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Virtual

Oct 17, 2024 1:30 PM - Oct 17, 2024 5:30 PM

(Central Europe Standard Time)

EMA Clinical Trial Information System (CTIS) Information Day

Focus of this event will be on the follow up steps transitioned clinical trials and the revised transparency rules. From 31 January 2025 onwards, in only a few months time, the transition period is over and sponsors will need to comply with their obligations under the CTR and its Delegated Acts for all clinical trials conducted in the EU/EEA. On 18 June 2024, the revised transparency rules for the Clinical Trials Information System (CTIS) will become applicable, with the launch of a new version of the CTIS public portal.

Overview

Since 31 January 2023, it has been mandatory for sponsors to submit all initial clinical trial applications via CTIS. In less than 7 months, from 31 January 2025 onwards, sponsors will need to comply with their obligations under the CTR and its Delegated Acts for all clinical trials conducted in the EU/EEA.

The virtual event aims to support sponsors of clinical trials in proceeding with the transition to meet the deadline of 31 January 2025. Speakers will share detailed metrics on transitioned clinical trials. In addition, comprehensive guidance and practical examples regarding the subsequent steps in transitioning trials will be presented.

Furthermore, the revised transparency rules for the Clinical Trials Information System (CTIS) will become applicable on 18 June 2024, with the launch of a new version of the CTIS public portal. During the event representatives from EMA will provide an overview of the revised transparency rules as well as a demonstration of the new functionalities of CTIS new public portal

Ample time is foreseen for Q&A. The faculty invites participants to submit related questions by 08 October latest. Submit your questions to emaevents@diaglobal.org.

Featured topics

  • Transition period from the Clinical Trials Directive (2001/20/EC) to the Clinical Trial Regulation – regulatory and practical aspects
  • Overview of the revised transparency rules
  • Demonstration of the new functionalities of CTIS new public portal

Who should attend?

This EMA CTIS Virtual Information Day is aimed at CTIS users from:

  • Pharmaceutical companies
  • Small and medium sized enterprises (SMEs)
  • Academic organisations
  • Contract Research Organisations (CROs)
  • Member State NCAs
  • Ethics Committee Members

Program Committee

  • Ana  Zanoletty Perez
    Ana Zanoletty Perez Head of Clinical Trials Transformation Workstream
    European Medicines Agency, Netherlands
  • Francesca  Scotti
    Francesca Scotti CTIS Transparency Lead
    European Medicines Agency, Netherlands
  • Marianne  Lunzer, DrMed
    Marianne Lunzer, DrMed Assessor, Dept of Clinical Trials, Federal Office for Safety in Health Care
    AGES, Austria
  • Peter Richard Arlett, MD, FFPM, FRCP
    Peter Richard Arlett, MD, FFPM, FRCP Head Data Analytics and Methods Task Force
    European Medicines Agency, Netherlands
  • Scott  Feiner
    Scott Feiner Senior Manager, Trial Disclosure
    AbbVie, United States

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