Global Clinical Trial Disclosure and Data Transparency Conference

Learn about the latest global requirements in clinical trial disclosure and data transparency, share best practices, and engage in in-depth discussions on hot topics.

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Session 1: Implementation of the Health Canada Requirements of Public Release of Clinical Information

Session Chair(s)

Merete Joergensen, MBA, MSc

Clinical Disclosure and Transparency Expert

Merete-J Consulting, Denmark

Health Canada recently implemented new regulations around the Public Release of Clinical Information. These new requirements cover both retroactive and proactive drug and device applications. Sharing information on best practices to ensure the process will run as smooth as possible both for industry and regulators. How might double work be avoided in relation to almost identical requirements in EU and Canada.

Learning Objective : At the conclusion of this session, participants should be able to:
Analyze and prepare for their organization’s process for the Disclosure according to the Health Canada initiative
Describe the industry perspective in preparing for the implementation
Discuss the requirements and practical processes

Speaker(s)

Overview of the Requirements and the Latest Feedback on the Response to the Received Comments (Remote Presentation)

Andre Molgat, PhD

Health Canada, Canada

Head of Operations, Public Release of Clinical Information

Industry Experience of Health Canada Submission

Julie Holtzople

Holtzople Consulting, United States

President

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