A multinational pharmaceutical company known for developing and manufacturing a wide range of innovative drugs and vaccines, have been exploring solutions for Hazard Evaluation and Risk Analysis to ensure the safety and efficacy of their products, as well as to comply with regulatory requirements
A recent acquisition by a first-tier medical device company resulted in a huge repository of medical devices for which remediation of risk files was required
Impending audit identified several improvement initiatives that required implementation.
The risk files required alignment with internal risk management protocols along with compliance to ISO 14971:2012 and ISO 13485:2016.
A core SME team from Indegene brainstormed and collaborated with the clinical and safety experts from the client’s team
Hazard Analysis Listing templates were developed for product categories with substantial number of products within its portfolio
Identified/modified hazards, hazardous situations, and harms for each device
Provided MedDRA terminologies for harms, Coding them for the standardised Verbatims
Utilized multiple sources of data for calculation of P2 (MAUDE, FAERS, internal complaints and AEs, clinical literature via search in PubMed and Embase)
Rigorous weekly touchpoints with clinical and safety experts for resolution of queries