Monitoring the manufacturing and quality of medicines: a fundamental task of pharmacovigilance

• Main Authors: Marco Sardella (Author), Glyn Belcher (Author), Calin Lungu (Author), Terenzio Ignoni (Author), Manuela Camisa (Author), Doris Irene Stenver (Author), Paolo Porcelli (Author), Margherita D'Antuono (Author), Nicola Gian Castiglione (Author), Anna Adams (Author), Giovanni Furlan (Author), Ilaria Grisoni (Author), Sarah Hall (Author), Laura Boga (Author), Valentina Mancini (Author), Mircea Ciuca (Author), David Chonzi (Author), Brian Edwards (Author), Arduino A Mangoni (Author), Marco Tuccori (Author), Elena Prokofyeva (Author), Fabio De Gregorio (Author), Mario Bertazzoli Grabinski Broglio (Author), Bert van Leeuwen (Author), Paola Kruger (Author), Christian Rausch (Author), Hervé Le Louet (Author)
• Format: Book
• Published: SAGE Publishing, 2021-08-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

The collection and assessment of individual case safety reports (ICSRs) is important to detect unknown adverse drug reactions particularly in the first decade after approval of new chemical entities. However, regulations require that these activities are routinely undertaken for all medicinal produc...