On-demand Webinar: How to transition existing trials under EU-CTR

Virtual

December 1, 2022

Virtual |

On January 31st, 2022, the way interventional clinical trials are conducted in the European Economic Area (EEA) underwent a major change through the European Union (EU) Clinical Trial Regulation 534/2014 (EU-CTR). However, many sponsors are not yet aware that the option to start a new clinical trial under the EU Clinical Trial Directive 2001/20/EC (EU-CTD) rules is only permitted until January 30th, 2023. Additionally, if you want to add further EEA countries after January 30th, 2023 to an ongoing trial conducted under the EU-CTD, this trial will need to be transitioned to the EU-CTR first. The transition of a clinical trial from the EU-CTD to the EU-CTR may require a substantial amendment under the EU-CTD prior to transitioning to EU-CTR, with a total transition timeline of up to 6 months.

Parexel have transformed their operations in line with the EU-CTR and are successfully supporting clients for submissions of clinical trials under the new regulation. In this webinar, Parexel regulatory and clinical experts share:

  • Lessons learned from first-hand EU-CTR submission and authorization experiences
  • Top tips for transitioning ongoing trials from EU-CTD to EU-CTR

Moderator: Bettina Goldberg, Head Clinical Regulatory Services (CTRS), Parexel

Speakers:
Ilona Salacanin, Executive Director, SSU Region Head – EMEA, Parexel
Ruediger Pankow, Principal Consultant, Parexel
Delphine Briclet, Senior Project Leader, Parexel

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