The 2nd Prequalification Team: Medicines (PQTm) (formerly Prequalification of Medicines Programme) Quality Workshop for Manufacturers will take place in Copenhagen, Denmark during 3-5 July 2019. The location will be at the Phoenix Hotel, Copenhagen.
The workshop will focus on the quality requirements of a generic finished pharmaceutical product (FPP) dossier as submitted to PQTm (including variations to prequalified products), but will also cover bioequivalence and biowaiver issues, as well as WHOPARs and product information, GMP/GCP inspection findings, WHO technical assistance and the Collaborative Registration Procedure (see draft programme).
This training is offered as an exceptional opportunity to hear 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, as well as in the final open Q&A session at the end of the workshop.
The training will not cover dosage forms or products which are not invited to PQTm (e.g. ointments, MDIs), or areas which PQTm does not assess (e.g. falsified medicines, toxicity studies), or vaccines and biologics.
The training is primarily aimed at FPP manufacturers that are participating, or intend to participate in PQTm and have not previously attended. Those who stand to benefit the most are those without extensive experience with PQTm, including new staff of experienced companies. The speakers/mentors are senior assessors in PQTm.
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) in an email to Dr Matthias Stahl at stahlm@who.int, no later than Friday, 24 May 2019. The number of places is limited and we may have to restrict the number of participants per company, depending on the interest. A separate confirmation whether you have been chosen to participate in the workshop will be sent out in due course.