​Pharmacovigilance

Pharmacovigilance Methodology

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 

Pharmacovigilance ​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

Pharmacovigilance

​Proactive
Active Communications
Best Methods Used
Involvement of All Units
Signals Detected & Evaluated 

Systems

​One Global Database
Transparent Tracking
Reduction of Duplication

People

​Correct Number
Training on the Process
Orientation in Lean 

Organizational Structure

​Process Aligned
Aligned Priorities, Roles and Responsibilities
Communication, Co-operation, Co-ordination and Empowerment

Performance Measurement

​Focused on Thoroughness, Integrity, Timely
Simple and Visible 
Aligned Targets, Rewords and Recognition