This Q&A document highlights some of the key points to consider for the successful qualification of digital technology-based methodologies intended to support approval of medicinal products.
The principal focus of the document is to support Qualification of methodologies based on digital technologies in the context of medicinal product development. It may also be of assistance to applicants in the preparation for other types of EMA procedures and interactions, such as Innovation Task Force (ITF) meetings, scientific advice briefing books drafting, and preparation of Marketing Authorisation Applications (MAAs).
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