A group of 22 health personnel in Windhoek received comprehensive training on international regulatory standards and dossier evaluation techniques.

This training will enable them to tackle complex challenges such as genotoxic impurities, nitrosamine contamination, and bio waiver applications.

The training conducted by the Namibia Medicines Regulatory Council with support from the World Health Organisation provided essential skills for evaluating pharmaceutical product dossiers to participants, including assessors, inspectors, pharmacovigilance pharmacists, analysts, a laboratory technologist, and a WHO Country Office staff member.

The two-week training covered both basic and intermediate principles of dossier assessment, including quality principles, good report writing, pharmaceutical development, and active pharmaceutical ingredient reviews.

Facilitators incorporated practical exercises and case studies to simulate real-world dossier reviews, enabling participants to refine their understanding of regulatory expectations and apply theoretical knowledge to actionable skills effectively.

WHO Representative in Namibia, Richard Banda, emphasised the WHO's commitment to strengthening regulatory systems to ensure equitable access to quality health products.

Dr. Banda also highlighted the importance of national medicines regulatory agencies in ensuring that health products are safe, effective, and of assured quality, protecting populations from substandard and falsified medicines.

The Director of Tertiary Healthcare and Clinical Support Services in the ministry, Johannes Gaeseb, re-emphasised the critical role of medicines regulation in public health.

Gaeseb reminded us that maintaining high standards of quality, safety, and efficacy is not just a technical task for the Namibia Medicines Regulatory Council, but a critical part of safeguarding public health, which in turn builds public confidence and promotes better treatment outcomes in Namibia.

Participants were awarded certificates upon successful completion of the training.

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Author
Celma Ndhikwa