Meeting on lessons learnt from sartan medicines containing N-nitrosamine impurities

• Date:
  Monday, 04 November 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.

Documents

Presentation - Background on cases of sartanswith N-nitrosamine impurities (A. Spinei)

Presentation - Information, coordination and public communication (N. Mbaeliachi)

Presentation - Cohort of concern compounds–current guidance on impurities (especially genotoxic/ carcinogenic impurities) (A. Hartmann)

Presentation - Patients‘ concerns and reactions to Sartans with N-nitrosamine impurities (C. Dehn)

Presentation - What is the role of General Practitioners / Family Physicians in ARB recalls? (T. Villanueva)

Presentation - Information, coordination and public communication (L. Tonel)

Presentation - Prevention of contamination with nitrosamine impurities (B. Hirschlerová)

Presentation - ICH M7 Principles -Impurity Identification and Control (R. Ogilvie)

Presentation - Sartan Case Study- Session 4: Prevention Part II (A. Teasdale)

Presentation - Current analytical testing methodology and capacity (A. Teasdale)

Presentation - Experiences from the Belgian & European Community Pharmacists Associations on the communication of the sartansrecall in 2018 (B. Machlien)

Presentation - Supply Chain Management and Surveillance (M. Wierer)

Presentation - Regulatory, Manufacturing and Supply Chain Aspects (M. Senis, J. M. de Ciura)

Presentation - Incident Management (K. O'Donnell)

Presentation - Recall and supply chain traceability (L.Paulo)