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Our Experience of EMA Patient and Consumer Training

By Inga Zalnerausine and Dominique Hamerlijnck, EFA Patient Representatives

Inga Zalnerausine and Dominique Hamerlijnck attended the EMA patient and consumer training on November 25th as representatives of EFA. There were about 40 representatives at the training, from approximately 24 patient and consumer organisations. 

It was an intensive day, as well as a very interesting one.   

EMA organised this meeting to help prepare us in our role as a patient or consumer representative in EMA meetings. The session was directed towards Scientific advice, the Scientific advisory group of CHMP (Committee of Medicinal product for Human Use), PRAC (Pharmacovigilance Risk Assessment) written consultation and EPAR (European Public Assessment) and safety communications on medicine.   

The training did not just consist of us listening to presentations. We received examples of the types of information we would receive for different types of advice. We were asked to read and think about how we would comment on the issues addressed in the papers, as if we were asked by EMA to participate in a meeting.

The group was divided into 3 breakout groups.  Each of these groups discussed their reactions and advise on the papers we had been given. There was a lot of discussion in the breakout groups. Not only about the content of the information but also about our role as patient or consumer representatives. We ended up with a compilation of both advise on our role as patients and answers to the questions asked in the documents.  It was very interesting because of the different experiences and points of view from the participants.

The sessions were chaired by different EMA representatives who were involved in the different areas addressed in the papers. It was interesting to see that the learning went both ways.

What we learned is that you have to read the documents really carefully. Small differences in wording are important. One example is: “added to existing standard of care” which means that in the study designed by the company the patient remains on their own medication while participating in the trial. This is important information when thinking about the design of a study, the effect on the participants and the relevance of the results.

Most of the questions in the documents are formulated by the pharmaceutical company. It is important to translate them to what you as a patient representative feel is important and how you can answer the questions from this perspective.

We were given an overview of the activities of EMA and the patient participation in the different subjects: from pre-submission to post authorisation, the different working parties and the public EMA documents. Most of us got a bit confused by all the acronyms used by EMA!

The day helped us to understand the different aspects of what EMA does and gave us insight into how we, as patient and consumer representatives, can prepare for meetings and increase our effectiveness.  It was very fruitful and an interesting learning experience. 

Inga Zalnerausine and Dominique Hamerlijnck

{jcomments on}

keeping on top of my symptoms and keeping well has been a constant struggle- but 
I’m happy to say that, with the help of the Asthma Society of Ireland, I am in control 
of my asthma. 
As we have heard earlier today, the long term devastating effects of smoking are 
clear. But for people with asthma the adverse effect of breathing in tobacco smoke 
are immediate- it restricts the airways, making it difficult to breathe and causing an 
asthma attack. More than one person each week dies in Ireland from an asthma 
attack and thousands more are hospitalised each year.
For people with asthma smoking is the most dangerous trigger of symptoms. As a 
person with asthma, prior to the smoking ban, restaurants and particularly pubs 
were no go areas for me. Yet, despite my best efforts to avoid smoke or places where 
people are smoking, tobacco still poses a significant risk to my health. 
Personally I have needed emergency care as the result breathing in someone else’s 
tobacco smoke at a hurling match. This took place outdoors when I wasn’t even 
standing next to the person smoking-so think of the effect it has when a parent of a 
child with asthma smokes in the home or the car. 
I worked for many years as a primary school teacher and principal in Wexford. 
Around one in every five children in Ireland has asthma and around one in every four 
people in Ireland smoke, meaning children with asthma inevitably come in contact 
with tobacco smoke- in parks, outside schools, in the home and in cars. These same 
children are the ones being targeted by the tobacco industry with novel packaging 
and branding.
Many people who smoke don’t notice the damage they are doing until it’s too late. 
But people with asthma can feel the effects of smoking on their breathing instantly. 
And yet despite the risks many people with asthma and parents of children with 
asthma smoke. Smoking with asthma may seem crazy to you or I, but we know that 
tobacco is so addictive it can override logic and even someone’s desire to quit. 
For this reason it is so important that the Irish Government takes action. Along with 
the Asthma Society of Ireland and the other charities here today, I fully support the 
introduction of plain tobacco packaging and Tobacco Free Ireland 2025 as vital 
measures in protecting the lives of children and adults with asthma.
Thank You