Nearly all companies worthy of mention have received a letter containing one or several of these notifications:
“You do not consistently report Adverse Drug Experiences (ADEs) within 15 days of initial notification…”
“You do not have adequate written procedures for managing from all sources…”
“You have failed to maintain records of all ADE’s for the prescribed time periods…”
This is often followed by a fire-drill response and attempts to mitigate the potential fines, sanctions and/or reprimands. The fact is, advertise event reporting is often run as a triage process: stop the bleeding, stabilize and try to return to normalcy.
The root cause of the problem is often the lack of an integrated Inbound Receipt and Triage (IRT) system. Despite firms’ desire to capture and process all adverse events in a proper and timely fashion, many rely on a manual (paper- or fax-based) system instead of an electronic, automated IRT workflow for Safety information processing worldwide.
The fines, loss of focus, people and time resources from this ungainly process collectively cost the world’s major pharmaceutical
companies close to $1 billion a year. The impact on those who are least able to bear it — Small & Medium-Sized Enterprises (SME’s) — is even greater.
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