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.