Benefits of Hiring Third Party Auditors to Succeed in an FDA Audit

Some Briefer Contemporary Definitions Of Epidemiology

This has been defined by various Pharmacovigilance training  sources as the scientific study of illness and disease in relation to how they occur within a given population which is the focus of the study. Around the world, this branch of science is documented in a vast array of literature. It’s primary aim is to help further scientific understanding of factors which influence the occurrence of the disease. This involves examination of:

how many patients are affected

  • how many new cases are recorded in a given timescale
  • whether they have any characteristics in common
  • where they live
  • whether that environment has any characteristics which could be relevant
  • whether the patients share any behavioural characteristics which could be relevant
  • any interventions which are helpful to control the disease

Some Briefer Contemporary Definitions Of Pharmacoepidemiology

This is the formal scientific study which examines the effects from using both drugs prescribed by doctors and those bought over the counter within a pre-determined population. There is a focus on how those medicines are used and consumed ‘in real life’ by patients; and for prescription drugs, there is also a focus on the manner in which those prescriptions are provided by doctors (or any other healthcare personel authorised to prescribe them).

Some Applications In Relation To Pharmacovigilance

These two scientific disciplines do not form part of routine services here, however they are used on the resulting drug safety data. The aim is to further understanding around how this data is relevant to how patients use medicines ‘in real life’.

The ‘Safety Specification’ of a new drug describes what is known about the safety profile of the drug and it forms part of the Risk Management Plan; epidemiology information is included in the Saftety Specification. It is vital to understand as much as possible about the disease; epidemiological data can provide crucial insights into what will be seen when the patient receives the drug. This can include the gender, age range and ethnicity of patients for whom the disease occurs. It could include the types of other drugs the patients are likely to be taking. It could include how the disease is likely to develop over time if treatment is not provided.