Pharma R&D Today

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The Challenges of Signal Detection in Spontaneous Reporting

Posted on September 13th, 2017 by in Pharmacovigilance

Pharmacovigilance is essential to pharmaceutical businesses. It facilitates the correct use of a drug, safeguarding the drug as a meaningful treatment option when the benefits it offers outweigh known risks, or measures can be taken to mitigate those risks. Continue reading “The Challenges of Signal Detection in Spontaneous Reporting” »

Validation: The importance of search formulas in Literature Monitoring

Posted on February 29th, 2016 by in Pharmacovigilance

A reasonable number of Market Authorization Holders (MAHs) have no ready answer to justify why they use a specific search formula for each specific product when Audit or Inspection time comes: Continue reading “Validation: The importance of search formulas in Literature Monitoring” »