On return from the summer break we participated in the European Medicines Agency (EMA) joint meeting between Patients and Consumers (PCWP) and Healthcare Professional Organisations (HCPWP).
At the meeting we discussed the PCWP/HCPWP work programmes for 2016 and were updated on a number of activities, including the need for collaboration in pharmacovigilance. This is the practice of analysing, detecting and preventing any adverse effects which may be caused by medication. This collaboration is critical to help ensure effective health protection and promotion of the new pharmacovigilance systems and services. We also learnt more about the results from VISUALIZE research study (PROTECT project) .
Discussions about the publication of clinical data for human medicines
The European Medicines Agency (EMA) also organised a meeting to discuss with stakeholders about two sets of guidance under development, 1) on the identification and redaction of commercially confidential information in the clinical reports submitted to EMA for publication, and 2) on the anonymisation of the clinical reports, in the context of the policy. EFA EU Policy and Membership Officer Jelena Malinina participated at the meeting to bring the perspective of allergy and airways diseases patients.
EMA also presented new technical guidance on the procedural aspects related to the submission of the clinical reports, for example practical matters of how material should be sent to EMA, as well as the workflow of the redaction consultation process and the overall process leading to publication.
Workshop on measures to reduce medicines’ risks
On the 16th of September, European Medicines Agency (EMA) organised a workshop on risk minimisation measures with representatives from patients’, consumers’ and healthcare professionals’ organisations. EFA was represented by Lina Buzermaniene, EFA EMA Expert and Jelena Malinina. During the workshop we attended an overview of the regulatory practices supporting the development of risk minimisation measures that might result from medicines commercialisation and consumption . In addition, EMA shared with the participants current practices/experience in the implementation and evaluation of the effectiveness of additional risk minimisation measures, with concrete examples. We also discussed challenges and opportunities posed by the implementation and evaluation of risk minimisation measures in real life clinical practice and how that can balanced with benefits and adherence to your medication.