Pharmacovigilance departments must contend with several complex challenges posed by sustained business growth combined with diverse, evolving regulatory requirements across both developed and developing economies.
This white paper delves into some of these challenges and how they affect multiple roles within the global pharmacovigilance of life sciences organizations. It also considers factors that will help pharmacovigilance and safety departments to meet expectations.
- Challenge: Compliance with latest regulations such as the E2B (R3), and IDMP are in various stages of being mandated across various ICH regions. Consideration: Implement efficient and cost-effective clinical safety and pharmacovigilance programs
- Challenge: Regulatory reporting requirements can require manual workarounds, increasing the risk of errors and workload. Consideration: Comprehensive solutions can eliminate redundant data entry and automate many case-processing functions
- Challenge: Manually sending cases across ICH regions can result in inefficient processing of AEs and drug safety reports. Consideration: A single, centralized solution provides a global view of safety issues
- Adopt solutions and methods to address specific challenges faced by the pharmacovigilance manager and QPPV