Joint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications

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TitleJoint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications
Date23/11/2017 - 23/11/2017
LocationEuropean Medicines Agency, London, UK
SummaryThe term ‘prior knowledge’ can refer to both a company’s proprietary knowledge of formulation and manufacturing development of medicinal products and external knowledge from published scientific literature. The use of such prior knowledge to support the development of product formulations, manufacturing processes and control strategies, could be justifiable in certain circumstances. Through a combination of presentations, industry case studies and panel discussions, this joint workshop with regulators and the pharmaceutical industry aims to reach an agreed understanding on what is (and isn’t) considered to be prior knowledge, how can such prior knowledge be used in regulatory submissions, how to justify its use and how to present it in the dossier. EMA will publish a report with conclusions from the workshop. It may also consider further follow-up guidance.

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Live broadcast

  • 23 November 2017
    9:00 - 17:00 UK time

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Registration

  • Registration by invitation only

Video recording

A video recording will be made available after the event