Menu Back toSession 3: EU CTIS and Organizational Readiness
Don't Miss Out!
Get your weekly Breakfast Briefing eNewsletter, filled with news, trends, and vital information from DIA!
Global Clinical Trial Disclosure and Data Transparency Conference
Session 3: EU CTIS and Organizational Readiness
Kelly Coulbourne, MS
- Director, Clinical Trial Disclosure and Data Transparency
- Arena Pharmaceuticals, United States
In January 2022, the EU Clinical Trial Regulation 536/2014 will come into effect when the EU Clinical Trial Information System (CTIS) goes live. The CTIS “will be the single-entry point for submitting clinical trial information in the EU” and clinical documents submitted to the CTIS will be made public per the EMA’s transparency rules. In this session, hear about experiences with the EMA’s Master Trainer Program, understand how organizations are preparing for go-live, and managing the challenges of the differences in disclosure obligations between the US and the EU and its member states.
Learning Objective : At the conclusion of this session, participants should be able to:
- Differentiate how organizations of various sizes are preparing for go-live of the EU CTIS
- Evaluate the EMA Master Trainer Program
- Discuss the differences between the EU and the US approaches to disclosure of trial information
- Senior Project Manager, Disclosure
- AbbVie, United States
Ruediger Pankow, DrSc
- Principal Consultant, Regulatory Affairs
- Parexel International, Germany
Tabassum "Tab" Y. Hoda
- Senior Manager, Clinical Trials Disclosure
- Amgen, United States
Global Clinical Trial Disclosure and Data Transparency Conference Resource Kit