Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment Guidance

  • By: Staff Editor
  • Date: December 05, 2016
  • Source:
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Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment Guidance

Pharmacovigilance plays a pivotal role in safeguarding ongoing safety of drug products. It is impossible to recognize all safety concerns during clinical trials. Once a drug is marketed, it is usually exposed to a large number of patients including those with co-morbid conditions.

Post marketing safety drug monitoring includes finding of drug interactions, evaluating the influence of inactive ingredients to the safety profile, methods for comparing safety profiles of similar drugs, investigation of the adverse effects on human health of drug residues in animals, e.g. antibiotics and hormones.

The FDA document provide guidelines to industry on good pharmacovigilance practices and pharmacoepidemiologic assessment of observational data regarding drugs, including biological drug products. The document does not provide guidance for blood and blood components.

Specifically, this document provides guidance on:

  • Safety signal identification
  • Pharmacoepidemiologic assessment and safety signal interpretation
  • Pharmacovigilance plan development

Identifying and Explaining Safety Signals:

This section of the guidance addresses the following areas:

  • Good reporting practice
  • Characteristics of a good case report
  • Developing a case series
  • Summary descriptive analysis of a case series
  • Use of data mining to identify product-event combinations
  • Safety signals that may warrant further investigation
  • Calculating reporting rates vs. incidence rates

Signal Investigation through Observational Studies:

This guidance document emphases on three types of non-randomized observational studies:

  • Pharmacoepidemiologic studies
  • Registries
  • Surveys

The FDA guidance has addressed these areas and more to ensure clarity in adhering to regulatory requirements.

Related Training:

Introduction of Post-Marketing Drug Safety Surveillance: Pharmacovigilance in FDA / CDER

PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation

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