Dublin, July 06, 2026 (GLOBE NEWSWIRE) -- The "Stability Testing of Pharmaceuticals and Biopharmaceuticals (Nov 9th - Nov 11th, 2026)" has been added to ResearchAndMarkets.com's offering.
Registration is now open for Stability Testing of Pharmaceuticals and Biopharmaceuticals, a three-day online training course delivered as part of the IPI training curriculum and running November 9–11, 2026, built to help organisations modernise stability programmes ahead of the new ICH Q1 (Draft) guidance.
The course arrives as stability requirements continue to tighten. As the course description notes, the updated ICH Q1 (Draft) brings enhanced clarity around protocol justification, statistical modelling, pooling decisions, and data interpretation, and organisations that fail to modernise their stability programmes risk delays, failed submissions, and avoidable resource costs. Designed to keep participants abreast of the latest developments, the course promises a complete, practical, and scientifically grounded approach for both small molecules and biologics, fully aligned with the existing ICH Q1A–Q1F, ICH Q1E, ICH Q5C, EU/CPMP and WHO guidelines alongside the new draft. The course carries 18 CPD hours.
Across three days, the agenda works through regulatory foundations for stability programmes and an overview of the new ICH Q1 draft, before covering stability study types, conditions and protocols, photostability under ICH Q1B, packaging considerations, and governance of stability samples and facilities on day one. Day two turns to requirements for existing products, line extensions and variations, data treatment, shelf-life assignment and extrapolation, matrixing and bracketing stability studies, bulk stability, and environmental zone considerations. Day three focuses specifically on stability for biopharmaceuticals, degradation pathways, analytical and bioassay considerations, cold chain and frozen storage stability, and designing a modern stability programme using the updated ICH Q1.
Why You Should Attend
- Get ahead of the new ICH Q1 (Draft) requirements around protocol justification, statistical modelling, pooling decisions, and data interpretation before they reshape submission expectations
- Learn from Paul Palmer, a practising EU/UK Qualified Person with over 35 years of pharmaceutical industry experience in development, manufacture, and supply of medicinal products and medical devices
- Learn from Farah Nadeem, an Operations Manager and Trainee Qualified Person with over 20 years of pharmaceutical QA experience across manufacturing, storage, and distribution
- Gain a dedicated, day-three focus on stability for biopharmaceuticals, including degradation pathways and cold chain/frozen storage considerations
- Earn 18 CPD hours while covering matrixing, bracketing, bulk stability, and environmental zone considerations for both small molecules and biologics
The course is designed for development scientists, analytical chemists, stability programme leaders, QC/QA specialists, regulatory affairs professionals, CMC and technical development teams, and formulation scientists. For teams responsible for defending stability programmes to regulators, the agenda connects directly to that work: Paul Palmer's decades leading development, manufacture, and supply of medicinal products, combined with Farah Nadeem's experience writing, reviewing, and auditing SOPs and QMS implementations and hosting regulatory inspections, give participants insight into how these evolving requirements play out in practice, not just in the guidance documents themselves.
Given the pace of the ICH Q1 draft's rollout and the operational risk of falling behind on protocol justification and statistical approaches, teams responsible for stability programme design are encouraged to confirm attendance well before the course begins.
Featured Speakers
Paul Palmer, Director / Pharmaceutical Consultant; practicing EU/UK Qualified Person with over 35 years of experience in pharmaceutical development, manufacture, and supply
Farah Nadeem,Operations Manager, Paul R. Palmer Limited / Pharmaceutical Consultant; Trainee Qualified Person and Pharmacist with over 20 years of QA experience
Course delivered as part of the IPI training programme. Registration and full course details available exclusively through Research and Markets.For more information about this training visit https://www.researchandmarkets.com/r/aqmw3w
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