Charalampos (or Babis) is a Change Management Officer for the Clinical Trials Information System (CTIS). He is responsible for various training related activities, including Sponsor and Member States Master Trainers and training material production. Charalampos has previous experience in ERP and CRM implementation projects, in activities related to UAT testing, process creation and user training. Prior to joining EMA, Charalampos worked as a Business analyst (supply chain or marketing) in the chemicals and electronics industries.

Sarah is a Change Management Officer for the Clinical Trials Information System (CTIS). She is responsible for communications planning, the CTIS user personas, and leading sponsor organisation modelling for CTIS from the EMA perspective. Sarah has previous experience in technology projects and change management from her time as a software product manager for an AI-based legal technology application. Prior to joining EMA, Sarah worked as a consultant on new technology projects for the European Commission and various EU agencies.

Pieter Vankeerberghen studied Industrial Pharmacy, obtained a Ph.D. in Pharmaceutical sciences and holds a master degree in informatics. After working for 4 years in R&D, first in Clinical Data Management and later as project manager in human pharmacology, he joined the Belgian authorities in 2000 leading various projects. From 2016 he led their R&D department for clinical trials and unmet medical need. In this role he was a Member State Product Owner for the CTIS project. Since August 2020, he is head of EMA clinical workstream and CTIS programme manager.

Programme Assurance Manager in the Clinical Trials Information System (CTIS) programme managed by the European Medicines Agency to enable implementation of the Clinical Trials Regulation (CTR). Educational background and degrees in veterinary medicine, toxicology and social sciences. More than 20 years of experience alternating between private and public sector in the area of medicines, including in research and development, assessment and regulation of medicines as well as management at EU & national level. At EMA since 2005.

Sara is currently Senior Manager, Scientific Programmes at DIA. In the EMEA region, she is responsible for engaging with external stakeholders and advancing the scientific content strategy by creating opportunities to integrate scientific and regulatory changes of interest in DIA initiatives. Additionally, she is responsible for the regional patient engagement and learning design initiatives, being the liason for the Middle East and SEE regions. Previously, she was Public Health Promotion Projects Manager at the Portuguese Pharmaceutical Society. Sara is a Master of Pharmacy since 2015 and a Soft skills Trainer since 2012, having delivered over 300h of Training internationally primarily focused on creating impactful interactions.

Working in Early Clinical Research for more than 25 years, and leading the implementation of the CT Directive and Belgian law on Clinical Trials for the Pfizer Clinical Research Unit (Brussels) as Regulatory Manager. Member of Pfizer internal workstreams on EU CTR and active tester of the portal since UAT 1 in early 2016. Currently Global Clinical Trial Application Submission Manager in Pfizer Global Regulatory Operations, managing submissions in various European countries as well as outside Europe. Strong advocate of the EU CTR and its portal.

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.

Ana Rodriguez qualified in Pharmacy in 1990 and received her PhD in molecular microbiology in 1995 at Universidad Complutense of Madrid. Since then she has been working in the clinical research field first in the pharmaceutical industry first and since September 2003 at EMA, after joining the Inspection Sector. She became Head of the Clinical and Non-clinical Compliance Service in 2009, being involved in the implementation of the Clinical Trials Regulation (CTR) since its publication as well as in the development of CTIS, providing the business perspective. She moved to the Clinical Trial Workstream in March 2020 with the role of CTIS deputy programme manager and CTIS expert.