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The European Commission (EC) has published a draft guidance - Annexure 22 – Artificial Intelligence - for GxP computerised systems which interface with Artificial Intelligence models to predict or classify data with direct impact on patient safety, quality and data...
USFDA has issued a Warning letter to Glenmark Pharma’s Pithampur manufacturing facility (FEI 3008565058). The facility was inspected in February 2025 by USFDA investigators Tamil Arasu and Saleem A Akhtar. The inspection revealed several critical deficiencies particularly concerning the manufacturing...
China’s rise in cutting-edge pharmaceutical innovation received a major fillip with the USFDA approval of Zegfrovy (sunvozertinib) for non-small cell lung cancer (NSCLC). Developed by Dizal (Jiangsu) Pharmaceutical Co., Ltd., it appears to be the first New Molecular Entity (NME)...
We value your feedback on the Posts, Discussions, Information presented by Qvents. Also write to us on Pharma Quality and Regulatory topics and subjects you would like Qvents to cover. Your feedback helps us in making and maintaining the Qvents portal as a useful resource for Pharma TechOps professionals. Please also write to us for general feedback, quality of contents, any irrelevant or offensive posts, threads, comments
Please feel free to contact us for any enquiries.
Email: contact@qvents.in
Phone: (+91) 9945519525
We value your feedback on the Posts, Discussions, Information presented by Qvents. Also write to us on Pharma Quality and Regulatory topics and subjects you would like Qvents to cover. Your feedback helps us in making and maintaining the Qvents portal as a useful resource for Pharma TechOps professionals. Please also write to us for general feedback, quality of contents, any irrelevant or offensive posts, threads, comments
Please feel free to contact us for any enquiries.
Email: contact@qvents.in
Phone: (+91) 9945519525
The European Commission (EC) has published a draft guidance - Annexure 22 – Artificial Intelligence - for GxP computerised systems which interface with Artificial Intelligence models to predict or classify data with direct impact on patient safety, quality and data...
USFDA has issued a Warning letter to Glenmark Pharma’s Pithampur manufacturing facility (FEI 3008565058). The facility was inspected in February 2025 by USFDA investigators Tamil Arasu and Saleem A Akhtar. The inspection revealed several critical deficiencies particularly concerning the manufacturing...
China’s rise in cutting-edge pharmaceutical innovation received a major fillip with the USFDA approval of Zegfrovy (sunvozertinib) for non-small cell lung cancer (NSCLC). Developed by Dizal (Jiangsu) Pharmaceutical Co., Ltd., it appears to be the first New Molecular Entity (NME)...
