Updates on the Implementation of Clinical Trials Data Sharing

Join Health Canada’s Marcin Boruk, SME Hazel Nicholls and Dr. Khaled El Emam as they explore industry updates around clinical trials data sharing and their implementation.

Starting from October 2016, the European Medicines Agency has been publishing clinical reports from procedures with CHMP decisions. At the same time, Health Canada has published their intent to implement a regulation for the sharing of clinical trials data from submissions with decisions. These are just two examples of recent developments in clinical trials data sharing.

In this webinar, Marcin Boruk, Hazel Nicholls and Khaled El Emam will provide an overview of recent developments in Policy 0070 implementation, lessons learned thus far about the clinical reports that have been shared, and experiences gained with risk-based anonymization methods when applied to Policy 0070 submissions. Additionally, they will give a review of the new Health Canada whitepaper on clinical trials data sharing.

For the review of EMA Policy 0070 submissions, the results from the following analysis will also be reviewed and discussed during the webinar: https://t.co/IgWAWsL45O

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