Bootcamp for TB Diagnostic Innovators in India
A five-day bootcamp to help Indian TB diagnostic innovators navigate product development, validation, regulatory pathways and global market access.
About this event
The bootcamp aims to build the pathway from Indian TB diagnostic innovation to validation, regulation and global access. Day 1 covers epidemiology and diagnostic gaps, India's innovation landscape, a keynote and panel discussion, and a TB diagnostics innovation showcase. Day 2 focuses on the R&D pathway, including IVD product development, design controls, critical pathways, valleys of death, target product profiles, use cases, research resources, funding and a critical-path gameboard. Day 3 addresses quality management systems, ISO standards, analytical and clinical studies, validation platforms and consortia, CDSCO pathways and health technology assessment in India. Day 4 focuses on global access through WHO target product profiles, technical specifications and recommendations, WHO prequalification, evidence packages, Global Fund and ERPD pathways, and Indian global success stories. Day 5 includes workshop recommendations, 16 technology pitch/showcase slots, case studies and an interactive product-development case study. The programme anticipates participation from 50+ speakers, regulators and funders.
Speakers
Dr Taslimarif Saiyed, C-CAMP
Prof. Madhukar Pai, McGill University (Convenors)