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Related Experiment Videos

Pharmacovigilance is Everyone's Concern: Let's Work It Out Together.

Bruce A Donzanti1

  • 1Genentech Inc, A Member of the Roche Group, South San Francisco, CA, USA.

Clinical Therapeutics
|November 24, 2018
PubMed
Summary

Drug safety, or pharmacovigilance (PV), has seen uneven progress. Sustained collaboration among stakeholders is key to addressing current challenges in the PV landscape.

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Area of Science:

  • Pharmacovigilance and Drug Safety
  • Regulatory Science
  • Health Technology Assessment

Background:

  • The field of pharmacovigilance (PV) has experienced significant advancements alongside areas of stagnation.
  • Assessing the PV landscape requires consideration of both regulatory frameworks and scientific/technological progress.

Purpose of the Study:

  • To highlight current issues within pharmacovigilance.
  • To propose solutions through stakeholder collaboration.
  • To provide a dual perspective on PV challenges, integrating regulatory and scientific viewpoints.

Main Methods:

  • Commentary and analysis of the current pharmacovigilance landscape.
  • Review of advancements and stagnation in drug safety.
  • Exploration of regulatory and science/technology perspectives.
Keywords:
adverse eventsdrug safetypharmacovigilanceregulatory

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Main Results:

  • Identified areas of dramatic advancement in PV.
  • Highlighted areas where PV progress has been slow or stagnant.
  • Emphasized the need for a multi-faceted approach to PV assessment.

Conclusions:

  • Current pharmacovigilance issues can be resolved through enhanced collaboration.
  • A sustained, collaborative effort among all stakeholders is crucial for future PV development.
  • Integrating regulatory and scientific/technological lenses offers a comprehensive view of the PV field.