Applications now closed
Due to the current COVID-19 pandemic, the 12th Annual Prequalification Unit - Medicines Assessment Team (PQT/MED) Quality Assessment Training cannot go ahead as planned. Instead PQT/MED will conduct a virtual training (see draft agenda below) with a condensed programme. The virtual training will take place from Monday, 28 September to Thursday, 01 October.
The virtual course will focus on the principal quality aspects of assessment of a generic product dossier (APIs and FPPs) as submitted to PQT/MED, and will also cover bioequivalence and biowaiver topics. The training will provide practical examples and solutions for common assessment issues. In order to make use of the best virtual time window for all participants, the training will take place over three hours (15:00 to 18:00 CEST) on four consecutive days, covering two talks per day.
The training is aimed at regulators from national medicines regulatory authorities (NMRAs) in emerging markets, and primarily quality assessors. The speakers/mentors are senior assessors in PQT/MED.