Reducing Regulatory Approval Time Via Smart Use of Language and Effective Registration Tracking

    With globalization on the increase, language is a vital component in life sciences, particularly in regulatory work. Connie Dominguez, founder of Regulatory Language Matters, explains the importance of clear and concise communication.

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    With globalization on the increase, language is a vital component in Life Sciences, particularly in regulatory work.  Connie Dominguez, founder of Regulatory Language Matters, explains the importance of clear and concise communication.

    If a main goal for a regulatory team is to reduce the time of overall process, from first request to final Ministry approval, then anything that can help with that is to be encouraged. It’s my belief that positive language and communication can play a significant role.

    That clear and effective communication is important in life, business, and beyond is a given. Yet a good many life sciences organizations do not always adhere to that principle, and ineffective use of language can play a large role in actually slowing down the regulatory approvals process.

    Whether it’s the language used by staff at a Life Sciences firm’s HQ or the tone and accuracy within dossiers or applications, clear communication is key. When you also factor in the importance of tracking registrations, it is apparent that there are many ways in which the approvals process can be slowed down.

    It’s a subject very close to me, and one that I intend to cover in greater depth at AMPLEXOR’s upcoming BE THE EXPERT 2018 conference in early June.

    Setting the tone for a smooth approvals process

    The language, including tone and vocabulary, used by an organization’s HQ or design center - often where a dossier originates from - can really set the mood for all subsequent communication. For example, imagine that someone requests a stability data report and is told ‘no, that won’t be ready until July’.

    There is immediately a negative tone to the exchange, which could easily affect future correspondence. This could readily be avoided by different use of language, such as ‘we are working hard on that, and it is scheduled to be available in July’. It’s just a different spin on the same response, but a more positive approach can set the tone for the on-going communication, making it more efficient.

    That approach also applies to the way documents themselves are written, those that are included in the dossier or application. Poor writing in documents mires the process down, and the importance of developing trust, whether that’s with employees, dealers, or ministry representatives, is vital.

    That’s not to say that I underestimate the inherent challenges in getting language right. For example, translations are complex and difficult, especially with the technical documents most common in life sciences.

    Better dossiers and registration tracking             

    Registration tracking is essentially what one wants to look for in order to report to management, so they have a strong basis for short and long-term planning with particular regard to R&D projects. For any organization it is vital to know what it can sell, where, and when.

    Yet a remarkable number of companies are unable to answer these simple questions, sometimes start-ups but larger firms too. The answer lies in the right tracking system – this will enable the answering of these fundamental questions that every company really should know.

    Knowing what pieces of information need to be tracked and how finely they need to be parsed can also help with self-regulation and reducing the approvals timeframe from an internal perspective. So for management this is a big deal, and regulatory teams can play a significant role in providing this.  

    As someone that has worked in global regulatory affairs and languages and translation, I know only too well what a difference strong and positive communication can have. So I am delighted to be coming to Croatia in June as part of AMPLEXOR’s BE THE EXPERT 2018 event, to discuss in more detail how language in life sciences, along with better registration tracking, can make an impact on reducing approval times and improving regulatory affairs.

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    Published on 07/05/18    Last updated on 07/05/18

    #Translation, #regulatory affairs

    About the author

    Connie Dominguez is the owner and founder Regulatory Language Matters and has more than 35 years’ experience in Global Regulatory Affairs leadership positions – registering products in pharmaceuticals, nutritionals, medical devices, and OTC products. Her abiding passion has been to reduce regulatory approval time and speed product to market for patients.

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