EU-CTR: Preparing for trial transition

The EU Clinical Trial Regulation 536/2014 became mandatory for all new interventional clinical trials phase I-V early this year, meaning the need to work under new rules driven by the aim of harmonization across the EEA, electronic submission, digitalization of clinical trials management and new rules applying transparency. As a result, there are changes and adaptations to conduct trials in the EU. 

Join Parexel’s regulatory experts in this webinar-on-demand, as they share Parexel’s experience of different aspects of working under the EU environment for clinical trials, analyze the impact of the new requirements, and describe learnings gained since the EU-CTR implementation.

Specific focus areas include:

  • Timelines and procedures 
  • Readiness check and impact of the transition of trials
  • Planning and resourcing
  • Lessons learned on transitions
     

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