Dr. Peter Arlett leads the Data Analytics and Methods Taskforce at the European Medicines Agency (EMA), overseeing clinical evidence, real-world data, AI, and safety reporting. He chairs the EMA Data Board and co-chairs several key groups, including the HMA-EMA Big Data Steering Group and the Vaccine Monitoring Platform. Before joining EMA in 2008, Dr. Arlett worked at the European Commission, served as a UK delegate to the European Committee for Human Medicinal Products, and held roles at the MHRA. He trained as a physician in Oxford and London, holds a medical degree from University College London, and is Honorary Professor at the London School of Hygiene and Tropical Medicine.

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.

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.

Linda Abdelall works on Clinical Trials at the European Commission, DG SANTE since April 2022. She coordinates the Clinical Trials Coordination and Advisory Group (CTAG) and the European Commission’s Clinical Trial Expert Group (CTEG). She is a pharmacist by training and has a MSc degree in Governance and Leadership in European Public Health from Maastricht University.

Scott has 15 years 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. Scott is designated as a CTIS subject matter expert by the EMA and serves as EuropaBio representative for the EU Clinical Trials Regulation.

Caroline is Associate Director in Global Regulatory Policy at Bristol Myers Squibb, based in Switzerland. She holds a Masters Degree in Political Sciences from Sciences Po Paris with a specialization in European Law. She has been working in the pharmaceutical industry for the past ten years. She has been working on preparing her organization and the industry in general for the implementation of the Clinical Trials Regulation since 2017. In particular, she has been leading the industry's efforts relevant to transitioning clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation since 2021, through cross-trade associations (representing big and small companies, commercial & academic sponsors) advocacy activities.

Leonard H. van den Berg is a professor of neurology who holds a chair in neurology focused on Motor Neuron Disorders at the University Medical Center Utrecht in the Netherlands. He is founder and director of the Netherlands ALS Center,and chair of the European Network to Cure ALS (ENCALS), a network of the European ALS Centres, and of TRICALS, a European Trial Consortium. As a practicing neurologist specializing in neuromuscular diseases, a major emphasis of his research has been in ALS and other motor neuron disorders, and he has been a principle investigator on numerous drug trials concerning treatment options for these diseases. He is author of over 650 peer reviewed publications.

Elena García Méndez is a Pharmacist, with post-graduate courses for a PhD program in Microbiology and a Master's Degree in Clinical Bioethics. She has an extensive experience in clinical research with drugs and advanced therapies in different therapeutic areas and in all phases of clinical development. She worked for 30 years in the Clinical Research/Operations department of a multinational pharmaceutical company holding different positions with increasing responsibility (from CRA to Head of Clinical Operations). She joined the Technical Secretariat of the Ethics Committee for the Research with Medicinal Products of Universitary Hospital La Paz - Hospital Cantoblanco - Hospital Carlos III in March 2021.

Laura is a Clinical assessor in the Clinical Trials Division of the Spanish Agency for Medicines and Medical Devices since January 2021. During the last two years, her focus was primarily on facilitation of the implementation of the Clinical Trials Regulation (CTR) and the Clinical Trials Information System (CTIS) in Spain. Laura was appointed Master Trainer in Spain in November 2021, and manages everything related with the CTR and CTIS since then.

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.