This live instructor-led webinar dives into the newly released draft revision of ICH Q1, one of the most significant updates to global stability testing in more than a decade. The new ICH Q1 draft introduces a risk-based framework that will directly impact shelf-life decisions, study design, and global submissions, and this session shows exactly how to adapt before it becomes mandatory. The ICH Q1 draft is not a minor update. It fundamentally changes how stability programs are designed, justified, and reviewed, and many existing protocols will no longer align with the new expectations. Teams that delay adaptation risk regulatory questions, rework, and extended timelines. Learn why regulators introduced a modernized, risk-based framework and how new approaches to shelf-life assignment, storage conditions, bracketing, and matrixing will transform development timelines.

Beyond theory, practical guidance will be provided on redesigning stability protocols, re-evaluating ongoing studies, and preparing regulatory submissions for FDA, EMA, and beyond. Real-world case examples and interactive discussion ensure that attendees gain not only knowledge of the draft, but actionable steps to apply it in their programs.

Attendees will also receive comparison materials of current vs. proposed ICH Q1 requirements and resources to begin implementing risk-based strategies in their own stability programs.

Learning Benefits

• Establish a clear, working understanding of the current ICH Q1 draft revision (Step 2) and its practical implications
• Design stability studies and assign shelf life using a risk-based framework aligned with the updated guideline
• Interpret revised climate-zone definitions and assess their impact on global stability strategies
• Implement bracketing and matrixing approaches to optimize testing efficiency and reduce study burden
• Evaluate and apply updated requirements for photostability testing and forced degradation studies
• Produce streamlined, inspection-ready regulatory submissions aligned with FDA and EMA expectations
• DeExecute accelerated risk assessment and implementation strategies to support faster program advancement

Who Should Attend

• Stability scientists and formulation teams
• Quality assurance and quality control professionals
• Regulatory affairs specialists preparing global dossiers
• Project managers overseeing pharmaceutical development
• Analytical method experts and laboratory managers
• Consultants advising on stability compliance