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    Should MLR review teams include regulatory in marketing concept reviews?

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    For many MLR review teams, optimizing collaboration during promotional review can be a challenge. Part of this challenge stems from each review team’s unique goals and what they’re trying to accomplish:

    • Marketing teams want to move fast so they can get new content to market or test new marketing channels or tactics
    • Regulatory teams want to ensure content is compliant, claims are accurately substantiated, and the company is protected should there be an audit

    In our experience working with life science companies, we found that one way to improve collaboration between regulatory and marketing during promotional review is to involve regulatory earlier in the review process. Specifically, involving regulatory teams in marketing concept review (or pre-approval) has several benefits–let’s break them down.

    Benefit #1: Marketing and agency rework is reduced

    When you include regulatory team members in marketing concept reviews, any issues or red flags can be addressed and resolved early. Teams can talk through feedback, establish consensus, and agree on a path to move forward that allows everyone to meet their goals. Not only will your process run smoother, but you’ll also dramatically reduce rework for marketing teams later on because everyone is on the same page before the content gets to a final state.

    Working with an agency? Treat concept reviews as the first step of your review process and loop all review teams in–including regulatory. Give everyone a chance to provide feedback and open up dialogue. Document feedback and identify next steps for your agency partners. This will reduce rework from your agency partners, thus also reducing agency fees.

    Concept review benefits

    Benefit #2: MLR reviews will be faster once content is final

    Involving regulatory during concept reviews not only reduces rework, but it also makes reviews faster once the content is final. When your content is submitted for promotional review, your regulatory team members will already be familiar with the content and have had their questions addressed. Therefore, they can focus their final reviews on content compliance–such as claims substantiation and verbiage usage–and process compliance.

    Benefit #3: Everyone has more opportunity to practice giving and receiving feedback

    Teams need to constantly work on improving collaboration–it’s a continuous exercise. Opening up dialogue and getting feedback early during concept review is beneficial for collaboration because:

    • Regulatory teams can get more comfortable with concept review and what feedback is most helpful in this early stage of content development;
    • All teams feel heard and that their opinions are valued; and
    • Any initial feedback can be discussed and debated, either through your promotional review system or a meeting.

    The long and short of it? Collaboration looks different for every team and every organization.

    Try involving your regulatory teams during concept review and open up a dialogue around what works and what doesn’t. Over time, you will learn which strategies are most helpful in achieving your goals and getting your critical content to market faster.

    Annalise Ludtke

    Senior Manager, Marketing Communications at Vodori

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