The program is assembled around key themes:

• Performance of Clinical Trials during the Pandemic: Lessons Learned
• Practical Aspects of the EU CTR and CTIS
• De-Centralization of Clinical Trials – Different Stakeholder Perspectives
• Future Developments and Projects on Clinical Trial Regulations

• Regulatory agencies (assessors, reviewers, inspectors)
• Sponsors of non-commercial clinical trials
• The pharmaceutical industry and contract research organisations, including:
 - Regulatory affairs personnel in clinical research
 - Professionals in charge of clinical trial strategy
 - Regulatory intelligence and policy professionals
 - Change managers for clinical trials business processes
 - Clinical research professionals working with submission, data, information sharing
 - Clinical safety professionals

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• Understand the impact of the new requirements on running clinical trials in Europe along with the practical and operational considerations for implementation by authorities and clinical trial sponsors
• Identify the opportunities and consider how to overcome the key challenges of the requirements particularly for novel clinical trial approaches
• Leverage insights on how companies and research institutions are fine-tuning and optimising processes to meet the requirements of the Clinical Trials Regulation
• Exchange views between regulators and other decision-makers, clinical trial sponsors, patients, and other stakeholders