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Virtual Event

2024年4月12日 (金) 午後 1:00 - 2024年4月12日 (金) 午後 5:30

(Central Europe Standard Time)

4051 Basel, Switzerland

Transitioning Clinical Trials from Directive 2001/20/EC to Regulation (EU) 536/2014 via CTIS

TO MEET THE TIMELINE FOR PROCESSING THE APPLICATION, THE TRANSITION APPLICATION MUST BE SUBMITTED TO THE CTIS PORTAL BY 16 OCTOBER 2024! THIS IS YOUR LAST CHANCE to attend this live virtual training course and enhance your knowledge in managing transition applications in CTIS in all theoretical as well as practical aspects.

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Send Email +41 61 225 51 51

概要

The transition period for the EU Regulation on clinical trials on medicinal products for human use is ending on 30 January 2025.

TO MEET THE TIMELINE FOR PROCESSING THE APPLICATION, THE TRANSITION APPLICATION MUST BE SUBMITTED TO THE CTIS PORTAL BY 16 OCTOBER 2024.

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.

特集トピック

    • 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

    参加対象

    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.

    学習目的

    • 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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