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 has served as 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.

Nate is Disclosure and Transparency professional with over 7 years of experience in the environment, working with CROs, Big Pharma, Non-Profit, and Small Biotech, as well as being a member of the DIA Disclosure Community Core Team, PhUSE CTD working group, Co-Author of Disclosure and Transparency white papers, and creator of the West Coast Disclosure and Transparency Community. At Ionis, Nate leads the Transparency Department and also manages Regulatory Policy.

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.

Julie Holtzople is a seasoned Clinical Trial Transparency professional. She spent 10 years building Clinical Transparency and Data Sharing at AstraZeneca, becoming an expert in Plain Language Summaries, Clinical Document Anonymization and Clinical Data Sharing. She also led the implementation and readiness for EU CTR Transparency requirements. Julie has been an active member of numerous CTT working groups and organizations contributing to CTT standards and best practices. Prior to AstraZeneca, she started her career as a management consultant working at Ernst & Young and then Booz Allen. Julie has recently returned to consulting. She specializes in Clinical Trial Transparency, process optimization and program delivery.

Kristin McDougall focuses on all things Transparency and Disclosure at d-wise. As the Director of Clinical Transparency she ensures a unified, reproducible approach to safeguarding the sharing of data and documents.

Rose-Marie joined Bayer in July 2013 and is a Senior Manager in EU Regulatory Policy & Intelligence, with special responsibility for CTR implementation and Transparency within the Company. Rose-Marie came to Bayer with over 20 years EU regulatory experience in both the prescription and non-prescription healthcare sectors gained within a number of large research based Pharmaceutical Companies; as well as having worked as a Senior Regulatory Consultant in a small CRO. Rose-Marie has a BSc (1st class hons) in Chemistry and Biochemistry.

Nick is a Policy Advisor for Regulatory Strategy at EFPIA. Nick’s current focus is on the revision of the general pharmaceutcal legislation, regulatory aspects of the Innovative Health Initiative (IHI), and the interface between the drug, device and diagnostics legislative frameworks in the EU. Prior to working at EFPIA, Nick spent 25 years at Pfizer within their Global Regulatory Sciences team. His last role in Pfizer was as Head of Europe and International Regulatory Policy. In this role he was also Co-Chair of EFPIA's Regulatory Strategy Committee. During 2019 Nick was President of TOPRA and Chairman of TOPRA's Board of Directors. Nick has a graduate degree in Genetics/Microbiology and a master’s degree in Information Science

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.

Elena is a pharmacist by training with a master in drug safety and pharmacovigilance. She joined Bayer as a Regulatory Policy & Intelligence Lead and provides direction and development of Regulatory Policy & Intelligence activities supporting Bayer’s pipeline and strategies, with a particular emphasis on the regulatory use and acceptance of RWD/RWE in drug development. Before joining Bayer, Elena was a Senior Manager, Scientific Programmes at Drug Information Association and engaged annually with over 500 stakeholders and volunteers from the entire healthcare ecosystem. In her free time, Elena is passionate about traveling, visiting art museums, painting and watching Formula 1 (#essereFerrari).

Céline Bourguignon has a track record of more than 25 years in the healthcare sector at European and international level both in the public and the private sector. Céline joined GSK in 2021 to lead the Greater China and Intercontinental & Emerging Market Regulatory Policy team. She joins from Cardinal Health where she served during the last three years as head of Quality, Regulatory and Clinical Affairs for the EMEA region, and as a member of the European Leadership team.Céline held various Chair or Vice-Chair positions within Medtech Europe (Eudamed, UDI & Supply chain, Regulatory Affairs Committee).

Dr Anne-Sophie Henry-Eude has a degree in pharmacy from the University of Lille in France and postgraduate degrees in Regulatory Affairs and in Pharmacovigilance & Pharmacoepidemiology. She worked in the pharmaceutical industry before joining EMA as product team leader for anti-infectives and later as paediatric coordinator in the HIV and vaccines field. In 2013 she put in place a Service to centralised activities linked to access to documents (Policy 0043) and later Clinical Data Publication (Policy 0070). Since 2021, she is Head of Documents Access & Publication, a Department, which manages transparency activities at EMA.

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.

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.

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.

Judith Creba has many years experience in drug development, regulatory affairs and strategy at Novartis. She has worked in a range of therapeutic areas, including Oncology, Infectious Diseases, and Cardiovascular, before moving into EU Regulatory Policy where she has represented Novartis on a number of trade association committees. Judith is currently involved in clinical trials policy and is co-chair of the EFPIA Clinical Research Expert Group. She is also leading implementation of the new EU clinical trial regulation within Novartis.

Amanda has extensive experience in health research, research ethics and patient engagement. She currently works as a freelance consultant and medical writer specialising in lay summaries. Formerly Amanda was Head of Policy and Public Affairs at the Health Research Authority (HRA) in the UK from 2012 to 2019. During th8is time she led an EU wide taskforce to work on the development of EU guidelines for lay summaries of clinical trials. Early in her career she worked for Boots Pharmaceuticals as Head of Business Information for before moving to the Department of General Practice at the University of Sheffield as a Research Fellow. She later took up the post of Director of Research & Development at the Northern General Hospital in Sheffield.

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.

Christopher Price LLB, MA, MTOPRA is a lawyer and biologist by training, he has built up more than 15 years of EU and global experience in clinical strategy & dossier management in several global biopharma companies and at CROs. As well as oncology, he has experience in antiviral, central nervous system, and immunology therapeutic areas. He has also worked in regulatory project management and eCTD submission management. Chris is a representative on behalf of EFPIA in the Clinical Trials Information System (CTIS) Process Owners group, which is working in close collaboration with the EMA, European Commission and the Member States on developing a fully functional system. Currently chair of the clinical trials special interest network at TOPRA.

Nancy Sager serves as Director, DIDP, Center for Drug Evaluation and Research (CDER), FDA. Her staff is responsible for reviewing and redacting a large variety of documents including internal memoranda, scientific reviews, and inspection documents to respond to Freedom of Information Act (FOIA) requests submitted by the public, third-party subpoenas and FOIA lawsuits, Congressional inquiries, and requests from federal, state, local, and foreign government officials. Prior to moving to DIDP, she held various positions in CDER including as a review chemist in the Office of Generic Drugs and as Special Assistant to the Director and Associate Director for Quality Implementation Chemistry in the Office of Pharmaceutical Science.

André Molgat is the Head of Operations for Health Canada's Public Release of Clinical Information initiative. He was previously a core member of the team responsible for the initiative's regulatory and policy development. André has a PhD in biochemistry and post-doctoral training in biochemistry and stem cell biology.

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.

Sameer Sharma works as a Clinical Trial Transparency Manager at Merck KGaA, Darmstadt, Germany since 2015. He has 10+ years of experience in the Clinical Trial Transparency and Medical Writing domain. At Merck, he is responsible for setting up the processes and overseeing redactions and anonymizations as per worldwide redaction regulations not limited to EMA policy 0070, Health Canada-PRCI, Japan PMDA, EMA Policy 0043, and ad hoc redaction requests. He holds a Masters in Pharmaceutical science and a registered Pharmacist.

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.