D5.1 - Analysis of policy implementation at EU level and different European Countries and CAP strategies

The deliverable 5.1 aims at analysing the agroecology policy implementation at EU level and different European countries and CAP strategies. It has been structured in sections by analysing the agroecology policy definition based on a literature review that considers policy, but also end-users needs and research advances to fully understand the agroecology perception from different perspectives to deliver more targeted policies. The second section evaluates the role of agroecology within the European policies from a global perspective linked to strategies and the post-2020 CAP. The third section analyses how agroecology was fostered in the past considering the rules of the post-2020 CAP. Whenever relevant, the linkages with organic farming as a well stablished concept was also evaluated.Due to the delay in delivery the CAP strategies, which will be approved in July 2022, it was not possible to provide a concrete and valid analysis of the CAP strategies at country level, which will be the basis of the next policy report to be delivered at the end of the project as the basis of EU agroecology strategy that will be adapted at country level

A European observational study to evaluate the safety and the effectiveness of safinamide in routine clinical practice: The SynapSES trial

Background: Safinamide modulates both dopaminergic and glutamatergic systems with positive effects on motor and non-motor symptoms of Parkinson's disease (PD). The drug utilization study SYNAPSES was designed to investigate the use of safinamide in routine clinical practice, as recommended by the European Medicines Agency. Objective: To describe the occurrence of adverse events in PD patients treated with safinamide in real-life conditions. Methods: The SYNAPSES trial is an observational, European, multicenter, retrospective-prospective cohort study. Patients were followed up to 12 months with analyses performed in the overall population and in patients aged >75 years, with relevant comorbidities and with psychiatric conditions. Results: Of the 1610 patients included, 82.4% were evaluable after 12 months with 25.1% of patients >75 years, 70.8% with relevant comorbidities and 42.4% with psychiatric conditions. During observation 45.8% patients experienced adverse events, 27.7% patients had adverse drug reactions and 9.2% patients had serious adverse events. The adverse events were those already described in the patients' information leaflet. The majority were mild or moderate and completely resolved and no differences were detected between the subgroup of patients. Clinically significant improvements were seen in the UPDRS motor score and in the UPDRS total score in 6540% of patients, according to the criteria developed by Shulman et al. Conclusion: The SYNAPSES study confirms the good safety profile of safinamide even in special groups of patients. Motor complications and motor scores improved with clinically significant results in the UPDRS scale maintained in the long-term