Tuesday, 28 June 2016

Draft definitions of regulatory intelligence

Defining Regulatory Intelligence

I have been attempting to come up with a succinct definition of regulatory intelligence and so far have two variants, for which I would greatly appreciate your feedback, either as a comment to this article or as an e-mail.

  1. Regulatory intelligence is the process of deriving regulatory strategy from the interpretation of multiple sources of scientific and regulatory knowledge.
  2. Regulatory intelligence is the process of interpreting and applying scientific and regulatory knowledge to produce regulatory strategy.

This article is an attempt to define RI in a more accurate and concise way than has been achieved to date and takes into account my previous articles on this blog on the subject.


Key word definitions

In order to appreciate what is encapsulated in the above draft definitions, I have provided references to definitions of key words contained in these, which you may find helpful.

3 comments:

  1. Dear Tim,

    It's an interesting topic and good definitions even if other groups has already worked on this topic and defined regulatory intelligence as:
    - The act of gathering and analyzing publicly available regulatory information. This includes communicating the implications of that information, and monitoring the current regulatory environment for opportunities to shape future regulations, guidance, policy, and legislation: DIA RING
    - Regulatory intelligence is the act of processing targeted information and data from multiple sources, analyzing the data in its relevant context and generating a meaningful output – e.g. outlining risks and opportunities – to the regulatory strategy. The process is driven by business needs and linked to decisions and actions. EU RING
    To my experience, to most suitable definition is the EU RING's.
    So in this way, your 1st definition is the good one because the second one lets supposed that the target of regulatory intelligence is to produce a strategy which is not the case, it's to create and manage knowledge to communicate and support stakelholders to developp their regulatory (compliance) strategy. Which is, to my opinion more translated into "deriving regulatory strategy from the interpretation of multiple sources of scientific and regulatory knowledge."

    Franck Deschamps
    International Product Compliance Manager
    Wilo S.E.

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    Replies
    1. Dear Franck,

      I really appreciate you taking the time to provide your feedback.

      Regarding the point you make about what regulatory strategy produces (the output), I really do believe it is regulatory strategy and not just an information stream (albeit a digested one). I have made a number of presentations on the subject and there appears to be consensus among the experts present that strategy is indeed the main deliverable of regulatory intelligence. Indeed, I made this point in a previous article and it was met with agreement among colleagues. I would be most interested to hear why you think that "is not the case".

      Regarding the definitions which emerged from the two RING groups, I highlighted where the DIA one falls short in my article.

      I would be most interested to hear further thoughts on this subject.

      Best regards,

      Tim Felgate
      Regulatory Intelligence Consultant

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  2. Dear Tim,

    Thank you for your feedback. I fully agree with your answer so I think our differences are more a problem of wording than of meaning.
    My understanding is that to deploy a compliance management system, you need to define (once having fully comprehended the context in which you work) a regulatory (compliance) strategy. To deploy this strategy, you need the inputs of the regulatory intelligence activities (identification and assessment of regulatory obligations) and the related analytics (predictive modeling) to plan to adress obligations & risks (and I think this action plan is maybe what you call strategy).
    But once again it can also be a difference due to the field of interest.

    Franck Deschamps
    International Product Compliance Manager
    Wilo S.E.

    ReplyDelete

If you have any comments or questions please let me know.