Professionals from Industry, Academia, Regulatory Authorities and other domain involved in:

• Clinical trial disclosure
• Data transparency/data sharing
• Transparency policies and compliance
• Statisticians and biometrics
• Medical writing, medical affairs, and medical communications
• Clinical operations
• Compliance/Legal
• Clinical Data Protection responsible
• Regulatory
• Publications
• Data management
• Clinical/Medical Research
• Patient Advocacy

• Benefit from the various perspectives on regulatory, legal aspects and practical challenges from large to smaller sponsor organisations.
• Leverage best practices on the practical implementation through case studies by the exchanging of views between regulators, industry, patients, academia and other stakeholders.
• Gain insights into how the transparency provisions in the EU Clinical Trial Regulation are implemented in the Clinical Trial Information System (CTIS) and how the latter works.
• Spotlight focus on disclosure requirements in the US, Canada, the EU, the UK, China, and Japan.
• Use a unique opportunity for networking and asking questions to your own specific situation and area of responsibility.

Attendees will:

• Learn about current and upcoming disclosure requirements, with spotlight on the US, Canada, the EU, the UK, China, and Japan
• Gain insights into how the transparency provisions in the EU Clinical Trial Regulation are implemented in the Clinical Trial Information System (CTIS) and how the latter works
• Explore the impact of data protection for personal data and options and functionality of protection of commercially confidential information
• Obtain practical suggestions for preparing disclosure-ready study documents, including redaction options
• Review the requirements for lay language summaries and options for producing these documents
• Network with regulators, industry, patients, academia and other stakeholders to ask questions and leverage best practices for your own specific situation and area of responsibility