The upcoming changes to European pharmacovigilance legislation are a talking point for pharma who need to fully understand and incorporate them into their day to day safety procedures. At last years World Drug Safety Congress Europe 2011 we had a great session focussed on these developments led by Abbotts's Vicki Edwards and the MHRA's Mick Foy. Both speakers broke down the legislation changes developments from a regulatory and operational viewpoint. I've spent some time looking at both their presentations and have highlighted below some of the summary points they raised to conclude the presentations.
The summary of regulatory points focussed on some of the key changes that will be delivered to the industry following the changes as well as looking at what the industry needs to do for fast and efficient roll out of the changes.
- PSURs, literature are inclusive and deliver early saving
- Patient reporting can be introduced across the community on time
- There is a consistent adoption in all territories
- Eudravigilance functionality is delivered on time
- Signal detection – assessment – action is the main beneficiary
The industry based summary provided a few take away big picture points for the industry to consider. These were:
- We remain in an ever changing regulatory environment
- European Pharmacovigilance Package will have major impact on Pharmaceutical Industry and Regulators
- Insight into Implementing Measures allows MAHs to start planning for implementation
Vicki Edwards and Mick Foy are both speaking at the World Drug Safety Congress Europe 2012. I look forward to hearing their update on this topic and how they see the response from the industry to the EU Pharmacovigilance Package.