MR Code of Conduct alerts archive
May 2010 - UK
From 1st May onwards BHBIA member companies must
ensure that all newly initiated UK MR projects have AE processes in
place that will be compliant with the ABPI's revised guidelines.
The revised Guidelines were issued in November 2009 and take effect
from 1st May 2010.
The revised Guidelines contain several changes
– one of them major. In brief, any event linked to a company’s drug
needs to be forwarded whether or not a patient identifier is
present.
When the UK AE Reporting Guidelines were first
launched in 2007, market researchers were required to forward AEs
that were cited in the context of an individual, identifiable
patient, and events cited in groups of patients did not need to be
forwarded (as an individual patient could not be identified).
However, MHRA inspections have made clear that this level of AE
collection does not go far enough. Consequently the ABPI issued
revised guidance which states that in the UK, pharma companies and
their legal agents e.g. agencies, must now forward all AEs that are
cited in the context of any actual patient or patients whether or
not a specific identifier is present. As a result AEs cited in
groups of patients and aggregated patient data now also need to be
forwarded whether or not specific identifiers are present.
For further information, see the BHBIA’s
web-based AE Reporting Training Programme which has been updated
and is available online through the BHBIA’s website to non-BHBIA
members, as are the Guidelines - http://www.bhbia.org.uk/