Due to the ongoing pandemic the 2020 3rd Annual Prequalification Unit - Medicines Team (PQT/MED) Quality Workshop for Manufacturers will be replaced by a Virtual Quality Workshop for Manufacturers, delivered by WHO PQT Medicines. The virtual workshop will take place from Sunday, 06 December through Wednesday, 09 December 2020.
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 workhop 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 and biotherapeutics.
The training 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.
If you are interested in attending this workshop, please fill out and submit the below application form (one application form per company) and attach the form, together with brief CV(s) to an email to Dr Matthias Stahl at stahlm@who.int, no later than COB Monday, 16 November 2020. We will restrict the number of participants to two people per company. A separate confirmation whether you have been chosen to participate in the workshop will be sent out in due course.
Related Documents