Week Ending May 24, 2024: Featuring HPRA CEO Nolan on the Global Quality Dossier

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The feature story in this Weekly Supplement focuses on a presentation by Ireland HPRA CEO Lorraine Nolan on the advancing international collaborative efforts to develop a global quality dossier – in particular, ICMRA’s Product Quality Knowledge Management (PQKMS) initiative, which she is cochairing, and its two collaborative post-approval change pilots. Nolan provided the insights at a “Quality Business Leadership Summit,” held at the Technical University of Dublin (TUD) in early May.

Along with a feature story on a presentation given at a recently held conference by a leading regulator that addresses 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.

Also provided, where applicable, are links to the parts of in-depth stories and Monthly Updates that have been released during the week.

Appended to the issue is a chronological listing of the headlines of the in-depth stories that IPQ has released since 2020. Readers of the Weekly Supplement are invited to click through to those that are of particular relevance to the regulatory presentation, news briefs, or compliance developments provided in the issue. Those of especially high relevance to the featured regulator story are indicated with a red star.