The 13th Annual Prequalification Team: Medicines (PQT/MED) Quality Assessment Training will be a virtual workshop that will take place on Monday 7 June through Thursday 10 June 2021.
The 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 time window for all participants, the training will take place over three hours (15:00 to 18:00 CEST) on four consecutive days.
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.
If several regulators from the same agency wish to participate, priority will be given to those who have not previously participated. A maximum of two people per NMRA will be accepted for the course.
If you are interested in attending this training, please obtain your NMRA's written approval as soon as possible, and attach it together with a CV in an email to Dr Matthias Stahl at stahlm@who.int no later than Friday, 30 April 2021. Without your NMRA’s written nomination we will not be able to process your application. The number of places is limited and a separate confirmation whether you have been chosen to participate in the training will be sent out in due course.