Overview

The live virtual training course aims to enhance knowledge in managing transition applications in CTIS.

Legal basis, regulatory and operational aspects of transitions will be explained. Practical case studies to manage the transition in CTIS will be demonstrated.

Participants will have the opportunity to ask questions in order to gain a comprehensive understanding of the CTIS transition activities required for compliance.

Featured topics

- Clinical trials in scope for transition
- Documentation requirements
- Sources of references and guidance
- Timing of transition and planning considerations
- Consolidating versus harmonizing dossier components
- Product cross-reference and “IMPD-Q only” application concept
- Master EMA database pre-conditions (IAM, OMS, XEVMPD)
- Expected process (timelines, RFI/responses, substantial modification to complete transition dossier)
- Initial transition application
- Subsequent Substantial Modification (SM)
- IMPD-Q only application scheme

Who should attend?

This training course is intended for knowledgeable sponsor workspace users (commercial sponsors, academia, CROs), including SMEs wishing to enhance knowledge how to transition ongoing clinical trials authorized under the CT Directive to the EU CT Regulation via CTIS.

Learning objectives

At the conclusion of this virtual live training course, participants will be able to:
- Recognise the legal and regulatory aspects for transition
- Develop a robust transition implementation strategy
- Identify the transition application dossier components
- Deploy the CTIS transition activities required for compliance

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