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    The ultimate terminology guide for the medical, legal, regulatory review process

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    Within every vertical, there is a set of vocabulary, lexicon, and jargon unique to an industry, and life sciences is no exception. When it comes to regulated content review, the lingo is extensive and always changing. For instance, some organizations may refer to the process as ad/promo review, promotional review, or something else entirely. For someone entering the space, variations like this can cause confusion.

    As an organization, we’ve participated in and developed software for the promotional review process for over a decade, so we’ve seen the full range of vocabulary used to describe this process. Using our knowledge, we have assembled the “ultimate” guide of terms to help everyone throughout your pharmaceutical, medical device, biotechnology, or diagnostics company stay on the same page. If you’re onboarding new staff, collaborating with new agencies, or just looking for a quick refresher, keep this resource on hand for a quick run-through of how everyone, everywhere talks about MLR review. 

     
     
    The Ultimate Terminology Guide For The Medical, Legal, Regulatory Review Process
     
     
    Term: Promotional Review

    What does it mean? Promotional review is an essential process within life sciences to ensure the release of high-quality, well-documented promotional, educational, and informational material that presents the products in a fair, balanced, and ethical manner.

    What else do you need to know? Promotional review, which is also sometimes called “promotional material review,” is a widely used umbrella term. In life sciences, customers depend on brands for the sake of their health. So truth, accuracy, compliance, and clarity are paramount for all advertising and promotional content. This is why all regulated content can benefit from a well-structured promotional review process. While the attention to detail required from numerous parties may make promotional review sound complicated, software solutions can help digitally transform your process. 

    Term: MLR

    What does it mean? MLR stands for “Medical, Legal, Regulatory.” It is an acronym/term to describe the promotional review process. Often, this acronym is used with the word “review” to describe the promotional review process: “MLR review.” MLR describes the primary groups involved in the review process, though not all.

    Why are there so many acronyms similar to this? You’ll hear slightly different versions of “MLR” because different iterations of the process sometimes result in different names. Some companies transpose the letters to reflect a different workflow order, calling it “MRL.” Others explicitly fold Marketing teams into the acronym and call it “MMLR review” (Marketing, Medical, Legal, Regulatory). Keep in mind, though, that if you’re partnering with (or working at) a device or diagnostics company, this is probably not an acronym that you’ll hear often. 

    Term: Ad/Promo

    What does it mean? Shorthand for “advertising and promotional.” This term can be used to describe both the type of content that is routed through promotional review and the review process itself.

    Where will you use it? Advertising and promotion are the name of the game when you’re getting the message out about your product, so you’ll find yourself using this term everywhere. It can distinguish what you’re working on from different types of regulated content. 

    Term: PRC

    What does it mean? The committee or group of individuals at life science companies that participate in the promotional review process.

    How do you use it? When you have a draft under promotional review, you can say it is with your promotional review committee, or PRC. Even teams that are adjacent to the review process should know this term to understand where they are with respect to the workflow. For instance, the sales team will want to know if content is waiting with the PRC for sign off.

    Term: Medical Information Review

    Definition: A content review process focused solely on medical information. The medical information review process can be a part of the larger promotional review process, depending on the piece of content.

    Why does this need its own term? Life science companies need to ensure that the medical statements they are making within their promotional content are accurate and backed up with the appropriate claim. Therefore, companies often have an extra step in their review process for medical experts to ensure content compliance. Separately, some content that is completely focused on medical information–like presentations to HCPs that include clinical data–need to go through a dedicated medical information review process. It is beneficial if companies invest in software that can support both promotional and medical information content reviews. “Medinfo” and “medsci” are other terms used to describe medical information review. 

    Term: Regulated Content Review

    Definition: A term used to describe any review process of regulated–including but not limited to advertising or promotional content.

    Why does this need its own term? This is a more general term that is all encompassing of the various types of regulated content the life sciences industry creates and publishes. Documenting the types of content that need to go through a dedicated review process should be captured in a publicly accessible document, such as an SOP. 

     
     

    At Vodori, we make it easy for life science companies to move fast–because healthcare can’t wait. We empower companies to move quickly with cloud software that is innovative, life-science focused, and delivered with an exceptional customer experience.

    Jessy Horrell

    Jessy is VP, Customer Success at Vodori. She is accountable for ensuring success across all Pepper Cloud customers including onboarding and professional services, customer success, and customer support.

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