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Session 6: Results Reporting according to EU Clinical Trials Regulation
Session Chair(s)
Merete Joergensen, MBA, MSc
Clinical Disclosure and Transparency Expert
Merete-J Consulting, Denmark
The EU Clinical Trials Regulation defines requirements for submission and disclosure of summaries of results of clinical trials for trials conducted according to the EU Clinical Trials Regulation. For the Clinical Study For trialreports used in a MAA that meet one or more of the three sets of requirements, this double session aims at presenting and clarifying how these requirements overlap, where they differ, and how they interact. The mutual recognition of submissions between EU and Canada has the benefit of having same documents made public at both places. How will the processes be impacted when the CSR is going to be made public via CTIS. Note: Marianne Luzner, Elizabeth Lieu, and Radu Popescu and will be participating virtually
Learning Objective : - Obtain knowledge of the most recent changes in the requirements for clinical trials result summaries disclosure in EU
- Appraise similarities and differences in the three 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)
Speaker(s)
Requirements in CTIS for Results Summaries, Lay Summaries and Interim Results, and CSRs Submissions
Marianne Lunzer, DrMed
AGES, Austria
Assessor, Dept of Clinical Trials, Federal Office for Safety in Health Care
Health Canada’s Public release of clinical Information (PRCI) and collaboration with EMA
Elizabeth Lieu
Health Canada, Canada
Senior Regulatory Affairs Officer
Main Differences between CSR Submission in CTIS and Policy 0070
Representative Invited
European Medicines Agency, Netherlands