16th Annual PQT Medicines Quality Assessment Training
10 – 13 June 2024 (virtual)
The 16th Annual Prequalification Team: Medicines (PQT/MED) Quality Assessment Training will be a virtual workshop that will take place on Monday 10 June through Thursday 13 June 2024.
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.
3rd Annual PQT Medicines Biotherapeutic Product (BTP) and Similar Biotherapeutic Product (SBP) assessment training 14 June 2024 (virtual)
The above-mentioned 16th Annual PQT Medicines Quality Assessment Training will be followed by the 3rd Annual Biotherapeutic Product (BTP) and Similar Biotherapeutic Product (SBP) assessment training, also virtual.
The biotherapeutics training will cover assessment of BTP and SBP dossiers, including practical examples. The workshop will focus on key requirements for a BTP/SBP dossier as submitted to PQT Medicines covering product analytical characterization and biosimilarity, process development concepts, comparability pre-post process changes and viral safety. The training will also include BTP/SBP-specific clinical and pharmacovigilance requirements. The workshop will take place over 4.5 hours (14:00 to 18:30 CET).
This training is aimed at regulators from National Medicines Regulatory Authorities (NMRAs) in emerging markets, quality as well as clinical assessors. The speakers/mentors are senior assessors in PQT/MED.
If you are interested in attending either of thee above trainings or both, please obtain your NMRA's written approval as soon as possible (signed and dated letter on Agency letterhead), and attach it together with a CV in an email to Dr Matthias Stahl at stahlm@who.int no later than COB Friday 17 May 2024, clearly stating which training(s) you will attend.
NOTE: Without your NMRA’s written nomination we will not be able to even begin processing your application. A separate confirmation whether you have been chosen to participate in the training(s) will be sent out in due course.