WHO is pleased to announce the Week of Quality for Vaccines and Biotherapeutic Products 2024. This virtual training program, organised by the Local Production & Assistance Unit (LPA) within the Innovation and Emerging Technologies Division (IET), builds on the success of the inaugural Week of Quality in 2023. This year, the program has a dedicated week for biologics to focus on strengthening the capacity of manufacturers in low- and middle-income countries (LMICs) regarding regulatory requirements for the development and dossier preparation of mRNA vaccines and biosimilars.
A Look at the Week of Quality for Vaccines and Biotherapeutic Products in May 2024
The Week of Quality for Vaccines and Biotherapeutic Products 2024 with the theme Exploring key aspects of vaccine and biotherapeutic regulatory compliance is tailored to empower manufacturers in LMICs with essential skills and knowledge needed to navigate various regulatory requirements for biological products outlined by WHO and other regulatory bodies. It emphasizes the importance of adhering to best practices for presenting quality data and information in regulatory documents, such as the Common Technical Document (CTD) or electronic CTD (eCTD). Effective compliance will facilitate smoother reviews and approvals, ultimately enhancing the availability of safe, effective, quality-assured finished medical products.
The Week of Quality for Vaccines and Biotherapeutic Products will be held over four days (June 10-13, 2024) using the Zoom platform (2 hours per day, 12:00-14:00 CEST/UTC+2). The program will be delivered through a combination of educational presentations, and engaging Q&A sessions. Participants will enhance their expertise in structuring or formatting regulatory documentation, receive a comprehensive understanding of the current international regulatory requirements, and strengthen their ability to provide rationales supporting the development and control of biological medical products. Topics to be presented include:
- CTD-dossier preparation and electronic submission
- Development of biosimilars, with a special focus on monoclonal antibodies
- mRNA vaccine manufacturing and testing, including considerations on lipid nanoparticles used as delivery vehicle
- A pick of vaccine innovations
Registration for the Week of Quality for Vaccines and Biotherapeutic Products 2024 is currently open. Register your interest to participate in this training program. The workshop is designed for manufacturers biological medical products in LMICs (particularly technical personnel involved in pharmaceutical development, routine production, quality control (QC), quality assurance (QA), dossier preparation, and regulatory affairs). Regulatory authorities (Ministry of Health, National Regulatory Authorities) in all WHO regions are also welcomed to attend. Secure your spot by registering your interest. Don't miss out!
Registration deadline: 06 June, 2024
For further information and inquiries about the Week of Quality or LPA's initiatives, please visit the LPA website and contact Dr Jicui Dong, Unit Head of the LPA Unit, at dongj@who.int, copying localproduction@who.int.