Workpackage 3

WP3 is about Data collection and Signal Detection, including Data Management Measures. In this WP, we work towards strengthening post-marketing surveillance activities with a focus on integrating the national PV systems with the MDR -TB treatment systems (aDSM). Our envisioned training approach targets all stakeholders in the PAVIA model, including staff at PV Centres, PHP staff, and healthcare professionals in the facilities providing MDR-TB treatment and beyond. The different stakeholders have different needs, and we will design specific modules and approaches to fit the learning objectives of each target group. We will help improve infrastructure for PV reporting from MDR-TB sites and build capacity for signal detection. In addition, we will provide hands-on support with improving reporting infrastructure, causality assessment and signal detection..

Supported by the Netherlands Pharmacovigilance Centre Lareb, all PAVIA countries, with the PV centres/NMRAs in the lead, will develop country-specific plans for strengthening PV skills and reporting mechanisms. As an established WHO-CC Lareb will provide the training for the NMRA staff, the University of Verona will develop the blended learning approach and KNCV will provide MDR-TB expertise and network.




Workpackage Deliverables:

  1. Country specific customised roadmaps for PV strengthening
  2. PV trained cohort ( PV staff and HCP)
  3. Training toolkit national PV training courses for healthcare professionals and PHP staff
  4. Improved/upgraded data collection and management tools per country
  5. Publication on the use of real-world data