From 25 to 27 August 2025, the Pharmacovigilance and Regulatory Working Groups of DCVMN met in New Delhi for a three-day in-person workshop focused on the Pharmacovigilance System Master File (PSMF) project, concluding with tangible deliverables and a roadmap for collaboration with WHO-SEARO.
DCVMN convened 26 participants from 10 member manufacturers, together with subject-matter consultants and DCVMN staff, to progress the PSMF project, a key effort to harmonize and strengthen pharmacovigilance practices across developing-country vaccine manufacturers.
The first day featured representatives from WHO-SEARO and focused on building a concrete collaboration action plan. Participants exchanged perspectives on the principal pharmacovigilance challenges faced by manufacturers operating in the SEARO region and identified aligned areas of interest where DCVMN and WHO-SEARO can work together to improve regulatory and safety outcomes.
Days two and three brought both working groups together for an intensive PSMF workshop. Working sessions combined practical case discussions, role mapping, and draft development work. By the close of the workshop the groups validated a set of core deliverables designed to be practical and adaptable to different national regulatory authorities (NRAs):
Workshop deliverables
- A PSMF guideline – a practical template to support PSMF preparation that can be adapted to meet specific NRA requirements.
- A defined QPPV role – a clear description of the responsibilities and expectations for the Qualified Person for Pharmacovigilance within manufacturers’ PV systems.
- Clarification of lifecycle PV tools – defined differentiation and interconnections between PSUR/PBRER requirements, Risk Management Plans (RMPs), and Post-Marketing Surveillance (PMS) across the vaccine lifecycle.
- Validated RACI matrices – role and responsibility matrices for PV activities that align cross-department interactions within manufacturers.
Next steps:
The working groups will finalise the draft guideline and RACI matrices for member review, and continue operationalising the WHO-SEARO/DCVMN collaboration plan. Outputs from this workshop will be shared with members to support implementation and regulatory dialogue at country level.
