Regulator Spotlight
At the CMC Strategy Forum North America, held in Washington DC, in late January 2025 in conjunction with the CASSS WCBP Conference, Health Canada Biologics and Radiopharmaceutical Drugs Directorate (BRDD) Senior Evaluator Jayda Siggers reviewed the expectations and challenges of using predictive data models to support marketing authorizations in the CMC arena. Her presentation covered: ● the types of data models submitted to Health Canada to date ● a case study involving the use of process capability and stability models for a monoclonal antibody submission ● reflections on lessons learned on model use ● a review of the regulatory expectations for data models, including filing requirements, and ● key takeaways.
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ABOUT THE WEEKLY SUPPLEMENT
Along with a feature story on a presentation or panel discussion at a conference in which leading regulators address the challenges and developments in a key area of concern, our Weekly Supplements include a summary listing of the “Updates in Brief,” drug GMP warning letters and recalls, and EMA non-compliance reports that have been posted on IPQ’s website during the week. Subscribers can then click through to the full posting.
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Appended to the issue is a chronological listing of the headlines of the featured regulator stories since IPQ began its Weekly Supplement series in February 2024. Also appended are the headlines of the in-depth stories that IPQ has released since 2020. Those of especially high relevance to the regulator insights provided in this issue are indicated with a red star. Click on the headlines to access the stories.