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DoubleTree Bethesdan

Sep 19, 2019 7:00 AM - Sep 20, 2019 3:15 PM

8120 Wisconsin Avenue, , Bethesda, MD 20814 , USA

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.

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

Session Chair(s)

Merete  Joergensen, MBA, MSc

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


Andre  Molgat, PhD

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

Julie G. Holtzople

Industry Experience of Health Canada Submission

Julie G. Holtzople

AstraZeneca, United States

Senior Director Clinical Transparency and Data Sharing

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