martes, 16 de julio de 2024

Office of Pharmaceutical Quality (OPQ) Reorganization JULY 11, 2024

https://www.fda.gov/drugs/news-events-human-drugs/office-pharmaceutical-quality-opq-reorganization-07112024?utm_medium=email&utm_source=govdelivery The U.S. Food and Drug Administration is announcing a webinar on the reorganization of the Center for Drug Evaluation and Research’s (CDER) Office of Pharmaceutical Quality (OPQ). This reorganization was implemented in January and does not result in any direct or immediate changes for individuals outside of FDA, including drug manufacturers. This reorganization enables OPQ to evolve and adapt to the ever-changing global health care landscape and: Streamline processes and systems for enhanced efficiency, eliminating operational redundancies and bottlenecks Embrace new technologies and tools as the key to staying ahead in a dynamic environment. Actively pursue innovation to make a meaningful difference in patients' lives Adopt a culture of continuous improvement, in which OPQ is consistently seeking better and more efficient ways of working and advancing the field OPQ restructured to increase its ability to respond to changes in workload, increasing complexity of pharmaceutical supply chains, and public health emergencies. OPQ created five new offices to allow quick response to demands and public health needs and allow for an integrated quality assessment of products throughout their lifecycle. This webinar describes OPQ’s new structure and how it continues to advance drug quality.

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