The 1st Prequalification Team: Medicines (PQTm) (formerly Prequalification of Medicines Programme) Quality Workshop for Manufacturers will take place in Copenhagen, Denmark during 4-6 July 2018. 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, and will include variations to prequalified products. The workshop 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 workshop is offered as an exceptional opportunity to hear assessors and inspectors explain the issues commonly encountered during assessments and inspections and how to best address them. In the topics covered, the basic requirements for the topic 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 breakout session at the end of the workshop. The breakout session will give participants the opportunity to bring forward issues to discuss with one of the trainers in a smaller group.
The workshop 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 medicines outside of PQTm (vaccines and biologics).
The workshop is primarily aimed at FPP manufacturers that are participating, or intend to participate in PQTm. 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), to an email to Dr Matthias Stahl at stahlm@who.int, no later than COB Friday, 4 May 2018, to express your interest. Since the number of places is limited, 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.