The World Health Organization (WHO) is pleased to announce the Week of Quality for Medicines 2025, a specialised virtual training workshop organised by the Local Production and Assistance (LPA) Unit within the Division of Innovation and Emerging Technologies (IET). Building on the strong momentum of the 2024 edition, this year’s programme takes a step further with the theme: Bridging Development and Prequalification: A Focus on Pharmaceutical Quality.
Advancing Pharmaceutical Development Through Regulatory Excellence
This three-day training (May 26–28, 2025) is designed to build capacity among manufacturers and regulators in low- and middle-income countries (LMICs) by strengthening their understanding of international quality standards and regulatory expectations for finished pharmaceutical products (FPPs) and active pharmaceutical ingredients (APIs).
Delivered via Zoom in daily 2.5-hour sessions (12:00–14:30 CEST), the programme features expert-led presentations and live Q&A discussions. Participants will deepen their knowledge of dossier preparation, master best practices for responding to CTD deficiencies, and gain practical insights into quality control strategies, Quality by Design (QbD), and biowaivers.
Key Topics Include:
- Identifying and addressing common CTD dossier deficiencies
- Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQAs) in QbD
- Extractables and leachables testing for injectable products
- Design of Experiments (DoE) for efficient pharmaceutical development
- Practical aspects of dissolution studies for QC and biowaivers
By the end of the workshop, participants will be better equipped to produce high-quality, compliant, and scientifically justified regulatory submissions, ultimately contributing to faster approvals and expanded access to safe and effective medicines.
Who Should Attend?
The training is tailored for FPP and API manufacturers in LMICs, especially technical professionals involved in:
- Pharmaceutical development and manufacturing
- Quality control (QC) and quality assurance (QA)
- Dossier preparation and regulatory affairs
Regulatory authorities, including representatives from Ministries of Health and National Regulatory Authorities (NRAs), are also encouraged to participate to support harmonisation and capacity-building efforts across WHO regions.
Registration deadline: 19 May 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 Medicines is organized with support from The Global Fund to Fight AIDS, Tuberculosis and Malaria.