The publication of ICH E2D(R1) has brought significant attention to evolving case processing and reporting requirements. But its implications may extend beyond individual case management.
As safety information increasingly originates from patient support programmes, organised data collection systems, digital engagement activities, market research programmes and real-world data sources, organisations may need to assess whether their existing governance frameworks remain fit for purpose.
Download this free guide to explore key considerations for:
- Defining roles and responsibilities across functions handling safety information
- Identifying and escalating adverse events from emerging data sources
- Strengthening vendor and third-party oversight
- Reviewing SOPs, training and governance documentation
- Supporting compliance monitoring and inspection readiness
