Session 1: Implementation of the Health Canada Requirements of Public Release of Clinical Information
Merete Joergensen, MBA, MSc
Clinical Disclosure and Transparency Expert, Former EFPIA, CREG Clinical Trials
Merete-J Consulting CVR: 34920818, 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
Overview of the Requirements and the Latest Feedback on the Response to the Received Comments (Remote Presentation): Andre Molgat, PhD
Head of Operations, Public Release of Clinical Information
Health Canada, Canada
Industry Experience of Health Canada Submission: Julie G. Holtzople
Senior Director Clinical Transparency and Data Sharing
AstraZeneca, United States
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