Moving into December

I am updating my blog page early because of an important event next week.

Next week on the 5th and 6th December there is a workshop at the European Medicines Agency looking at measuring the impact of pharmacovigilance activities in the EU. This workshop is referenced on my News section, but is so important that I am mentioning it here also. The workshop will be live streamed so visit EMA PV workshop for more details, and to join this important meeting.

I have kept below some of the information on the DSRU meeting in Prague, for those who were on Thanksgiving holiday and didn’t read it. It was a stimulating meeting:

The conference has been stimulating as we have discussed the principles of risk minimisation and the issues we face in all companies as we seek to minimise risks and the burden of any measures on patients and healthcare systems. There is clearly still much to be developed on this, but the thorny issue of what is effective risk minimisation remains elusive. My specific topics have been “Does One size fit all? Divergence of risk minimisation requirements amongst the 28 Member States” and “Risk Minimisation case studies and global considerations”.

As those who know me know, I am passionate about risk minimisation and the need to maximise benefit and minimise risk  but also the need to balance the negative impact of such measures on healthcare systems and patients against their benefits in minimising risks.

Prague is a beautiful city and early morning/late evening walks have been great opportunities to see the city (and shop!). Whilst a little early for the Christmas markets, I did find one and managed to buy another glass globe for my collection.

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Happy Thanksgiving!

Five orange pumpkins sit in a row in front of a distressed, wooden background.

Happy Thanksgiving to all my US colleagues.

This week I am  speaking at the DSRU conference in Prague “Monitoring the Effectiveness of Risk Minimisation”.

The conference has been stimulating as we have discussed the principles of risk minimisation and the issues we face in all companies as we seek to minimise risks and the burden of any measures on patients and healthcare systems. There is clearly still much to be developed on this, but the thorny issue of what is effective risk minimisation remains elusive. My specific topics have been “Does One size fit all? Divergence of risk minimisation requirements amongst the 28 Member States” and “Risk Minimisation case studies and global considerations”.

As those who know me know, I am passionate about risk minimisation and the need to maximise benefit and minimise risk  but also the need to balance the negative impact of such measures on healthcare systems and patients against their benefits in minimising risks.

Prague is a beautiful city and early morning/late evening walks have been great opportunities to see the city (and shop!). Whilst a little early for the Christmas markets, I did find one and managed to buy another glass globe for my collection.

 

Tuesday 8th November

Yesterday I was at the EMA/DIA information day on Risk management Planning and Post Authorisation Studies. There was a lot of information presented and very good discussion as well as extra time devoted to networking (and meeting with old friends). I definitely cannot do the day justice in a single blog post, but will try to capture the key points from the day. It is hoped that the guidance and template will be finalised and available in January 2017. As was said many times – the devil is in the details, and once the guidance and template become finalised and available we will need to reflect on what needs to change in our company approaches and processes.

Watch out for a consultation on the transitional arrangements – this is your chance to have your say on whether a short or longer transitional period is better.

It is clear that the new guidance (and template) represent a new way of thinking about these plans and their place in the lifecycle of our products. In general I think this will make the RMP more fit for the purpose of managing the important risks but clearly challenges still remain. The guidance will contain some examples and the template will also contain examples. The decision has been taken to move away from the modular approach and just have the single (collated) document as the template.

There is more emphasis in the new guidance on the baseline assessment for the initial RMP  and how we reach the identification of the key risks that will be included. Much of the information will be in the submitted CTD but will need collating for this section, which will be locked at the time of approval. Sadly there is still considerable mixing up of the terms adverse events, adverse reactions and risks which will complicate the interpretation of the guidance.

The section on post authorisation safety studies was really concentrating on where these fit in the risk management planning process. In that context there was a lot of attention given to the classifications of such studies and in particular the thorny question of whether a study is category 1 or 3. The advisory group on classification of post-authorisation studies (CPAS) presentation explained how this group is involved in trying to standardise the approach.

The day concluded with a session on risk communication looking at the role of the NCAs in coordinating such information, the view of patients and how we might better utilise the communication methods that the prescribers and patients prefer for improving information provision.