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.

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.

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 before joining EMA in 2016, as a procedure manager in the Human medicines division. In 2019 she joined the clinical trials team, becoming first the business responsible of the EudraCT database, and then taking the lead of the implementation of the revised CTIS transparency rules in the new CTIS public portal, which was launched in June 2024.

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.

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.

Lora has 20+ years of business experience, including more than a decade of pharmaceutical industry experience. She started her career in the military serving four years of active duty in the Medical Service Corp for the U.S. Army. In her first pharmaceutical industry position, Lora served for 4 years as Director of Operations for a small medical writing company. She transitioned to Transparency and Disclosure in 2014. During her 8 years in Transparency and Disclosure, Lora has overseen delivery of 5500+ redacted and anonymized documents to support European Medicines Agency Policy 0070, Health Canada Public Release of Clinical Information, other global disclosure regulations and broader corporate transparency policies for many sponsors.

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.

Susanne is as a Scientific Officer in the Clinical Trials Section at Paul-Ehrlich-Institut (PEI), the German Federal Institute for Vaccines and Biomedicines. She is a Biologist by training and holds a PhD in Virology. Before joining PEI, Susanne has worked over 15 years in a global CRO, initially as a CRA, and for several years as a Manager, specializing in clinical risk management and central monitoring. Susanne is a member of the Clinical Trials Coordination Group (CTCG).

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.

Friederike Heckmann is a qualified nurse working on clinical trials since 2014. From 2014 to 2021 she was a study nurse in oncology. As of 2021, Friederike is Approval Officer for the Westfalen Lippe Ethics Committee.