23rd April 2017

We have just returned from an amazing 12 day hiking holiday in Turkey.

We often take hiking holidays, usually self guided, usually in Europe and usually in September. This year we needed to go in April and so were looking at somewhere where we could enjoy spring flowers and mountains that wasn’t too cold! The Lycian Way walk in Turkey by InnTravel seemed to fit the bill and off we went.

The walking was amazing; long days with such varied scenery and surrounded by history and offset by the beautiful azure blue sea. An added advantage was the enjoyment of the spring flowers on the mountainsides – wild cyclamen, poppies and many I don’t know the name of. The area we were walking in was very remote and very quiet.  However, the enjoyment wasn’t just the walking and scenery, but also the hospitality and the food. Simple fresh food set off with fresh herbs, sunshine and fresh air.

We stayed in some wonderful places – look up these 2 as good examples:

Olympos Mountain Lodge

Hoyran Wedre

As you can imagine we came back refreshed and relaxed, although I find my self looking out of my London window and wishing for the blue sea.

 

30 March

UPDATE on 4 April 2017: the long awaited update to GVP V is now available. It was released as many of us were enjoying the ISPE mid-year meeting!

New GVP V guidance

And the link for the new template.

New GVP V template

I think that amidst the sunshine, we will be spending some time digesting the changes and the impact to our processes.

As I write this the sun is shining (again!) and it really feels like Spring, a time for new beginnings…..

As a part of the pharmacovigilance community, I know that we are all awaiting the revision to GVP V which I understand from rumour is likely to be published either later this week or in April.

In only 2 days it will be the mid-year meeting for the International Society of Pharmacoepidemiology in London. I will be attending and might manage to post updates from there. If the weather holds, it will be a lovely time to be visiting London.

 

01 March

I am not sure where the first 2 months of the year have gone. It seems inconceivable that we are now in March – except that when I look at my garden the daffodils are poking their heads through and the crocuses are in bloom. I personally love Spring as the days get longer and the garden comes to life again. I always look forward to the flowering of the magnolia “tulip” trees as they symbolize Spring for me.

magnolia

On a professional note I am very busy with interesting work which is satisfying. I am also looking forward to the mid-year ISPE meeting, which this year will be held in London – and that explains the banner photo for this update!

 

10 February 2017

I posted a link recently to a paper on the BBC site looking at cultural difference. I found the article fascinating and in particular how behavioural studies use generalisation from Western Educated, Industrialised, Rich and Democratic populations (or WEIRD) to apply to other cultures. For those who would like a bit more reading on the matter try the article by Henrich et al Behav Brain Sci. 2010 Jun;33(2-3):61-83.

This article started me thinking about how we communicate benefits and risks to patients and healthcare professionals and how we might be able to do it better if we incorporated more patient perspectives which would give a variety of cultural viewpoints

The photograph is from a holiday in December – I’m trying to hold on to the memories for as long as possible!

24 January 2017

This blog update is being written from Washington DC where I am at the DIA annual PV and Risk Management Strategies meeting (DIA PV&RM 2017).

It is a very interesting conference as the PV and Risk Management community looks to develop and implement best practice. I am presenting in a session looking at advances in benefit-risk with a particular focus on how we can provide better tools for the healthcare provider/patient discussions on medicines.

I arrived in DC on Saturday, the day of the Women’s March, and the day after the inauguration. I have vowed to keep politics out of this blog, but it was clear that the Women’s March was a passionate event that was joined by women all over the world.

As noted by Hans-Georg Eichler in the opening key note address: We are living in interesting times.

09 January 2017

The most important part of my first post of 2017 is to wish everyone all the best for this new year, and I hope that you had a good break (if not a rest!) over the Christmas/New Year period. After a lovely holiday in St Lucia, see the photo at the top of the page, I had a wonderful Christmas break which I enjoyed with my husband, children and grandchildren.

It is good to reflect back on 2016 as we go into the New Year and for me 2016 had good times, parts I didn’t like and also some sad times.  It saw the launch of my new company which is going well with a good flow of work, and I am looking forward to developing new partnerships in 2017. I am sure that many of you also have mixed feelings about  personal and global events in the year that has gone and how they will impact the year to come.

As we go into 2017 my plan for this blog is that it will remain a mix of personal and professional thoughts during the year that I will aim to update every 2 weeks. This means that the next update will be around the time I fly to Washington DC for the DIA Pharmacovigilance and Risk Management Strategies meeting (23-25 January) where I will be speaking in a session on Advances in Benefit-Risk. I may see some of you there.

 

Christmas Greetings

 

This will be my final blog post of 2016 and  it has been a very interesting year for me!

The decision to become an independent consultant and to set up up Wise Pharmacovigilance and Risk Management Ltd obviously is at the forefront of my mind as I reflect on the year. The new business is going well and I am enjoying a little more time to spend with friends and family. 

The photograph at the top of the page was taken in the ancient church in Vers L’Eglise in Switzerland on a walking holiday this summer. The stained glass window was created in 1946: “Peace on Earth. Goodwill to men”

As we move towards the Christmas break I would like to take the opportunity to wish you a peaceful and happy Christmas whatever you may be doing, and I look forward to working with you in 2017.

christmas-tree

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.

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.