Workshop room 1 12:00 to 14:00
Javier Fernández (Organic and inorganic impurities technician)
Alberto Carazo (Industrial Business Director)
Throughout the session we will review the background of the nitrosamines crisis and its implications. Similarly, we will review the current situation following the implementation, at the request of the EMA, of the risk assessment of the presence of these substances in pharmaceutical products. Finally, we will discuss what could be the ways to evolve in the short, medium and long term, providing recommendations to marketing authorisation holders on alternatives for optimal management of this situation.