14th Annual PQT Medicines Quality Assessment Training
14 – 17 June 2022 (Virtual)
The 14th Annual Prequalification Team: Medicines (PQT/MED) Quality Assessment Training will be a virtual workshop that will take place on Tuesday, 14 June through Friday, 17 June 2022.
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.
1st Biotherapeutic Product (BTP) and Similar Biotherapeutic Product (SBP) assessment training
18 June 2022 (Virtual)
The above-mentioned 14th Annual PQT Medicines Quality Assessment Training will be followed by the 1st 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 hours (14:00 to 18:00 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 these trainings or both, 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, 13 May 2022, clearly stating which training(s) you will attend.
NOTE: Without your NMRA’s written nomination to the training(s) we will not be able to process your application. A separate confirmation whether you have been chosen to participate in the training(s) will be sent out in due course.
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