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Global Clinical Trial Disclosure and Data Transparency Conference

Learn about the latest requirements in clinical trial disclosure and data transparency, share best practices, and engage in in-depth discussions on hot topics.


Session 3: EU CTIS and Organizational Readiness

Session Chair(s)

Kelly  Coulbourne, MS

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

Speaker(s)

Scott  Feiner

Speaker

Scott Feiner

  • Senior Project Manager, Disclosure
  • AbbVie, United States
Ruediger  Pankow, DrSc

Speaker

Ruediger Pankow, DrSc

  • Principal Consultant, Regulatory Affairs
  • Parexel International, Germany
Tabassum "Tab" Y. Hoda

Speaker

Tabassum "Tab" Y. Hoda

  • Senior Manager, Clinical Trials Disclosure
  • Amgen, United States