Scott has over a decade of experience with clinical trial disclosure, initially working for smaller sponsors as a one-person clinical trial disclosure department, to later operating in larger organizations, serving as an expert in summary results reporting and clinical document redaction/anonymization for public disclosure. As part of implementation planning for the EU Clinical Trials Regulation, Scott is AbbVie’s representative in the EMA CTIS sponsor master trainer programme.

Marianne is a medical doctor by training and joined AGES in 2008 as a pharmacovigilance assessor. She was an alternate PRAC member between 2015 and 2017. In 2017, she joined the clinical trial unit at AGES as a safety assessor and has since been part of the Clinical Trials Facilitation and Coordination Group (CTFG) group. Since 2022 she is chairing the group now called Clinical trials coordination group (CTCG). Marianne contributed to the CTFG best practice guidelines for safety assessors for clinical trials and is a member of the drafting team for the Commission implementing regulation for the cooperation in safety assessment of clinical trials.

Francesca Scotti is a pharmaceutical chemist, who worked for pharmaceutical industries in the field of compliance of clinical trials. She joined EMA in 2016 first as procedure manager in the Human medicines division. In 2019, she joined the clinical trials team as a business responsible of the EudraCT database, where she particularly focused on supporting sponsors in raising their compliance with clinical trials’ results posting requirements. Since the last year, she is also leading the implementation of the revised transparency rules in the CTIS public portal.

Ana qualified as a pharmacist and following various roles managing clinical trials for the biopharmaceutical industry joined EMA in 2006. At EMA she spent her initial years coordinating initial marketing authorisation procedures, and later transitioned into the management of post-authorisation procedures. Ana has been Programme Manager for the Accelerating Clinical Trials in the EU (ACT EU), a European clinical trials transformation initiative which is co-lead by EC, HMA and EMA, and is currently the Head of the Clinical Trials Transformation workstream at EMA.

Noémie Manent is the Operations Lead in the Clinical Trial Transformation team at the European Medicines Agency, facilitating change management for member states and sponsors with the implementation of the clinical trial Regulation. She has played an essential role in the set up of structured summary results for clinical trials. Also, she has experience in the coordination of inspections for marketing authorisation application. Noemie has more than 15 years experience working in clinical R&D for small and medium enterprises in industry and academia mainly in France and the United Kingdom.

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.

Polyana Bastos is a strategic regulatory lawyer with extensive expertise in clinical trials, regulatory compliance, quality, data transparency, trade compliance, and policy and regulatory advocacy. Polyana also leads the legal support for J&J’s Clinical Trial Data Transparency Initiative, including the Yale University Open Data Access (YODA) Project data sharing collaboration. As a clinical data transparency subject matter expert, she advises on various internal and external policy work and J&J’s transition to the EU Clinical Trials Regulation. Polyana represents J&J in the EFPIA Clinical Research Expert Group (CREG), serving as co-lead of the Clinical Trial Transparency arm of CREG.

Peter Arlett is Head of the Data Analytics and Methods Taskforce at the European Medicines Agency. In this role he leads on operations and transformation on clinical evidence at the EMA including clinical trials, real world evidence, safety reporting and data science including AI. He is Chair of the EMA Data Board, Co-Chair of the HMA-EMA Big Data Steering Group, Co-chair of the EMA AI Coordination Group, Co-chair of the Vaccine Monitoring Platform Steering Group and Member of the ACT EU Steering Group In addition to his role at EMA, Peter is Honorary Professor at the London School of Hygiene and Tropical Medicine. He is also a Fellow of the Royal College of Physicians of Edinburgh and of the Faculty of Pharmaceutical Medicines of London

Fatima Pimentel joined Syneos Health in 2021 as an Associate Director, Site Start-Up & Regulatory and is also responsible for the training and development of the new CTIS Portal Team. She worked as a Regulator in the Portuguese Agency INFARMED, I.P, between 2005-2021 in the Clinical Trial Unit, as a senior CT coordinator. Fatima was part of several EMA CT groups as well as CTFG. Fátima studied Industrial Pharmacy and obtained a POS-degree in Clinical trials Monitoring. Joining the EMA-CTIS project almost from start as a MS Product Owner and master trainer. Currently she is a trainer in the EMA/DIA CTIS sponsor trainings.

Prior to joining the University Hospital Heidelberg (KKS) 10 years ago, she gained some years’ experience in the pharmaceutical industry. KKS acts with more than 80 staff members as a kind of CRO and provides services to support mainly investigator initiated clinical trials in academic institutions, but also for smaller industries. Since March 2020 Andrea joins EMA´s Clinical Trial Information System testing as a representative of the academia on behalf of the German KKS-Network. This is an association of 26 clinical trial centers, all located at medical faculties and university hospitals with the common task to strengthen activities in clinical trials.