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Business & Regulation Standards & Regulation, Small Molecules

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The EMA has launched an online scientific advice tool – IRIS – to give scientists easy access to guidelines on data integrity and regulatory procedures. Once registered on the platform, developers can access information related to orphan designations and parallel distribution, as well as search for Research Product Identifiers for new medicinal products. The EMA also encourages researchers to use the platform to apply for briefing meetings with its Innovation Task Force – a multidisciplinary group that offers scientific, regulatory, and legal advice.

The platform is a key part of the agency’s “digital transformation process” and, though only launched in October 2020, plans for IRIS’ expansion have already been made. The platform will be updated to cover a wider range of regulatory and scientific procedures. In the meantime, the regulatory body wants scientists to get to grips with the new tool and has published procedural guidelines to support its use.

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Maryam Mahdi

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After finishing my degree, I envisioned a career in science communications. However, life took an unexpected turn and I ended up teaching abroad. Though the experience was amazing and I learned a great deal from it, I jumped at the opportunity to work for Texere. I'm excited to see where this new journey takes me!

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