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Webinar ICH Q1 Stability Testing of Drug Substances and Drug Products

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As pharmaceutical and medical device companies prepare for the next phase of regulatory evolution, the ICH Q1 Draft Guideline for Stability Testing of Drug Substances and Drug Products is sparking important conversations across quality, regulatory, and analytical teams. This webinar, hosted by StabilityHub and presented by Q1 Scientific and Cambrex, brings together leading experts to discuss the draft guideline and explore its implications for global stability programs.

Date: September 25, 2025
Time: 17:00 (IST) | 18:00 (CET) | 12:00 (EDT)
Location: Online (Hosted by StabilityHub)
Presenters:

  • Aideen Glynn, Quality Manager at Q1 Scientific. Aideen brings over 18 years’ experience in pharmaceutical quality systems and stability program management. She leads Q1 Scientific’s compliance and quality initiatives and has deep insight into how regulatory changes impact real-world operations.
  • Daniel Kirschner, Ph.D., Executive Director, Analytical and Biopharmaceutical Services at Cambrex. Daniel has 15+ years in pharma, with 8+ years in CDMO sector focused on analytical R&D, method validation, and regulatory support. With a background in analytical development and regulatory strategy, Daniel offers a scientific perspective on how the draft guideline may influence testing protocols and data evaluation

Panellists:

  • Sherilyn Campie, Director and Head Of Quality Control at Accord BioPharma (US)
  • Walter Routh, Founder of Sagana Consulting and Associate Editor at StabilityHub
  • John O’Neill, Founder of the Pharmaceutical Discussion Group and Editor at StabilityHub

Following the release of the revised ICH Q1 draft guidelines, pharmaceutical and medical device companies are actively discussing the implications for stability testing. In our recent article, “Public Opinion on the New ICH Q1 Draft Guidelines”, we explored the initial reactions, emerging concerns, and opportunities for innovation.

Now, we’re taking the conversation further.

As the ICH Q1 Draft Guideline continues to shape the future of stability testing, formal feedback from regulatory authorities is beginning to clarify the path forward. Building on our earlier article, this webinar explores the structured responses submitted to the EMA and FDA, offering a deeper look at how the guideline is being received across the pharmaceutical and medical device landscape.

What you’ll learn about the ICH Q1 draft guidelines

Watch Aideen Glynn, Daniel Kirschner and a panel of industry experts in this StabilityHub webinar that explores the draft ICH Q1 guidance and formal industry feedback. This session will help you understand the potential changes, benchmark your current practices, and prepare for what might be next in stability testing.

Listen to:

  • Key updates in the draft ICH Q1 guidelines and what they mean for your stability programs
  • Key themes from the EMA’s stakeholder summary (published August 8, 2025) and FDA’s public comments (closed August 25, 2025)
  • Expert perspectives on potential implementation challenges and opportunities
  • Live Q&A  addressing specific questions and debating changes to the draft ICH Q1 guidelines

Why watch this webinar about the ICH Q1 draft guidelines?

This session is ideal for professionals in Quality, Regulatory Affairs, and Analytical Development who want to:

  • Understand regulator feedback on the ICH Q1 Draft
  • Benchmark their internal readiness against emerging expectations
  • Prepare for potential refinements and harmonization challenges

Whether you’re preparing for new product submissions, reviewing your stability storage strategy, or simply want to stay ahead of regulatory changes, this session provides valuable insights and practical guidance.

Watch the webinar online to learn more about the ICH Q1 draft guidelines

As the ICH Q1 Draft Guideline continues to evolve, staying informed is essential. This webinar offers a unique opportunity to hear directly from industry experts and StabilityHub editors as they unpack the latest regulatory feedback and discuss what it might mean for your future stability programs.

Watch the webinar replay here: