Pharmacovigilance is a process involving detection, assessment, understanding, and prevention of adverse events—ensures that medicines are used in the full knowledge of risks (opens in a new window); patients, health professionals, pharmaceutical companies and medicines regulators all contribute to pharmacovigilance activity. Knowledge acquired from the activity is used to continually reassess the balance between benefits and harms of medicines and for optimising drug (opens in a new window); therapy in the individual.
By maintaining vigilance for unwanted effects of medicines and by reporting them, clinicians play an important role in establishing a drug’s adverse-effect profile. Spontaneous reporting of suspected adverse effects (Yellow Card reports in the UK), together with post-authorisation (post-marketing) safety studies and literature reports, all contribute to the knowledge on adverse effects of medicines.
PharmaConsult will provide help in accessing up-to-date sources of information on adverse effects in order to select a medicine and to prescribe it in a way that minimises the risk of harm. Anticipating and minimising adverse reactions to medicines can have a very substantial effect on morbidity, hospitalisation, and on mortality.
a) Regulatory GVP Compliance auditing
PharmaConsult will carry out an Audit of the Pharmacovigilance Management system and provide observations on the compliance with Good Vigilance Practice Regulations to prepare organisations for a Regulatory Authority Inspection.
Good Pharmacovigilance Practice compliance Audits comprise of:
- Collecting and managing data on the safety of medicines
- Looking at the data to detect ’signals’ (any new or changing safety issue)
- Evaluating the data and making decisions with regard to safety issues
- Acting to protect public health (including regulatory action)
- Communicating with stakeholders
- Audit, both of the outcomes of action taken and of the key processes involved.
b) QPPV activity
Whether you need an urgent solution for an unexpected problem or are seeking to outsource your entire pharmacovigilance processes – our experienced experts will be there for you to help in providing:
- Aggregate Report Writing
- EU-QPPV / Local-QPPV
- ICSR, Signalling and Risk Management
- Pharmacovigilance & Clinical Safety
- Risk Management Plan
- VigiLit: Literature Surveillance