Meeting on lessons learnt from sartan medicines containing N-nitrosamine impurities
Date:
04/11/2019
Location:
European Medicines Agency, Amsterdam, the Netherlands
The European Medicines Agency organised a meeting to discuss lessons learnt from recent cases of sartan (angiotensin receptor blockers) medicines containing N-nitrosamine impurities. It discussed how to better prevent and manage cases of medicines with N-nitrosamine impurities in the future.
The meeting brought together patients and healthcare professional organisations, industry associations and European Union and international regulatory authorities.
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Presentation - Background on cases of sartanswith N-nitrosamine impurities (A. Spinei) (PDF/635.84 KB)
First published: 23/06/2020 -
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Presentation - Information, coordination and public communication (N. Mbaeliachi) (PDF/261.51 KB)
First published: 23/06/2020 -
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Presentation - Cohort of concern compounds–current guidance on impurities (especially genotoxic/ carcinogenic impurities) (A. Hartmann) (PDF/422.13 KB)
First published: 23/06/2020 -
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Presentation - Patients‘ concerns and reactions to Sartans with N-nitrosamine impurities (C. Dehn) (PDF/2.05 MB)
First published: 23/06/2020 -
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Presentation - What is the role of General Practitioners / Family Physicians in ARB recalls? (T. Villanueva) (PDF/639.81 KB)
First published: 23/06/2020 -
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Presentation - Information, coordination and public communication (L. Tonel) (PDF/768.04 KB)
First published: 23/06/2020 -
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Presentation - Prevention of contamination with nitrosamine impurities (B. Hirschlerová) (PDF/200.72 KB)
First published: 23/06/2020 -
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Presentation - ICH M7 Principles -Impurity Identification and Control (R. Ogilvie) (PDF/343.69 KB)
First published: 23/06/2020 -
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Presentation - Sartan Case Study- Session 4: Prevention Part II (A. Teasdale) (PDF/800.12 KB)
First published: 23/06/2020 -
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Presentation - Current analytical testing methodology and capacity (A. Teasdale) (PDF/686.62 KB)
First published: 23/06/2020 -
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Presentation - Supply Chain Management and Surveillance (M. Wierer) (PDF/482.96 KB)
First published: 23/06/2020 -
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Presentation - Regulatory, Manufacturing and Supply Chain Aspects (M. Senis, J. M. de Ciura) (PDF/366.17 KB)
First published: 23/06/2020 -
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Presentation - Incident Management (K. O'Donnell) (PDF/1.44 MB)
First published: 23/06/2020 -
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Presentation - Recall and supply chain traceability (L.Paulo) (PDF/242.99 KB)
First published: 23/06/2020