For UK pharmaceutical and life sciences leaders
Your pharmacovigilance system was built for one product, not the company you are now
Each new product and market multiplies your adverse event reporting obligations. A PV infrastructure that was adequate at launch becomes a compliance liability faster than most teams anticipate.
Two minutes. Solva follows up with specific pharmacovigilance infrastructure options.
- A growing backlog of individual case safety reports (ICSRs) awaiting processing
- Delayed submission of expedited reports to regulatory authorities
- Periodic Safety Update Reports (PSURs) that are incomplete or do not meet current MHRA/EMA guidelines
- A Qualified Person for Pharmacovigilance (QPPV) who is visibly overwhelmed and unable to effectively oversee the PV system
- Increased workload for PV teams leading to burnout and high staff turnover
- Diversion of internal resources to address regulatory findings, impacting other critical business functions
- Significant fines from the MHRA for non-compliance, potentially reaching millions of pounds
- Costs associated with mandatory third-party audits and remediation plans, which can be substantial
- Damage to the company's standing with regulatory bodies, leading to increased scrutiny
- Erosion of trust among healthcare professionals and patients, impacting future product uptake
Risk management was the topic with the highest proportion of findings (32% of all findings) across 32 pharmacovigilance inspections conducted between April 2021 and March 2022 (MHRA, 2023)
Frequently asked questions
Why does this problem persist?
Pharmacovigilance obligations increase significantly with each new product and each new market. Companies that don't invest in scalable PV infrastructure find themselves with a growing backlog of case processing, late expedited reports, and PSUR submissions that don't meet current requirements - all of which are triggers for MHRA inspection and potential regulatory action.
What is the cost of leaving it unaddressed?
No verified UK data available for specific costs cited in problem card
This is exactly what I do with UK private practices. Answer the few questions above and I'll come back personally with where to start. Paul.