The Local Production and Assistance (LPA) Unit in the Regulation and Prequalification Department (RPQ), and Access to Medicines and Health Products Division (MHP), at WHO Headquarters, with financial support from the Bill & Melinda Gates Foundation (BMGF), proudly presents the inaugural Week of Quality, an annual event dedicated to recognizing the pivotal role of quality in the pharmaceutical and in vitro diagnostics (IVD) industries. This year, under the title “On the origin of specifications”, the workshop focusses on the establishment of specifications to ensure the release of safe, effective, and high-quality vaccines, medicines, and IVDs.
The sessions will provide invaluable guidance on quality data requirements, Chemistry, Manufacturing, and Control (CMC) standards, risk management, and WHO prequalification (PQ), expert review panel for diagnostics (ERPD), emergency use listing (EUL), and licensing requirements, as part of addressing the basis of a dependable control strategy, including patient-centric specifications and how the control strategy relates to manufacturing consistency and assurance that the product will meet product quality expectations.
The Week of Quality aims to foster knowledge exchange, promote best practices, and support sustainable local production in low- and middle-income countries (LMICs). By attending, manufacturers will gain a deeper understanding of quality and CMC standards, ultimately leading to enhanced product quality and improved applications.
The Week of Quality: On the origin of specification will take place virtually via the Zoom platform from 12 to 16 June 2023.
This exclusive event targets technical personnel involved in production, dossier preparation, quality control (QC), quality assurance (QA), and regulatory affairs. LMIC manufacturers of essential medicines, vaccines, and IVDs, are invited to join this unique training workshop. And officers from national regulatory authorities, and government ministries are welcome to join.
Don't miss this opportunity to enhance your knowledge, strengthen your applications, and contribute to the continuous improvement of health product quality to optimize access.
Registration deadline: 8 June 2023
For further information, please contact Dr Jicui DONG, Unit Head, LPA Unit dongj@who.int, and in copy localproduction@who.int