Merete Joergensen holds an MSc in Statistics and an MBA in Management of Technology. She has more than 30 years of experience in Clinical Research. From 2004 she has been building up the area of Clinical Trials Disclosure in Novo Nordisk. She is now working as a senior specialist for the area of clinical disclosure. Prior she headed up Biostatistics in Novo Nordisk A/S for 15 years and worked 7 years as a Clinical Statistician at the medical faculty at Copenhagen University. Further she is Clinical Trials Transparency pillar lead, under the Clinical Research Expert Group in EFPIA.

Scott has over a decade 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. As part of implementation planning for the EU Clinical Trials Regulation, Scott is AbbVie’s representative in the EMA CTIS sponsor master trainer programme.

Robert Paarlberg is Principal of Paarlberg & Associates LLC, a consultancy specializing in regulatory policy, regulatory intelligence and global clinical trial disclosure strategy and operations. Prior to founding Paarlberg & Associates LLC, Bob worked at Pharmacia (Upjohn) and UCB. Bob is former Chair of DIA’s Clinical Trial Disclosure Community. Bob has more than 40 years of pharmaceutical industry experience with the vast majority of his experience in US and international regulatory affairs. Bob has been active in the clinical trial disclosure and transparency space since 2005.

Matthias Zerm is a Lead Expert Clinical Trial Disclosure and R&D Processes at Merz Therapeutics located in Frankfurt/Germany. In this role he coordinates and oversees all clinical trial disclosure activities including registration and results submissions. He is also involved in a wide range of organizational and process-related projects at Merz Therapeutics, such as preparing for the EU-CTR. He is a biologist by training and has >15 years of global experience in the clinical research arena.

Thomas M. Schindler, PhD, has studied biology and linguistics, was a member of the TransCelerate Return of Results and Clinical Research Access work streams, is contributing to the Good Lay Summary Practice initiative and the Plain Language Summary Guidance of PFMD. He has some 25 years of experience in both medical affairs and regulatory medical writing, and leads the plain language and lay summary initiatives as head of Innovation Medical Writing at Boehringer Ingelheim Pharma.

Joyce Swart is the Clinical Disclosure Lead at Alcon Research, LLC, a major eye care device company operating in the global marketplace. For over 10 years she has been responsible for understanding disclosure requirements specific to medical device trials, developing disclosure practices and processes for companywide implementation, and overseeing the registration of medical device trials on ClinicalTrials.gov and other public registries. She is also skilled in registering drug studies and posting results on ClinicalTrials.gov and EudraCT. Joyce received her B.S. from Rutgers University, New Brunswick, New Jersey.

Thomas Wicks is the Head of Data and Partnerships at Citeline, where he is responsible for the organization’s data governance and interoperability as well as tracking regulatory requirements and clinical data sharing trends that shape the company’s clinical transparency solutions and services. He has over 25 years of experience with compliance management solutions, specializing in applications for life sciences with a focus on clinical trial disclosure and transparency since 2007.

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

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.

Rebecca Williams, PharmD, MPH, is a Clinical Trials Subject Matter Expert with Essex, Part of Emmes Group. In this role she supports strategic policy and data initiatives with the National Cancer Institute’s Coordinating Center for Clinical Trials. Prior to this role she was the Acting Director of ClinicalTrials.gov at the National Library of Medicine (NLM) after having served as the Assistant Director for over a decade. She has also worked in regulatory and policy aspects of prescription drug advertising and promotion at the Food and Drug Administration and as a consultant. She received her Pharm.D. from the University of Wisconsin-Madison and MPH from Johns Hopkins Bloomberg School of Public Health.

Dr. Anna M. Fine joined the National Library of Medicine, NIH in 2018 and is Acting Director of CinicalTrials.gov. She leads the scientific, policy, regulatory and outreach activities related to the operation of ClinicalTrials.gov, including the modernization initiative. Her previous experience includes over a decade of service in stakeholder engagement, adverse drug event reporting, and supervisory roles at the U.S. Food and Drug Administration. Prior to that, she was Chief of Pharmacy Services at Hanscom Air Force Base in Massachusetts. Dr. Fine has a PharmD from Northeastern Univ. and an MS in psychopharmacology from William James College. She completed a postgraduate year two drug information residency at Stanford Hospital.

Vilmantas Navickas is the principal operations manager at Boehringer Ingelheim, responsible for clinical trial disclosure activities globally. He has more than ten years of experience in disclosure and data transparency, leading and collaborating with teams for design, implementation of processes, solutions, and initiatives.

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.

Radu Popescu has been with the European Medicines Agency (EMA) for more than 10 years and worked in various positions. Currently, he is a member of the Documents Access and Publication Service. Following the completion of his medical training he was attracted by clinical research. He worked for several CROs before joining the EMA. His career path followed the clinical data trail from its source (the research centre) to where the final review is performed (the regulator). He had the opportunity to work in several countries: Romania his home country, Sweden, The UK and now The Netherlands. This path satisfied his quest for new challenges and allowed him to experience the multiple connotations of the EU motto: ‘United in Diversity’.

Currently Head of Strategic & Technical Operations within Regulatory Affairs at Bayer Pharma leading a global team focusing on submission, labeling, outsourcing, quality management, and RIM activities. Before that Gerd directed the global Regulatory Strategy teams for oncology, hematology, and ophthalmology at Bayer. He was member of the DIA Euro organizing committees for the meetings 2018 in Glasgow and 2020 in Brussels.

