Joint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications
The 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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Agenda - Joint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications (PDF/91.11 KB)
First published: 28/07/2017
Last updated: 22/11/2017
EMA/CHMP/BWP/149179/2017 -
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Meeting report - Joint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications (PDF/174.36 KB)
First published: 04/04/2018
Last updated: 04/04/2018
EMA/CHMP/BWP/187162/2018 -
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Organising committee - Joint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications (PDF/113.32 KB)
First published: 28/07/2017
Last updated: 22/11/2017
EMA/466502/2017 -
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List of participants - Joint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications (PDF/87.06 KB)
First published: 01/12/2017
Last updated: 01/12/2017 -
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Presentation - Welcome, introduction and goals of the workshop - Joint BWP/QWP workshop with stakeholders in relation to prior knowledge and its use in regulatory applications (V Jekerle/B Dooley) (PDF/210.93 KB)
First published: 01/12/2017
Last updated: 01/12/2017 -
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Presentation - Regulators perspective: using prior knowledge in applications - Session 1 (Mats Welin) (PDF/367.83 KB)
First published: 01/12/2017
Last updated: 01/12/2017 -
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Presentation - General considerations from industry - Session 1 (Markus Goese) (PDF/940.8 KB)
First published: 01/12/2017
Last updated: 01/12/2017 -
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Presentation - Regulators perspective - Session 2 (Keith Pugh) (PDF/631.63 KB)
First published: 01/12/2017
Last updated: 01/12/2017 -
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Presentation - General considerations from industry- Session 2 (Keith Watson) (PDF/922.4 KB)
First published: 01/12/2017
Last updated: 01/12/2017 -
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Presentation - Case study 1- First-in-man (FIM) to commercial for a lyophilised (NBE) product - Session 2 (Michael Siedler) (PDF/4.44 MB)
First published: 01/12/2017
Last updated: 01/12/2017 -
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Presentation - Case study 2 - Development of a lower dose paediatric strength IR tablet - Session 2 (Matt Popkin) (PDF/467.83 KB)
First published: 01/12/2017
Last updated: 01/12/2017 -
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Presentation - Case study 3 - Use of platform technologies for adenovirus-vectored vaccines - Session 2 (Mark van Ooij) (PDF/606.16 KB)
First published: 01/12/2017
Last updated: 01/12/2017 -
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Presentation - The regulator’s perspective - Session 3 (Seà¡n Barry) (PDF/602.37 KB)
First published: 01/12/2017
Last updated: 01/12/2017 -
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Presentation - General considerations from industry - Session 3 (Ron Ogilvie) (PDF/435.68 KB)
First published: 01/12/2017
Last updated: 01/12/2017 -
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Presentation - Case study 1 - Application of prior knowledge for process parameter definition - Session 3 (Bob Kuhn) (PDF/714.37 KB)
First published: 01/12/2017
Last updated: 01/12/2017 -
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Presentation - Case study 2 - Validation efficiencies from quality by design (QbD) and prior knowledge - Session 3 (Frank Zettl) (PDF/701 KB)
First published: 01/12/2017
Last updated: 01/12/2017 -
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Presentation - Case study 3 - Prior knowledge to streamline viral safety and resin lifetime studies - Session 3 (Marie Murphy, Paul Talierco, Nancy Cauwenberghs) (PDF/1.16 MB)
First published: 01/12/2017
Last updated: 01/12/2017 -
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Presentation - Case studies and questions and answers - Session 3 (Nancy Cauwenberghs) (PDF/466.56 KB)
First published: 01/12/2017
Last updated: 01/12/2017 -
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Presentation - Regulators' perspective - Session 4 (R. Martijn van der Plas) (PDF/197.62 KB)
First published: 01/12/2017
Last updated: 01/12/2017 -
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Presentation - General considerations from industry - Session 4 (Andrew Lennard) (PDF/544.55 KB)
First published: 01/12/2017
Last updated: 01/12/2017 -
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Presentation - Case study 1- Use of prior knowledge to support specification setting for a multivalent vaccine - Session 4 (Charles Kline) (PDF/433.75 KB)
First published: 01/12/2017
Last updated: 01/12/2017 -
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Presentation - Case study 2 - Oligonucleotide control strategy - Session 4 (Rachel Orr) (PDF/679 KB)
First published: 01/12/2017
Last updated: 01/12/2017 -
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Presentation - Case study 3 - Use of prior knowledge in the control strategy for biotechnology products - Session 4 (Darrin Cowley, Jette Wypych) (PDF/483.63 KB)
First published: 01/12/2017
Last updated: 01/12/2017 -
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Presentation - Case study 4 - Use of prior knowledge for setting acceptance criteria - Session 4 (Thomas Stangler, Koen Nauwelaerts) (PDF/500.69 KB)
First published: 01/12/2017
Last updated: 01/12/2017 -
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Presentation - Regulator’s perspective and experience on prior knowledge and accelerated access - Session 5 (Veronika Jekerle) (PDF/431.18 KB)
First published: 01/12/2017
Last updated: 01/12/2017 -
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Presentation - General considerations for accelerated access schemes (PRIME/adaptive/accelerated pathways) - Session 5 (Ronald Imhoff, Richard Keane) (PDF/605.81 KB)
First published: 01/12/2017
Last updated: 01/12/2017 -
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Presentation - Case study 1 - Atezolizumab: Accelerated development - Session 5 (Andrea Challand) (PDF/398.87 KB)
First published: 01/12/2017
Last updated: 01/12/2017 -
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Presentation - Case study 2 - Avelumab integrated Mab example - Session 5 (Isabelle Colmagne-Poulard) (PDF/2.12 MB)
First published: 01/12/2017
Last updated: 01/12/2017 -
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Presentation - General discussion, summing up and way forward - Session 6 (Brian Dooley) (PDF/289.46 KB)
First published: 01/12/2017
Last updated: 01/12/2017