The 11th Annual Prequalification Team: Medicines (PQTm) (formerly Prequalification of Medicines Programme) quality assessment training will take place in Copenhagen, Denmark during 27‒30 May 2019. The location will be at the Phoenix Hotel (Copenhagen).
The course will focus on the quality aspects of assessment of a generic product dossier (APIs and FPPs) as submitted to PQTm, but will also cover bioequivalence and biowaiver issues, as well as product information and labelling considerations (see draft programme). The training will provide practical examples and solutions for common assessment issues. Participants are expected to have the Model Dossier training tool downloaded on their laptops for practical exercises. (Model dossier can be downloaded at https://extranet.who.int/prequal/content/medicines-fpps)
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 PQTm.
Breakout sessions will also be included in which issues brought forward by the participants can be discussed in a smaller group with one of the trainers.
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 nomination as soon as possible, and attach it together with a CV in an email to Dr Matthias Stahl at firstname.lastname@example.org no later than Friday, 22 March 2019. Note, an application without a written and signed official nomination by your agency will be considered incomplete and will not be progressed further. Further, the number of places is limited and a separate confirmation whether you have been chosen to participate in the training or not will be sent out in due course.