Regional Pharmacovigilance Regulations:

Challenges with Non-Harmonized Regulatory Expectations

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Organizations in the Life Sciences industry agree that adverse event reporting rates are growing significantly over time. Indeed, as of May 2019, the World Health Organization (WHO) reported over 20 million adverse event reports (ADRs) in its database that have been received from countries all across the world. This is a reflection of a greater number of national databases gathering important adverse event data to ensure the safe and effective use of medicinal products.

With the increasing global awareness in safety reporting, the volumes of ADRs in MAH/national/global databases are also expected to increase at the same time. To derive meaningful insights from these huge volumes of safety data, it is important that the ADRs obtained from various sources are compiled and collated in a meaningful manner.

Download this whitepaper to learn about:

  • The evolution of safety data standards
  • Regional implementation specifications
  • Challenges for MAHs/CROs
  • The potential solution: automation-enabled PV database systems