Pharmacovigilance Methodology

Pharmacovigilance

An ongoing assessment of the benefit-risk profile of products based on the collection and collation of reports of adverse events, from whatever the source.

Adverse Event (AE)

Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a casual relationship with its treatment. An AE can therefore be any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

Serious Adverse Event (SAE)

Any untoward medicinal occurrence that at any dose:

Results in death
Is life threatening
Requires hospitalization
or prolongation of existing hospitalization
Results in persistent or significant disability, incapacity

Process Flow

Collect and collate AE reports from clinical trials
Collect and collate Spontaneous AE reports from consumers and health professionals
Collect and collate AE reports from literature sources and regulatory authorities
Assess the seriousness and expectations of the reports
Enter the data into a suitable central databaseProvide a medical evaluation of the report
Provide an analysis of similar events for expedited reports
Ensure that reporting timelines for expedited reports are met

Adverse Events Include

Exacerbation of a preexisting illness
Increased frequency or severity of a pre-existing condition
Condition diagnosed after study drug initiated
Continuous or persistent symptom or disease present at baseline which worsens

FDA Reporting Requirements

Serious: 15-day written IND Safety Report: Unexpected - Drug related
Serious-Fatal: 7-day Phone or Fax Report: Unexpected-Drug related-Life threatening or Fatal

Lean Principles for Case Handling

Process

Efficient & Streamlined
Simple & Visible
Harmonized Across Departments
Right First Time Approach
Agreed Business Rules

Standards

Consistent
Simple & Readable
Understood by All

External

Compliance
Quality Assessments
Gain Regulators Confidence