HRPRES2020: Working Group of Quality Managers (WGQM) virtual meeting
As part of the Croatian Agency for Medicinal Products and Medical Devices’ (HALMED) activities during the Croatian Presidency of the Council of the European Union, the Working Group of Quality Managers meeting was held on 9 and 10 June 2020. Due to the COVID-19 pandemic circumstances, the meeting was held virtually.
Organisational support was provided by WGQM chair Klaus Stüwe, BSc biotech. et biol. mol., of the Austrian Agency for Medicinal Products and Medical Devices (BASG-AGES) who also chaired the meeting.
Prof Siniša Tomić, PhD, Head of HALMED, welcomed participants to the meeting and emphasised importance of this working group, whose activities represent a significant contribution to the improvement of quality standards and to the development of best practices within the European Medicines Regulatory Network.
WGQM chair Klaus Stüwe informed the participants on the EMRN Strategy update, as well as on the status of the WGQM documents revision. Moreover, a call for candidates to apply for the position of the WGQM’s chair and co-chair was sent out, whereas elections will be held during the next WGQM meeting in November 2020.
Hrvoje Tumir, PhD, HALMED, Croatian representative in WGQM, presented the work of the HMA’s Benchmarking of the European Medicines Agencies (BEMA) Steering Group in 2020 and announced plans for organising the next BEMA cycle, in accordance with defined key performance indicators (KPIs). During the second part of the meeting, representatives of the National Competent Authorities exchanged information on the most important experiences related to continuity plans and the challenges related to the risk management during the COVID-19 pandemic. Furthermore, the participants discussed current topics related to the implementation of internal audits and the status of the training for internal auditors.
Approximately 60 participants attended the meeting, including members of WGQM and representatives of the European Medicines Agency. The participants evaluated the meeting as very successful and important for maintaining the continuity of the WGQM’s work.
Working Group of Quality Managers (WGQM) operates within the Heads of Medicines Agencies by providing guidance relating to quality management within the Member States, as well as best practice benchmarking and principles within the European Union. WGQM improves the exchange of quality management expertise and reports to HMA on all cases where best practices are considered to be beneficial for European Medicines Regulatory Network.