Catherine D’Arcy is a Program Manager for Vivli, Inc., a small non-profit company dedicated to global data sharing. Prior to joining Vivli, Catherine gained over 30 years of experience in the pharmaceutical industry, most recently managing data sharing requests for GSK, and prior to that within various aspects of clinical trial operations, including project management, resource management and data management. She has a bachelor’s degree in Medical Biochemistry from the University of London.

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.

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.

Etienne has been with Health Canada since 2016 and with Public Release of Clinical Information team since 2020. Prior to joining PRCI, Etienne acquired experience reviewing clinical trial applications in Health Canada's Biologics and Radiopharmaceuticals Drugs Directorate, as well regulatory assessment and review in the Controlled Substances and Cannabis Branch. He has an MSc in Pharmaceutical Sciences: Drug Development from the University of Montreal.

Sandeep works for Novo Nordisk as a Senior Disclosure Medical Writer. He has an overall experience of 8 years in clinical trials disclosure and transparency. His expertise includes registration and results submissions on ClinicalTrials.gov and EudraCT, clinical document redaction/anonymization for public disclosure to support European Medicines Agency Policy 0070, Health Canada Public Release of Clinical Information, and other global disclosure regulations.

Education 1989-1995 Medicine, University of Cologne, Germany Occupational Carreer Until 2000 Doctoral Thesis on animal models for sepsis research 1998-2002 Research associate (MD) Department for Visceral Surgery, University of Cologne, Germany 2000-2002 Research associate (MD) Department for Surgery II, Biochemical and Experimental Division, University of Cologne 2002-2005 Research associate (MD) Coordinating Center for Clinical Trials Cologne Current Postion Since 2005 Head of the Office of the Ethics Committee of the Medical Faculty of the University of Cologne, Germany Miscellanous Since 2014 Member of the board of the Working Party of Medical Ethics Committees in Germany EC Representive in several EMA working groups

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.

Adian Talib holds a Master's of Science in Biochemistry with a minor emphasis on Pharmaceutical Law. She has more six years of experience in Clinical Research spreading from site level monitoring to industry. She currently holds a position with BeiGene as a data disclosure associate. Adian is skilled in registering drug studies and posting results on ClinicalTrials.gov, EudraCT, CTIS, jRCT, and ChinaDrugTrials. Integrating companies into adapting international regulations for registrations and ensuring transparency among clinical trials is a continuous goal of Adian's.

Aaron Mann is Chief Executive Officer at the Clinical Research Data Sharing Alliance. Aaron led the 2021 multi-stakeholder effort to establish CRDSA and initially served as CRDSA’s Senior Vice President, Data Science. Before co-founding CRDSA, Aaron was Roche and Genentech’s Global Program Lead for Industry Collaborations Data Sharing Initiatives. As part of his role at Roche, Aaron served as the industry lead for DataCelerate, TransCelerate BioPharma’s data-sharing platform, and Platform Lead for the industry’s COVID-19 patient-level data-sharing initiative.

Dr. Elke Stahl, Clinical Trial Unit BfArM, Germany. Clinical Trials Senior Expert. CoChair of the Clinical Trial Facilitation Group (CTFG) till 2022. Involved in EMA’s EU CTIS groups as BfArM’s representative, National Contact Point for the CTR in Germany, representative in European Commissions CT working groups. Prior BfArM 10 years experiences as a pharmacokineticist at Bayer HealthCare AG, Germany, in early research up to candidate selection. PostDoc at Hoffmann-La Roche Inc and University of North Carolina (UNC). Ph.D. in pharmacology and licenced pharmacist.

Wendy Wimmer is a Director in the Clinical Data Disclosure & Transparency department at Merck Sharp & Dohme. She has over 25 years of clinical research experience and over the last 6 years has created and currently manages a centralized document transparency functional area for her company. Most recently, she has been responsible for the implementation of the transparency processes accompanying the initiation of the EU Clinical Trial Regulation.

Julia A Gindele studied pharmaceutical biology and biological sciences in Germany and obtained a doctoral degree in human biology. In 2020, she decided to become a medical writer and joined the Medical Writing group at Boehringer Ingelheim Pharma. She is currently completing a plain language writing degree. She supports the development of lay summaries across all therapeutic areas and regularly writes and reviews lay summaries. In addition, she develops scripts and storyboards for lay summary videos and videos to support trial recruitment. Besides, she supports the development of other lay language documents and gained experience with the new lay protocol synopsis.

Director of Data Analytics Centre at the Danish Medicines Agency and co-chair of HMA / EMA Big Data Steering Group. 20 years for life science experience in academia and industry. Been leading EU framework programme workpackages, IMI and TransCelerate Biopharma workstreams in the past. Currently active in development of FHIR for clinical research and use of AI/ML in life science.

Rob is a partner at Consilium, a consultancy partnership between Rob Hemmings and Tomas Salmonson, both long-standing contributors to the EU regulatory network. Consilium supports companies in the design of clinical development programmes, the design, analysis and interpretation of clinical trials, regulatory strategy and regulatory interactions. Previously Rob worked at AstraZeneca and then for 19 years at the MHRA, during which time he served as CHMP member at EMA for 11 years and chaired the Scientific Advice Working Party at EMA. Rob has co-authored multiple regulatory guidance documents and continues to work on any and all aspects of evidence generation and regulatory policy in respect of medicine’s development.