Auditing

As part of the European pharmacovigilance regulations defined in Good Pharmacovigilance Practices (GVP) each Marketing Authorisation Holder needs to regularly audit its pharmacovigilance system. This includes companies such as vendors, distributors, local PV representatives and co-licensees. GVP outlines the process each Marketing Authorisation Holder needs to follow in order to complete a risk assessment of each third party. Once the risk assessment is defined, the next step is to create the audit schedule and put in place the resources to conduct the required audits.

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.

Your approach to auditing will depend on your vendor management and audit processes. If needed, we can help you develop your standard operating procedures in this area. This includes your risk assessment of third parties and creation of an audit schedule.

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Training

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
 

Talk to Us

Elizabeth Ursell is our Technical Director, based in Harlow (UK). If you would like to talk to us about third party risk assessment for pharmacovigilance, pharmacovigilance audits or training, please get touch with Elizabeth at: eursell@diamondpharmaservices.com
or call her on +44 (0) 203 911 9410