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.

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.

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.

Pharmacist with a Master degree in Pharmacovigilance, working experience at EMA in the Compliance and Inspection department, since 2016 working on the development CTIS and leading on CTIS transparency aspects, EMA liaison at the Clinical Trials Coordination Group (CTCG) and from October 2023 Programme Manager for the ACT EU initiative.

Monique Al is currently special advisor at the Central Committee on Research Involving Human Subjects (CCMO) in The Netherlands. Since May 2023 she is the vice-chair of the Clinical Trial Coordination Group. She is the lead of the CTCG ethics advisory group. Her background is Clinical Nutrition with a PhD in Human Biology. She has worked for several nutritional and pharmaceutical companies in the field of clinical research before she started in 2001 as a scientific staff member at the CCMO.

Marianne is a qualified pharmacist that have been working with regulatory affairs in clinical research within AstraZeneca for more than 20 years. She has led regulatory submissions for new medicines in different phases in development. Currently, she is leading the work with ensuring internal procedures are compliant with external requirements globally, which includes the implementation of the new Clinical Trial Regulation within the company. Marianne is also a CTIS sponsor product owner working with EMA testing the different functionalities of the system.

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.

Maria Elgaard is a special adviser and project manager at the Danish Medicines Agency and currently in an interim position as team manager in the CT unit. Educational background is M.SC.Pharm and she has been working as an assessor of clinical trials application for several years. As of 2016 she has been increasingly engaged in the CTIS project currently as MSPO and master trainer. Nationally she has been appointed business specialist in both the European and the Danish IT solutions for handling clinical trials and other national systems with interaction to the clinical trials area.

Outi Konttinen has served as an executive secretary of the national committee since 2001. She is Master of Social Sciences, political science and public health as her main subjects. Outi has been appointed to represent Finland and/or Finnish RECs in the following EU institutions and other EU-level bodies: European Commissions Clinical Trials Expert Group; European Network on Research Ethics Committees (EUREC); EMA CTIS expert group and Union database meeting with Member States, EMA.

Roxana-Mirela Spulber joined the European Medicines Agency in November 2021 as a Change Management Officer in the TDA-CTS team. Roxana has extensive marketing experience, having worked for Oracle and IBM for 14 years. Today, she is a member of the operation workstream for the Clinical Trial Information System (CTIS), Data Analytics and Methods Task Force, focusing on training and events.

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

Maria has been working in Clinical Research for over 10 years as a Study Coordinator, CRA and Study Manager. She has been with Eli Lilly for almost 3 years, initially as a Sr. Trial Capabilities Associate and more recently as a Sr. Manager for Trial Capabilities. Maria is the Eli Lilly Master Trainer for CTIS and has been involved in the rollout of the CTR within Lilly, as well as the preparation for the initial clinical trials submitted through the CTIS portal.