戻る Agenda
Session 3: EU CTIS and Organizational Readiness
Session Chair(s)
Kelly Coulbourne, MS
Director, Clinical Trial Transparency and Disclosure
Pfizer Inc, 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)
Speaker
Scott Feiner
AbbVie, United States
Senior Manager, Trial Disclosure
Speaker
Ruediger Pankow, DRSC
Independent Consultant, Germany
Clinical Trial Regulatory Consultant | CTIS SME
Speaker
Tabassum "Tab" Y. Hoda
Amgen, United States
Senior Manager, Clinical Trials Disclosure