Training of the European Medicines Agency’s Quality Working Party (QWP) hosted in Zagreb
01.12.2025
Training of the European Medicines Agency’s (EMA) Quality Working Party (QWP) was held in Zagreb from 27 to 28 November 2025. The meeting was organised by the Agency for Medicinal Products and Medical Devices of Croatia (HALMED). Titled "QWP 2025 training on quality and (bio)equivalence aspects of locally applied, locally acting, cutaneous and gastro-intestinal tract products and oral modified release products”, the meeting was conducted in a hybrid format and brought together around 282 assessors from the national competent authorities of the European Union Member States, of which 82 participated on site and around 200 participated virtually.
Rajka Truban Žulj, MParm, spec., Assistant Director of HALMED, and Nick Lee, PhD, Co-Chair of the Quality Working Party, welcomed the participants and emphasised the importance of continuous professional development in the field of quality assessment of medicinal products. In their opening remarks, they highlighted the importance of knowledge exchange and scientific dialogue as a foundation for informed regulatory decision-making, wishing the participants productive and insightful sessions.
In her welcome address, Rajka Truban Žulj stated: "I would like to thank the Quality Working Party for its continuous dedication and for recognising the importance of providing professional and scientific training opportunities. The topics covered in this year’s programme reflect the complexity and evolution of medicinal products and are a testament to the expertise of the members of the Quality Working Party, whose work is important for ensuring that medicinal products placed on the market meet the highest quality standards.”
QWP Co-Chair Nick Lee added: "Thank you to all participants for your willingness to engage in dialogue and expand your knowledge in areas that are becoming increasingly complex in our assessment work. I would also like to thank HALMED for hosting and organising this event, as well as the EU NTC for their support in making it possible.” Mr Lee also expressed his gratitude to Ivica Malnar, MPharm, PhD, - Croatia’s representative in the Quality Working Party and Senior Assessor for medicinal product documentation at HALMED - for his contribution to the organisation and coordination of the meeting.
The training served as a platform for assessors from national competent authorities across the European Union to exchange experiences and discuss key aspects related to quality evaluation of medicines. The two-day programme featured 16 expert presentations on locally applied and locally acting cutaneous medicines and oral modified-release formulations, delivered through the following thematic sessions: Introduction and development of locally applied, locally acting cutaneous products; Different formulation aspects for locally applied, locally acting cutaneous products; Equivalence aspects of locally applied, locally acting cutaneous products; Control strategy for locally applied, locally acting cutaneous products; Quality and equivalency aspects of oral modified release dosage forms.
Each session encouraged discussion and participant engagement. The presentation "In vitro dissolution studies with alcohol for oral modified release products”, held by Maja Lusina Kregar, MPharm, PhD, HALMED’s Principal Advisor for Medicinal Product Documentation Assessment, provided valuable insights into methodological considerations and regulatory expectations related to dissolution studies involving alcohol.
The training reaffirmed the importance of European regulatory collaboration and ongoing professional development of assessors working in the field of medicinal product quality, thereby contributing to the safe and effective use of medicines across the European Union. By hosting this event, HALMED further strengthened the European regulatory network and supported continued successful cooperation among European quality assessors.
The Quality Working Party (QWP) is a joint working party of the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Veterinary Medicinal Products (CVMP). The QWP provides recommendations to the European Medicines Agency's (EMA) scientific committees on all matters related to quality aspects of medicines with chemical active substances.
More information about the Quality Working Party is available here.
