Nice clarification, Carrie ! I just want to make a comment about having one procedure covering reporting obligations for multiple regions (jurisdictions). Over time, on multiple occasions, I have seen citations in FDA Warning Letters for companies that appeared to have one procedure combining language or requirements for multiple regions. This was done in such a manner that FDA felt very uncomfortable with this, fearing that FDA reporting obligations were not assured to be met. The most recent example comes from a Warning Letter to EuroDiagnostica AB (Malmo, Sweden) as per the below link and excerpt from that Letter. So, just make sure your single procedure addressing reporting obligations for multiple regions properly and unambiguously implements the precise wording and requirements from each region.
b. The procedure, as written, combines language from the requirements of other regulatory or competent authorities with the requirements in 21 CFR Part 803 in a manner that will result in incomplete, inadequate or even non-reporting of adverse events that meet the reportability requirements under 21 CFR Part 803.
Hope this helps and with kindest regards,
Director, Regulatory Affairs
Sent: 25-Oct-2017 17:18
From: Anonymous Member
Subject: Adverse Event Reporting vs Vigilance Reporting
This message was posted by a user wishing to remain anonymous
What is the difference between the two?
Also, could we use these two names interchangeably?