Pharmacovigilance

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
See PowerPoint presentation for more details - More about process flow    

Process Requirements

• 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 pre-existing 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