicinal products. Her current work includes helping companies obtain MIA(IMP) and MIA licences, and preparing for and hosting regulatory inspections.
To reserve a place on“Stability Testing of Pharmaceuticals and Biopharmaceuticals,” register your interest directly through Research and Markets at:
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