The World Health Organization (WHO) is pleased to announce the Week of Quality for Vaccines and Biotherapeutic Products 2025, a dedicated virtual training workshop organised by the Local Production and Assistance (LPA) Unit. Now in its third edition, the training will focus on the theme: Vaccines and Biotherapeutics – Quality Aspects and Dossier Preparation: A Practical Guide for Manufacturers to Align with Prequalification Standards.
Advancing biologic product quality through technical excellence
Taking place from 24 to 26 June 2025, this three-day training is designed to strengthen technical and regulatory capacity in low- and middle-income countries (LMICs), equipping participants with practical knowledge on dossier preparation and essential quality-related elements for vaccines and biotherapeutic products.
Structured into six expert-led sessions delivered over Zoom in daily 2.5-hour segments (12:00–14:30 CET), the workshop will feature technical presentations, interactive polls, and live Q&A segment. The sessions aim to support manufacturers and regulators in aligning with WHO prequalification (PQ) expectations to accelerate access to safe and effective biological products.
Key Topics Include:
- Chemistry, Manufacturing and Controls (CMC) aspects and WHO recommendations for vaccine lot release
- Product characterisation, process development, validation and quality control testing for biotherapeutics
- Dossier preparation guidance for manufacturing to align with WHO PQ, and quality control sections
By the end of the workshop, participants will be better prepared to ensure the quality, stability, and regulatory compliance of vaccines and biotherapeutics throughout their lifecycle, supporting public health goals through harmonized approaches.
Who Should Attend?
The training is designed for professionals from vaccine and biotherapeutic manufacturers in LMICs, especially those involved in:
- Pharmaceutical development and manufacturing of biologicals
- The biological product’s lifecycle
- Dossier compilation and regulatory affairs
Regulators, including staff from National Regulatory Authorities (NRAs) and Ministries of Health, are also strongly encouraged to attend to promote regulatory convergence and enhance national oversight capabilities.
Registration deadline: 16 June 2025
For further information, please visit the LPA webpage or contact:
Dr Jicui Dong, Unit Head, LPA Unit: dongj@who.int
Copy to: localproduction@who.int
The Week of Quality 2025 for Vaccines and Biotherapeutic Products is organized with support from the European Commission's Directorate-General for International Partnerships.