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Session 2: EU Clinical Trials Information System (CTIS)
Session Chair(s)
Scott Feiner
Senior Manager, Trial Disclosure
AbbVie, United States
The implementation of the revised transparency rules on June 18th 2024 removed all deferrals in CTIS, immediately making public thousands of clinical trials, but limited to structured data only. Beginning June 18th 2024, applications submitted in CTIS lead to publication of study documents, but with different publication rules for historical and non-historical trials. This session brings together sponsor experiences navigating these challenges with experts on the operational details of CTIS for discussions on best practices under the new transparency rules.
Learning Objective : - Explain how CTIS will disclose documents for historical trials and non-historical trials
- Recognize how the same action in CTIS can produce different publication behaviors
- Develop best practices for sponsors to plan SM, NSMs and AMSC applications with transparency considerations in mind
- Understand how operational details in CTIS impact public disclosure for both applications and summary results
Speaker(s)
Speaker
Christopher Pfitzer, MA
Biogen, United States
Head of Clinical Trial Transparency Strategy
Speaker
Ruediger Pankow, DrSc
Independent Consultant, Germany
Clinical Trial Regulatory Consultant | CTIS SME
End-to-End Experience with EU CTR 536/2014 Transparency Requirements
Stuart Donald, PhD
Krystelis Ltd., United Kingdom
Co-CEO
Speaker
Representative Invited
European Medicines Agency, Netherlands