25th September 2016

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.

11th September 2016

The weather this week in London is definitely an “Indian Summer” but the mornings tell the tale that autumn is approaching and as the summer holiday season comes to a close we start to get ready for the autumn conferences.

Regulations are changing rapidly across the globe with many countries/regions adopting variations (or translations) of the European Medicines Agency Good Pharmacovigilance guidance documents. Our processes need to change to keep up with the changing, and occasionally conflicting, requirements. Conversations at the conferences we attend help us to learn from each other and  review where we are with the systems and processes we have in place for managing benefit-risk of our products.

In the midst of the work it is important that we remember the other things that matter. I have enjoyed the summer spending time with family and including a lovely hiking week in the Swiss Vaudoise Alps immediately after ICPE in Dublin.