Event
M
16 - 19 May, 2016 - 08:30 - 13:00 (CEST)
Copenhagen K,
Denmark
The 8th Annual Prequalification Team: medicines (PQTm) (formerly Prequalification of Medicines Programme) quality assessment training took place in Copenhagen, Denmark during 16‒19 May 2016, at the Phoenix Hotel (Copenhagen K).
The course focused on quality aspects in the assessment of a generic product dossier (APIs and FPPs) as submitted to PQTm, but also covered bioequivalence and biowaiver issues as well as product information and labeling considerations. The training focused on providing practical examples and solutions for common assessment issues.