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Session 7: Panel Discussion: Challenges and Complexities of Submitting CSR’s via CTIS in EU, Policy 0070 in EU and Results Reporting via CTIS and the PRCI (Canada)
Session Chair(s)
Merete Joergensen, MBA, MSc
Clinical Disclosure and Transparency Expert
Merete-J Consulting, Denmark
In continuation of the Session on Results Reporting via CTIS (EU), Policy 0070 (EU) and PRCI (Canada) this Session aims to provide further information on the visions for future collaboration, and mutual collaboration for ensuring harmonized documents being made available. The panel discussion with central representatives from Regulators in EU and Canada, from sponsor organizations and CROs aims to give ample opportunities for asking questions.
Learning Objective : - Recognize the value and opportunities in visions for increased collaboration and mutual recognition of same documents for disclosure via different platforms
- Express your views on opportunities and challenges in relation to the current experience with the Policy 0070 and the PRCI
- Ask your questions and obtain clarification from Regulators and Sponsor organizations
Speaker(s)
Writing Clinical Study Reports Meeting CTIS, Policy 0070 and the PRCI Requirements
Laura Dodd, MSc
Instem, United States
Director, Clinical Trial Transparency
Panelist
Representative Invited
Health Canada, Canada
Panelist
Francesca Scotti
European Medicines Agency, Netherlands
CTIS Transparency Lead
Panelist
Honz Slipka, MSc
Certara, Canada
Senior Transparency Specialist
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