Dr Samvel Azatyan is a Paediatrician with a PhD in clinical pharmacology and medical products regulation. Over his more than 24 years at WHO, he has had a wide range of leadership roles associated with the regulation of medical products, including supporting regulatory collaboration, convergence and harmonization, as well as regulatory capacity building and facilitation of products introduction in the countries. Dr Azatyan has also led various projects aiming at development of national regulatory systems, as well as the development and implementation of the concept of reliance in regulation of medical products. Dr Azatyan is currently leading the Regulatory Convergence and Networks Team at the WHO's Headquarters in Geneva, Switzerland.

Francis P. Crawley is the Executive Director of the Good Clinical Practice Alliance – Europe (GCPA) and the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) in Brussels, Belgium. He is a philosopher specialised in ethical, legal, and regulatory issues in health research, having taught at several European, Asian, and Middle East universities. He is an expert in ethical review, data protection, and data sharing. He is a Data Protection Officer (DPO) on European Commission funded clinical research programmes. He currently chairs the methodologies sub-group of the Real Word Data Working Group at the Faculty of Pharmaceutical Medicine, Royal Colleges of Physicians.

Viktoriia Dobrova is PhD (Medical Device) and Doctor of Science (Pharmacy), professor, and Vice-chair of the Research Ethics Committee of the Clinical and Diagnostics Centre of the National University of Pharmacy, Ukraine. She focused on studies in the fields of quality management and good statistics practice clinical trials, cost-effectiveness analysis, and research ethics. She took part in research ethics projects at international as well as national levels. She was involved in the development of regulatory guidelines, Master Degree Program “Clinical trials” for Clinical Research Professionals in Ukraine, and designed the curriculum and core courses for it. Now she is a Research Associate at Heidelberg University Hospital, Germany.

Taisa Herasymchuk received a PhD degree in Pharmacy at Danylo Halytskyi Lviv National Medical University. She has significant work experience in the field of medicinal products regulation from expert to management positions, previously she served as Head of the Registration Materials (Quality Part) Expert Evaluation Department, Head of the Biologicals/Biotechnological Medicinal Products Materials (Quality Part) Expert Evaluation Department of the Pharmaceutical Activity Board at the State Expert Center of MoH of Ukraine, and as a Director of the Central Laboratory for Quality Control of Medicinal Products of MoH of Ukraine.

Ina Rondak is working for the EMA as a Statistician in the Methodology workstream of the Data Analytics and Methods Task Force since 2020 and was seconded to the EMA as National Expert since 2015. Prior to that she worked at the Institute of Medical Statistics and Epidemiology of the university hospital of TU München and holds a degree in Statistics from LMU München and a Postgraduate Diploma in Medical Statistics from the University of Auckland. She was coordinating the development of the methodological guidance in relation to the COVID-19 pandemic and the war in Ukraine.

Stefan Strasser trained as a medical doctor at the University of Innsbruck in Austria. He joined the Austrian Medicines and Medical Devices Agency in 2009 as a clinical assessor. His special interest are the regulatory and process aspects of clinical trials with medicinal products, medical devices and IVDs as well as their interfaces (combination products and combination trials). He is a member of several working groups of the EC and the EMA, including the CT Experts Group on Clinical Trials, the Clinical Trials Facilitation Group and the EUDAMED CI/PS WG. Since 2019 he is the head of the department of clinical trials and responsible for the implementation of the various regulations (CTR, MDR and IVDR) regarding clinical trials.