PQT MEDICINES 9TH ANNUAL MEDICINES QUALITY WORKSHOP FOR MANUFACTURERS – 28 September - 1 October 2026
The 9th Annual Medicines Quality Workshop for Manufacturers, organized by WHO PQT Medicines, will be held virtually from 28 September to 1 October 2026.
The workshop will focus on the key quality requirements for generic finished pharmaceutical product (FPP) dossiers submitted to PQT Medicines. It will also cover bioequivalence and biowaiver considerations, WHO Public Assessment Reports (WHOPARs) and product information, GMP and GCP inspection findings, and WHO’s experience with implementation of the Collaborative Registration Procedure (see draft programme).
To accommodate participants across different regions, the workshop will be delivered over four consecutive days, with sessions running from 14:00 to 18:15 CET each day. The programme will comprise multiple presentations per session.
This workshop offers a unique opportunity to hear directly from PQT Medicines assessors and inspectors about common deficiencies encountered during dossier assessment and inspections, as well as practical approaches to addressing them. For each topic, participants will gain an understanding of the applicable requirements and learn how dossiers and compliance practices can be strengthened to facilitate and expedite the path to prequalification. Dedicated question-and-answer sessions will follow each presentation.
The training will not cover dosage forms or product categories that are not currently invited for submission to PQT Medicines (e.g. ointments and metered-dose inhalers), areas outside the scope of PQT Medicines assessments (e.g. falsified medicines and toxicology studies), or vaccines.
The workshop is primarily intended for FPP manufacturers that currently participate in, or plan to participate in, the PQT Medicines programme. It will be particularly beneficial for companies with limited experience of PQT Medicines, as well as new staff members of more experienced manufacturers. All sessions will be delivered by senior assessors and inspectors from PQT Medicines.
PQT MEDICINES 6th ANNUAL BIOTHERAPEUTIC PRODUCT (BTP) AND SIMILAR BIOTHERAPEUTIC PRODUCT (SBP) WORKSHOP FOR MANUFACTURERS – 2 October 2026
The above-mentioned 2026 PQT Medicines 9th Annual Medicines Quality Workshop for Manufacturers will be followed by the 6th Annual Biotherapeutic Product (BTP) and Similar Biotherapeutic Product (SBP) Workshop for Manufacturers, which will take place virtually on Friday, 2 October 2026.
The biotherapeutics workshop will provide a comprehensive overview of the WHO Prequalification Programme for biotherapeutic products, including its requirements, progress, and achievements. The programme will cover the key requirements for BTP/SBP dossiers submitted to PQT Medicines, including analytical characterization and demonstration of biosimilarity, process development principles, comparability following manufacturing process changes, and viral safety considerations. In addition, participants will receive insights into the clinical and pharmacovigilance requirements specific to BTPs and SBPs (see draft BTP/SBP programme).
The workshop will be conducted over 4.5 hours, from 14:00 to 18:30 CET on 2 October 2026.
Those interested in attending either workshop, or both workshops, are invited to complete and submit the relevant application form(s). Please note that a separate application form is required for each workshop; applicants wishing to attend both workshops must therefore submit both forms.
Completed application forms, signed and dated by the applicant’s supervisor, together with a brief curriculum vitae, should be sent by email to Mr Wondiyfraw Worku at zelekew@who.int no later than close of business on Friday, 18 September 2026.
Applicants will be informed in due course whether they have been selected to participate in the workshop(s).