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Nov 18, 2021 1:45 PM - Nov 18, 2021 6:00 PM

(Central Europe Standard Time)

Pre-conference Workshop: CTIS: What You Need to be Prepared For Disclosure Considerations



A detailed description of the CTIS environment. While issues related to the Clinical Trial Regulation will be addressed, the focus of this workshop is the working environment for sponsor users and administrators of CTIS, with heavy emphasis on understanding the public disclosure aspects of information submitted to CTIS.


- Individuals who plan to use CTIS daily or administer CTIS users

- Organizations without a representative in the EMA CTIS Sponsor Master Trainer Programme

- Strongly recommend attendees have a familiarity with Regulation EU 536/2014 and the EMA’s CTIS Sponsor Handbook


- Understanding the transparency impacts of CTIS, including sponsor obligations under GDPR

- Best practices for interacting with CTIS, tailored to your organization structure

- Understand how CTIS interacts with other EMA systems (e.g IAM, OMS, xEVMPD, SPOR)

- What can be done today to prepare your organization for CTIS;

- How your internal organization structure impacts work within CTIS (workload)

- Understand how to best utilize existing EMA CTIS training materials.

Workshop Agenda:

13:45 Participants Log-In and Connect

14:00 Intro to CTIS and Best Practices  
Scott Feiner, Clinical Trial Disclosure Specialist, AbbVie, USA

14:45  Break 

15:00 Disclosure Best Practices in CTIS: Disclosure, Redactions, Deferrals 

Scott Feiner, Clinical Trial Disclosure Specialist, AbbVie, USA
 16:15 Break

 16:30 How Does CTIS interact with other Systems? IAM, OMS, xEVMPD

Scott Feiner, Clinical Trial Disclosure Specialist, AbbVie, USA

 17:30 Q & A or Round Table Discussion

 18:00 End of Pre-conference Workshop

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