Just recently I read the latest Safety Observer which details a number of updates and documents sent out for comments by regulatory authorities.
The new EU GVP module VIII (PASS studies) has been released and there are also updates to the ENCePP guidance both for the methods guidance and the PAS register. The EU has also released the final biologics specific GVP guidance. CIOMS has released 2 new guidance documents one on SMQs and the other on meta-analysis of safety data. The FDA has released its final guidance related to the use of the PBRER
In terms of documents for comment there are changes planned for the EU GVP module IX (Signal Management). The current draft for comment seems to be simplified and closer to the CIOMS guidance document. An update for EU GVP module VI (ICSRs) has also released for comment.
ICH M4E which revised the presentation of the beenfit-risk information in the CTDhas reached step 4, and will now be implemented.
With all these changes and draft guidances it is so important that we take the opportunity to learn from each other.
Tomorrow I am heading to the 3rd Pharmacovigilance and Risk Management Summit in Vienna. These conferences are an excellent opportunity to learn from each other and to keep up to date with the many changes that are happening in pharmacovigilance and risk management.