Regulator Spotlight
At the June 2025 PDA Advanced Therapy Medicinal Product (ATMP) Conference held in Gothenburg, Sweden, EMA Pharmaceutical Quality Scientific Administrator Dolça Rogers discussed and shared case studies on: ● common CMC challenges for ATMPs and ● how the agency is engaging in international collaborations for more harmonized outcomes.
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ABOUT THE WEEKLY SUPPLEMENT
Along with a feature story on a presentation or panel discussion in which regulatory agency and pharmacopeia leaders 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.