PQT Medicines 4th Annual Medicines Quality Workshop for Manufacturers - 27-30 September 2021
Like in 2020, the 2021 4th Annual Medicines Quality Workshop for Manufacturers delivered by WHO PQT Medicines will be a virtual workshop. The workshop will take place from Monday 27 September through Thursday 30 September 2021.
The workshop will focus on key quality requirements of a generic finished pharmaceutical product (FPP) dossier as submitted to PQT Medicines and will also cover bioequivalence and biowaiver issues, WHOPARs (WHO Public Assessment Reports) and product information, as well as GMP/GCP inspection findings (see draft programme). In order to make use of the best virtual window of time for all participants, the workshop will take place over four hours (14:00 to 18:00 CET) on four consecutive days, covering several talks per day.
This workshop is offered as an exceptional opportunity to hear PQT Medicines assessors and inspectors explain the issues commonly encountered during assessment and inspection and how to best address them. In the topics covered, the requirements will be described followed by how dossiers can be improved to enhance and expedite the process towards prequalification. Attendees will get the opportunity to ask questions following each talk.
The training will not cover dosage forms or products which are not invited to PQT Medicines (e.g. ointments, MDIs), or areas which the PQT Medicines team does not assess (e.g. falsified medicines, toxicity studies), or vaccines.
The workshop is primarily aimed at FPP manufacturers that are participating, or intend to participate in PQT Medicines. Those who stand to benefit the most are those without extensive experience with PQT Medicines, including new employees of experienced companies. The speakers/mentors are senior assessors/inspectors in PQT Medicines.
PQT Medicines 1st Biotherapeutic Product (BTP) and Similar Biotherapeutic Product (SBP) Workshop for Manufacturers – focus on insulin - 01-02 October 2021
The abovementioned 2021 PQT Medicines 4th Annual Medicines Quality Workshop for Manufacturers will be followed by PQT Medicines 1st Biotherapeutic Product (BTP) and Similar Biotherapeutic Product (SBP) Workshop for Manufacturers from Friday, 01 October through Saturday, 02 October 2021.
The biotherapeutics workshop will provide a detailed overview of the requirements, progress and results of the WHO pilot projects on prequalification of trastuzumab, rituximab and human insulin. The workshop will include 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. Furthermore, insight on BTP/SBP-specific clinical, pharmacovigilance and GMP requirements will be provided during the training (see draft BTP/SBP program). The workshop will take place over 3.5 hours (15:00 to 18:30 CET) on two consecutive days, covering several talks per day.
If you are interested in attending either of these workshops or both workshops, please fill out and submit the corresponding application form(s) (NOTE: there is a separate application form for each workshop, so if you wish to attend both workshops, both forms need to be filled out, further note we want only one application form per workshop per company). Attach the form(s), signed and dated by your supervisor, together with brief CV(s) to an email to Dr Matthias Stahl at stahlm@who.int, no later than COB Friday 27 August 2021. A separate confirmation whether you have been chosen to participate in the workshop(s) will be sent out in due course.