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The evolution of pharmacovigilance ecosystems: does Moore‘s law invite the use of Ockam’s razor?
  • Marion Mueller,
  • David Lewis,
  • Amalia Alexe
Marion Mueller
Novartis Pharma AG

Corresponding Author:[email protected]

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David Lewis
Novartis Pharma AG
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Amalia Alexe
Advanced Accelerator Applications SA
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“Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medication-related problem”, according to the WHO. With the increasing volume of legislation, pharmacovigilance systems have shifted from reactive (responding to emerging risks), to planned, active, risk-proportionate approaches operating throughout the lifecycle of medicines. Whilst medicines are beneficial to society, adverse reactions represent a significant cause of concern. They are a major cause of failed regulatory authorizations, and withdrawal from the marketplace post-approval. Evaluation of real-world data plays an increasingly important role in pharmacovigilance. There is great interest on the part of the regulators, MAHs, academia and patients in optimizing the use of safety data. Innovative approaches, including pharmacogenetics and passive measures (sensors), will lead to increased complexity in data collation and evaluation, and inevitably to an increase in the volume of case reports. There is a multiplicity of regulations and guidelines on how to manage these data, with an inherent lack of harmonization. We summarize the current characterization of safety data types, sources, and the classification of these data. Using this benchmark, we discuss the future requirements of an effective pharmacovigilance ecosystem, keeping the principle of parsimony in mind.
05 Jun 2022Submitted to British Journal of Clinical Pharmacology
08 Jun 2022Submission Checks Completed
08 Jun 2022Assigned to Editor
09 Jun 2022Reviewer(s) Assigned
26 Jun 2022Review(s) Completed, Editorial Evaluation Pending
30 Jun 2022Editorial Decision: Revise Major
06 Aug 20221st Revision Received
08 Aug 2022Submission Checks Completed
08 Aug 2022Assigned to Editor
08 Aug 2022Review(s) Completed, Editorial Evaluation Pending
09 Aug 2022Editorial Decision: Accept