Sixth Annual Prequalification Assessment Training

6^th Annual PQT Medicines Quality Assessment Training - 18-21 May 2014

The 6^th annual Prequalification Team Medicines (PQT Medicines; former Prequalification of Medicines Programme) assessment training in 2014 took place in Copenhagen, Denmark during 18-21 May. The course focused on quality aspects in the assessment of a generic product dossier (APIs and FPPs) as submitted to PQT Medicines but also covered bioequivalence issues and biowaivers, as well as product information and labeling considerations (see Agenda below).

The training wasprimarily aimed at quality assessors from NMRAs in emerging markets. The speakers/mentors are senior assessors in PQT Medicines.