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As evidence of this, the market for PV software is projected to reach $207.7M by 2024, according to a report by Grand View Research. In an effort to focus limited assets on R&D and other activities, many life science companies are outsourcing their pharmacovigilance (PV) efforts, including adverse event detection while other customers are augmenting manual workflows with software.

Sponsors are required to report any serious adverse events they find to be unexpected and could reasonably have been caused by their drugs.

In May of 2020, the FDA restated its 2012 guidance for adverse reporting during flu pandemics to include COVID-19. However, even during these unprecedented times, adverse event reporting still acts a key mechanism for maintaining the three-way trust between regulatory agencies, bio-pharmaceutical companies and the public. The COVID-19 pandemic and the race to find effective treatments for this disease has caused both the FDA and bio-pharmaceutical organizations around the world to re-imagine the typical timelines associated with bringing drugs to patients. Bio-pharmaceutical companies have always had a responsibility to report adverse events (AE), whether in clinical development or post market-approval scenarios, to the Food and Drug Administration (FDA).