RSNN Expert Meeting Report - Regulatory Readiness Levels

16 December 2021
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The RSNN expert meeting on the topic of ‘Regulatory Readiness Levels as a tool to drive regulatory innovation’ took place on 29 June 2021. Eighteen experts affiliated to academia, industry, and government bodies were invited to discuss the topic. The full report of the meeting is now available.

The motive for the meeting was triggered during the RSNN-EMA workshop in November 2020, when the problem was highlighted that a significant delay exists between the high pace of regulatory innovations and their implementation in the regulatory framework. Regulatory authorities have the complex task to ensure protection of public health while facilitating access to the best possible healthcare interventions in a timely and affordable manner. This necessitates an adaptive regulatory framework that is ‘ready’ to incorporate innovations in medicinal product development as well as the regulatory science methods to assess these products.

Research questions discussed during the meeting were:

  • Can a concept tool to assess the ‘readiness’ of novel regulatory methodology help to establish (early) multi-disciplinary interaction?
  • If so, could this concept be based on the existing TRL-system?
  • What are the similarities and differences in the implementation process between technological and regulatory innovation?

The results and conclusions of the expert meeting can be found in the full meeting report linked below:

Expert Meeting Report Regulatory Readiness (English, PDF file)
Expert Meeting Report Regulatory Readiness (Nederlands, PDF file)