Top themes for 2012 – EU legislation, signal analysis and benefit risk

In Regulation and Compliance by aliceLeave a Comment

Top drug safety themes for 2012 – EU legislation, signal analysis and benefit/risk.

The World Drug Safety Congress Europe 2012 has a brand new producer working on it, our in- office action man, Nick. He is bringing some fresh eyes to the event and has spent the last few weeks researching the topic inside and out. He has been speaking to some key players in the industry to really understand what is of interest currently, what challenges are affecting the industry at the moment and what topics need to be included in the event for discussion.

Here's what he has to say about what's happened to date:

What are the 3 big themes that pharma have been telling you they want to hear about at the event in September?

Nick says:

1 – The new European pharmacovigilance legislation and the operational implications of this for pharma

2- Safety signal analysis and how different tools can be used like patient reports & EHR

3- RISK! Benefit-risk communication, risk minimisation effectiveness and the diversity of risk management approaches

Have you got any speakers confirmed so far?

Nick says:

  • Dr Omer De Mol, VP, PhV and Medical Information, Genzyme
  • Dr Sue Rees, Head of PhV and Safety Risk Management, Eisai
  • Dr Astrid Herpers, Head of EU-QPPV office, EU-QPPV, Boehringer-Ingelheim
  • Mick Foy, Group Manager of the Pharmacovigilance Signal Management Group, MHRA
  • Dr Felix Arellano, VP, BSCP Global Vaccine Development, GSK

What new topics will be included in this event this year?

Nick says: Lots including: EU Commisions new information of AR reporting, PSMF and improving drug therapy using personalised medicines

Also, there will be discussions on the growing importance of patient reports in pharmacovigilance. I found this excellent article on ‘The missing voice of patients in drug-safety reporting' in the New England Journal – http://www.nejm.org/doi/full/10.1056/NEJMp0911494

Also there is a bit of a change to the agenda format this year with 2 brand new streams. These will be separated into safety in i) patient groups i.e. paediatrics, geriatrics, population subgroups in terms of genomic profiles 2) specific product class studies including a brand new focus on the development of companion diagnostics and how it can influence drug safety decisions

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