Fergus Sweeney is Head, Clinical Studies and Manufacturing Taskforce at the European Medicines Agency since March 2020, covering Clinical Studies (Clinical Trial Information System), Biological Health Threats and Vaccine Strategy and supports strategy development in manufacturing and personal data protection in health research on medicines. He joined the EMA Inspections Service in 1999, and became Head of Compliance and Inspections (2009) and Head of Division Inspections and Human Medicines Pharmacovigilance in 2013 (including Scientific Committee Services from 2016). He has a BA (Physiology 1979) a Dr de 3eme Cycle (cancer biology 1982), and PhD (Pharmacology 1986). Fergus worked in clinical research mainly in QA from 1982 to 1999.

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.

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.

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.

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.

Kristof is an industrial pharmacist. Being a Belgian national, he started working for the Belgian Federal Agency of Medicines and Health Products in 2005, and in 2009 he took up the responsibility for the Research and Development division, in charge of clinical trial applications. He was the Belgian member and secretary of the Clinical Trial Facilitation Group, and the Belgian representative in the European Commissions Clinical Trial Expert Group. He was also part of the negotiations of the Clinical Trial Regulation in 2013 and 2014. After a brief period working for the association of the Belgian pharmaceutical industry from 2016 onwards, he joined the EU Commission in 2019.

Stéphanie Kromar joined the European Organisation For Research And Treatment Of Cancer (EORTC) in 2013. Since September 2022, she is the Head of the Regulatory Affairs department. She has experience in the preparation, submission, and follow-up of Clinical Trials Applications from the development until the end of the trial, on complex trial designs and she provides regulatory advice. She has an in-depth knowledge of the CT Regulation, was involved in the CTIS project almost since the beginning and she also took part to the review of the CTIS training material.

Ruediger Pankow holds a university degree in Biology and is a Regulatory Affairs professional with more than 17 years of experience in the clinical research and trials regulatory space, mostly in the CRO industry. His specific area of expertise is the EU Clinical Trials Regulation 536/2014 (EU CTR) and EU CTR implementation at industry level, including for his past employer Parexel. Since 2019 he has been continuously involved for ACRO as an industry stakeholders' representative (sponsor product owner / external SME) in EMA's Clinical Trial Information System (CTIS) delivery project, and is DIA instructor of EMA's CTIS sponsor end user training programme.