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.

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.

Edit is a board-certified pathologist with a Ph.D. in cell and molecular biology. Before joining the European Commission in 2016, she worked as a postdoctoral fellow at the Diabetes Research Center of the Vrije Universiteit Brussel (VUB) and then as a translational research physician at the European Organisation for Research and Treatment of Cancer (EORTC). Edit worked in the medical devices team in DG SANTE between 2016-2018, when she moved to work at the clinical trials team.

Dr. Lungu has over 30 years’ experience in drug development, clinical research, Pharmacovigilance and quality assurance. He conducted more than 160 Pharmacovigilance quality system audits in more than 40 countries around the globe. Apart of audits, he is a dedicated trainer of the official EMA EudraVigilance and XEVMPD training programmes and led over 300 offerings since 2004.

Pierre-Frédéric Omnes recently joined Transperfect Life Sciences & has over 20 years of experience in global CROs and Pharma Companies as Regulatory Affairs consultant, overseeing numerous multinational clinical trial applications globally. He is a subject matter expert on SSU and Regulatory Operations in global clinical trials as well as on the EU CTR 536/2014 for corporate readiness, implementation, EU Portal, transparency. Pierre is part of the EMA-led initiative developing the CTIS as Lead Product Owner representing the Industry & Academia, continuing his engagement of several years in User Acceptance Testings, Workshops and Analysis& Design sessions related to the system development.

José is an expert in the field of Pharmacovigilance and Drug Safety. He has experience both from the Regulatory (Danish Medicines Agency), and from the Pharmaceutical Industry, where he has been responsible for Pharmacovigilance IT systems, databases and electronic transmissions. He has been training EVWeb and XEVMPD training courses since 2004, and collaborates in the development of these training courses. He provides also EU QPPV services and local QPPV services in Spain for Pharmaceutical Companies.

Ruediger holds a university degree in Biology and is a clinical regulatory affairs professional with history of more than 16 years in the CRO industry at Parexel, where he last was Principal Consultant in the clinical trial regulatory services. He was involved in his company's EU Clinical Trials Regulation 536/2014 (EU CTR) readiness implementation, and has contributed for ACRO to EU CTR stakeholder activities with EU Regulators and EMA. Since 2019 he has been a sponsor product owner for ACRO in EMA's Clinical Trials Information System (CTIS) delivery project providing input on design and development of system functionalities and guidance material, and is DIA instructor of EMA's CTIS sponsor user training programme.

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.