Overview

Are you losing sleep over the challenges of using the CTIS platform, worrying about potential mistakes that could result in application withdrawals? Join our workshop in November and say goodbye to those anxieties. Learn not only how to save time, but also truly master the CTIS platform.

The pharmaceutical and clinical trials sectors are in the midst of a major transformation, driven by the introduction of a new legal framework. Our workshop is tailored to give you the confidence to effectively navigate the challenges this presents, as well as the opportunity to redefine how we conduct clinical trials.

The workshop will not cover user administration, notifications, annual safety reporting, ad-hoc assessments, corrective measures or results posting.

Featured topics

- Application of dossier sections and dossier components
- Product sections and possible pathways to defining products depending on its role in the clinical trial (IMP, AxMP) and marketing authorization status
- IMPD-Q only clinical trial application concept to support a separate sponsor trial application
- Management of responses to RFIs, withdrawal, or resubmission of an application
- Management of substantial and non-substantial modifications in practice

See the video below for a message from one of the trainers that will help you master the CTIS and pave your path to success:

What you will learn

At the conclusion of this activity, participants should be able to:
- Learn best practices for managing applications in the CTIS, helping to avoid withdrawals or lapses in your clinical trials, and saving valuable time and resources.
- Gain a comprehensive understanding of the application functionalities, allowing you to harness the full potential of this system to streamline your processes.
- Discover the intricacies of document submission, including which documents should be submitted and the main rules governing this process. Ensure compliance and efficiency in your trials.
- Experience hands-on live system demonstrations under the guidance of our experienced trainers. Walk away with practical skills that you can implement immediately.
- Understand the application dossier components
- Know the different alternatives to add and define unauthorized and authorized medicinal product(s) in the application dossier
- Use the procedures of responses to RFIs or withdrawal for applications under evaluation
- Describe the principles for subsequent non-substantial modifications and substantial modification applications for relevant business situations

Who should attend?

Sponsor workspace users (commercial sponsors, academia, CROs,) including SMEs wishing to enhance practical knowledge of the system functionalities.

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