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Ask the Experts: EU-CTR – How to tackle the Requests for Information (RFIs) Challenge?

Post thumbnail Ask the Experts: EU-CTR – How to tackle the Requests for Information (RFIs) Challenge?

The EU CTR (Clinical Trials Regulation) no. 536/2014 became effective on 31 January 2022. Among all the challenges, Sponsors often foresee the challenge of RFIs as being a worrisome topic.

Our experience has shown that indeed, for CTAs submitted under the EU CTR, the coordinated assessment of Part I can lead to a cumulated hundred of RFIs. Nonetheless, RFIs shall be addressed within a maximum of 12 calendar days, in parallel of which participating member states may raise Part II RFIs.

From both operational and organizational perspectives, this critical period requires anticipation and a thorough preparation, especially considering that most of the time, important core documents (protocol, IB, IMPD, etc.) have to be updated to satisfyingly address the RFIs.

Our experts have practical experience of Response to RFIs gained over the past year and will attempt to answer your questions on this topic. We will also share some practical tips and advice on how to best prepare for making this process as smooth as possible, including the following parts:

  • What is an RFI?
  • What types of Request for Information are there?
  • What can CTA-RFIs cover?
  • When can RFIs be raised during the CTA Review?
  • How much time do sponsors have to respond to a CTA RFI?
  • What are the consequences of not responding to CTA RFIs?

Download: Answers to the key questions

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    Featured Speakers

    Gaëlle Preiss, Pharm.D.
    Director, Clinical Research
    Gaëlle has over 15 years of experience in Regulatory Science in the biopharmaceutical industry and in consulting for various types…
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    Jannette Hernandez thumbnail
    Jannette Hernandez
    Senior Regulatory Scientist, Clinical Operations
    Jannette has extensive hands-on experience in obtaining and maintaining clinical trial authorizations, as well as other permits pertaining to the conduct of clinical trials, such as import and export licenses for investigational product, ancillary supplies and biological samples. Since the date that EU CTR became effective, Jannette has been actively involved in serveral projects with regards to this topic.