HALMED Hosted the Final Conference of the EU Project SAFE CT in Zagreb
19.03.2026
The international conference "SAFE CT Final Conference”, organised by the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) on behalf of the SAFE CT consortium, was held in Zagreb on 19 March 2026.
The conference was organised on the occasion of the conclusion of the EU project "Safety Assessment Cooperation and Facilitated Conduct of Clinical Trials - SAFE CT”. The project is implemented with the aim of strengthening the competencies of safety assessors in clinical trials within the regulatory network of the European Union and the European Economic Area. Within the project, HALMED led Work Package 1: Coordination and also actively participated in other work packages of the project.
At the opening of the conference, participants were welcomed by Prof. Siniša Tomić, Head of the Agency for Medicinal Products and Medical Devices (HALMED), Marianne Lunzer, Chair of the Clinical Trials Coordination Group (CTCG) within the Heads of Medicines Agencies (HMA); and Ivana Kosier Mihalic, Principal Coordinator for Safety Assessment of Medicines in Clinical Trials at HALMED and Coordinator of the SAFE CT project.
Prof. Tomić recalled that the SAFE CT project had been designed to address the challenges related to building expertise, establishing sustainable cooperation mechanisms and creating the foundations needed for high-quality safety assessments that had emerged following the introduction of the Clinical Trials Regulation. He stated: "Through twinning and mentoring activities within SAFE CT, assessors gained real-world experience and developed a consistent approach to safety assessments. At the same time, the Clinical Trials Coordination Group developed a clinical trials safety curriculum, providing structured onboarding tool and comprehensive reference on pharmacovigilance in clinical trials." He also emphasised that the project results had been very encouraging: "According to the satisfaction survey conducted at the end of last year, the majority of participants expressed satisfaction with the training received. They also expressed readiness to share obtained knowledge further. This is, perhaps, the most important achievement - sustainable and confident network of safety assessors."
In her opening remarks, Marianne Lunzer thanked all project participants and stated: "It is truly encouraging to see how quickly progress can be made. When I think back to the initial drafts at the start of the project and look at the new, developed and functional network of assessors before us today, I can see how much we have all progressed together.” Lunzer also added that aligning ways of working makes a real difference, as it enables better cooperation, greater efficiency and a clearer shared direction.
During the conference, the activities of all work packages implemented throughout the project were presented, starting with Work Package 5: Capacity Building, followed by Work Package 4: Sustainability, Work Package 3: Evaluation, Work Package 2: Dissemination, and concluded with Work Package 1: Coordination. Particular emphasis was placed on the experience of new assessors employed within the SAFE CT project, as well as on the experience of their mentors. Furthermore, an event was enriched by two plenary presentations: one from the perspective of the Chair of the CTCG, offering an overview of evolution of safety assessment in clinical trials to the present day, and the other presentation from the perspective of the pharmaceutical industry, addressing the challenges related to safety reporting in clinical trials.
The final conference brought together around 70 representatives of competent national regulatory authorities from the member states of the European Union and the European Economic Area, and provided an opportunity to present the project’s key results and exchange experience gained during its implementation.
The SAFE CT project is implemented over a four-year period, from 1 May 2022 to 30 April 2026, and involves a total of 22 EU/EEA countries. The aim of the project is the successful implementation of Regulation (EU) No 536/2014 on clinical trials and Commission Implementing Regulation (EU) 2022/20, which introduced a new concept of cooperation and work-sharing among member states in the field of safety assessment of medicinal products in clinical trials. In order to maximise the efficiency and quality of assessments, the SAFE CT project improves organisational and professional capacities for safety assessment in clinical trials by providing much-needed resources for the recruitment and training of new assessors in EU/EEA member states. The project also provides mentoring programmes for assessors, strengthened communication and knowledge exchange among member states, and builds a network of experts in clinical trial pharmacovigilance.
The SAFE CT project is co-funded by the EU4Health programme and implemented by the European Health and Digital Executive Agency (HaDEA).
Further information about the project is available here.
Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or HaDEA. Neither the European Union nor the granting authority can be held responsible for them.
