09 May 2011 Posted in
We have published two new pieces of pharmacovigilance guidance today.
1. Guidance notes on patient safety and pharmacovigilance in patient support programmes
The ABPI Pharmacovigilance Expert Network (PEN) has put together a set of best practice guidance notes. These have been created to help companies deal with drug safety issues when they are conducting patient support programmes.
2. Updated guidelines for the collection of adverse event reports - the role of the company representative
These guidelines cover the role of the company representative in the ‘adverse event’ collection process. This process helps to protect patient safety by ensuring each company has a full set of medicine safety data that it can use to perform safety checks.
The ‘ABPI guidelines on the role of the company representative role in the collection of adverse event’ reports were drafted in 2007 and have now been updated by the ABPI PEN to keep them current.