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Session 6: Results Reporting via CTIS and Policy 0070
Session Chair(s)
Merete Joergensen, MBA, MSc
Clinical Disclosure and Transparency Expert
Merete-J Consulting, Denmark
Clinical Study Reports from clinical trials conducted in EU and intended to be part of a MAA might in many cases be subject to the disclosure rules for the requirements from the EU Clinical Trial Regulation requirements, EU Policy 0070, and Health Canada’s Public release of Clinical Information. This session aims at clarifying how these requirements overlap, where they differ, and how they interact. The mutual recognition of submissions between EU and Canada have the benefit of having same documents made public at both places. How are the processes impacted when also the CSR is going to be made public via CTIS, in accordance with the EU Clinical Trials Regulation.
Learning Objective : - Appraise similarities and differences in the 3 different sets of disclosure requirements for the clinical Study Report (EU Clinical Trials Regulation, EU Policy 0070 and Health Canada’s Public release of Clinical Information)
- Organize improved working processes to efficiently meet the different requirements with effective utilization of resources for preparing and anonymizing documents for disclosure
Speaker(s)
Speaker
Francesca Scotti
European Medicines Agency, Netherlands
CTIS Transparency Lead
Speaker
Representative Invited
European Medicines Agency, Netherlands
Examinations of Risk-based Techniques and Related Processes
Representative Invited
Health Canada, Canada
Approach to Clinical Trial Transparency & Disclosure is Changing – EMA’s Policy 0070 is a Large Contributor
Honz Slipka, MSc
Certara, Canada
Senior Transparency Specialist
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