The 5th annual Prequalification of Medicines Programme (PQP) assessment training in 2013 will take place in Copenhagen, Denmark during 13-16 March. The location will be Adina Hotel, Amerika Plads. The course focuses on quality aspects in the assessment of a generic product dossier (APIs and FPPs) as submitted to PQP but also covers bioequivalence issues and biowaivers, as well as product information and labeling considerations (see draft programme).
One-on-one sessions are also included in which issues of the participant's own choice can be discussed more in depth. The training will be more hands-on than ever and many practical examples will be given. The training is primarily aimed at quality assessors from NMRAs in emerging markets. The speakers/mentors will be senior assessors in PQP.
If you are interested in attending this training please send an e-mail to Dr M Stahl at stahlm@who.int (please attach a CV) as soon as possible and no later than Friday, 11 January 2013.
Please make sure to obtain your organization's approval to attend, as early as possible. This is very important. Further, if you are several from one and the same regulatory authority who wish to participate, please decide within your organization who should come. WHO PQP cannot decide this. Normally we accept a maximum of two people per NMRA to the training. Needless to say the number of places are limited and a separate confirmation as to whether you have been included in the training or not will be sent out in due course.