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The European Clinical Trials Environment Under the Accelerating Clinical Trials (ACT EU) Initiative: Two Years On
Session Chair(s)
Ana Zanoletty Perez
Head of Clinical Trials Transformation Workstream
European Medicines Agency, Netherlands
Accelerating Clinical Trials in the EU (ACT EU) and the successful launch of the clinical trial regulation have modernized the clinical trial environment. This session is focused on how Europe is embracing the change and will also present other international initiatives offering opportunities for collaboration.
Learning Objective : Describe how ACT EU, together with other EU initiatives, is providing a platform to optimize clinical research and development, and fostering innovation through joint collaborations between member states, ethics committees, and stakeholders, bringing tangible benefits for patients, sponsors, and regulators; Discuss other international clinical trial initiatives and potential areas of collaboration.
Speaker(s)
FDA Update on Clinical Trials
Kevin Bugin, PhD, MS, RAC
FDA, United States
Deputy Director of Operations, Office of New Drugs, CDER
Clinical Trials Transformation Initiative (CTTI): Innovation though collaboration
Sara Bristol Calvert, PharmD
Clinical Trials Transformation Initiative (CTTI), United States
Director of Projects
Patient Perspectives on ACT EU: Foundational to Clinical Trial Priorities
Deborah Collyar
Patient Advocates In Research (PAIR), United States
President
Advances in Clinical Trials: WHO update
Marion Laumonier, MSc
World Health Organization (WHO), Switzerland
Technical Officer, Regulatory Convergence and Networks
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