Auditing and Inspections
Diamond PV has conducted successful audits of UK and European pharmaceutical companies leading to favourable regulatory pharmacovigilance inspection outcomes. In order to ensure we are providing the best PV system in conjunction with our client, we undertake both self-audits and external audits. We provide a comprehensive assessment of the current systems in place and share advice on areas that require improvement. We have also been successfully inspected by the MHRA on several occasions.
All staff who may potentially be contacted regarding an adverse drug reaction must be trained on how to recognise it, how to handle it, and what to do next. We can provide drug safety training to staff to ensure they meet these requirements.
We can offer more extensive training to suit individual needs, such as:
- Pharmacovigilance Auditing
- Volume 10 and Clinical Trials Directive Training
- Basic Pharmacovigilance Training for non PV staff
- Basic Pharmacovigilance Training for PV professionals
- Intermediate Pharmacovigilance Training for PV professionals
PV Systems and Documentation
Our team can support the development of PV systems and prepare associated documentation for clients.
- Standard Operating Procedures (SOPs)
- Pharmacovigilance System Master Files (PSMFs)
- Risk Management Plans (RMPs)
- Development Safety Update Reports (DSURs)
- Named patient / compassionate use program Annual Safety Reports
- Periodic Safety Update Reports (PSURs)